drugset / Trial / NCT02806362

Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)

NCT02806362

Phase 3 Withdrawn AbbVie
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.

Timeline

Start
2016-09
Primary completion
2018-06
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ritonavir Other / unclassified 100 mg
Subject ombitasvir Small molecule 25 mg
Subject paritaprevir Small molecule 50 mg