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

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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
We found this trial at
5
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, Georgia
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Coronado, California
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Germantown, Tennessee
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Houston, Texas
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