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Clinical trials for Pure red cell aplasia

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    5 result(s) found for: Pure red cell aplasia. Displaying page 1 of 1.
    EudraCT Number: 2005-004944-30 Sponsor Protocol Number: AFX01-06 Start Date*: 2006-02-23
    Sponsor Name:Takeda Development Centre Europe Ltd
    Full Title: An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease
    Medical condition: Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10005329 - Blood and lymphatic system disorders 10002965 Aplasia pure red cell PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000932-70 Sponsor Protocol Number: APHP200067 Start Date*: 2021-12-09
    Sponsor Name:ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS
    Full Title: Randomized prospective trial evaluating the efficacy of the antiCD38 monoclonal antibody isatuximab in the treatment of PCRA by major ABO mismatch after allogeneic hematopoietic stem cell transplan...
    Medical condition: Pure cell red aplasia by major ABO mismatch after allogeneic hematopoietic stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002965 Aplasia pure red cell PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-001151-22 Sponsor Protocol Number: Alesaa Start Date*: 2007-06-06
    Sponsor Name:UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
    Full Title: ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS.
    Medical condition: Aplastic anemia and single-lineage bone marrow failure
    Disease: Version SOC Term Classification Code Term Level
    13.1 10005329 - Blood and lymphatic system disorders 10002965 Aplasia pure red cell PT
    13.1 10005329 - Blood and lymphatic system disorders 10047350 Very few granulocyte precursors LLT
    13.1 10005329 - Blood and lymphatic system disorders 10002967 Aplastic anaemia PT
    13.1 10005329 - Blood and lymphatic system disorders 10001507 Agranulocytosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005129-31 Sponsor Protocol Number: BH21260 Start Date*: 2008-10-22
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not...
    Medical condition: To gain more experience with MIRCERA administered under clinical practice conditions and according to the approved label by performing a non-inferiority study comparing MIRCERA to other ESAs in ter...
    Disease: Version SOC Term Classification Code Term Level
    19.1 10005329 - Blood and lymphatic system disorders 10058116 Nephrogenic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed) CZ (Completed) IT (Completed) SE (Completed) LT (Completed) GR (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-016522-14 Sponsor Protocol Number: 20090160 Start Date*: 2011-07-14
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin alfa for the Treatment of Anaemic Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
    Medical condition: Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004851 10028536 Myelodysplastic syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) BE (Completed) GR (Completed) DE (Completed) IT (Completed) AT (Completed)
    Trial results: View results
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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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