At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 171 enrolled
Drug / intervention
ABT-450/r/ABT-267 +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.
An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267 and Ribavirin for Hepatitis C Virus. Completed, enrolled 171 participants.
Detailed Summary
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJan 2014
Primary CompletionApr 2015
Study CompletionSep 2015
TodayJul 2026
First PostedDec 30, 2013
Enrollment StartJan 1, 2014
Primary CompletionApr 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.5 years ago
Interventions
ABT-450/r/ABT-267drug
Tablet; ABT-450 coformulated with ritonavir and ABT-267
Ribavirindrug
Capsule