A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VX-135 High Dose with ribavirin 12 weeks of a high dose of VX-135 in combination with ribavirin |
Drug: VX-135
12 weeks of VX-135
Drug: ribavirin
12 weeks of ribavirin
|
| Experimental: VX-135 Low Dose with ribavirin 12 weeks of a low dose of VX-135 in combination with ribavirin |
Drug: VX-135
12 weeks of VX-135
Drug: ribavirin
12 weeks of ribavirin
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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]
- 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]
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | California | La Jolla | California | United States | |
| 2 | Florida | Orlando | Florida | United States | |
| 3 | Georgia | Marietta | Georgia | United States | |
| 4 | Tennessee | Germantown | Tennessee | United States | |
| 5 | Texas | Arlington | Texas | United States | |
| 6 | Texas | Houston | Texas | United States |
Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
- Study Director: Medical Monitor, Vertex Pharmaceuticals Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX12-135-101