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5-day Defibrotide for Hepatic SOS/VOD
NCT04313036Phase 2
Key facts
- Status
- Unknown
- Start
- Mar 2021
- Primary completion
- May 2022
- Countries
- 1
- Sponsor
- Loyola University Chicago
- Modality
- Antisense DNA, Small Interfering RNA (siRNA), Recombinant Proteins and Enzymes
- Drugs
- defibrotide
- Conditions
- sinusoidal obstruction syndrome (SOS)
01
Overview
Phase 2, open-label, single-arm trial of defibrotide in sinusoidal obstruction syndrome (SOS), sponsored by Loyola University Chicago. Primary endpoint: Overall Survival at 100 days. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Defibrotide Arm
Single group receiving 5 days of defibrotide with potential extension to 21 days based on response.
03
Who it enrols
Adult patients post-allogeneic stem cell transplant diagnosed with hepatic SOS/VOD by Baltimore or Modified Seattle Criteria, excluding those with significant bleeding or anticoagulant use.
04
Endpoints
Primary
Overall Survival
Secondary
Complete Response at Day 100
Complete Response at Day 5
Complete Response at Day 30
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