Clinical trial NCT01846494: Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Official title: Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C positive subjects previously exposed to BMS 986094 and Hepatitis C positive subjects not previously exposed to BMS 986094.

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.


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)

Primary outcomes:
measure: Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
timeFrame: 5 years
Secondary outcomes:
measure: Composite of Death and Cardiovascular and Renal Dysfunction
timeFrame: 5 years
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: San Diego
country: United States
facility: Tuan Nguyen, MD
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Gastroenterology and Hepatology
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster Heart Foundation
state: Pennsylvania
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigation de Diego
Study officials:
affiliation: Duke Clinical Research Institute
name: Adrian F. Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: