CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 167 enrolled
Drug / intervention
Daclatasvir +1 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.

Search/NCT00663208
NCT00663208Phase 2Completed

Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of Daclatasvir in Subjects Infected With Hepatitis C Virus Genotype 1

Bristol-Myers Squibb·interventional·Posted Apr 22, 2008·Updated Oct 14, 2015

In Brief

A Phase 2 clinical trial evaluating Daclatasvir and Placebo for Chronic Hepatitis C. Completed, enrolled 167 participants across 8 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2008
Enrollment StartMay 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.2 years ago

Interventions

Daclatasvirdrug

Capsule, Oral, Approximately 182 days from initial dosing

Placebodrug

Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel