At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 136 enrolled
Drug / intervention
ABT-493/ABT-530 +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, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)
In Brief
A Phase 3 clinical trial evaluating ABT-493/ABT-530, sofosbuvir (SOF), and 1 other intervention for Chronic Hepatitis C Virus and Hepatitis C Virus. Completed, enrolled 136 participants.
Detailed Summary
The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus, Hepatitis C Virus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionJan 2017
Study CompletionMar 2017
TodayJul 2026
First PostedMar 30, 2016
Enrollment StartApr 8, 2016
Primary CompletionJan 19, 2017
Study CompletionMar 24, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.3 years ago
Interventions
ABT-493/ABT-530drug
Co-formulated tablet
sofosbuvir (SOF)drug
Tablet
ribavirin (RBV)drug
Capsule