<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/NCT03235349</url>
  </required_header>
  <id_info>
    <org_study_id>M15-593</org_study_id>
    <nct_id>NCT03235349</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection</brief_title>
  <acronym>VOYAGE-2</acronym>
  <official_title>An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir&#xD;
      (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian&#xD;
      participants with compensated cirrhosis with or without human immunodeficiency virus (HIV)&#xD;
      co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN)&#xD;
      (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir&#xD;
      with RBV with or without IFN.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</measure>
    <time_frame>12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Virologic Failure</measure>
    <time_frame>12 or 16 weeks depending on the treatment regimen</time_frame>
    <description>On-treatment virologic failure was defined as meeting one of the following:&#xD;
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements &gt; 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or&#xD;
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA &lt; 15 IU/mL during the treatment period, or&#xD;
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Post-treatment Relapse</measure>
    <time_frame>From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).</time_frame>
    <description>Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; 15 IU/mL at the end of treatment, excluding re-infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of HCV/HIV Co-infected Participants Achieving SVR12</measure>
    <time_frame>12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen</time_frame>
    <description>SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Hepatitis C Virus (HCV)</condition>
  <arm_group>
    <arm_group_label>Glecaprevir/Pibrentasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glecaprevir/Pibrentasvir</intervention_name>
    <description>Coformulated tablet for oral administration</description>
    <arm_group_label>Glecaprevir/Pibrentasvir</arm_group_label>
    <other_name>ABT-493/ABT-530</other_name>
    <other_name>MAVYRET™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be of Asian descent.&#xD;
&#xD;
          -  Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3,&#xD;
             4, 5 or 6 infection.&#xD;
&#xD;
          -  Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal&#xD;
             to 1000 IU/ mL at Screening Visit.&#xD;
&#xD;
          -  Chronic HCV infection defined as one of the following:&#xD;
&#xD;
               -  Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or&#xD;
&#xD;
               -  A liver biopsy consistent with chronic HCV infection;&#xD;
&#xD;
          -  HCV treatment-naïve to any approved or investigational HCV treatment or&#xD;
             treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon&#xD;
             [pegIFN] with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.&#xD;
             Previous treatment must have been completed &gt;= 8 weeks prior to screening.&#xD;
&#xD;
          -  Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening and no current&#xD;
             or past clinical evidence of Child-Pugh B or C Classification or clinical history of&#xD;
             liver decompensation including ascites noted on physical exam, bleeding varices, use&#xD;
             of diuretics for ascites, or hepatic encephalopathy.&#xD;
&#xD;
          -  Absence of hepatocellular carcinoma (HCC)&#xD;
&#xD;
        Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must&#xD;
        also meet the following criteria:&#xD;
&#xD;
          -  Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening.&#xD;
&#xD;
          -  Naïve to treatment with any antiretroviral therapy (ART) with a cluster of&#xD;
             differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ % &gt;=&#xD;
             29%), or&#xD;
&#xD;
          -  On a stable, qualifying HIV-1 ART regimen with CD4+ count &gt;= 200 cells/mm³ (or CD4+ %&#xD;
             &gt;= 14%) at Screening; and plasma HIV-1 RNA below lower limit of quantification (LLOQ)&#xD;
             by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once&#xD;
             during the 12 months prior to Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive test result for hepatitis B surface antigen (HbsAg) or positive test result&#xD;
             for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.&#xD;
&#xD;
          -  Any cause of liver disease other than chronic HCV-infection.&#xD;
&#xD;
          -  HCV genotype performed during screening indicating co-infection with more than one HCV&#xD;
             genotype&#xD;
&#xD;
          -  Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection&#xD;
&#xD;
          -  Chronic human immunodeficiency virus, type 2 (HIV-2) infection&#xD;
&#xD;
        Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:&#xD;
&#xD;
          -  For participants on stable ART, taking anti-retroviral agent(s) other than those&#xD;
             permitted&#xD;
&#xD;
          -  Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic&#xD;
             infection within 12 months of Screening or prophylaxis for an AIDS-associated&#xD;
             opportunistic infection within 6 months of screening&#xD;
&#xD;
          -  Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Peoples Hospit /ID# 156851</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou Eighth People's Hosp /ID# 156865</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital /ID# 156827</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University /ID# 156866</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Nanjing /ID# 156869</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province People's Hospital /ID# 156867</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hosp of Jilin Univ /ID# 156825</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Sixth People's Hospital of Shenyang /ID# 156854</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong /ID# 157337</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital of Fudan University /ID# 156909</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Public Health Cli Ctr /ID# 156837</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201508</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital /ID# 156835</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Di Tan Hospital, Capital Medical University /ID# 156852</name>
      <address>
        <city>Beijing</city>
        <zip>100015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Hospital of Peking Uni /ID# 156850</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital /ID# 156843</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Youan Hosp, Cap Med Un /ID# 163418</name>
      <address>
        <city>Beijing</city>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2nd Affiliated Hosp Chongqing /ID# 156838</name>
      <address>
        <city>Chongqing</city>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mengchao Hepatobiliary Hospita /ID# 156907</name>
      <address>
        <city>Fuzhou</city>
        <zip>350025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army 81 Hospital /ID# 156868</name>
      <address>
        <city>Nanjing</city>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University /ID# 156829</name>
      <address>
        <city>Shenyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Aff Hosp Xinjiang Med Uni /ID# 156891</name>
      <address>
        <city>Urumqi</city>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767</name>
      <address>
        <city>Xi'an</city>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420</name>
      <address>
        <city>Xi'an</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial Peoples Hosp /ID# 157371</name>
      <address>
        <city>Zhengzhou, Henan</city>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hosp /ID# 163411</name>
      <address>
        <city>Busan</city>
        <state>Busan Gwang Yeogsi</state>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National Univ Bundang ho /ID# 163408</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital /ID# 163384</name>
      <address>
        <city>Busan</city>
        <state>Gyeongsangbugdo</state>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan Nat Univ Yangsan Hosp /ID# 163385</name>
      <address>
        <city>Yangsan-si,</city>
        <state>Gyeongsangnamdo</state>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital /ID# 163399</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 163402</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital /ID# 163412</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 163401</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center /ID# 163398</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>November 4, 2019</results_first_submitted>
  <results_first_submitted_qc>November 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 21, 2019</results_first_posted>
  <last_update_submitted>November 4, 2019</last_update_submitted>
  <last_update_submitted_qc>November 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis C Virus (HCV)</keyword>
  <keyword>Genotype 1 to 6</keyword>
  <keyword>Cirrhosis</keyword>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>Human Immunodeficiency Virus</keyword>
  <keyword>co-infection</keyword>
  <keyword>Treatment-naïve</keyword>
  <keyword>treatment-experienced</keyword>
  <keyword>interferon</keyword>
  <keyword>Asian</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Coinfection</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <provided_document_section>
    <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>April 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03235349/Prot_000.pdf</document_url>
    </provided_document>
    <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>January 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03235349/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 34 sites in China and South Korea. Eligible participants were chronic hepatitis C (HCV) genotype (GT)1-6-infected adults with compensated cirrhosis with or without HIV co-infection who were HCV treatment-naïve or treatment-experienced with regimens containing interferon (IFN), pegylated IFN, ribavirin, and/or sofosbuvir.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Glecaprevir/Pibrentasvir</title>
          <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 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="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Glecaprevir/Pibrentasvir</title>
          <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="160"/>
          </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="57.83" spread="11.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </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="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </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>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Genotype</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Genotype 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genotype 6</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior HCV Treatment History</title>
          <description>Treatment-experienced includes treatment with interferon (IFN; alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Treatment-naive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Treatment-experienced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HCV Ribonucleic Acid (RNA) Level</title>
          <units>log₁₀ IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.16" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Human Immunodeficiency Virus (HIV) Co-infection Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hepatitis C infection only</title>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>HCV / HIV co-infection</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.</time_frame>
        <population>All enrolled participants who received at least 1 dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>Glecaprevir/Pibrentasvir</title>
            <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.</description>
          <population>All enrolled participants who received at least 1 dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.</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="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="98.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-treatment Virologic Failure</title>
        <description>On-treatment virologic failure was defined as meeting one of the following:&#xD;
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements &gt; 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or&#xD;
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA &lt; 15 IU/mL during the treatment period, or&#xD;
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.</description>
        <time_frame>12 or 16 weeks depending on the treatment regimen</time_frame>
        <population>All enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Glecaprevir/Pibrentasvir</title>
            <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Virologic Failure</title>
          <description>On-treatment virologic failure was defined as meeting one of the following:&#xD;
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements &gt; 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or&#xD;
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA &lt; 15 IU/mL during the treatment period, or&#xD;
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.</description>
          <population>All enrolled participants who received at least 1 dose of study drug.</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="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Post-treatment Relapse</title>
        <description>Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; 15 IU/mL at the end of treatment, excluding re-infection.</description>
        <time_frame>From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).</time_frame>
        <population>All enrolled participants who received at least one dose of study drug, with HCV RNA &lt; 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Glecaprevir/Pibrentasvir</title>
            <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Post-treatment Relapse</title>
          <description>Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; 15 IU/mL at the end of treatment, excluding re-infection.</description>
          <population>All enrolled participants who received at least one dose of study drug, with HCV RNA &lt; 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.</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="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.1" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of HCV/HIV Co-infected Participants Achieving SVR12</title>
        <description>SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen</time_frame>
        <population>No HCV-HIV co-infected participants were enrolled in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Glecaprevir/Pibrentasvir</title>
            <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of HCV/HIV Co-infected Participants Achieving SVR12</title>
          <description>SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.</description>
          <population>No HCV-HIV co-infected participants were enrolled in the study</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Glecaprevir/Pibrentasvir</title>
          <description>Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>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="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>UPPER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>BILE DUCT STONE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>HEPATIC LESION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>LIVER ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>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="29" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="160"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT03235349
org study id: M15-593
nct id: NCT03235349
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir
      (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian
      participants with compensated cirrhosis with or without human immunodeficiency virus (HIV)
      co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN)
      (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir
      with RBV with or without IFN.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
time frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
measure: Percentage of Participants With On-treatment Virologic Failure
time frame: 12 or 16 weeks depending on the treatment regimen
description: On-treatment virologic failure was defined as meeting one of the following:
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.
measure: Percentage of Participants With Post-treatment Relapse
time frame: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).
description: Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection.
measure: Percentage of HCV/HIV Co-infected Participants Achieving SVR12
time frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen
description: SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
arm group label: Glecaprevir/Pibrentasvir
arm group type: Experimental
description: Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
intervention type: Drug
intervention name: Glecaprevir/Pibrentasvir
description: Coformulated tablet for oral administration
arm group label: Glecaprevir/Pibrentasvir
other name: ABT-493/ABT-530
other name: MAVYRET™
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
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country: China
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Infections
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Coinfection
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Liver Cirrhosis
mesh term: Immunologic Deficiency Syndromes
mesh term: Fibrosis
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 