A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFN alpha-2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patients

• Conditions: Chronic Hepatitis C Genotype 2 and 3 patients; MedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2010-020034-26-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-22
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Key inclusion criteria are:

Written informed consent prior to any assessment;
Males or females aged =18 and = 70 years;
BMI between = 18 and = 36 kg/m2;
Chronic hepatitis C virus infection;
Plasma HCV RNA = 10000 IU/ml; no upper limit;
Infection with HCV genotype 2 or 3;
HCV treatment naïve;
Female patients of child bearing potential must have a negative pregnancy test at screening and immediately prior to first administration of study drug.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria are:

Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer;
Any contraindications to peg-IFNa2a and/or RBV treatment;
Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years;
HBsAg positive or HIV positive;
Elevated (= ULN) total bilirubin level at screening.
Gilbert´s disease.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients.;Secondary Objective: The key secondary objective is to evaluate the proportion of patients with RVR on interferon free treatment who also achieve SVR 24 in treatment-naïve chronic hepatitis C genotype 2/3 patients.;Primary end point(s): Proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients