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Clinical trials for 2015-000087-34

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43424   clinical trials with a EudraCT protocol, of which   7183   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: 2015-000087-34. Displaying page 1 of 1.
    EudraCT Number: 2015-000087-34 Sponsor Protocol Number: XM22-08 Start Date*: 2015-06-05
    Sponsor Name:Merckle GmbH
    Full Title: An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 μg/kg B...
    Medical condition: Neutropenia in pediatric patients diagnosed with Ewing family of Tumors or rhabdomyosarcoma receiving chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10005329 - Blood and lymphatic system disorders 10029354 Neutropenia PT
    19.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) SK (Completed) CZ (Completed) BG (Completed) DE (Ongoing) ES (Completed) RO (Completed) PL (Completed) BE (Completed) HR (Completed)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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