NCT01183169

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Conditions

• Hepatitis C

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 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
DRUG	Placebo	ALV placebo soft gel capsules administered orally

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-08-17
• Last updated: 2016-08-25
• Results posted: 2016-08-25

Locations

75 sites across 14 countries: United States, Australia, Belgium, France, Germany, Hungary, Italy, Poland, Puerto Rico, Romania, Spain, Taiwan, Turkey (Türkiye), United Kingdom