N/A
Completed N=113
Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Source: ClinicalTrials.gov NCT01846494 ↗Enrolled (actual)
113
Serious AEs
2.7%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause — 1; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause |
1; 2 | — |
| SECONDARY Composite of Death and Cardiovascular and Renal Dysfunction |
31.1; 35.2 | 0.6173 |
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.
- 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)
Data sourced from ClinicalTrials.gov (NCT01846494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.