A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Ribavirin

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