drugset / Trial / NCT05524246

Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index

NCT05524246

Phase 1 Completed 25 enrolled Children's Hospital Medical Center, Cincinnati
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2023-01-27
Primary completion
2024-12-31
Completion
2025-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Pravastatin Small molecule Oral