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NCT03339297 · ClinicalTrials.gov registry record · Phase 2

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

A Phase 2 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
152
Enrollment target

NCT03339297: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.

NCT03339297 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03339297, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
152 participants
Enrollment target

Study Summary

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

Primary Outcome

Cumulative Incidence Percentage of Grade B to D aGvHD was defined using the International Bone Marrow Transplant Registry (IBMTR) Severity Index. Grade B is defined as Skin stage = 2 or Liver stage = 1 to 2 or GI stage = 1 to 2. Grade C is defined as Skin stage = 3 or Liver stage = 3 or GI stage = 3. Grade D is defined as a Skin stage = 4 or Liver stage = 4 or GI stage = 4.

Interventions

  • DRUG Standard of Care
  • DRUG Defibrotide

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2018-02-21
Est. Completion 2020-05-12
Phase Phase 2
Jazz Pharmaceuticals

128 total trials

What the finished NCT03339297 record still lists

NCT03339297 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT03339297 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03339297 about?

NCT03339297 is a clinical study titled "An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)". This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

What is the current status of trial NCT03339297?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2018-02-21. Estimated completion is 2020-05-12.

What interventions are being tested in trial NCT03339297?

The interventions under investigation include: Standard of Care (DRUG), Defibrotide (DRUG).

Who is sponsoring clinical trial NCT03339297?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03339297's enrollment target sits among peer trials

152 452nd of 2000 higher than 1,547 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03339297, the US trial registry maintained by the National Library of Medicine. NCT03339297 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.