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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Hepatitis C Infection

Treatments

Drug: Placebo
Drug: Peginterferon alpha-2a
Drug: Daclatasvir
Drug: ribavirin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00874770
EUDRACT# 2009-010149-29
AI444-014

Details and patient eligibility

About

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-hepatitis C virus activity.

Enrollment

74 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • 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 Criteria:

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

74 participants in 4 patient groups

Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Experimental group
Description:
Active Comparator
Treatment:
Drug: ribavirin
Drug: Daclatasvir
Drug: Peginterferon alpha-2a
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Experimental group
Description:
Active Comparator
Treatment:
Drug: ribavirin
Drug: Daclatasvir
Drug: Peginterferon alpha-2a
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Experimental group
Description:
Active Comparator
Treatment:
Drug: ribavirin
Drug: Daclatasvir
Drug: Peginterferon alpha-2a
Placebo, Peginterferon alpha-2a, ribavirin (D)
Active Comparator group
Treatment:
Drug: ribavirin
Drug: Peginterferon alpha-2a
Drug: Placebo

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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