Status:
COMPLETED
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
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Chronic Hepatitis C Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01516918
Start Date
February 1 2012
End Date
December 1 2013
Last Update
October 20 2014
Active Locations (43)
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1
Birmingham, Alabama, United States
2
San Diego, California, United States
3
Englewood, Colorado, United States
4
Bradenton, Florida, United States