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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
tablet, 400-mg twice daily
tablet, 1125-mg twice daily
tablet, 1000-mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
Time frame: 12 weeks
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
Time frame: up to 48 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
Time frame: 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
Time frame: 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
Time frame: up to 48 weeks
The association of the IL-28B genotype with SVR12
Proportion of subjects who have SVR12 by IL-28B genotype
Time frame: 12 weeks
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
Time frame: After the last planned dose of study drug or after time of failure
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
subcutaneous injection, 180-mcg, once weekly
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Birmingham, Alabama, United States
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San Diego, California, United States
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Englewood, Colorado, United States
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Bradenton, Florida, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
...and 33 more locations