A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: BMS-790052 (Daclatasvir); Drug: BMS-650032 (Asunaprevir)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497834

AI447-026

Details and patient eligibility

About

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

Enrollment: 224 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV-1b infected patient
• HCV RNA viral load of ≥ 100,000 IU/mL at screening
• Ages 20 to 75 years
• Non-responder to Interferon plus Ribavirin therapy
• Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

Exclusion criteria

Patients who have -

• Hepatocellular carcinoma
• Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
• Severe or uncontrollable complication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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224 participants in 1 patient group

Daclatasvir + Asunaprevir

Experimental group

Treatment:

Drug: BMS-790052 (Daclatasvir)

Drug: BMS-650032 (Asunaprevir)