Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Infection

Treatments: Drug: Ribavirin; Drug: Placebo; Drug: Peginterferon alfa-2b; Drug: BMS-790052

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016912

AI444-021

Details and patient eligibility

About

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Enrollment: 51 patients

Sex: All

Ages: 20 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 ≥10*5* IU/mL at screening
• Naïve or nonresponsive to the current standard of care

Key Exclusion Criteria:

• Cirrhosis
• Hepatocellular carcinoma
• Coinfection with hepatitis B virus, HIV-1 or HIV-2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 5 patient groups, including a placebo group

Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Experimental group

Description:

Treatment Naive

Treatment:

Drug: BMS-790052

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Drug: BMS-790052

Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Experimental group

Description:

Treatment Naive

Treatment:

Drug: BMS-790052

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Drug: BMS-790052

Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)

Placebo Comparator group

Description:

Treatment Naive

Treatment:

Drug: Placebo

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)

Experimental group

Description:

Non-Responder

Treatment:

Drug: BMS-790052

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Drug: BMS-790052

Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)

Experimental group

Description:

Non-Responder

Treatment:

Drug: BMS-790052

Drug: Peginterferon alfa-2b

Drug: Ribavirin

Drug: BMS-790052