An international, multicenter study evaluating cure rate and safety with Boceprevir in triple combination therapy with Peginterferon alfa-2a (40KD) and Ribavirin in previously untreated patients with genotype 1 chronic hepatitis C.
- Conditions
- Genotype 1 CHC virus infectionMedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-004810-41-AT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Treatment-naïve adult women and men with chronic hepatitis C monoinfection, genotype 1 and compensated liver disease including cirrhosis
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 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 8
Exclusion Criteria
- Women with ongoing pregnancy or breast feeding
- Male partners of women who are pregnant
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