At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 636 enrolled
Drug / intervention
ABT-450/r/ABT-267, ABT-333 +4 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, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333, Ribavirin, and 3 other interventions for Chronic Hepatitis C Infection. Completed, enrolled 636 participants.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartNov 2012
Primary CompletionOct 2013
Study CompletionOct 2014
TodayJul 2026
First PostedOct 30, 2012
Enrollment StartNov 1, 2012
Primary CompletionOct 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.7 years ago
Interventions
ABT-450/r/ABT-267, ABT-333drug
ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirindrug
Capsule (double-blind treatment period), tablet (open-label treatment period)
Placebo for ABT-450/r/ABT-267drug
Tablet
Placebo for ABT-333drug
Tablet
Placebo for ribavirindrug
Capsule