NCT01215643

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis C
• Chronic Pain

Interventions

Type	Name	Description
DRUG	Alisporivir	ALV 200 mg soft gel capsules administered orally
DRUG	Peginterferon alfa-2a	PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
DRUG	Ribavirin	RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-10-06
• Last updated: 2016-08-30
• Results posted: 2016-08-30

Locations

73 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, India, Italy, Poland, Puerto Rico, South Korea, Taiwan, Thailand, United Kingdom