Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
- Conditions
- Hepatitis C
- Registration Number
- NCT01846494
- Lead Sponsor
- Duke University
- 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 infected patients who have never taken BMS-986094.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Subjects will be enrolled based on prior enrollment in the BMS 986094 studies or treatment-naïve HCV subjects with no known cardiovascular abnormalities.
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All Subjects must give informed consent prior to participation in the study.
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Subject participated in the Phase 1 or Phase 2 trials with BMS 986094 (including placebo arm) OR
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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
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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)
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause 5 years
- Secondary Outcome Measures
Name Time Method Composite of Death and Cardiovascular and Renal Dysfunction 5 years Reported as percentage of participants experiencing one or more of the following endpoints: all-cause mortality, rehospitalization for cardiac/renal cause, increase in BNP to \>100 or doubling from baseline, new onset of LVEF \<50%, new onset of eGFR \<60% or \>= 25% reduction from baseline.
Trial Locations
- Locations (13)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Scripps Clinic
🇺🇸San Diego, California, United States
Tuan Nguyen, MD
🇺🇸San Diego, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Options Health Research
🇺🇸Tulsa, Oklahoma, United States
Lancaster Heart Foundation
🇺🇸Lancaster, Pennsylvania, United States
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