NCT01193361

Ph IIA Study (SOC +/- NS5B)

Official Title:

A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Summary

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

Eligibility

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

Disease(s) and\or Condition(s)

Hepatitis C Virus

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: BMS-791325
    • Description: Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
    • Arm Group Labels: Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
    • Type: DRUG
    • Name: BMS-791325
    • Description: Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
    • Arm Group Labels: Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
    • Type: DRUG
    • Name: Placebo
    • Description: Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
    • Arm Group Labels: Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
    • Type: DRUG
    • Name: Peg-interferon alfa-2a
    • Description: Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
    • Arm Group Labels: Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
    • Type: DRUG
    • Name: Ribavirin
    • Description: Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
    • Arm Group Labels: Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin, Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Sponsor
  • Bristol-Myers Squibb