<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993250</url>
  </required_header>
  <id_info>
    <org_study_id>CR108264</org_study_id>
    <secondary_id>64294178HPC2003</secondary_id>
    <nct_id>NCT02993250</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive</brief_title>
  <official_title>A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutical K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutical K.K.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the safety and tolerability of a combination&#xD;
      treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese&#xD;
      participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis&#xD;
      and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1&#xD;
      or 2 chronic HCV infection with compensated cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Actual">May 7, 2018</completion_date>
  <primary_completion_date type="Actual">May 7, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)</time_frame>
    <description>An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment</measure>
    <time_frame>Week 4 (follow-up phase)</time_frame>
    <description>SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (&lt;) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment</measure>
    <time_frame>Week 12 (follow-up phase)</time_frame>
    <description>SVR12 was defined as HCV RNA &lt; LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment</measure>
    <time_frame>Week 24 (follow-up phase)</time_frame>
    <description>SVR 24 was defined as HCV RNA &lt; LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Viral Relapse</measure>
    <time_frame>End of treatment up to Week 24 (follow up phase)</time_frame>
    <description>Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA &lt; LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (&gt;=) LLOQ during follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Failure</measure>
    <time_frame>EOT up to Week 12 (follow up phase)</time_frame>
    <description>On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA &gt;= LLOQ (15 IU/mL) at the actual EOT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Virologic Response</measure>
    <time_frame>Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)</time_frame>
    <description>Percentage of participants with On-treatment Virologic Response with HCV RNA &lt; LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Achieve HCV RNA Not Detected or HCV RNA &lt;LLOQ</measure>
    <time_frame>EOT up to Week 24 (follow up phase)</time_frame>
    <description>Time to Achieve HCV RNA not Detected or HCV RNA &lt;LLOQ (15 IU/mL) was reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (Chronic Hepatitis C Without Cirrhosis)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AL-335</intervention_name>
    <description>Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.</description>
    <arm_group_label>Cohort 1 (Chronic Hepatitis C Without Cirrhosis)</arm_group_label>
    <arm_group_label>Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)</arm_group_label>
    <other_name>JNJ-64146212</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Odalasvir (ODV)</intervention_name>
    <description>Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.</description>
    <arm_group_label>Cohort 1 (Chronic Hepatitis C Without Cirrhosis)</arm_group_label>
    <arm_group_label>Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)</arm_group_label>
    <other_name>JNJ-64289901</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simeprevir (SMV)</intervention_name>
    <description>Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.</description>
    <arm_group_label>Cohort 1 (Chronic Hepatitis C Without Cirrhosis)</arm_group_label>
    <arm_group_label>Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)</arm_group_label>
    <other_name>TMC435</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  All participants must have HCV genotype 1 or 2 infection, determined at screening&#xD;
&#xD;
          -  HCV ribonucleic acid (RNA) plasma levels greater than or equal to (&gt;=)10,000&#xD;
             international units per Milliliter (IU/mL), determined at screening&#xD;
&#xD;
          -  Direct-acting antiviral (DAA)-naive participants, defined as not having received&#xD;
             treatment with any approved or investigational DAA drug for chronic HCV infection;&#xD;
             prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or&#xD;
             without ribavirin (RBV) is allowed&#xD;
&#xD;
          -  Participants without cirrhosis or with compensated cirrhosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection with HCV genotype - 3, 4, 5, or 6&#xD;
&#xD;
          -  Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or&#xD;
             hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive)&#xD;
&#xD;
          -  Prior treatment with any investigational or approved HCV DAA, either in combination&#xD;
             with PegIFN or IFN free&#xD;
&#xD;
          -  Any evidence of liver disease of non-HCV etiology. This includes, but is not limited&#xD;
             to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver&#xD;
             disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin&#xD;
             deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is&#xD;
             considered clinically significant by the investigator&#xD;
&#xD;
          -  Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of&#xD;
             the following: history or current clinical evidence of ascites, bleeding varices, or&#xD;
             hepatic encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutical K.K., Japan Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutical K.K.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Amagasaki-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bunkyo-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hiroshima-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kagoshima-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kurume-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Musashino-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagoya-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omura-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sakai-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sapporo-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suita-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>May 3, 2019</results_first_submitted>
  <results_first_submitted_qc>September 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 11, 2019</results_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simeprevir</mesh_term>
    <mesh_term>Odalasvir</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT02993250/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT02993250/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
          <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
          <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
          <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
          <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.3" spread="11.1"/>
                    <measurement group_id="B2" value="54.9" spread="6.76"/>
                    <measurement group_id="B3" value="57.8" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
        <time_frame>Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment</title>
        <description>SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (&lt;) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).</description>
        <time_frame>Week 4 (follow-up phase)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment</title>
          <description>SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (&lt;) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="84.6" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="71.5" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment</title>
        <description>SVR12 was defined as HCV RNA &lt; LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.</description>
        <time_frame>Week 12 (follow-up phase)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment</title>
          <description>SVR12 was defined as HCV RNA &lt; LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="84.6" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="71.5" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment</title>
        <description>SVR 24 was defined as HCV RNA &lt; LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.</description>
        <time_frame>Week 24 (follow-up phase)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment</title>
          <description>SVR 24 was defined as HCV RNA &lt; LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="84.6" upper_limit="100"/>
                    <measurement group_id="O2" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Viral Relapse</title>
        <description>Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA &lt; LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (&gt;=) LLOQ during follow-up.</description>
        <time_frame>End of treatment up to Week 24 (follow up phase)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)] and had at least 1 postbaseline efficacy measurement in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Viral Relapse</title>
          <description>Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA &lt; LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (&gt;=) LLOQ during follow-up.</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)] and had at least 1 postbaseline efficacy measurement in this study.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-treatment Failure</title>
        <description>On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA &gt;= LLOQ (15 IU/mL) at the actual EOT.</description>
        <time_frame>EOT up to Week 12 (follow up phase)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Failure</title>
          <description>On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA &gt;= LLOQ (15 IU/mL) at the actual EOT.</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-treatment Virologic Response</title>
        <description>Percentage of participants with On-treatment Virologic Response with HCV RNA &lt; LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.</description>
        <time_frame>Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Virologic Response</title>
          <description>Percentage of participants with On-treatment Virologic Response with HCV RNA &lt; LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7"/>
                    <measurement group_id="O2" value="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.5"/>
                    <measurement group_id="O2" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 4: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                    <measurement group_id="O2" value="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12: &lt; 15 IU/mL not detected</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Achieve HCV RNA Not Detected or HCV RNA &lt;LLOQ</title>
        <description>Time to Achieve HCV RNA not Detected or HCV RNA &lt;LLOQ (15 IU/mL) was reported.</description>
        <time_frame>EOT up to Week 24 (follow up phase)</time_frame>
        <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
            <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
            <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Achieve HCV RNA Not Detected or HCV RNA &lt;LLOQ</title>
          <description>Time to Achieve HCV RNA not Detected or HCV RNA &lt;LLOQ (15 IU/mL) was reported.</description>
          <population>Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" spread="1.68"/>
                    <measurement group_id="O2" value="18.6" spread="3.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)</time_frame>
      <desc>Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)].</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: Chronic Hepatitis C Without Cirrhosis</title>
          <description>Participants received AL-335 800 milligram (mg) (2*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis</title>
          <description>Participants received AL-335 800 mg (2*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular Block First Degree</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Supraventricular Extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eye Discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Motility Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood Cholesterol Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>As the sponsor decided to discontinue the development of JNJ-64294178, the study enrollment to reach the target number of participants was not completed in Cohort 2.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Leader</name_or_title>
      <organization>Janssen Pharmaceutical K.K., Japan</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993250
org study id: CR108264
secondary id: 64294178HPC2003
nct id: NCT02993250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate the safety and tolerability of a combination
      treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese
      participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis
      and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1
      or 2 chronic HCV infection with compensated cirrhosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Adverse Events (AEs)
time frame: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
description: An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment
time frame: Week 4 (follow-up phase)
description: SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment
time frame: Week 12 (follow-up phase)
description: SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment
time frame: Week 24 (follow-up phase)
description: SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.
measure: Percentage of Participants With Viral Relapse
time frame: End of treatment up to Week 24 (follow up phase)
description: Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.
measure: Percentage of Participants With On-treatment Failure
time frame: EOT up to Week 12 (follow up phase)
description: On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.
measure: Percentage of Participants With On-treatment Virologic Response
time frame: Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)
description: Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.
measure: Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ
time frame: EOT up to Week 24 (follow up phase)
description: Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.
arm group label: Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
arm group type: Experimental
description: Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
arm group label: Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
arm group type: Experimental
description: Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).
intervention type: Drug
intervention name: AL-335
description: Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
arm group label: Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
arm group label: Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
other name: JNJ-64146212
intervention type: Drug
intervention name: Odalasvir (ODV)
description: Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
arm group label: Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
arm group label: Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
other name: JNJ-64289901
intervention type: Drug
intervention name: Simeprevir (SMV)
description: Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
arm group label: Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
arm group label: Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
other name: TMC435
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutical K.K.
facility: 
facility: 
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country: Japan
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Virus Diseases
mesh term: Hepatitis
mesh term: Simeprevir
mesh term: Odalasvir
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: As the sponsor decided to discontinue the development of JNJ-64294178, the study enrollment to reach the target number of participants was not completed in Cohort 2.
point of contact: 