Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients (HEPCAT)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus

Treatments: Drug: peg-interferon alfa-2a; Drug: ribavirin; Drug: Daclatasvir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125189

2010-018295-24 (EudraCT Number)

AI444-010

Details and patient eligibility

About

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Enrollment: 558 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
• HCV RNA viral load of ≥100,000 IU/mL
• No previous exposure to interferon, pegIFNα, or RBV
• Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
• Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
• Body mass index of 18 to 35 kg/m^2

Exclusion criteria

• Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
• Evidence of a 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: Quadruple Blind

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558 participants in 3 patient groups, including a placebo group

Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)

Experimental group

Treatment:

Drug: Daclatasvir

Drug: ribavirin

Drug: peg-interferon alfa-2a

Drug: Daclatasvir

Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)

Experimental group

Treatment:

Drug: Daclatasvir

Drug: ribavirin

Drug: peg-interferon alfa-2a

Drug: Daclatasvir

Placebo plus peg-interferon alfa-2a and ribavirin

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: ribavirin

Drug: peg-interferon alfa-2a