chronic hepatitis C virus infection MedDRA version: 15.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female subjects, 18 to 70 years of age, inclusive - Subjects have IL28B CC genotype determined during screening - Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 343 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - Subjects have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C - Subjects have evidence of hepatic decompensation - Subjects have evidence of cirrhosis - Subjects have diagnosed or suspected hepatocellular carcinoma - Subjects have 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. Steatosis is allowed if clinically asymptomatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a 12-week regimen of telaprevir, Peg-IFN, and RBV in treatment-naive and prior relapser subjects with genotype 1 CHC and IL28B CC genotype;Secondary Objective: To evaluate the safety of a 12-week regimen of telaprevir, Peg-IFN, and RBV To evaluate the virologic response to a 12-week regimen of telaprevir, Peg-IFN, and RBV;Primary end point(s): - Proportion of subjects assigned to the 12-week regimen of telaprevir and Peg-IFN/RBV (T12/PR12) who have sustained virologic response (SVR) 12 weeks after last planned dose of study drug (SVR12);Timepoint(s) of evaluation of this end point: 12 weeks after last planned dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of randomized subjects who have SVR 24 weeks after the last planned dose of study drug (SVR24) • Proportion of randomized subjects who have SVR at Week 72 • Proportion of randomized subjects who have relapse; relapse is defined as having undetectable HCV RNA at end of treatment followed by detectable HCV RNA during follow-up • Proportion of subjects who have on-treatment virologic failure, defined as subjects who meet futility rule or subjects who complete the assigned treatment duration and have detectable HCV RNA at the end of treatment • Safety as indicated by AEs, clinical laboratory results, electrocardiograms (ECG), and vital signs • Amino acid sequence of the HCV NS3•4A protease domain;Timepoint(s) of evaluation of this end point: Study Week 72 | — |
Countries
Austria, Canada, Germany, Israel, Poland, United States
Contacts
Public ContactMedical Information Center
Vertex Pharmaceuticals Incorporated
Outcome results
None listed