At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 381 enrolled
Drug / intervention
ABT-450/r/ABT-267, ABT-333 +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.
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333 and Ribavirin (RBV) for Chronic Hepatitis C Infection and Compensated Cirrhosis. Completed, enrolled 381 participants.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionJan 2014
Study CompletionSep 2014
TodayJul 2026
First PostedOct 11, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.7 years ago
Interventions
ABT-450/r/ABT-267, ABT-333drug
Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet
Ribavirin (RBV)drug
Capsule