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Clinical trials for Bioproducts

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   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).

    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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    1 result(s) found for: Bioproducts. Displaying page 1 of 1.
    EudraCT Number: 2007-007520-17 Sponsor Protocol Number: 800088NAP2001 Start Date*: 2008-07-25
    Sponsor Name:Janssen-Cilag International N.V, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Effect of RWJ-800088 on The Prevention of Chemotherapy-Induced Anemia and The Prevention of Chemotherapy-Induced Thromb...
    Medical condition: Chemotherapy induced anaemia and chemotherapy induced thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029521 Non-small cell lung cancer stage IIIB LLT
    9.1 10029522 Non-small cell lung cancer stage IV LLT
    9.1 10039884 Secondary thrombocytopenia LLT
    9.1 10054606 Secondary anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
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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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