- Conditions
- Chronic Hepatitis C Genotype 1 patientsMedDRA version: 15.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-020033-14-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 459
Chronic hepatitis C G1 viral infection Plasma HCV RNA level lower limit = 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit; HCV genotype 1; Previous non-responders/ relapsers to SOC after treatment for at least 12 weeks.
other inclusion criteria may apply
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 442
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception.
other exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): cEVR (complete early virologic response) i.e. HCV RNA < 25 IU/mL (by Limit of Quantitation, LOQ);Timepoint(s) of evaluation of this end point: 12 weeks ;Main Objective: To demonstrate that in chronic hepatitis C Genotype 1 patients with previous non-response to peg-IFNa2a/RBV or with previous relapse after peg-IFNa2a/RBV treatment triple therapy with DEB025 leads to a superior cEVR (by Limit of Quantification, LOQ, i.e. HCV RNA < 25 IU/mL) rate as compared to peg-IFN/RBV ;Secondary Objective: To demonstrate that triple therapy with DEB025 plus peg-IFNa2a/RBV variable treatment duration followed by peg-IFN/RBV to complete a total treatment duration of 48 weeks leads to a superior SVR12 (HCV RNA < LOQ at the end of 12 week post-treatment follow-up) rate as compared to peg-IFN/RBV for 48 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): SVR12: sustained virologic response 12 weeks following cessation of therapy, defined as HCV RNA negative (by LOQ);Timepoint(s) of evaluation of this end point: 12 weeks post treatment