At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 177 enrolled
Drug / intervention
Glecaprevir/Pibrentasvir (G/P) 300mg/120mg +1 moredrug
Likely dose
Glecaprevir/Pibrentasvir (G/P) 300mg/120mgfrom 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 Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy
In Brief
A Phase 3 clinical trial evaluating Glecaprevir/Pibrentasvir (G/P) 300mg/120mg and Ribavirin 200Mg Tablet for Hepatitis C and HCV. Completed, enrolled 177 participants across 31 sites.
Detailed Summary
The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, HCV
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill, AbbVie
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartApr 2017
Primary CompletionDec 2018
Study CompletionFeb 2020
TodayJul 2026
First PostedMar 27, 2017
Enrollment StartApr 20, 2017
Primary CompletionDec 28, 2018
Study CompletionFeb 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.3 years ago
Interventions
Glecaprevir/Pibrentasvir (G/P) 300mg/120mgdrug
daily
Ribavirin 200Mg Tabletdrug
Weight-based 1000-1200 mg