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Higher defibrotide doses may help severe transplant complication

NCT ID NCT05987124

Disease control Sponsor: New York Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether increasing the dose of defibrotide can safely help patients with a serious liver condition called SOS/VOD that occurs after a stem cell transplant. The condition can damage the kidneys and lungs and often does not improve with standard defibrotide doses. Researchers will enroll 20 patients and gradually raise their dose every few days, monitoring for side effects and response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
defibrotide (Defitelio)
What this could lead to
If successful, this could provide a treatment option for patients with severe liver SOS/VOD after stem cell transplant who are not helped by standard doses.
What could go wrong
This is a small, early-phase trial with only 20 participants. Higher doses may increase bleeding risk, and it is unclear if they will improve survival or organ function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HCT recipients (Auto or Allograft) * SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I). * Unresponsive to standard defibrotide therapy as defined by at least one of the following: * Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day). * Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day). * Age 1 month - 75 years Exclusion Criteria: * Patients who did not receive HCT. * Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH). * Active bleeding and/or hemorrhage of at least grade 2 and above. * History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide. * Female patients who are pregnant or breast feeding.

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Conditions

The condition(s) this trial relates to.

hepatic veno-occlusive disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sinusoidal obstruction syndrome Veno-occlusive disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New York Medical College

    RECRUITING

    Vallhala, New York, 10595, United States

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