A multicentre, randomized, double-blind, placebocontrolled, parallel-group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a andribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2 plus ribavirin treatment-nonresponders

• Conditions: Chronic Hepatitis C Genotype 1 patients; MedDRA version: 11Level: LLTClassification code 10008912Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2010-020033-14-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-20
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

1. Patients eligible for inclusion in this study have to fulfill all of the following criteria:
2. Written informed consent must be obtained before any assessment is performed.
3. Males or females aged =18 and = 65 years;
4. BMI between = 18 and = 36 kg/m2;
5. HBsAg negative and HIV negative;
6. Chronic hepatitis C viral infection on record and diagnosed by two tests performed at an interval of at least 6 months (the initial diagnosis can be based on positive HCV antibodies or quantitative or qualitative HCV RNA measurement). Furthermore, chronicity needs to be confirmed by a positive HCV RNA test, i.e. qPCR (quantitative polymerase chain reaction); thus the 2nd test may be performed at screening;
7. Plasma HCV RNA level lower limit = 10000 IU/ml assessed by qPCR (quantitative
polymerase chain reaction) or equivalent at screening; no upper limit;
8. HCV genotype 1;
9. Previous non-responders to SOC (with peg-IFNa 2a or 2b and RBV) after full dose
treatment for at least 12 weeks with detectable HCV RNA at the end of treatment. A
minimum of 3 months must have elapsed since the patient's last treatment when the patient qualified as a non-responder and recruitment into this study.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening in this trial.
•Ongoing or recent use of any other medication which are known inhibitors/inducers of cytochrome 450 3A, substrates of cytochrome 450 3A, substrates of P-gp, or substrates/inhibitors of OATPs, MRP2 or BSEP (list of unauthorized medications).
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. Any medical contraindication to treatment with IFN and/or RBV.
•Patients with evidence of cirrhosis at the time of screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified