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-IFNa2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patients
- Conditions
- Chronic Hepatitis C Genotype 2 and 3 patientsMedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2010-020034-26-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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) no
F.1.3.1 Number of subjects for this age range
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.
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
- 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
- Secondary Outcome Measures
Name Time Method