Chronic Hepatitis C Virus
Conditions
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.
Interventions
DRUGVX-222
tablet, 400-mg twice daily
DRUGtelaprevir
tablet, 1125-mg twice daily
DRUGribavirin
tablet, 1000-mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
BIOLOGICALpeginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) | 24 weeks | — |
| 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 | — |
| 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 safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. | up to 48 weeks | — |
| 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. |
| VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations | 12 weeks | — |
| The association of the IL-28B genotype with SVR12 | 12 weeks | Proportion of subjects who have SVR12 by IL-28B genotype |
Countries
Canada, Germany, Poland, United Kingdom, United States
Outcome results
None listed