<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/NCT01726946</url>
  </required_header>
  <id_info>
    <org_study_id>VX12-135-101</org_study_id>
    <nct_id>NCT01726946</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C</brief_title>
  <official_title>A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vertex Pharmaceuticals Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vertex Pharmaceuticals Incorporated</source>
  <brief_summary>
    <textblock>
      A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135&#xD;
      in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments</measure>
    <time_frame>Up to 52 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)</measure>
    <time_frame>36 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who have virologic relapse</measure>
    <time_frame>Up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -&lt;LLOQ HCV RNA</measure>
    <time_frame>Up to 64 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who have virologic breakthrough</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>as measured by on-treatment HCV RNA values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)</measure>
    <time_frame>up to 28 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment</measure>
    <time_frame>Up to 60 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>VX-135 High Dose with ribavirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of a high dose of VX-135 in combination with ribavirin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VX-135 Low Dose with ribavirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of a low dose of VX-135 in combination with ribavirin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VX-135</intervention_name>
    <description>12 weeks of VX-135</description>
    <arm_group_label>VX-135 High Dose with ribavirin</arm_group_label>
    <arm_group_label>VX-135 Low Dose with ribavirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin</intervention_name>
    <description>12 weeks of ribavirin</description>
    <arm_group_label>VX-135 High Dose with ribavirin</arm_group_label>
    <arm_group_label>VX-135 Low Dose with ribavirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Subjects (male and female) must be between the ages of 18 and 60 years at screening&#xD;
&#xD;
          -  Subjects must have genotype 1 Chronic Hepatitis C&#xD;
&#xD;
          -  Subjects must be treatment naïve&#xD;
&#xD;
          -  Subjects must have laboratory values at screening within limits as specified by the&#xD;
             protocol&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of cirrhosis&#xD;
&#xD;
          -  Female subjects who are pregnant or nursing or male subjects with a female partner of&#xD;
             childbearing potential who is unwilling to adhere to the contraception requirements,&#xD;
             is pregnant or nursing, or planning to become pregnant during the study&#xD;
&#xD;
          -  Any other cause of significant liver disease in addition to hepatitis C&#xD;
&#xD;
          -  Human immunodeficiency virus -1 or -2&#xD;
&#xD;
          -  Diagnosis of or suspected hepatocellular carcinoma&#xD;
&#xD;
          -  History of organ transplant, with the exception of corneal transplants and skin grafts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Vertex Pharmaceuticals Incorporated</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <disposition_first_submitted>March 6, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>March 27, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 16, 2015</disposition_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>HCV</keyword>
  <keyword>CHC</keyword>
  <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>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01726946
org study id: VX12-135-101
nct id: NCT01726946
lead sponsor: 
A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135
      in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
time frame: Up to 52 weeks
measure: The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
time frame: 16 weeks
measure: The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
time frame: 24 weeks
measure: The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
time frame: 36 weeks
measure: The proportion of subjects who have virologic relapse
time frame: Up to 52 weeks
measure: Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA
time frame: Up to 64 weeks
measure: The proportion of subjects who have virologic breakthrough
time frame: Up to 52 weeks
description: as measured by on-treatment HCV RNA values
measure: The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
time frame: up to 28 weeks
measure: The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
time frame: Up to 60 weeks
arm group label: VX-135 High Dose with ribavirin
arm group type: Experimental
description: 12 weeks of a high dose of VX-135 in combination with ribavirin
arm group label: VX-135 Low Dose with ribavirin
arm group type: Experimental
description: 12 weeks of a low dose of VX-135 in combination with ribavirin
intervention type: Drug
intervention name: VX-135
description: 12 weeks of VX-135
arm group label: VX-135 High Dose with ribavirin
arm group label: VX-135 Low Dose with ribavirin
intervention type: Drug
intervention name: ribavirin
description: 12 weeks of ribavirin
arm group label: VX-135 High Dose with ribavirin
arm group label: VX-135 Low Dose with ribavirin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Vertex Pharmaceuticals Incorporated
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ribavirin