Pharmacokinetics, pharmacodynamics and safety of DEB025/alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 patients who have previously failed interferon therapy or are intolerant or unable to take interfero
- Conditions
- Chronic hepatitis CMedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-003751-38-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 52
1. Written informed consent must be obtained before any assessment is performed;
2. HCV G2/3 patients who previously failed a course of interferon based therapy or were intolerant of interferon or are unable to take interferon based on the presence of a contraindication as defined by the label of pegIFN (Pegasys and/or PegIntron);
3. Chronic hepatitis C virus infection diagnosed
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes;
3.History of pancreatitis or history strongly suggestive of previous pancreatitis;
4. HBsAg positive or HIV positive.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate pharmacodynamics, pharmacokinetic between 2 treatment groups receiving different doses of DEB025 in combination with RBV ;Secondary Objective: To evaluate the efficacy among 2 treatment groups with different doses of DEB025 in combination with RBV ;Primary end point(s): • viral load drop from baseline through week 12<br>• changes in serum triglycerides from baseline through week 12<br>• proportion of patients who develop confirmed Stage II hypertension (SBP =160 mm Hg or DBP =100 mm Hg)<br>• changes in platelet count from baseline through week 12.;Timepoint(s) of evaluation of this end point: treatment week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): HCV RNA viral load SVR4 and SVR12;Timepoint(s) of evaluation of this end point: post-treatment week 4 and week 12