A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
Phase 2
Completed
- Conditions
- Chronic Hepatitis C Virus
- Interventions
- Registration Number
- NCT01516918
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Inclusion Criteria
- Subjects must have genotype 1 Chronic Hepatitis C
- Subjects must have compensated cirrhosis
- Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
- Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Exclusion Criteria
- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
- Any contraindication to Peg-IFN or RBV therapy
- Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
- A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Quadruple Regimen peginterferon-alfa-2a All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks. Quadruple Regimen VX-222 All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks. Quadruple Regimen telaprevir All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks. Quadruple Regimen ribavirin All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.
- Primary Outcome Measures
Name Time Method The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) 12 weeks
- Secondary Outcome Measures
Name Time Method The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment up to week 12 VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations 12 weeks The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment up to 48 weeks The association of the IL-28B genotype with SVR12 12 weeks Proportion of subjects who have SVR12 by IL-28B genotype
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure After the last planned dose of study drug or after time of failure The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. up to 48 weeks The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) 24 weeks