At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 276 enrolled
Drug / intervention
Daclatasvir +3 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.
An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C
In Brief
A Phase 2 clinical trial evaluating Daclatasvir, Asunaprevir, and 2 other interventions for Hepatitis C Virus Infection. Completed, enrolled 276 participants across 106 sites in 19 countries.
Detailed Summary
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesArgentina, Australia, Austria, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, New Zealand, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionSep 2014
Study CompletionDec 2014
TodayJul 2026
First PostedSep 2, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.8 years ago
Interventions
Daclatasvirdrug
Asunaprevirdrug
Pegylated interferon alfa-2adrug
Ribavirindrug