Hepatitis C
Conditions
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.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Puerto Rico, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| HCV Patients Not Exposed to BMS-986094 Hepatitis C patients without exposure to BMS-986094 | 50 |
| Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 Hepatitis C infected patients with previous exposure to BMS-986094 | 63 |
| Total | 113 |
Baseline characteristics
| Characteristic | Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 | Total | HCV Patients Not Exposed to BMS-986094 |
|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 9.74 | 51.9 years STANDARD_DEVIATION 9.9 | 54.2 years STANDARD_DEVIATION 9.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 28 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 85 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 57 Participants | 95 Participants | 38 Participants |
| Sex: Female, Male Female | 22 Participants | 42 Participants | 20 Participants |
| Sex: Female, Male Male | 41 Participants | 71 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 2 / 63 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 50 | 2 / 63 |
Outcome results
Primary
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
Time frame: 5 years
Population: Only subjects who were assessed at least once for each component of the composite endpoint were included for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HCV Patients Not Exposed to BMS-986094 | Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause | 1 Participants |
| Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 | Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause | 2 Participants |
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.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCV Patients Not Exposed to BMS-986094 | Composite of Death and Cardiovascular and Renal Dysfunction | 31.1 percentage of participants |
| Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 | Composite of Death and Cardiovascular and Renal Dysfunction | 35.2 percentage of participants |
p-value: 0.6173Log Rank