CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Glecaprevir/pibrentasvirdrug
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/NCT03069365
NCT03069365Phase 3Completed
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A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-5)

AbbVie·interventional·Posted Mar 3, 2017·Updated Mar 4, 2019

In Brief

A Phase 3 clinical trial evaluating Glecaprevir/pibrentasvir for Hepatitis C Virus (HCV). Completed, enrolled 101 participants across 38 sites in 10 countries.

Detailed Summary

This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
CountriesCanada, Germany, Greece, Italy, Poland, Puerto Rico, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartMar 28, 2017
Primary CompletionFeb 20, 2018
Study CompletionJun 5, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.3 years ago

Interventions

Glecaprevir/pibrentasvirdrug

Film-coated tablet