Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus

Treatments: Drug: BMS-790052; Drug: ribavirin; Drug: peginterferon alfa-2a; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170962

AI444-011

2010-019378-34 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Enrollment: 512 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects chronically infected with HCV genotype 1
• Non-responder to prior therapy with peginterferon alfa and ribavirin
• HCV RNA viral load of 100,00 IU/mL
• Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
• Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
• Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion criteria

• Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
• Evidence of medical condition associated with chronic liver disease other than HCV
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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512 participants in 5 patient groups

Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin

Experimental group

Description:

(prior null responders)

Treatment:

Drug: BMS-790052

Drug: peginterferon alfa-2a

Drug: ribavirin

Drug: BMS-790052

Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin

Experimental group

Description:

(prior null responders)

Treatment:

Drug: BMS-790052

Drug: peginterferon alfa-2a

Drug: ribavirin

Drug: BMS-790052

Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin

Experimental group

Description:

(prior partial responders)

Treatment:

Drug: BMS-790052

Drug: peginterferon alfa-2a

Drug: ribavirin

Drug: BMS-790052

Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin

Experimental group

Description:

(prior partial responders)

Treatment:

Drug: BMS-790052

Drug: peginterferon alfa-2a

Drug: ribavirin

Drug: BMS-790052

Arm 5: Placebo plus peginterferon alfa-2a and ribavirin

Experimental group

Description:

(prior partial responders only)

Treatment:

Drug: peginterferon alfa-2a

Drug: ribavirin

Drug: Placebo