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Clinical trials for 2011-005042-35

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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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: 2011-005042-35. Displaying page 1 of 1.
    EudraCT Number: 2011-005042-35 Sponsor Protocol Number: PRO053-CLIN-01 Start Date*: 2013-08-23
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase I/II, open-label, dose escalating with 48 week treatment study to assess the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of BMN 053 (previously known as PRO053)...
    Medical condition: Duchenne muscular dystrophy resulting from a mutation correctable by BMN 053-induced DMD exon 53 skipping
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Prematurely Ended) BE (Completed) IT (Prematurely Ended) NL (Prematurely Ended) FR (Ongoing)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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
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