13 completed, 3 recruiting, 2 no longer available, 2 unknown. 15 Phase 2, 4 Phase 3, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Completed 8, Recruiting 3, Unknown 2, Terminated 1, Withdrawn 1 |
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Defibrotide Prophylaxis of Transplant Associated-Thrombotic Microangiopathy for Neuroblastoma Defibrotide - Transplant-Associated Thrombotic Microangiopathy, Neuroblastoma | Phase 2 | Withdrawn | University of California, San Francisco | 2024-08-01 | 2024-08-07 | |
| Defibrotide Dose-escalation for SOS Post-HSCT Defibrotide - Sinusoidal Obstruction Syndrome, Veno-occlusive Disease | Phase 2 | Recruiting | New York Medical College | 20 | 2024-03-20 | 2026-04-15 |
| 5-day Defibrotide Treatment for Hepatic SOS/VOD Defibrotide - Sinusoidal Obstruction Syndrome, Veno-occlusive Disease | Phase 2 | Unknown | Loyola University | 24 | 2021-03-11 | 2021-04-23 |
| Defibrotide in Children With High Risk Kawasaki Disease Defibrotide - Kawasaki Disease | Phase 2 | Unknown | New York Medical College | 2 | 2021-02-24 | 2023-10-26 |
| Defibrotide for the Treatment of Severe COVID-19 Defibrotide - Covid19 | Phase 2 | Recruiting | Brigham and Women's Hospital | 42 | 2021-01-01 | 2026-07-20 |
| Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS) Defibrotide - COVID, Sars-CoV2 | Phase 1 | Completed | Gregory Yanik | 13 | 2020-10-01 | 2023-05-09 |
| Defibrotide in COVID-19 Pneumonia Defibrotide Injection - Patients With COVID-19 Pneumonia Will Allow to Detect an Absolute Reduction in the Rate of Respiratory-failure | Phase 2 | Completed | IRCCS San Raffaele | 50 | 2020-05-20 | 2022-07-19 |
| Defibrotide as Prevention and Treatment of Respiratory Distress and Cytokine Release Syndrome of Covid 19. Defibrotide, Placebo - COVID19 | Phase 2 | Completed | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | 156 | 2020-04-08 | 2023-06-07 |
| A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity Defibrotide - DLBCL, Neurotoxicity Syndromes | Phase 2 | Terminated | Jazz Pharmaceuticals | 25 | 2019-10-04 | 2021-12-09 |
| Defibrotide TMA Prophylaxis Pilot Trial Defibrotide - Thrombotic Microangiopathies | Phase 2 | Completed | University of California, San Francisco | 25 | 2018-05-01 | 2021-09-16 |
| An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD) Defibrotide, Standard of Care - Graft-versus-host Disease, Acute-graft-versus-host Disease | Phase 2 | Completed | Jazz Pharmaceuticals | 152 | 2018-02-21 | 2021-08-18 |
| Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome Defibrotide - Sickle Cell Disease, Acute Chest Syndrome | Phase 2 | Completed | New York Medical College | 20 | 2018-01-12 | 2023-12-08 |
| Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease Defibrotide - Sickle Cell Disease | Phase 2 | Recruiting | New York Medical College | 40 | 2017-07-01 | 2026-07-27 |
| Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide Defibrotide, Placebo (0.9% sodium chloride), Lipopolysaccharide - Healthy Volunteers, Endotoxemia | Phase 4 | Completed | Bernd Jilma | 20 | 2017-04-18 | 2019-12-19 |
| Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Defibrotide, Best Supportive Care - Veno-occlusive Disease | Phase 3 | Completed | Jazz Pharmaceuticals | 372 | 2016-09-01 | 2022-03-02 |
| Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study Defibrotide - Hepatic Veno-Occlusive Disease | Phase 3 | Completed | Jazz Pharmaceuticals | 1206 | 2007-12-01 | 2017-11-30 |
| Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients Defibrotide - Severe Hepatic Veno-Occlusive Disease | Phase 3 | Completed | Jazz Pharmaceuticals | 134 | 2006-07-01 | 2017-01-30 |
| Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients Prednisone, Melphalan, Thalidomide - Multiple Myeloma | Phase 1 / Phase 2 | Completed | Silvio Aime | 24 | 2006-02-01 | 2016-05-10 |
| Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide Defibrotide - Hepatic Veno-Occlusive Disease | Phase 2 / Phase 3 | Completed | European Society for Blood and Marrow Transplantation | 360 | 2005-12-01 | 2011-06-09 |
| Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver Defibrotide - Liver Diseases | No longer available | Emory University | 2005-11-01 | 2014-07-01 |
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Hepatic Veno-Occlusive Disease (7) · COVID-19 (4) · Anemia, Sickle Cell (2) · Thrombotic Microangiopathies (2) · Acute Chest Syndrome (1) · Endotoxemia (1) · Graft vs Host Disease (1) · Inflammation (1) · Liver Diseases (1) · Mucocutaneous Lymph Node Syndrome (1) · Multiple Myeloma (1) · Multiple Organ Failure (1) · Neoplasms, Plasma Cell (1) · Neuroblastoma (1) · Neurotoxicity Syndromes (1)
Jazz Pharmaceuticals (5) · New York Medical College (4) · University of California, San Francisco (2) · Bernd Jilma (1) · Brigham and Women's Hospital (1) · Dana-Farber Cancer Institute (1) · Emory University (1) · European Society for Blood and Marrow Transplantation (1) · Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (1) · Gregory Yanik (1) · IRCCS San Raffaele (1) · Loyola University (1) · Silvio Aime (1) · St. Jude Children's Research Hospital (1)
United States (16) · Italy (5) · Austria (3) · Canada (3) · France (3) · Germany (3) · Spain (3) · United Kingdom (3) · Belgium (2) · Israel (2) · Australia (1) · Bulgaria (1) · Croatia (1) · Greece (1) · Ireland (1)
Christine Higham, MD (2) · Mitchell Cairo, MD (2) · Paul Richardson, M.D. (2) · Bernd Jilma, MD (1) · Gregory Yanik, MD (1) · John Horan, MD (1) · Mitchell S Cairo, MD (1) · Mitchell S. Cairo, MD (1) · Patrick A Hagen, MD (1) · Paul Richardson, MD (1) · Selim Corbacioglu, MD (1) · William Tappe, M.D. (1) · Wing Leung, M.D. (1)
PMID 37231094, PMID 12393437, PMID 20053869, PMID 22364685, PMID 26825712, PMID 29767845, PMID 32950693, PMID 33750072, PMID 35253361, PMID 35413279, PMID 36519326, PMID 36569951, PMID 37001534, PMID 37399456, PMID 42117493
P30CA015704 (1)