At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 187 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, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-II)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333 and Ribavirin for Chronic Hepatitis C Infection. Completed, enrolled 187 participants.
Detailed Summary
The purpose of this study is to evaluate the safety and antiviral activity 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) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionJan 2014
Study CompletionOct 2014
TodayJul 2026
First PostedAug 29, 2012
Enrollment StartAug 1, 2012
Primary CompletionJan 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.8 years ago
Interventions
ABT-450/r/ABT-267, ABT-333drug
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirindrug
Tablet