Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)

Completed

• Conditions: Hepatitis C

• Registration Number: NCT01846494
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Study Start: 2013-05-10
• Primary Completion: 2018-03-19
• Study Completion: 2018-03-19
• Status Verified: 2018-12
• Results First Submitted: 2018-12-12
• Results First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Results First Posted: 2019-03-22
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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)

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause	5 years

Secondary Outcome Measures

Name	Time	Method
Composite of Death and Cardiovascular and Renal Dysfunction	5 years	Reported as percentage of participants experiencing one or more of the following endpoints: all-cause mortality, rehospitalization for cardiac/renal cause, increase in BNP to \>100 or doubling from baseline, new onset of LVEF \<50%, new onset of eGFR \<60% or \>= 25% reduction from baseline.

Trial Locations

Locations (13)

Asheville Gastroenterology Associates, PA; 🇺🇸 Asheville, North Carolina, United States

Scripps Clinic; 🇺🇸 San Diego, California, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Alamo Medical Research; 🇺🇸 San Antonio, Texas, United States

Kansas City Gastroenterology and Hepatology; 🇺🇸 Kansas City, Missouri, United States

Tuan Nguyen, MD; 🇺🇸 San Diego, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Fundacion de Investigation de Diego; 🇵🇷 San Juan, Puerto Rico

Lancaster Heart Foundation; 🇺🇸 Lancaster, Pennsylvania, United States

Options Health Research; 🇺🇸 Tulsa, Oklahoma, United States

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

Central Texas Clinical Research; 🇺🇸 Austin, Texas, United States