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Clinical trials for Aplastic Anemia

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   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: Kojima, S., Hibi, S., Kosaka, Y., et al. Immunosuppressive therapy using antithymocyte globulin, cyclosporine, and danazol with or without human granulocyte colony-Stimulating factor in children with acquired aplastic anemia Blood 96(6): 2049-2054.Kojima, S., Hibi, S., Kosaka, Y., et al. Immunosuppressive therapy using antithymocyte globulin, cyclosporine, and danazol with or without human granulocyte colony-Stimulating factor in children with acquired aplastic anemia Blood 96(6): 2049-2054.
    Active substance: FILGASTRIM
    Study summary document link (including results):
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    Document reference: 27278
    Study title: PROSPECTIVE OPEN PILOT COMPARATIVE STUDY OF SAFETY & EFFICACY OF FCA PARENTERAL/ORAL VS STANDARD PROPHYLACTIC REGIMEN IN PREVENTION OF FUNGAL INFECTIONS IN PTS WITH PANCYTOPENIA CAUSED BY CHEMOTHERAPY OR IN PTS SUFFERING FROM APLASTIC ANEMIA
    Active substance: FLUCONAZOLE
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    Document reference: 27396
    Study title: PROSPECTIVE OPEN PILOT COMPARATIVE STUDY OF SAFETY & EFFICACY OF FCA PARENTERAL/ORAL VS STANDARD PROPHYLACTIC REGIMEN IN PREVENTION OF FUNGAL INFECTIONS IN PTS WITH PANCYTOPENIA CAUSED BY CHEMOTHERAPY OR IN PTS SUFFERING FROM APLASTIC ANEMIA
    Active substance: FLUCONAZOLE
    Study summary document link (including results):
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    Document reference: 27761
    Study title: Immunosuppressive therapy using antithymocyte globulin, cyclosporine, and danazol with or without human granulocyte colony-stimulating factor in children with acquired aplastic anemia - Kojima S. et al - 2000 (Blood 96: 2049 - 2054) - Publication - Ref18 of Clinical Expert Report -
    Active substance: LENOGRASTIM
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    Document reference: 31034
    Study title: Myelodysplastic syndrome and acute myelogenous leukemia as a late clonal complication in children with acquired aplastic anemia - Ohara A. et al - 1997 (Blood 90: 1009 - 1013) - Publication - Ref22 of Clinical Expert Report -
    Active substance: LENOGRASTIM
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    Document reference: 31035
    Study title: Intense muscle uptake of Ga-67 citrate and Tc-99m MDP in a patient with aplastic anemia.Batte WG Jr., Yeh SD, Rosenblum MK, Larson SM. Clin Nucl Med 1991 Jun;16(6):421-4.
    Active substance: TECHNETIUM (99mTc) MEDRONIC ACID
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    Document reference: 48566
    Study title: A multicenter European randomized parallel-group phase III study to evaluate safety and efficacy of rHuG-CSF (lenograstim) in the first 12 weeks of the treatment of de novo severe aplastic anemia - 1998 (Blood, 92 (10) suppl 1 : abs 1551, p 376 a)
    Active substance: LENOGRASTIM
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    Document reference: 31028
    Study title: Antilymphocyte globulin, cyclosporine, prednisolone, and granulocyte colony-stimulating factor for severe aplastic anemia: an update of the GITMO / EBMT study on 100 patients. European Group for Blood and Marrow Transplantation (EBMT) Working party on Severe Aplastic Anemia and the Gruppo Italiano Trapianti di Midolio Osseo (GITMO). - Bacigalupo A. et al - 2000 (Blood 95: 1931 - 1931) - Publication - Ref17 of Clinical Expert Report -
    Active substance: LENOGRASTIM
    Study summary document link (including results):
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    Document reference: 31032
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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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