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Anticoagulant

Defibrotide for Sinusoidal Obstruction Syndrome

Phase 2
Waitlist Available
Led By Patrick A Hagen, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights

Study Summary

This trial is testing a shorter, 5-day course of defibrotide for patients with a complete response to the therapy. The goal is to improve overall survival rates.

Eligible Conditions
  • Veno-occlusive Disease
  • Sinusoidal Obstruction Syndrome
  • Bone Marrow Transplant Complications

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Day 100 overall survival
Secondary outcome measures
Complete response day 100
Complete response day 30
Complete response day 5

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02876601
81%
Headache
38%
Flu-like Symptoms
19%
Chills
13%
Nausea
13%
Arthralgia
6%
Precollapse
6%
Dizziness
6%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Defibrotide Plus LPS
Placebo Plus LPS
Defibrotide Plus Placebo
Placebo/Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: DefibrotideExperimental Treatment1 Intervention
5 day course of defibrotide at standard dosing 25 mg/kg/day in 4 divided doses of 6.25 mg/kg. If not in CR by day 5, will be given for >/= 21 days or per discretion of enrolling physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defibrotide
FDA approved

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,910 Total Patients Enrolled
Patrick A Hagen, MDPrincipal InvestigatorLoyola University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
5-day Defibrotide Treatment for Hepatic SOS/VOD
Hagen, Patrick A 2021. "5-day Defibrotide Treatment for Hepatic SOS/VOD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04313036.
~6 spots leftby Apr 2025
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