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VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01581138
Collaborator
(none)
64
Enrollment
18
Locations
2
Arms
17
Duration (Months)
3.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 12 week treatment

Drug: VX-222
400 mg tablets twice daily for oral administration

Drug: telaprevir
1125 mg tablets twice daily for oral administration
Other Names:
  • VX-950, INCIVEK, INCIVO, TELAVIC

    • Drug: ribavirin
    1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
    Other Names:
  • Copegus

    		•
    Experimental: 16 week treatment

    Drug: VX-222
    400 mg tablets twice daily for oral administration

    Drug: telaprevir
    1125 mg tablets twice daily for oral administration
    Other Names:
  • VX-950, INCIVEK, INCIVO, TELAVIC

    • Drug: ribavirin
    1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
    Other Names:
  • Copegus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment [12 weeks after the last planned dose of treatment]

    Secondary Outcome Measures

    1. The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) [up to 20 weeks]

    2. The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug [24 weeks after the last planned dose of the study drug]

    3. The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug [4 weeks after the last planned dose of the study drug]

    4. The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT) [48 weeks either after the last planned dose of study drug or after time of failure]

    5. The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT) [up to 16 weeks]

    6. Time to achieve <LLOQ undetectable HCV RNA [up to 16 weeks]

    7. The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT) [up to 16 weeks]

    8. The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12 [12 weeks after the last planned dose of treatment]

    9. The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure [48 weeks either after the last planned dose of study drug or after time of failure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit

    • Subjects will be treatment naïve

    • Subjects must have documentation of the presence or absence of cirrhosis

    Exclusion Criteria:

    • History or other clinical evidence of significant or unstable cardiac disease

    • Evidence of hepatic decompensation

    • Diagnosed or suspected hepatocellular carcinoma

    • Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis

    • History of organ transplant, with the exception of corneal transplants and skin grafts

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Anaheim California United States
    3 Riverside California United States
    4 San Diego California United States
    5 Englewood Colorado United States
    6 Orlando Florida United States
    7 Marietta Georgia United States
    8 Baltimore Maryland United States
    9 New York New York United States
    10 Asheville North Carolina United States
    11 Winston-Salem North Carolina United States
    12 Cincinatti Ohio United States
    13 Pittsburgh Pennsylvania United States
    14 Germantown Tennessee United States
    15 Nashville Tennessee United States
    16 Austin Texas United States
    17 San Antonio Texas United States
    18 Norfolk Virginia United States

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    • Study Director: Medical Monitor, Vertex Pharmaceuticals Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01581138
    Other Study ID Numbers:
    • VX11-222-108
    First Posted:
    Apr 20, 2012
    Last Update Posted:
    Jul 4, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic
    Ribavirin

    Study Results

    No Results Posted as of Jul 4, 2014