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

Vertex Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Chronic Hepatitis C Virus

Treatments

Biological: peginterferon-alfa-2a

Drug: ribavirin

Drug: telaprevir

Drug: VX-222

Study type

Interventional

Funder types

Industry

Identifiers

NCT01516918

VX11-222-106

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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