5-day Defibrotide Treatment for Hepatic SOS/VOD

Status unconfirmed · Phase 2

Conditions studied: Sinusoidal Obstruction Syndrome, Veno-occlusive Disease, Bone Marrow Transplant Complications

In brief

Sinusoidal Obstruction Syndrome (SOS), also referred to as hepatic veno-occlusive disease (VOD), is rare but serious complication of allogeneic stem cell transplantation (allo-SCT). Defibrotide is the only FDA approved therapy to treat SOS and has significantly improved outcomes. When applied early, SOS symptoms often quickly improve and an abbreviated course can be applied. This study is looking at an abbreviated 5 day course of defibrotide in those patients with a complete response to therapy with the primary outcome being day 100 overall survival as compared to history data.

Key facts

Study ID

NCT04313036

Run by

Loyola University

People needed

24

Starts

2021-03-11

Expected to finish

2022-08-01

Last updated by the study team

2021-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who underwent allogeneic stem cell transplantation
• Age >/= 18 years
• Diagnosed hepatic SOS/VOD either by Baltimore Criteria or Modified Seattle Criteria including up to 60 days post-transplantation.

You may not qualify if…

• Significant uncontrolled bleeding
• Prior or concurrent systemic t-PA
• Concomitant use of therapeutic heparin or other anticoagulants (except use of heparin for central access patency)
• Hemodynamic instability (>1 pressor gent to maintain blood pressure)

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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