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 |
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.
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
13
sites
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)