Overview

This trial is active, not recruiting.

Condition hepatitis c
Sponsor Duke University
Start date April 2013
End date April 2018
Trial size 113 participants
Trial identifier NCT01846494, Pro00042419, Pro00044788

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Hepatitis C infected patients with previous exposure to BMS-986094
Hepatitis C patients without exposure to BMS-986094

Primary Outcomes

Measure
Cardiovascular dysfunction
time frame: 5 years
Renal dysfunction
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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)

Additional Information

Official title Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Principal investigator Adrian F. Hernandez, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Duke University.