Trials / Completed
CompletedNCT00854802
A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 290 (actual)
- Sponsor
- Debiopharm International SA · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.
Detailed description
This is an international, multicentre, randomised, double-blind, placebo-controlled, 4-arm, parallel-group, multiple dose phase II study comparing 3 Debio 025 (alisporivir)/peg-IFNα2a/ribavirin regimens to SOC treatment in treatment naïve chronic HCV genotype 1 patients. Patients are randomised into 1 of 4 arms receiving either Debio 025/peg-IFNα2a/ribavirin triple therapy for a fixed treatment duration of 48 weeks (Treatment A) or 24 weeks (Treatment B), Debio 025/peg-IFNα2a/ribavirin triple therapy for a response-based treatment duration of 24 or 48 weeks (Treatment C), or blinded SOC treatment for 48 weeks (Treatment D). Follow-up is 24 weeks in all treatment arms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Debio 025 | Debio 025 supplied in soft gel capsules |
| DRUG | Peg-IFNα2a | Peg-IFNα2a supplied in pre-filled syringes |
| DRUG | Ribavirin | Ribavirin supplied in tablets |
| DRUG | Debio 025 placebo | Debio 025 placebo supplied in soft gel capsules |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2009-03-03
- Last updated
- 2016-02-17
Locations
40 sites across 7 countries: Belgium, France, Germany, Italy, Poland, Romania, Spain
Source: ClinicalTrials.gov record NCT00854802. Inclusion in this directory is not an endorsement.