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NCT02013037 · ClinicalTrials.gov registry record · Phase 3
The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
A Phase 3 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
NCT02013037 is a Phase 3 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 36 participants.
The verdict
NCT02013037, a Phase 3 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
Study Summary
All individuals who receive a heart transplant are at risk for developing antibody-mediated rejection (AMR). An antibody is a protein produced by the body's immune system when it detects a foreign substance, called an antigen. The mechanism of an antibody is to attack an antigen. In antibody mediated rejection, antibodies will attack the transplanted heart, causing injury to the heart. The purpose of this investigation is to determine if a study drug, called eculizumab (Soliris), is safe to use in heart transplant recipients, and determine if it reduces risk of antibody-mediated rejection.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-11 |
| Est. Completion | 2020-04-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02013037
The ClinicalTrials.gov registry entry for NCT02013037 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT02013037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02013037 about?
NCT02013037 is a clinical study titled "The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation". All individuals who receive a heart transplant are at risk for developing antibody-mediated rejection (AMR). An antibody is a protein produced by the body's immune system when it detects a foreign substance, called an antigen. The mechanism of an antibody is to attack an antigen. In antibody mediate...
What is the current status of trial NCT02013037?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2012-11. Estimated completion is 2020-04-30.
What interventions are being tested in trial NCT02013037?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT02013037?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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