Status:
COMPLETED
Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Lead Sponsor:
Duke University
Conditions:
Hepatitis C
Eligibility:
All Genders
Brief Summary
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 infe...
Eligibility Criteria
Inclusion
- 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.
- All Subjects must give informed consent prior to participation in the study.
- Subject participated in the Phase 1 or Phase 2 trials with BMS 986094 (including placebo arm) OR
- Subject with known hepatitis C (Control)
- No previous exposure to BMS 986094
- 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
- For subjects who participated in the Phase 1 or Phase 2 trials with BMS 986094, there are no exclusion criteria
- For the control group of subjects without exposure to BMS 986094, the following exclusion criteria, based on clinically available data, apply:
- 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
- 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
- History of liver transplantation
- Co-infection with HIV (positive test for anti-HIV Ab)
- Prior history of cardiomyopathy (ejection fraction ≤ 50%) or history of heart failure
- Signs or symptoms of decompensated heart failure or
- Prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)
Exclusion
Key Trial Info
Start Date :
May 10 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01846494
Start Date
May 10 2013
End Date
March 19 2018
Last Update
March 22 2019
Active Locations (13)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
Scripps Clinic
San Diego, California, United States, 92037
3
Tuan Nguyen, MD
San Diego, California, United States, 92105
4
Quest Clinical Research
San Francisco, California, United States, 94115