Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center Phase 3 Study to Determine Safety & Efficacy
Sponsor: FDA Office of Orphan Products Development
A PHASE3 clinical study on Severe Hepatic Veno-Occlusive Disease, this trial is completed. The trial is conducted by FDA Office of Orphan Products Development and has accumulated 10 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
10 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
▶ Show 5 earlier versions
-
Dec 2021 — Dec 2022 [monthly]
Completed PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jul 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- FDA Office of Orphan Products Development
- Jazz Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .