A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Status: | Recruiting |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 5/27/2013 |
Start Date: | November 2012 |
Contact: | Central Contact Center |
Email: | medicalinfo@vrtx.com |
Phone: | 617-341-6777 |
A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
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
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
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