An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hep C Patients who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin Therapy.
- Conditions
- Hepatitis C Virus (HCV) genotype-1 infectionMedDRA version: 14.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-001180-53-IT
- Lead Sponsor
- JANSSEN R&D IRELAND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 744
- Genotype 1 hepatitis C infection (confirmed at screening) - patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection - patient must have had at least 1 documented previous course of treament with PegINFa-2a or PegINFa-2b in combination with RBV (at least 12 weeks for null responder and 20 for partial responder) - Plasma HCV RNA of >10,000 IU/mL at screening
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
- Infection with HIV or non genotype 1 hepatitis C - liver disease not related to hepatitic C infection - hepatic decompensation - significant laboratory abnormalities or other active diseases - previous CHC treatment other than PegIFN and RBV - pregnant or planning to become 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