At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 230 enrolled
Drug / intervention
Glecaprevir/Pibrentasvirdrug
Likely dose
Glecaprevir/Pibrentasvir 100 mgfrom 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.
A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1
In Brief
A Phase 3 clinical trial evaluating Glecaprevir/Pibrentasvir for Hepatitis C Virus (HCV). Completed, enrolled 230 participants across 42 sites in 10 countries.
Detailed Summary
A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
CountriesBulgaria, Canada, France, Germany, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartAug 2017
Primary CompletionAug 2018
TodayJul 2026
First PostedJul 11, 2017
Enrollment StartAug 7, 2017
Primary CompletionAug 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.0 years ago
Interventions
Glecaprevir/Pibrentasvirdrug
Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.