At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 129 enrolled
Drug / intervention
ombitasvir/paritaprevir/ritonavir and dasabuvir +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.
Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With Hepatitis C Virus (HCV) Infection (CORAL-I)
In Brief
A Phase 2 clinical trial evaluating ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, and 1 other intervention for Chronic Hepatitis C Infection. Completed, enrolled 129 participants.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartFeb 2013
Primary CompletionNov 2016
Study CompletionJul 2017
TodayJul 2026
First PostedFeb 4, 2013
Enrollment StartFeb 25, 2013
Primary CompletionNov 2, 2016
Study CompletionJul 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.4 years ago
Interventions
ombitasvir/paritaprevir/ritonavir and dasabuvirdrug
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
ombitasvir/paritaprevir/ritonavirdrug
Tablet; ombitasvir coformulated with paritaprevir and ritonavir
ribavirindrug
tablet