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Clinical trials for Thrombotic microangiopathies

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    8 result(s) found for: Thrombotic microangiopathies. Displaying page 1 of 1.
    EudraCT Number: 2020-003168-22 Sponsor Protocol Number: 2020/0206/HP Start Date*: 2021-09-02
    Sponsor Name:Rouen University Hospital
    Full Title: Multicenter, uncontrolled pilot study evaluating the efficacy of eculizumab in the treatment of gemcitabine-induced thrombotic microangiopathies.
    Medical condition: Thrombotic microangiopathies induced by gemcitabine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001032-11 Sponsor Protocol Number: OMS721-TMA-001 Start Date*: 2014-09-30
    Sponsor Name:Omeros Corporation
    Full Title: A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombo...
    Medical condition: Three forms of thrombotic microangiopathies (TMA): - atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA - thrombotic thrombocytopenic purpura (TTP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) BE (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000144-61 Sponsor Protocol Number: ALXN1210-TMA-313 Start Date*: 2020-08-17
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Open-label, Randomized, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)
    Medical condition: Hematopoietic stem cell transplant-associated thrombotic microangiopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) SE (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000761-16 Sponsor Protocol Number: ALXN1210-TMA-314 Start Date*: Information not available in EudraCT
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to < 18 years of age) with Thrombotic Microangiopathy...
    Medical condition: hematopoietic stem cell transplant-associated thrombotic microangiopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003157-27 Sponsor Protocol Number: Sobi.PEGCET-201 Start Date*: 2021-12-17
    Sponsor Name:SWEDISH ORPHAN BIOVITRUM AB (PUBL)
    Full Title: An Open-label, Single-arm, Multicenter Pilot Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Pegcetacoplan in Patients with Transplant-associated Thrombotic Microangiopathy (...
    Medical condition: Transplant-Associated Thrombotic Microangiopathy (TA-TMA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005328-13 Sponsor Protocol Number: ALXN1210-TMA-315 Start Date*: 2021-10-04
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated wi...
    Medical condition: thrombotic microangiopathy associated with a trigger
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    20.0 10047065 - Vascular disorders 10062198 Microangiopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002727-38 Sponsor Protocol Number: OMS721-HCT-002 Start Date*: Information not available in EudraCT
    Sponsor Name:Omeros Corporation
    Full Title: A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant...
    Medical condition: Thrombotic microangiopathies following haematopoietic stem cell transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10064477 Coagulopathies and bleeding diatheses (excl thrombocytopenic) HLGT
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    20.0 10005329 - Blood and lymphatic system disorders 10053567 Coagulopathies HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) HU (Completed) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000086-17 Sponsor Protocol Number: AK901 Start Date*: 2020-08-06
    Sponsor Name:Akari Therapeutics Plc
    Full Title: Multicentre Study of nomacopan in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    21.1 10042613 - Surgical and medical procedures 10063581 Stem cell transplant PT
    22.0 10042613 - Surgical and medical procedures 10067859 Allogenic stem cell transplantation PT
    22.0 10042613 - Surgical and medical procedures 10081347 Autologous haematopoietic stem cell transplant PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Prematurely Ended)
    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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