At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 343 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.
A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
In Brief
A Phase 3 clinical trial evaluating Glecaprevir/Pibrentasvir for Hepatitis C Virus (HCV). Completed, enrolled 343 participants across 113 sites in 19 countries.
Detailed Summary
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
CountriesBulgaria, Canada, Czechia, France, Greece, Hungary, Ireland, Israel, Italy, Poland, Portugal, Puerto Rico, Romania, Russia, Spain, Taiwan, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartApr 2017
Primary CompletionJul 2019
Study CompletionNov 2019
TodayJul 2026
First PostedMar 24, 2017
Enrollment StartApr 28, 2017
Primary CompletionJul 31, 2019
Study CompletionNov 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.3 years ago
Interventions
Glecaprevir/Pibrentasvirdrug
Tablet