Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
CARE-Hep C
2 other identifiers
observational
113
2 countries
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2013
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2018
CompletedResults Posted
Study results publicly available
March 22, 2019
CompletedMarch 22, 2019
December 1, 2018
4.9 years
May 1, 2013
December 12, 2018
December 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
5 years
Secondary Outcomes (1)
Composite of Death and Cardiovascular and Renal Dysfunction
5 years
Study Arms (2)
Hepatitis C Virus (HCV) patients exposed to BMS-986094
Hepatitis C infected patients with previous exposure to BMS-986094
HCV patients not exposed to BMS-986094
Hepatitis C patients without exposure to BMS-986094
Eligibility Criteria
Hepatitis C positive subjects previously exposed to BMS 986094 and Hepatitis C positive subjects not previously exposed to BMS 986094.
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (13)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Scripps Clinic
San Diego, California, 92037, United States
Tuan Nguyen, MD
San Diego, California, 92105, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415-1829, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Lancaster Heart Foundation
Lancaster, Pennsylvania, 17603, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Fundacion de Investigation de Diego
San Juan, 00927, Puerto Rico
Biospecimen
Plasma, serum, and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allison DeLong
- Organization
- Duke Clinical Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian F. Hernandez, MD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
May 10, 2013
Primary Completion
March 19, 2018
Study Completion
March 19, 2018
Last Updated
March 22, 2019
Results First Posted
March 22, 2019
Record last verified: 2018-12