drugset / Trial / NCT02442271

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

NCT02442271

Phase 3 Completed 222 enrolled AbbVie
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

Timeline

Start
2015-04-27
Primary completion
2016-07-04
Completion
2016-09-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg
Subject Ritonavir Other / unclassified 100 mg
Subject dasabuvir Small molecule 250 mg
Subject ombitasvir Small molecule 25 mg
Subject paritaprevir Small molecule 150 mg