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NCT02298933 · ClinicalTrials.gov registry record · Phase 2
Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia
A Phase 2 study of Thrombocytopenia and Alloimmune Platelet Refractoriness, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02298933: Completed Phase 2 study of Thrombocytopenia and Alloimmune Platelet Refractoriness, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02298933 is a Phase 2 study of Thrombocytopenia and Alloimmune Platelet Refractoriness that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants, below the 311-participant average among 20 other Thrombocytopenia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02298933, a Phase 2 study of Thrombocytopenia and Alloimmune Platelet Refractoriness, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens when people do not have enough normal platelets. Getting a transfusion of another person s platelets can help stop too much bleeding. But because these cells are from other people, the body may reject them,putting them at risk for serious bleeding complications. This conditions is called alloimmune platelet refractoriness . There are evidence that in many patients, platelet counts fail to increase after a platelet transfusion because the transfused platelets are destroyed by the body s defence soldier, called complement . Researchers want to see if a drug, that inhibits complement, can help increase platelet levels and reduce bleeding Objectives: \- To see if eculizumab increases platelet levels more after a transfusion. To see if it reduces the chance of bleeding too much. Eligibility: \- Adults 18-75 years old who have thrombocytopenia and alloimmune platelet refractoriness. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will have the procedures listed below. They can have them while they are in the hospital. Or they can go to the outpatient clinic for them. Each visit may take up to 3 hours. * Participants will get a meningitis vaccine if needed. Then they will get the study drug as an infusion. * Participants will have a platelet transfusion. Their blood will be drawn every 24 hours until the platelet count is less than 10,000 per 1 microliter of blood. * They will take antibiotics for 14 days. * Participants will have a checkup and blood drawn twice a week for 2 weeks. They will get more transfusions if needed.
Primary Outcome
To evaluate the safety and efficacy of eculizumab to increase the platelet increment, defined as Corrected Count Increment (CCI) \>7500/μL at 10-60 min together with CCI\>5000/μL at 18-24 hrs post transfusion in patients with platelet refractoriness following treatment with eculizumab and platelet transfusion.
Conditions Studied
Interventions
- DRUG Eculizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-11-21 |
| Est. Completion | 2017-08-08 |
| Phase | Phase 2 |
What the finished NCT02298933 record still lists
NCT02298933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 311-participant average among 20 other Thrombocytopenia trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Thrombocytopenia appearing as the primary indexed condition, and to 1 intervention - of which Eculizumab is the first listed.
NCT02298933 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02298933 about?
NCT02298933 is a clinical study titled "Complement Inhibition Using Eculizumab to Overcome Platelet Transfusion Refractoriness in Patients With Severe Thrombocytopenia". Background: \- Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens when people do not have enough normal platelets. Getting a transfusion of another person s platelets can help stop too much bleeding. But because these cells are from other people, the body may re...
What is the current status of trial NCT02298933?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-11-21. Estimated completion is 2017-08-08.
What conditions does trial NCT02298933 study?
This clinical trial studies the following conditions: Thrombocytopenia, Alloimmune Platelet Refractoriness.
What interventions are being tested in trial NCT02298933?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT02298933?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02298933 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02298933's enrollment target sits among peer trials
10 21st of 20 the lowest of 20 other Thrombocytopenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thrombocytopenia 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.
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