Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
CompletedPhase 2NCT01215643
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Brief summary (from the registry)
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
Study details
- Official title
- 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-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
- Conditions
- Hepatitis C
- Chronic Pain
- Interventions
- Drug: Alisporivir
- Drug: Peginterferon alfa-2a
- Drug: Ribavirin
- Sponsor
- Debiopharm International SA
- Start date
- 2010-10
- Primary completion
- 2012-05
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, Belgium, Canada, France, Germany, India, Italy, Poland, Puerto Rico, South Korea, Taiwan, Thailand, United Kingdom, United States
- Total sites listed
- 73
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria: * Chronic hepatitis C viral infection * Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit) * HCV genotype 2 or 3 * No previous treatment for hepatitis C infection Exclusion criteria: * Evidence of cirrhosis at the time of screening * Evidence of hepatocellular carcinoma at the time of screening * Any other cause of relevant liver disease other than HCV * Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN) * Other protocol-defined inclusion/exclusion criteria may apply
Canadian sites (2)
| Facility | City | Province |
|---|---|---|
| Novartis Investigative Site | Vancouver | British Columbia |
| Novartis Investigative Site | Toronto | Ontario |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01215643