NCT01846494已完成不适用
Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 13
- 主要终点
- Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Exclusion Criteria
- •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)
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
时间窗: 5 years
次要结局
- Composite of Death and Cardiovascular and Renal Dysfunction(5 years)
研究者
研究点 (13)
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