drugset / Trial / NCT02094443

Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

NCT02094443

Phase 2 Completed 52 enrolled Debiopharm International SA
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Timeline

Start
2014-03
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisporivir Protein / enzyme biologic 300 mg Oral
Subject Alisporivir Protein / enzyme biologic 400 mg Oral
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral