CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Daclatasvir +4 moredrug
Likely dose
Daclatasvir 10 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/NCT01017575
NCT01017575Phase 2Completed
CompareCT.gov

A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Bristol-Myers Squibb·interventional·Posted Nov 20, 2009·Updated Sep 11, 2015

In Brief

A Phase 2 clinical trial evaluating Daclatasvir, Placebo, and 2 other interventions for Hepatitis C Infection. Completed, enrolled 55 participants across 6 sites.

Detailed Summary

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Infection
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2009
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.6 years ago

Interventions

Daclatasvirdrug

Tablets, Oral, 10 mg, daily, 24-48 weeks

Daclatasvirdrug

Tablets, Oral, 60 mg, daily, 24-48 weeks

Placebodrug

Tablets, Oral, 0 mg, daily, 48 weeks

Peginterferon alfa-2adrug

Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks

Ribavirindrug

Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks