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Clinical trials for Defibrotide

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    10 result(s) found for: Defibrotide. Displaying page 1 of 1.
    EudraCT Number: 2020-001409-21 Sponsor Protocol Number: IMIB-DFC-2020-02 Start Date*: 2020-04-01
    Sponsor Name:FFIS
    Full Title: A prospective, multicenter, randomized, parallel, double-blind, placebo-controlled phase IIb clinical trial to evaluate intravenous infusion of Defibrotide in the prevention and treatment of respir...
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004316-18 Sponsor Protocol Number: 2006-05 Start Date*: 2017-11-21
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: Defibrotide for Patients with Hepatic Veno-occlusive Disease (VOD): A Treatment IND Study
    Medical condition: Hepatic Veno-Occlusive Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10047207 Veno-occlusive liver damage LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005524-13 Sponsor Protocol Number: I-ICRNS-005-PRCLD-DVT-01 Start Date*: 2006-03-22
    Sponsor Name:CRINOS S.p.A.
    Full Title: Defibrotide in the prevention of recurrences in venous thrombosis: DEPRIVE. A randomised, multicentre, European, double blind, parallel group study, to assess the efficacy and tolerability of defib...
    Medical condition: DVT and PE are part of the same disease that can be defined Venous Thromboembolism (VTE). Treatment of the acute phases is well established: LMWH during the first days and OAT for 3-12 months. Afte...
    Disease: Version SOC Term Classification Code Term Level
    10051055 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001513-20 Sponsor Protocol Number: DEFI-VID19 Start Date*: 2020-05-06
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: Use of Defibrotide to reduce progression of acute respiratory failure rate in patients with COVID-19 pneumonia
    Medical condition: Severe COVID-19 pneumonia
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003309-16 Sponsor Protocol Number: JZP963-201 Start Date*: 2018-04-25
    Sponsor Name:Jazz Pharmaceuticals Inc.
    Full Title: A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pe...
    Medical condition: Prevention of Acute Graft-versus-Host Disease (aGvHD) after allogeneic hematopoietic stem cell transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10068908 AGVHD LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) IT (Completed) BE (Completed) PT (Completed) AT (Completed) GR (Completed) BG (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002004-10 Sponsor Protocol Number: 15-007 Start Date*: 2016-10-13
    Sponsor Name:Jazz Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Un...
    Medical condition: Prevention of Hepatic Veno-Occlusive Disease following Hematopoietic Stem Cell Transplant
    Disease: Version SOC Term Classification Code Term Level
    19.0 10019805 - Hepatobiliary disorders 10047207 Veno-occlusive liver damage LLT
    19.0 10019805 - Hepatobiliary disorders 10047217 Venoocclusive syndrome of the liver LLT
    19.0 10019805 - Hepatobiliary disorders 10047216 Venoocclusive liver disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) BE (Completed) DE (Prematurely Ended) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000592-33 Sponsor Protocol Number: N/A Start Date*: 2006-03-02
    Sponsor Name:Gentium S.p.A [...]
    1. Gentium S.p.A
    2. EBMT Trial Office
    Full Title: Prospective Study of the Incidence and Outcome of Venoocclusive Disease (VOD) with the Prophylactic Use of Defibrotide (DF, Gentium, Italy) in Pediatric Stem Cell Transplantation
    Medical condition: Hepatic veno-occlusive disease following hematopoietic stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10047217 Venoocclusive syndrome of the liver LLT
    9.1 10047207 Veno-occlusive liver damage LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) IE (Completed) GB (Completed) AT (Completed) IT (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003293-25 Sponsor Protocol Number: MM2005 Start Date*: 2005-10-05
    Sponsor Name:AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
    Full Title: A PHASE II, MULTI-CENTER, OPEN LABEL STUDY OF MELPHALAN, PREDNISONE, THALIDOMIDE AND DEFIBROTIDE IN ADVANCED AND REFRACTORY MULTIPLE MYELOMA PATIENTS
    Medical condition: MULTIPLE MYELOMA
    Disease: Version SOC Term Classification Code Term Level
    6.1 10051381 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000690-63 Sponsor Protocol Number: I-ICRNS-003-PRCLD-01 Start Date*: 2004-12-23
    Sponsor Name:CRINOS S.P.A.
    Full Title: An Italian randomised, multicentre, double blind study to assess the efficacy and tolerability of defibrotide (Prociclide) versus placebo in the treatment of acute phase of haemorrhoids with thromb...
    Medical condition: vascular disease at thrombotic risk
    Disease: Version SOC Term Classification Code Term Level
    6.1 10019022 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-005612-40 Sponsor Protocol Number: DAM/001/08 Start Date*: 2008-11-27
    Sponsor Name:FARMACEUTICI DAMOR
    Full Title: Open-label, controlled, randomised, multicentre, parallel group clinical trial of efficacy and tolerability of heparan sulfate slow-release 120 mg tablets and defibrotide 400 mg capsules in the tre...
    Medical condition: Patients with chronic venous insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013283 Disorder vascular peripheral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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