A multicenter, randomized, open label, parallel-groupphase IIB study on the efficacy and safety of oral regimensof DEB025 alone or in combination with ribavirin versusStandard of Care (peg-IFNa2a plus ribavirin) in treatmentnaïvehepatitis C genotype 2 and 3 patients

• Conditions: hepatitis C genotype 2 and 3; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-020034-26-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 9 October 2012

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 = 65 years;
• BMI between = 18 and = 32 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 immediately prior
to first administration of study drug.
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
F.1.3 Elderly (>=65 years) no
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;
• Cirrhosis, decompensated liver disease or complicated portal hypertension;
• Hepatocellular carcinoma;
• Pregnant, nursing or lactating women or women of child-bearing potential UNLESS they are using
two birth control methods;
• Men whose female partners are pregnant or contemplating pregnancy. Fertile males UNLESS the
patient and his partner agree to comply with acceptable contraception;
• Ongoing or recent use of any other medication (including over the counter medication and herbal
products) within 2 weeks before study start or within 5 drug half-lives of that medication (whichever is longer) that 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;
• Any other cause of relevant liver disease other than HCV;
• History of moderate, severe, or uncontrolled psychiatric disease, especially depression.

Study & Design

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