Trial Outcomes & Findings for Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C) (NCT NCT01846494)
NCT ID: NCT01846494
Last Updated: 2019-03-22
Results Overview
Recruitment status
COMPLETED
Target enrollment
113 participants
Primary outcome timeframe
5 years
Results posted on
2019-03-22
Participant Flow
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.
Participant milestones
| Measure |
HCV Patients Not Exposed to BMS-986094
Hepatitis C patients without exposure to BMS-986094
|
Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
Hepatitis C infected patients with previous exposure to BMS-986094
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
63
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
30
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
Baseline characteristics by cohort
| Measure |
HCV Patients Not Exposed to BMS-986094
n=50 Participants
Hepatitis C patients without exposure to BMS-986094
|
Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
n=63 Participants
Hepatitis C infected patients with previous exposure to BMS-986094
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 9.74 • n=99 Participants
|
50.2 years
STANDARD_DEVIATION 9.74 • n=107 Participants
|
51.9 years
STANDARD_DEVIATION 9.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Only subjects who were assessed at least once for each component of the composite endpoint were included for analysis.
Outcome measures
| Measure |
HCV Patients Not Exposed to BMS-986094
n=46 Participants
Hepatitis C patients without exposure to BMS-986094
|
Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
n=57 Participants
Hepatitis C infected patients with previous exposure to BMS-986094
|
|---|---|---|
|
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 yearsReported 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.
Outcome measures
| Measure |
HCV Patients Not Exposed to BMS-986094
n=50 Participants
Hepatitis C patients without exposure to BMS-986094
|
Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
n=63 Participants
Hepatitis C infected patients with previous exposure to BMS-986094
|
|---|---|---|
|
Composite of Death and Cardiovascular and Renal Dysfunction
|
31.1 percentage of participants
|
35.2 percentage of participants
|
Adverse Events
HCV Patients Not Exposed to BMS-986094
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
HCV Patients Not Exposed to BMS-986094
n=50 participants at risk
Hepatitis C patients without exposure to BMS-986094
|
Hepatitis C Virus (HCV) Patients Exposed to BMS-986094
n=63 participants at risk
Hepatitis C infected patients with previous exposure to BMS-986094
|
|---|---|---|
|
General disorders
Death
|
2.0%
1/50 • 58 months
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.
|
0.00%
0/63 • 58 months
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/50 • 58 months
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.
|
1.6%
1/63 • 58 months
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.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/50 • 58 months
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.
|
1.6%
1/63 • 58 months
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place