At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 363 enrolled
Drug / intervention
ABT-450/r/ABT-267 +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, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT I)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267 and Placebo for Chronic Hepatitis C Infection. Completed, enrolled 363 participants.
Detailed Summary
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionOct 2014
Study CompletionOct 2015
TodayJul 2026
First PostedDec 30, 2013
Enrollment StartDec 1, 2013
Primary CompletionOct 1, 2014
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.5 years ago
Interventions
ABT-450/r/ABT-267drug
Tablet; ABT-450 coformulated with ritonavir and ABT-267
Placebodrug
Tablet