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NCT05524246 · ClinicalTrials.gov registry record · Phase 1
Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT05524246 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 25 participants.
The verdict
NCT05524246, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Chemotherapy and radiation used in patients undergoing bone marrow transplant (BMT) disrupts the endothelial lining (a thin layer of cells inside the blood vessels) which is found all throughout the body including the kidney, heart, lungs, and intestines. Disruption of this endothelial lining can lead to complications such as graft-vs-host disease (GVHD), thrombotic microangiopathy (TMA) and veno-occlusive disease (VOD). The purpose of this research study is to help investigators see if pravastatin is safe and well tolerated in patients undergoing BMT to see if it will reduce endothelial injury after BMT. The investigator hypothesizes that prophylactic pravastatin in pediatric allogeneic hematopoietic stem cell transplant recipients with elevated BMI is safe and feasible.
Interventions
- DRUG Pravastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-01-27 |
| Est. Completion | 2025-03-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05524246
The ClinicalTrials.gov registry entry for NCT05524246 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pravastatin is the first listed.
NCT05524246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05524246 about?
NCT05524246 is a clinical study titled "Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index". Chemotherapy and radiation used in patients undergoing bone marrow transplant (BMT) disrupts the endothelial lining (a thin layer of cells inside the blood vessels) which is found all throughout the body including the kidney, heart, lungs, and intestines. Disruption of this endothelial lining can le...
What is the current status of trial NCT05524246?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-01-27. Estimated completion is 2025-03-05.
What interventions are being tested in trial NCT05524246?
The interventions under investigation include: Pravastatin (DRUG).
Who is sponsoring clinical trial NCT05524246?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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