Ph IIA Study (SOC +/- NS5B) (HEPCAT)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus

Treatments: Drug: Ribavirin; Drug: Peg-interferon alfa-2a; Drug: Placebo; Drug: BMS-791325

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193361

AI443-012

Details and patient eligibility

About

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
• HCV RNA ≥ 10*5* IU/mL at Screening
• Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
• Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
• Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening

Exclusion criteria

• Liver transplant recipients
• Documented or suspected HCC by imaging or liver biopsy
• Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 3 patient groups, including a placebo group

Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

Experimental group

Treatment:

Drug: BMS-791325

Drug: Peg-interferon alfa-2a

Drug: BMS-791325

Drug: Ribavirin

Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

Experimental group

Treatment:

Drug: BMS-791325

Drug: Peg-interferon alfa-2a

Drug: BMS-791325

Drug: Ribavirin

Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Peg-interferon alfa-2a

Drug: Ribavirin