Status:

COMPLETED

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Hepatitis C Infection

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatiti...

Eligibility Criteria

Inclusion

  • Key
  • Patients chronically infected with hepatitis C virus (HCV) genotype 1
  • HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
  • Treatment naive
  • Key

Exclusion

  • Women of child-bearing potential
  • Cirrhosis
  • Coinfection with HIV or hepatitis B virus

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2011

Estimated Enrollment :

74 Patients enrolled

Trial Details

Trial ID

NCT00874770

Start Date

June 1 2009

End Date

January 1 2011

Last Update

October 23 2015

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, United States, 36116

2

University Of Colorado Denver & Hospital

Aurora, Colorado, United States, 80045

3

Yale University School Of Medicine

New Haven, Connecticut, United States, 06520

4

Mercy Medical Center

Baltimore, Maryland, United States, 21202