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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Infection

Treatments: Drug: Daclatasvir; Drug: Peginterferon alfa-2a; Drug: Placebo; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017575

AI444-022

Details and patient eligibility

About

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Enrollment: 55 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects chronically infected with hepatitis C virus (HCV) genotype 1
• HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
• The current standard of care naïve or non-responder

Key Exclusion Criteria:

• Cirrhosis
• HCC
• Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 5 patient groups, including a placebo group

Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)

Experimental group

Description:

Treatment Naive

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Peginterferon alfa-2a

Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)

Experimental group

Description:

Treatment Naive

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Peginterferon alfa-2a

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

Placebo Comparator group

Description:

Treatment Naive

Treatment:

Drug: Ribavirin

Drug: Placebo

Drug: Peginterferon alfa-2a

Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)

Experimental group

Description:

Non-Responder

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Peginterferon alfa-2a

Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)

Experimental group

Description:

Non-Responder

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Peginterferon alfa-2a