At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 419 enrolled
Drug / intervention
ABT-450/r/ABT-267, ABT-333 +2 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, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333, Ribavirin, and 1 other intervention for Chronic Hepatitis C Infection. Completed, enrolled 419 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 StartDec 2012
First PostedJan 2013
Primary CompletionDec 2013
Study CompletionAug 2014
TodayJul 2026
First PostedJan 14, 2013
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.5 years ago
Interventions
ABT-450/r/ABT-267, ABT-333drug
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirindrug
Capsule
Placebo for ribavirindrug
Capsule