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Clinical trials for 2010-023909-35

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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    • 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 ).  
     
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    1 result(s) found for: 2010-023909-35. Displaying page 1 of 1.
    EudraCT Number: 2010-023909-35 Sponsor Protocol Number: BVT.BSSL-030 Start Date*: 2011-06-24
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Wee...
    Medical condition: Prevention of growth retardation due to lack of bile salt-stimulated lipase in enteral nutrition
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036590 Premature baby PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) HU (Completed) FR (Ongoing) CZ (Completed) PL (Prematurely Ended) ES (Prematurely Ended) IT (Completed) Outside EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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