CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
ombitasvir/paritaprevir/ritonavir +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02265237
NCT02265237Phase 3Completed
CompareCT.gov

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)

AbbVie·interventional·Posted Oct 15, 2014·Updated Aug 31, 2017

In Brief

A Phase 3 clinical trial evaluating ombitasvir/paritaprevir/ritonavir and ribavirin for Hepatitis C Virus. Completed, enrolled 184 participants.

Detailed Summary

The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis is to assess the safety and to compare the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\], to a clinically relevant threshold \[based on SVR rates for HCV genotype 4-infected participants treated with pegylated interferon (pegIFN)/RBV\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 15, 2014
Enrollment StartOct 28, 2014
Primary CompletionJul 28, 2016
Study CompletionApr 7, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.7 years ago

Interventions

ombitasvir/paritaprevir/ritonavirdrug

tablets

ribavirindrug

tablets