At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 305 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-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)
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 305 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 1a (HCV GT1a) infection without cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedApr 2013
Primary CompletionDec 2013
Study CompletionSep 2014
TodayJul 2026
First PostedApr 17, 2013
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.2 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