Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, HCV, CHC
Brief summary
A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
Interventions
DRUGVX-135
12 weeks of VX-135
DRUGribavirin
12 weeks of ribavirin
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects (male and female) must be between the ages of 18 and 60 years at screening * Subjects must have genotype 1 Chronic Hepatitis C * Subjects must be treatment naïve * Subjects must have laboratory values at screening within limits as specified by the protocol Key
Exclusion criteria
* Evidence of cirrhosis * Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study * Any other cause of significant liver disease in addition to hepatitis C * Human immunodeficiency virus -1 or -2 * Diagnosis of or suspected hepatocellular carcinoma * History of organ transplant, with the exception of corneal transplants and skin grafts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments | Up to 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) | 24 weeks | — |
| The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24) | 36 weeks | — |
| The proportion of subjects who have virologic relapse | Up to 52 weeks | — |
| The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4) | 16 weeks | — |
| The proportion of subjects who have virologic breakthrough | Up to 52 weeks | as measured by on-treatment HCV RNA values |
| The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) | up to 28 weeks | — |
| The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment | Up to 60 weeks | — |
| Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA | Up to 64 weeks | — |
Countries
United States
Outcome results
None listed