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

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

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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