drugset / Trial / NCT02114151

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

NCT02114151

Phase 3 Completed 103 enrolled Janssen Infectious Diseases BVBA
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

Timeline

Start
2014-04
Primary completion
2015-01
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 150 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral