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Clinical trials for Human lactation

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   44336   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).

    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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    6 result(s) found for: Human lactation. Displaying page 1 of 1.
    EudraCT Number: 2010-019372-72 Sponsor Protocol Number: MV22970 Start Date*: 2010-04-16
    Sponsor Name:Pharmahungary Group
    Full Title: An Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza during Lactation.
    Medical condition: Lactating women who present with clinical symptoms indicative of influenza will be recruited to receive immediate treatment with oseltamivir at a standard dose of 75 mg twice daily. These subjects ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022000 Influenza LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001910-33 Sponsor Protocol Number: AGAL02603 Start Date*: 2007-12-05
    Sponsor Name:Genzyme Europe BV
    Full Title: A Multicenter, Multinational Study of the Effects of Fabrazyme® (agalsidase beta) Treatment on Lactation and Infants
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016016 Fabry's disease PT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Ongoing)
    Trial results: View results
    EudraCT Number: 2007-002245-20 Sponsor Protocol Number: EICAS Start Date*: 2008-08-15
    Sponsor Name:Zentralinstitut für Seelische Gesundheit Mannheim
    Full Title: Evaluation of potential central glucoregulatory compounds to treat/ameliorate the symptoms of schizophrenia: a proof-of-concept study in healthy volunteers
    Medical condition: Basic ressearch on schizophrenia. This is a proof-of-concept trial. The hypothesis is that substances that regulate the central glucose utilisation might ameliorate symptoms of schizophrenic psyc...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002189-34 Sponsor Protocol Number: HLX11-BC301 Start Date*: 2022-10-26
    Sponsor Name:Shanghai Henlius Biotech, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy o...
    Medical condition: HER2-Positive and HR-Negative Early-stage or Locally advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-002752-27 Sponsor Protocol Number: NCT-2014-0235/N2M2 Start Date*: 2018-04-04
    Sponsor Name:University Hospital Heidelberg
    Full Title: Umbrella protocol for phase I/IIa trials of molecularly matched targeted therapies plus radiotherapy in patients with newly diagnosed glioblastoma without MGMT promoter methylation: NCT Neuro Maste...
    Medical condition: Patient with newly diagnosed glioblastoma with unmethylated MGMT promoter
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004270-43 Sponsor Protocol Number: AIEOP-BFMALL2009 Start Date*: Information not available in EudraCT
    Sponsor Name:Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Full Title: International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
    Medical condition: acute lymphoblastic leukemia in children and adolescents 1 to <18 years of age
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) AT (Completed) IT (Completed)
    Trial results: (No results available)
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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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