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Defibrotide Dose-escalation for SOS Post-HSCT

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Aug 1, 2026 to Aug 1, 2027
    • Study completion date: Aug 1, 2027 to Aug 1, 2028
    • Site details revised
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2023 to Mar 20, 2024
    • Study sites: 0 to 1
    v3
  3. Start date: Aug 1, 2023 to Dec 1, 2023v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic cell transplantation (HCT) associated with either kidney and/or lung impairment that has not obtained a complete response (CR) or progressed in severity with standard doses of defibrotide.
Trial Details
NCT Number NCT05987124
Lead Sponsor New York Medical College
Conditions
(from sponsor)		 Sinusoidal Obstruction Syndrome, Veno-occlusive Disease
Related terms Hepatic Veno-Occlusive Disease
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov