A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | January 2012 |
Contact: | Central Contact Center |
Email: | medicalinfo@vrtx.com |
A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen
(VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with
cirrhosis.
Inclusion Criteria:
- Subjects must have genotype 1 Chronic Hepatitis C
- Subjects must have compensated cirrhosis
- Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV
without evidence of response. Subjects who are considered to be relapsers to Peg
IFN/RBV, or who are partial or null responders will be considered
- Subjects with hemophilia may be permitted to enroll with permission of the medical
monitor
Exclusion Criteria:
- Any previous treatment with an investigational drug or drug regimen for the treatment
of hepatitis C, or previous treatment with an approved protease inhibitor
- Any contraindication to Peg-IFN or RBV therapy
- Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or
bleeding esophageal varices
- A history of acquired immunodeficiency infection, organ transplantation or have an
ongoing requirement for immunosuppressive medicines
We found this trial at
19
sites
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