VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Phase 2
Completed
- Conditions
- Chronic Hepatitis C Virus
- Interventions
- Registration Number
- NCT01581138
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 12 week treatment VX-222 - 16 week treatment VX-222 - 16 week treatment ribavirin - 12 week treatment telaprevir - 12 week treatment ribavirin - 16 week treatment telaprevir -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Time to achieve <LLOQ undetectable HCV RNA up to 16 weeks 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 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 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 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 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 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 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