Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01846494
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hepatitis C

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 113 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Actual Study Start Date : May 10, 2013
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Composite of Death and Cardiovascular and Renal Dysfunction [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Plasma, serum, and urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846494


Locations
Layout table for location information
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Scripps Clinic
San Diego, California, United States, 92037
Tuan Nguyen, MD
San Diego, California, United States, 92105
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415-1829
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
United States, Oklahoma
Options Health Research
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Lancaster Heart Foundation
Lancaster, Pennsylvania, United States, 17603
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Alamo Medical Research
San Antonio, Texas, United States, 78215
Puerto Rico
Fundacion de Investigation de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Adrian F. Hernandez, MD Duke Clinical Research Institute
  Study Documents (Full-Text)

Documents provided by Duke University:
Additional Information:

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01846494    
Other Study ID Numbers: Pro00042419
Pro00044788 ( Other Identifier: Duke eIRB Biorepository Protocol Number )
First Posted: May 3, 2013    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections