A study to compare the safety and effectiveness of a quadruple drug regimen (VX-222, telaprevir, peginterferon alfa-2a and ribavirin) to a triple drug regimen (placebo, telaprevir, peginterferon alfa-2a and ribavirin) in treating chronic hepatitis C virus in subjects with cirrhosis who are treatment naive or nonresponders and relapsers to previous Peg-IFN/Ribavirin therapy.
- Conditions
- Chronic Hepatitis C VirusMedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-004150-26-GB
- Lead Sponsor
- Vertex Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
- Subjects (male and female, including those of childbearing potential) must be between the ages of 18 and 70 years
- Subjects must have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects must have documentation of compensated cirrhosis
- Subjects must have never received treatment for hepatitis C (treatment naive) or must not have achieved SRV24 adter at least one prior course of Peg-IFN/RBV therapy of standard duration. For subjects who have previously received treatment, the last dose of Peg-IFN/RBV must have been at least 12 weeks before the Screening Visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
-History of any illness that, in the opinion of the investigator or general practitioner might confound the results of the study or pose an additional risk to the subject
- Any contraindication to Peg-IFN or RBV therapy, or history of severe AEs while on Peg-IFN or RBV
- Evidence of hepatic decompensation
- Any other cause of significant liver disease in addition to hepatitis C
- Diagnosed or suspected hepatocellular carcinoma
- History of organ transplant, with the exception of corneal transplants and skin grafts
- A medical condition that requires frequent or prolonged use of systemic corticosteroids or immunosuppressive drugs
- History of acute pancreatitis
- History or other clinical evidence of chronic pulmonary disease associated with functional impairment
- History of other evidence of sever retinopathy or clinically significant ophthalmological disorder
- History of illicit substance or alcohol abuse within 1 year before the Screening Visit
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method