Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pro00044788 | Other Identifier | Duke eIRB Biorepository Protocol Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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.
All Subjects must give informed consent prior to participation in the study.
Subject participated in the Phase 1 or Phase 2 trials with BMS 986094 (including placebo arm) OR
Subject with known hepatitis C (Control)
Exclusion Criteria
For subjects who participated in the Phase 1 or Phase 2 trials with BMS 986094, there are no exclusion criteria
For the control group of subjects without exposure to BMS 986094, the following exclusion criteria, based on clinically available data, apply:
Not provided
Not provided
Not provided
Not provided
Hepatitis C positive subjects previously exposed to BMS 986094 and Hepatitis C positive subjects not previously exposed to BMS 986094.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian F. Hernandez, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| Scripps Clinic |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HCV Patients Not Exposed to BMS-986094 | Hepatitis C patients without exposure to BMS-986094 |
| FG001 | Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 | Hepatitis C infected patients with previous exposure to BMS-986094 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2013 |
Not provided
Not provided
Not provided
Not provided
Plasma, serum, and urine
| San Diego |
| California |
| 92037 |
| United States |
| Tuan Nguyen, MD | San Diego | California | 92105 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415-1829 | United States |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | United States |
| Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| Lancaster Heart Foundation | Lancaster | Pennsylvania | 17603 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Fundacion de Investigation de Diego | San Juan | 00927 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HCV Patients Not Exposed to BMS-986094 | Hepatitis C patients without exposure to BMS-986094 |
| BG001 | Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 | Hepatitis C infected patients with previous exposure to BMS-986094 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause | Only subjects who were assessed at least once for each component of the composite endpoint were included for analysis. | Posted | Count of Participants | Participants | 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. | Posted | Number | percentage of participants | 5 years |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HCV Patients Not Exposed to BMS-986094 | Hepatitis C patients without exposure to BMS-986094 | 1 | 50 | 1 | 50 | 0 | 0 |
| EG001 | Hepatitis C Virus (HCV) Patients Exposed to BMS-986094 | Hepatitis C infected patients with previous exposure to BMS-986094 | 2 | 63 | 2 | 63 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 20.1 | Systematic Assessment | Not attributed to cardiac or renal dysfunction. |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison DeLong | Duke Clinical Research Institute | 919-668-6855 | allison.delong@duke.edu |
| Nov 27, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|