At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 350 enrolled
Drug / intervention
PSI-7977 +2 moredrug
Likely dose
PSI-7977 400 mgfrom 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.
Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
In Brief
A Phase 2 clinical trial evaluating PSI-7977, Daclatasvir, and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 350 participants across 18 sites in 2 countries.
Detailed Summary
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesPuerto Rico, United States
CollaboratorsPharmasset
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionJan 2013
Study CompletionOct 2013
TodayJul 2026
First PostedMay 25, 2011
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago
Interventions
PSI-7977drug
Tablets, oral, 400 mg, once daily
Daclatasvirdrug
Tablets, oral, 60 mg, once daily
Ribavirindrug
Tablets, oral, 200 mg