Longitudinal Assessment of Cardiovascular and Renal Health in Patients with Hepatitis-C [Protocol: CARE-Hep C]

Trial ID:
IRB-13-6134
Paul Pockros
The purpose of this study is to monitor the cardiovascular and renal health of patients who previously took BMS-986094 (an investigational medication for hepatitis C) in comparison to hepatitis C infected patients who have never taken BMS-986094.

Inclusion Criteria:

    Subjects will be enrolled based on prior enrollment in the BMS 986094 studies or treatment-naïve HCV subjects with no known cardiovascular abnormalities.

    • 1. All Subjects must give informed consent prior to participation in the study.
    • 2. Subject participated in the Phase 1 or Phase 2 trials with BMS 986094 (including placebo arm) OR
    • 3. Subject with known hepatitis C (Control)
      • 1. No previous exposure to BMS 986094
      • 2. Treatment naive at study entry (No prior hepatitis C treatment experience at the time of enrollment, including but not limited to: standard interferon, pegylated interferon, ribavirin, boceprevir, telaprevir, or other experimental drugs for hepatitis C).

      Exclusion Criteria:

    • 1. For subjects who participated in the Phase 1 or Phase 2 trials with BMS 986094, there are no exclusion criteria:
      • 2. For the control group of subjects without exposure to BMS 986094, the following exclusion criteria, based on clinically available data, apply:
        • 1. Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by an indirect bilirubin >2, ALT or AST laboratory values ≥ 10 times the upper limit of normal, or other evidence of decompensated liver disease or hepatocellular carcinoma
        • 2. Chronic liver disease other than HCV not limited to Hepatitis B virus (positive test for HBsAg), hemochromatosis, auto-immune hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease
        • 3. History of liver transplantation
        • 4. Co-infection with HIV (positive test for anti-HIV Ab)
        • 5. Prior history of cardiomyopathy (ejection fraction ≤ 50%) or history of heart failure
        • 6. Signs or symptoms of decompensated heart failure or
        • 7. Prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)

Contact Info:

  • Jennifer Murphy
  • jennifer.murphy@duke.edu