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

• Status: Completed
• Trial end date: 2014-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

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

Details

• Lead Sponsor: Alios Biopharma Inc.
• Collaborator: Vertex Pharmaceuticals Incorporated
• Treatments: Ribavirin

Criteria

Key Inclusion Criteria:

• Subjects (male and female) must be between 18-60 years of age

• Subjects must have Chronic Hepatitis C

• Subjects must be treatment naive

• 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

• Diagnosis of or suspected hepatocellular carcinoma