TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis 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: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-001180-53-NO
- Lead Sponsor
- Tibotec Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 763
- Genotype 1 hepatitis C infection (confirmed at screening)
- A liver biopsy within 3 years before screening (or between the screening and baseline visit) is required, showing chronic hepatitis C infection. In case of contradicitions, alternative methods must be used to determine or confirm the stage of liver disease.
- 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 728
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
- 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 Main Objective: To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNa-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: Reference is made to section 2.1 (Objectives), pages 42 and 43 of the Clinical Trial Protocol;Primary end point(s): The proportion of patients with sustained virological response 12 weeks after the planned end of treatment (SVR12);Timepoint(s) of evaluation of this end point: At Week 60
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of patients with sustained virological response 24 weeks after the planned end of treatment (SVR24);Timepoint(s) of evaluation of this end point: At Week 72