At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 295 enrolled
Drug / intervention
ABT-493/ABT-530 +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 Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)
In Brief
A Phase 3 clinical trial evaluating ABT-493/ABT-530 and OBV/PTV/r for Chronic Hepatitis C Virus and Hepatitis C Virus. Completed, enrolled 295 participants.
Detailed Summary
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve, and DAA treatment-experienced Japanese adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus, Hepatitis C Virus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedMar 2016
Primary CompletionNov 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedMar 14, 2016
Enrollment StartFeb 22, 2016
Primary CompletionNov 14, 2016
Study CompletionFeb 9, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.3 years ago
Interventions
ABT-493/ABT-530drug
Co-formulated tablet
OBV/PTV/rdrug
Co-formulated tablet