NCT01318694

Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,081 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

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	ALV Placebo	ALV placebo soft gel capsules administered orally

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-03-18
• Last updated: 2016-09-30
• Results posted: 2016-09-30

Locations

146 sites across 21 countries: United States, Argentina, Australia, Belgium, Canada, France, Germany, Hong Kong, Hungary, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, Vietnam