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Clinical trials for 2011-000078-80

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
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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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).

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    1 result(s) found for: 2011-000078-80. Displaying page 1 of 1.
    EudraCT Number: 2011-000078-80 Sponsor Protocol Number: PMR-EC-1207 Start Date*: 2011-09-08
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated with an Advagraf or Prograf B...
    Medical condition: Prophylaxis of heart, liver and kidney transplant rejection in paediatrics
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10050434 Prophylaxis against liver transplant rejection LLT
    14.0 10042613 - Surgical and medical procedures 10050432 Prophylaxis against heart transplant rejection LLT
    14.0 10042613 - Surgical and medical procedures 10050436 Prophylaxis against renal transplant rejection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) BE (Completed) PL (Completed) IT (Completed) FR (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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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