<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/NCT02214420</url>
  </required_header>
  <id_info>
    <org_study_id>PJPIIS-01-14</org_study_id>
    <nct_id>NCT02214420</nct_id>
  </id_info>
  <brief_title>SMV + SOF With/Without RBV for IFN-II Patients With CHC</brief_title>
  <official_title>Simeprevir (SMV) + Sofosbuvir (SOF) With or Without Ribavirin (RBV) for Interferon-intolerant or Ineligible (IFN-II) Patients With Chronic Hepatitis C (CHC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SC Liver Research Consortium, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen, LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SC Liver Research Consortium, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated&#xD;
      (PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation&#xD;
      of underlying psychiatric disorders, or autoimmune disorders. These patients will not be&#xD;
      candidates for treatment with the approvals of SMV and SOF in early 2014 due to the&#xD;
      combination with PEG-regimens. Results of the COSMOS study suggest that these patients are&#xD;
      likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,&#xD;
      and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed&#xD;
      in order to confirm this hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Viral Response</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>SMV+SOF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMV+SOF+RBV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simeprevir</intervention_name>
    <arm_group_label>SMV+SOF</arm_group_label>
    <arm_group_label>SMV+SOF+RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir</intervention_name>
    <arm_group_label>SMV+SOF</arm_group_label>
    <arm_group_label>SMV+SOF+RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <arm_group_label>SMV+SOF+RBV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Targeted at least 20% enrollment of patients with cirrhosis&#xD;
&#xD;
          2. Adults &gt;/= age 18 years.&#xD;
&#xD;
          3. Active infection with hepatitis C virus (HCV) genotype 1&#xD;
&#xD;
          4. Must have health insurance that covers therapy with SOF+RBV&#xD;
&#xD;
          5. Female patients of childbearing age must have a negative pregnancy test prior to&#xD;
             initiating therapy, use at least two effective methods of contraception during&#xD;
             treatment, and undergo monthly pregnancy tests.&#xD;
&#xD;
          6. Patients must be either IFN-ineligible due to psychiatric, autoimmune, neurological,&#xD;
             or other causes that are confirmed appropriate by the PI; OR,&#xD;
&#xD;
          7. IFN-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other&#xD;
             causes deemed appropriate by the PI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of HIV co-infection&#xD;
&#xD;
          2. Presence of hepatocellular carcinoma (HCC)&#xD;
&#xD;
          3. Prior organ transplantation&#xD;
&#xD;
          4. Any history of hepatic decompensation&#xD;
&#xD;
          5. Patients taking any of the following medications:&#xD;
&#xD;
               -  Anticonvulsants- Carbamazepine, Oxcarbazepine, Phenobarbital, or Phenytoin.&#xD;
&#xD;
               -  Anti-infectives-erythromycin, clarithromycin, or telithromycin.&#xD;
&#xD;
               -  Antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or&#xD;
                  voriconazole.&#xD;
&#xD;
               -  Antimycobacterials- rifampin, rifabutin or rifapentine.&#xD;
&#xD;
               -  Corticosteroids- systemic dexamethasone.&#xD;
&#xD;
               -  Propulsives- Cisapride.&#xD;
&#xD;
               -  Herbals- Milk thistle or St. John's Wart.&#xD;
&#xD;
          6. Patients that have been exposed to direct acting anti-viral agents&#xD;
&#xD;
          7. Patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) &lt;50&#xD;
             mL/min/1.73m2) or with end stage renal disease (ESRD).&#xD;
&#xD;
          8. Patients with platelet count &lt;50 x109/L, Hemoglobin &lt;10 g/dL, or Neutrophils &lt;0.5&#xD;
             x109/L.&#xD;
&#xD;
          9. Women who are pregnant.&#xD;
&#xD;
         10. Men whose partners are pregnant or plan on becoming pregnant.&#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>Paul Pockros, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scripps Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scripps Clinic</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mt. Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Centers of America, LLC</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>April 17, 2018</results_first_submitted>
  <results_first_submitted_qc>April 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2018</results_first_posted>
  <last_update_submitted>May 21, 2018</last_update_submitted>
  <last_update_submitted_qc>May 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SC Liver Research Consortium, LLC</investigator_affiliation>
    <investigator_full_name>Paul J. Pockros, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Simeprevir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SMV+SOF</title>
          <description>Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)&#xD;
Simeprevir&#xD;
Sofosbuvir</description>
        </group>
        <group group_id="P2">
          <title>SMV+SOF+RBV</title>
          <description>Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day&#xD;
Simeprevir&#xD;
Sofosbuvir&#xD;
Ribavirin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SMV+SOF</title>
          <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)&#xD;
Simeprevir&#xD;
Sofosbuvir</description>
        </group>
        <group group_id="B2">
          <title>SMV+SOF+RBV</title>
          <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day&#xD;
Simeprevir&#xD;
Sofosbuvir&#xD;
Ribavirin</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="14"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.84" lower_limit="22" upper_limit="76"/>
                    <measurement group_id="B2" value="58.31" lower_limit="35" upper_limit="67"/>
                    <measurement group_id="B3" value="53.95" lower_limit="22" upper_limit="76"/>
                  </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="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </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>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.47" lower_limit="18.8" upper_limit="46.1"/>
                    <measurement group_id="B2" value="27.56" lower_limit="19.1" upper_limit="42.9"/>
                    <measurement group_id="B3" value="28.67" lower_limit="18.8" upper_limit="46.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sustained Viral Response</title>
        <description>Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SMV+SOF</title>
            <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)&#xD;
Simeprevir&#xD;
Sofosbuvir</description>
          </group>
          <group group_id="O2">
            <title>SMV+SOF+RBV</title>
            <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day&#xD;
Simeprevir&#xD;
Sofosbuvir&#xD;
Ribavirin</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Viral Response</title>
          <description>Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>SMV+SOF</title>
          <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)&#xD;
Simeprevir&#xD;
Sofosbuvir</description>
        </group>
        <group group_id="E2">
          <title>SMV+SOF+RBV</title>
          <description>IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day&#xD;
Simeprevir&#xD;
Sofosbuvir&#xD;
Ribavirin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="13" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea or other GI discomfort</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough and cold symptoms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Photosensitivity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritis or rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Paul Pockros</name_or_title>
      <organization>Scripps Clinic</organization>
      <phone>(858) 554-8879</phone>
      <email>Pockros.paul@scrippshealth.org</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/NCT02214420
org study id: PJPIIS-01-14
nct id: NCT02214420
lead sponsor: 
collaborator: 
has dmc: No
Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated
      (PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation
      of underlying psychiatric disorders, or autoimmune disorders. These patients will not be
      candidates for treatment with the approvals of SMV and SOF in early 2014 due to the
      combination with PEG-regimens. Results of the COSMOS study suggest that these patients are
      likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy,
      and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed
      in order to confirm this hypothesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained Viral Response
time frame: 12 weeks
description: Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.
arm group label: SMV+SOF
arm group type: Active Comparator
description: IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)
arm group label: SMV+SOF+RBV
arm group type: Active Comparator
description: IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day
intervention type: Drug
intervention name: Simeprevir
arm group label: SMV+SOF
arm group label: SMV+SOF+RBV
intervention type: Drug
intervention name: Sofosbuvir
arm group label: SMV+SOF
arm group label: SMV+SOF+RBV
intervention type: Drug
intervention name: Ribavirin
arm group label: SMV+SOF+RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Pockros, MD
role: Principal Investigator
affiliation: Scripps Clinic
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: SC Liver Research Consortium, LLC
investigator full name: Paul J. Pockros, MD
investigator title: Principal Investigator
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Ribavirin
mesh term: Sofosbuvir
mesh term: Simeprevir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 