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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:May 10, 2013
End Date:March 19, 2018

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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)
We found this trial at
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
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Asheville, North Carolina 28801
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Kansas City, Missouri 64131
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Lancaster, Pennsylvania 17603
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Minneapolis, Minnesota 55414
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New York, New York 10065
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San Antonio, Texas 78215
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San Diego, California 92037
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San Diego, California 92105
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San Francisco, California 94115
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Tulsa, Oklahoma 74137
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