Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)

Duke University

Status: Completed

Conditions: Hepatitis C

Study type: Observational

Funder types: Other

Identifiers

NCT01846494

Pro00044788 (Other Identifier)

Pro00042419

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

113 participants in 2 patient groups

Hepatitis C Virus (HCV) patients exposed to BMS-986094

Description:

Hepatitis C infected patients with previous exposure to BMS-986094

HCV patients not exposed to BMS-986094

Description:

Hepatitis C patients without exposure to BMS-986094