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

Completed

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01846494

Run by

Duke University

People needed

113

Starts

2013-05-10

Expected to finish

2018-03-19

Last updated by the study team

2019-03-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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)

Where it is running

• 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
• Central Texas Clinical Research — Austin, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Fundacion de Investigation de Diego — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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