drugset / Trial / NCT05987124

Defibrotide Dose-escalation for SOS Post-HSCT

NCT05987124

Phase 2 Recruiting 20 enrolled New York Medical College
NaSingle-groupOpen-labelTreatment

Summary

This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic cell transplantation (HCT) associated with either kidney and/or lung impairment that has not obtained a complete response (CR) or progressed in severity with standard doses of defibrotide.

Timeline

Start
2024-03-20
Primary completion
2027-08-01
Completion
2028-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Defibrotide Oligonucleotide (other) 100 mg/kg Intravenous