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

Hepatitis C Clinical Trial

— CARE-Hep C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846494
• Other study ID #: Pro00042419
• Secondary ID: Pro00044788
• Status: Completed
• Start date: May 10, 2013
• Est. completion date: March 19, 2018

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigation de Diego	San Juan
United States	Anaheim Clinical Trials	Anaheim	California
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Central Texas Clinical Research	Austin	Texas
United States	Kansas City Gastroenterology and Hepatology	Kansas City	Missouri
United States	Lancaster Heart Foundation	Lancaster	Pennsylvania
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Weill Cornell Medical Center	New York	New York
United States	Alamo Medical Research	San Antonio	Texas
United States	Scripps Clinic	San Diego	California
United States	Tuan Nguyen, MD	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Options Health Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause		5 years
Secondary	Composite of Death and Cardiovascular and Renal Dysfunction	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.	5 years