CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 546 enrolled
Drug / intervention
Placebo +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/NCT03222583
NCT03222583Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

AbbVie·interventional·Posted Jul 19, 2017·Updated Dec 23, 2019

In Brief

A Phase 3 clinical trial evaluating Placebo and Glecaprevir/Pibrentasvir for Hepatitis C Virus (HCV). Completed, enrolled 546 participants across 48 sites in 3 countries.

Detailed Summary

This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
CountriesChina, Singapore, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 19, 2017
Enrollment StartOct 4, 2017
Primary CompletionOct 18, 2018
Study CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.0 years ago

Interventions

Placebodrug

Matching placebo tablet for oral administration

Glecaprevir/Pibrentasvirdrug

Coformulated tablet for oral administration