At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 230 enrolled
Drug / intervention
Daclatasvir +2 moredrug
Likely dose
Daclatasvir 30 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.
A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C
In Brief
A Phase 2 clinical trial evaluating Daclatasvir, Simeprevir, and 1 other intervention for Hepatitis C Virus. Completed, enrolled 230 participants across 26 sites in 6 countries.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesArgentina, France, Germany, Hungary, Spain, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionAug 2013
Study CompletionNov 2013
TodayJul 2026
First PostedJun 27, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.0 years ago
Interventions
Daclatasvirdrug
Tablets, oral, 30 mg, once daily
Simeprevirdrug
Capsule, oral, 150 mg, once daily
Ribavirindrug
Tablets, oral, 500-600 mg, twice daily