At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 116 enrolled
Drug / intervention
Daclatasvir +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 Phase 3 Evaluation of Daclatasvir, Sofosbuvir, and Ribavirin in Genotype 1-6 Chronic Hepatitis C Infection Subjects With Cirrhosis Who May Require Future Liver Transplant and Subjects Post-Liver Transplant
In Brief
A Phase 3 clinical trial evaluating Daclatasvir, Sofosbuvir, and 1 other intervention for Hepatitis C. Completed, enrolled 116 participants across 5 sites.
Detailed Summary
This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMar 2014
Primary CompletionNov 2014
Study CompletionJan 2016
TodayJul 2026
First PostedJan 10, 2014
Enrollment StartMar 1, 2014
Primary CompletionNov 1, 2014
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.5 years ago
Interventions
Daclatasvirdrug
Sofosbuvirdrug
Ribavirindrug