CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 558 enrolled
Drug / intervention
Daclatasvir +4 moredrug
Likely dose
Daclatasvir 20 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.

Search/NCT01125189
NCT01125189Phase 2Completed
CompareCT.gov

A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

Bristol-Myers Squibb·interventional·Posted May 18, 2010·Updated Oct 23, 2015

In Brief

A Phase 2 clinical trial evaluating Daclatasvir, Placebo, and 2 other interventions for Hepatitis C Virus. Completed, enrolled 558 participants across 64 sites in 11 countries.

Detailed Summary

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesAustralia, Canada, Denmark, Egypt, France, Germany, Italy, Mexico, Puerto Rico, Sweden, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.1 years ago

Interventions

Daclatasvirdrug

Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response

Daclatasvirdrug

Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response

Placebodrug

Tablets, oral, 0 mg, once daily, 24 weeks

peg-interferon alfa-2adrug

Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response

ribavirindrug

Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response