NCT00663208

A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Daclatasvir	Capsule, Oral, Approximately 182 days from initial dosing
DRUG	Placebo	Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-04-22
• Last updated: 2015-10-14
• Results posted: 2015-10-14

Locations

8 sites across 2 countries: United States, Puerto Rico