Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Pegylated-interferon alfa-2a; Drug: BMS-790052; Drug: BMS-650032; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012895

AI447-011

2010-024637-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Enrollment: 215 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects ages 18 to 70 years
• HCV-Infected Genotype 1 Null responders to current standard of care
• Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Exclusion criteria

• Evidence of a medical condition associate with chronic liver disease other than HCV
• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
• History of Cancer within 5 years of enrollment
• History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
• History of clinically significant cardiac disease
• History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Documented cirrhosis within 12 months prior to dosing
• Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 7 patient groups

Arm 1: Sentinel A

Experimental group

Description:

BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily

Treatment:

Drug: BMS-650032

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032

Arm 2: Sentinel B

Experimental group

Description:

BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin

Treatment:

Drug: BMS-650032

Drug: Ribavirin

Drug: Pegylated-interferon alfa-2a

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032

Arm 3: Expansion A1

Experimental group

Description:

BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily

Treatment:

Drug: BMS-650032

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032

Arm 4: Expansion A2

Experimental group

Description:

BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily

Treatment:

Drug: BMS-650032

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032

Arm 5: Expansion B1

Experimental group

Description:

BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin

Treatment:

Drug: BMS-650032

Drug: Ribavirin

Drug: Pegylated-interferon alfa-2a

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032

Arm 6: Expansion B2

Experimental group

Description:

BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin

Treatment:

Drug: BMS-650032

Drug: Ribavirin

Drug: Pegylated-interferon alfa-2a

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032

Arm 7: Expansion B3

Experimental group

Description:

BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin

Treatment:

Drug: BMS-650032

Drug: Ribavirin

Drug: BMS-650032

Drug: BMS-790052

Drug: BMS-650032