drugset / Trial / NCT02993250

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

NCT02993250

Phase 2 Completed 33 enrolled Janssen Pharmaceutical K.K.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.

Timeline

Start
2016-12-21
Primary completion
2018-05-07
Completion
2018-05-07

Drugs

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