Hepatitis CCARE-Hep CNCT01846494
Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
An observational study of Hepatitis C, run by Duke University at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- How many people
- 113 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 10 May 2013to 19 Mar 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hepatitis C positive subjects previously exposed to BMS 986094 and Hepatitis C positive subjects not previously exposed to BMS 986094.
Who may be able to join
- 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)
- No previous exposure to BMS 986094
- 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).
Who cannot join
- 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:
- 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
- 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
- History of liver transplantation
- Co-infection with HIV (positive test for anti-HIV Ab)
Show all 9Show fewer
- Prior history of cardiomyopathy (ejection fraction ≤ 50%) or history of heart failure
- Signs or symptoms of decompensated heart failure or
- Prior history of coronary artery disease, acute myocardial infarction or coronary artery revascularization (percutaneous or coronary artery bypass grafting)
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Central Texas Clinical Research
Austin, Texas, 78705
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Lancaster Heart Foundation
Lancaster, Pennsylvania, 17603
Hennepin County Medical Center
Minneapolis, Minnesota, 55415-1829
Weill Cornell Medical Center
New York, New York, 10021
Alamo Medical Research
San Antonio, Texas, 78215
Scripps Clinic
San Diego, California, 92037
Tuan Nguyen, MD
San Diego, California, 92105
Quest Clinical Research
San Francisco, California, 94115
Options Health Research
Tulsa, Oklahoma, 74104
About this study
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.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start10 May 2013
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian F. Hernandez, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846494
- Sponsor's protocol ID
- Pro00042419
- Other IDs
- Pro00044788
- Acronym
- CARE-Hep C
- Status last verified
- Dec 2018
- First submitted
- 1 May 2013
- Last updated
- 22 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Cardiovascular and Renal Health in Patients With Hepatitis-C (CARE-Hep C)
- ClinicalTrials.gov ID
- NCT01846494
- Acronym / sponsor ID
- CARE-Hep C / Pro00042419
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 May 2013 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 22 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hepatitis C positive subjects previously exposed to BMS 986094 and Hepatitis C positive subjects not previously exposed to BMS 986094.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause
Time frame: 5 years
1 secondary outcome
Composite of Death and Cardiovascular and Renal Dysfunction
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian F. Hernandez, MD principal investigator
Duke Clinical Research Institute
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Duke University at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.