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

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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
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