Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01846494
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01846494
Study Brief:
Protocol Section:
NCT01846494