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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: Completed Phase 3 study, sponsored by Cedars-Sinai Medical Center.
NCT02013037 is a Phase 3 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 36 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The efficacy of Eculizumab will be assessed by a composite endpoint of: 1. the incidence of pathologic AMR with a Grade ≥ 2 2. the incidence of left ventricular dysfunction, as defined by a left ventricular ejection fraction (LVEF) ≤ 40% or a decrease of \>15% from baseline prior to the initiation of Eculizumab treatment.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-11 |
| Est. Completion | 2020-04-30 |
| Phase | Phase 3 |
What the finished NCT02013037 record still lists
NCT02013037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT02013037 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02013037's enrollment target sits among peer trials
36 1901st of 2000 higher than 98 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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