drugset / Trial / NCT02765490

Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

NCT02765490

Phase 2 Completed 365 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

Timeline

Start
2016-11-09
Primary completion
2017-08-09
Completion
2017-11-16

Drugs

EvaluationDrugModalityDoseRoute
Subject ADAFOSBUVIR Small molecule 800 mg
Subject Odalasvir Small molecule 25 mg
Subject Simeprevir Small molecule 75 mg