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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01846494
• Collaborator: (none)
• Enrollment: 113
• Locations: 13
• Actual Duration (Months): 58.3
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Intervention/Treatment	Phase
Hepatitis C

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 113 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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: Mar 19, 2018
• Actual Study Completion Date: Mar 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause [5 years]

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

4. No previous exposure to BMS 986094

5. 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:

3. 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

1. 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

2. History of liver transplantation

3. Co-infection with HIV (positive test for anti-HIV Ab)

4. Prior history of cardiomyopathy (ejection fraction ≤ 50%) or history of heart failure

5. Signs or symptoms of decompensated heart failure or

6. Prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials	Anaheim	California	United States	92801
2	Scripps Clinic	San Diego	California	United States	92037
3	Tuan Nguyen, MD	San Diego	California	United States	92105
4	Quest Clinical Research	San Francisco	California	United States	94115
5	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415-1829
6	Kansas City Gastroenterology and Hepatology	Kansas City	Missouri	United States	64131
7	Weill Cornell Medical Center	New York	New York	United States	10021
8	Asheville Gastroenterology Associates, PA	Asheville	North Carolina	United States	28801
9	Options Health Research	Tulsa	Oklahoma	United States	74104
10	Lancaster Heart Foundation	Lancaster	Pennsylvania	United States	17603
11	Central Texas Clinical Research	Austin	Texas	United States	78705
12	Alamo Medical Research	San Antonio	Texas	United States	78215
13	Fundacion de Investigation de Diego	San Juan		Puerto Rico	00927

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Adrian F. Hernandez, MD, Duke Clinical Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 18, 2013

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01846494
• Other Study ID Numbers: Pro00042419; Pro00044788
• First Posted: May 3, 2013
• Last Update Posted: Mar 22, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis

Study Results

Participant Flow

Recruitment Details	113 participants recruited from 10 May 2013 (first participant first visit) to 10 Mar 2018 (last participant last visit) at 15 clinical sites. One participant was followed by the Duke Clinical Research Institute (DCRI) call center.

Arm/Group Title	HCV Patients Not Exposed to BMS-986094	Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
Arm/Group Description	Hepatitis C patients without exposure to BMS-986094	Hepatitis C infected patients with previous exposure to BMS-986094
Period Title: Overall Study
STARTED	50	63
COMPLETED	20	25
NOT COMPLETED	30	38

Baseline Characteristics

Arm/Group Title	HCV Patients Not Exposed to BMS-986094	Hepatitis C Virus (HCV) Patients Exposed to BMS-986094	Total
Arm/Group Description	Hepatitis C patients without exposure to BMS-986094	Hepatitis C infected patients with previous exposure to BMS-986094	Total of all reporting groups
Overall Participants	50	63	113
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.2 (9.74)	50.2 (9.74)	51.9 (9.90)
Sex: Female, Male (Count of Participants)
Female	20 40%	22 34.9%	42 37.2%
Male	30 60%	41 65.1%	71 62.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 30%	13 20.6%	28 24.8%
Not Hispanic or Latino	35 70%	50 79.4%	85 75.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	3 4.8%	3 2.7%
Asian	2 4%	1 1.6%	3 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 18%	2 3.2%	11 9.7%
White	38 76%	57 90.5%	95 84.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2%	0 0%	1 0.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Only subjects who were assessed at least once for each component of the composite endpoint were included for analysis.

Arm/Group Title	HCV Patients Not Exposed to BMS-986094	Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
Arm/Group Description	Hepatitis C patients without exposure to BMS-986094	Hepatitis C infected patients with previous exposure to BMS-986094
Measure Participants	46	57
Count of Participants [Participants]	1 2%	2 3.2%

2. Secondary Outcome

Title	Composite of Death and Cardiovascular and Renal Dysfunction
Description	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.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HCV Patients Not Exposed to BMS-986094	Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
Arm/Group Description	Hepatitis C patients without exposure to BMS-986094	Hepatitis C infected patients with previous exposure to BMS-986094
Measure Participants	50	63
Number [percentage of participants]	31.1 62.2%	35.2 55.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HCV Patients Not Exposed to BMS-986094, Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6173
	Comments
	Method	Log Rank
	Comments

Adverse Events

Time Frame	58 months
Adverse Event Reporting Description	Non-serious adverse events were not collected. Collection, evaluation, and reporting of serious adverse events (SAEs) was limited to SAEs related to cardiac and renal events dysfunction and SAEs resulting in death. Serious adverse events were collected and recorded on the SAE page of the eCRF from the signing of informed consent to the end of the follow-up period.
Arm/Group Title	HCV Patients Not Exposed to BMS-986094		Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
Arm/Group Description	Hepatitis C patients without exposure to BMS-986094		Hepatitis C infected patients with previous exposure to BMS-986094
All Cause Mortality
	HCV Patients Not Exposed to BMS-986094		Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/50 (2%)		2/63 (3.2%)
Serious Adverse Events
	HCV Patients Not Exposed to BMS-986094		Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/50 (2%)		2/63 (3.2%)
Cardiac disorders
Cardiac arrest	0/50 (0%)		1/63 (1.6%)
General disorders
Death	1/50 (2%)		0/63 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma	0/50 (0%)		1/63 (1.6%)
Other (Not Including Serious) Adverse Events
	HCV Patients Not Exposed to BMS-986094		Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.