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Clinical trials

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    7,376 result(s) found. Displaying page 157 of 369.
    EudraCT Number: 2009-011396-77 Sponsor Protocol Number: 6096A1-3014-WW Start Date*: 2009-10-09
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunize...
    Medical condition: Pneumococcal infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061353 Pneumococcal infection LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-017013-29 Sponsor Protocol Number: TMC114-TiDP29-C232 Start Date*: 2010-07-08
    Sponsor Name:Janssen R&D Ireland
    Full Title: Continued access to darunavir/ritonavir (DRV/rtv) in HIV-1 infected children and adolescents aged 3 years and above
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002172-92 Sponsor Protocol Number: AZA-AML-004 Start Date*: 2015-04-27
    Sponsor Name:Celgene Corporation
    Full Title: A randomized, multicenter, open-label, Phase 2 study with a safety run-in part to evaluate safety, pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children and...
    Medical condition: Treatment of children and young adults with molecular relapse of acute myeloid leukemia (AML) after first complete remission (CR1).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-002821-32 Sponsor Protocol Number: FENDEEP Start Date*: 2021-12-09
    Sponsor Name:Neurologia Aplicada, SLP
    Full Title: The FENDEEP Study: Fenfluramine for the treatment of different types of developmental and epileptic encephalopathies: a pilot trial exploring epileptic and non-epileptic outcomes.
    Medical condition: Five different types of developmental and epileptic encephalopathies (DEEs): SYNGAP1 and STXBP1 encephalopathies, inv-dup(15) encephalopathy, multifocal or bilateral Malformations of Cortical Devel...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004150-27 Sponsor Protocol Number: KAR0001HEARTCAT Start Date*: 2005-11-03
    Sponsor Name:Universitätsklinik für Kinder- und Jugendheilkunde
    Full Title: RANDOMIZED CONTROLLED TRIAL COMPARING TWO HEPARINIZATION PROTOCOLS FOR PROPHYLAXIS OF SHORT- AND LONG-TERM THROMBOTIC COMPLICATIONS OF PEDIATRIC CARDIAC CATHETERIZATION The HEARTCAT – Study (HEpar...
    Medical condition: Patients requiring diagnostic or interventional cardiac catheterisation (without Stent, device or catheter ablation)
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001680-72 Sponsor Protocol Number: TAK-390MR_206 Start Date*: 2012-10-09
    Sponsor Name:Takeda Development Centre Europe Ltd
    Full Title: A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescen...
    Medical condition: Heartburn in Adolescent subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10066874 Gastroesophageal reflux disease LLT
    14.1 100000004856 10019326 Heartburn LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PT (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001681-15 Sponsor Protocol Number: TAK-390MR_207 Start Date*: 2012-10-17
    Sponsor Name:Takeda Global Research & Development Centre (Europe) Ltd
    Full Title: A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenan...
    Medical condition: Heartburn and Erosive Esophagitis in Adolescent Subjects
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10018203 GERD LLT
    14.1 10017947 - Gastrointestinal disorders 10019326 Heartburn LLT
    14.1 10017947 - Gastrointestinal disorders 10063657 Erosive esophagitis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003561-17 Sponsor Protocol Number: ECP-002 Start Date*: 2013-08-09
    Sponsor Name:Edimer Pharmaceuticals, Inc.
    Full Title: A Phase 2 open-label, dose-escalation study to evaluate the safety, pharmacokinetics, immunogeniticy and pharmacodynamics/efficacy of EDI200, an EDA-A1 replacement protein, administered to male inf...
    Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED) is caused by inherited defects in the ectodysplasin (EDA) gene that disrupt synthesis and/or function of the primary translational product EDA-A1....
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10072592 Hypohidrotic ectodermal dysplasia LLT
    Population Age: Newborns, Under 18 Gender: Male
    Trial protocol: DE (Completed) GB (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-000353-31 Sponsor Protocol Number: DEEP-2 Start Date*: 2012-11-29
    Sponsor Name:CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
    Full Title: Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate the efficacy and safety of deferiprone compared to deferasirox in paediatric patients aged from 1 month to l...
    Medical condition: Chronic iron overload
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004861 10065974 Chronic iron overload LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) Outside EU/EEA GR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003243-34 Sponsor Protocol Number: C2661002/D3720C00009 Start Date*: 2015-02-02
    Sponsor Name:Pfizer Inc.
    Full Title: Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis
    Medical condition: Late-onset Sepsis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000005053 10040054 Sepsis, bacteraemia, viraemia and fungaemia NEC HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) IT (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000043-27 Sponsor Protocol Number: 191622-105 Start Date*: Information not available in EudraCT
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
    Medical condition: Upper limb spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000084-24 Sponsor Protocol Number: 191622-112 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment of Pediatric Lower Limb Spasticity: Open-label Study
    Medical condition: Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005541-30 Sponsor Protocol Number: APD003 Start Date*: 2016-08-23
    Sponsor Name:UCB BioPharma SPRL
    Full Title: AN OPEN-LABEL, EXPLORATORY, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINAS...
    Medical condition: Activated PI3K delta Syndrome (APDS)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-000393-76 Sponsor Protocol Number: ZKI-SCT-HAPLO-0106 Start Date*: 2006-10-25
    Sponsor Name:Johann Wolfgang Goethe-Universität Frankfurt am Main
    Full Title: Allogenic stem cell transplantation with CD3/CD19 depleted stem cells from haploidentical related and non-related donators in pediatric patients with and without malignant systemic diseases.
    Medical condition: Pediatric patients with malignant and non-malignant high-risk diseases, where the allogeneic stem cell transplantation represents the only option for a curative therapy and where an adequate HLA-id...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003370-40 Sponsor Protocol Number: GBT440-031 Start Date*: 2017-04-05
    Sponsor Name:Global Blood Therapeutics, Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10040644 Sickle cell disease LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004914-40 Sponsor Protocol Number: A3921103 Start Date*: 2012-09-19
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH JUVENILE IDIOPATHIC ARTHRITI...
    Medical condition: JUVENILE IDIOPATHIC ARTHRITIS
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10059176 Juvenile idiopathic arthritis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) HU (Completed) SK (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-006024-35 Sponsor Protocol Number: cysteamine gel formulation/07/cysta Start Date*: 2008-02-04
    Sponsor Name:Orphan Europe SARL
    Full Title: Adaptive dose regimen of Cystadrops for cOrneal Crystal deposiTs and ocular manifestations in nephropathic cystinosis : an open label, dose-response pilot study
    Medical condition: Nephropathic cystinotic patients with cystine crystals corneal deposits
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004483-19 Sponsor Protocol Number: RRK5908 Start Date*: 2017-09-09
    Sponsor Name:University Hospitals Birmingham NHS Foundation Trust
    Full Title: A randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis
    Medical condition: Bacterial Vaginosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10004055 Bacterial vaginosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002455-97 Sponsor Protocol Number: 13381 Start Date*: 2016-10-19
    Sponsor Name:University of Southampton
    Full Title: Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care
    Medical condition: Respiratory tract infections in children aged between 6 months and 12 years
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10066740 Acute respiratory tract infection LLT
    21.1 10021881 - Infections and infestations 10024968 Lower respiratory tract infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002551-22 Sponsor Protocol Number: HZA114971 Start Date*: 2017-02-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Study HZA114971, A Multicentre Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a One-Year Regimen of Orally Inhaled Fluticasone Furoate 50 mcg once dai...
    Medical condition: Paediatric Subjects with Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
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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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