CompletedPhase 3

Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

United States1,206 participantsStarted 2007-12

Plain-language summary

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

Who can participate

SexALL

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Inclusion criteria

✓. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven:
✓.1 Baltimore Criteria- Bilirubin ≥2 mg/dL and at least 2 of the following clinical findings:
✓.2 Modified Seattle Criteria: At least two of the following
✓.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible.
✓. Patient must also provide written informed consent.

What they're measuring

Survival by Day+100 Post Stem Cell Transplant or Chemotherapy

Timeframe: Day +100 from HSCT or 100 days from start of chemotherapy

Trial details

NCT IDNCT00628498

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2017-11-02

View on ClinicalTrials.gov More Hepatic Veno-Occlusive Disease trials