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Contact Information:

Study Location:

London


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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

Completed

Open to: All Genders

Age: 18 Years - 70 Years

Medical Conditions

Chronic Hepatitis C Virus


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




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.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2012

Sep 2013

Interventional

Intervention Type : Drug
Intervention Description : tablet, 400-mg twice daily

Intervention Arm Group : Quadruple Regimen

Intervention Type : Drug
Intervention Description : tablet, 1125-mg twice daily

Intervention Arm Group : Quadruple Regimen

Intervention Type : Drug
Intervention Description : tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily

Intervention Arm Group : Quadruple Regimen

Intervention Type : Biological
Intervention Description : subcutaneous injection, 180-mcg, once weekly

Intervention Arm Group : Quadruple Regimen

You can take part if:


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




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • London
  • Plymouth
  • Scotland


The study is sponsored by Vertex Pharmaceuticals Incorporated .



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for Trial ID: NCT01516918

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