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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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    7,375 result(s) found. Displaying page 1 of 369.
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    EudraCT Number: 2006-001095-21 Sponsor Protocol Number: A5I16 Start Date*: 2016-04-19
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed),...
    Medical condition: Pertussis, adsorbed diphtheria and tetanus toxoids, inactivated poliomyelitis and polysaccharide of H. influenza type b bound to tetanus toxoid
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-016877-14 Sponsor Protocol Number: H1N1-2009 Start Date*: 2009-11-04
    Sponsor Name:COPSAC
    Full Title: H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A-H1N1v Vaccination in Pregnant Women
    Medical condition: Protection against Influenza A H1N1v disease
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005629-65 Sponsor Protocol Number: RG_12-269 Start Date*: 2014-01-15
    Sponsor Name:University of Birmingham
    Full Title: Management of Transformed Chronic myeloid leukaemia: Ponatinib and Intensive chemotherapy: a dose finding study
    Medical condition: Chronic Myeloid Leukaemia (CML) in Blast Phase
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-002505-62 Sponsor Protocol Number: STH16404 Start Date*: 2013-11-14
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: SarCaBon: A randomised phase II trial of Saracatinib versus placebo for cancer-induced bone pain
    Medical condition: Cancer-induced bone pain
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10049038 Metastatic bone pain LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-003488-71 Sponsor Protocol Number: OVG-2013/04 Start Date*: 2013-12-12
    Sponsor Name:University of Oxford
    Full Title: A pilot study of the impact of BCG administration on the immunogenicity of serogroup C meningococcal conjugate vaccine in healthy infants
    Medical condition: Vaccine responses
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-020841-29 Sponsor Protocol Number: ADAPT Start Date*: 2011-07-07
    Sponsor Name:King`s College London [...]
    1. King`s College London
    2. Guy`s & St Thomas` NHS Foundation Trust
    Full Title: The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
    Medical condition: Severe eczema in children
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10003641 Atopic eczema LLT
    19.0 100000004858 10014189 Eczema allergic atopic LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001109-22 Sponsor Protocol Number: PBGM01-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Passage Bio, Inc.
    Full Title: A Phase 1/2 Open-Label, Multicenter, Dose Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of a Single Dose of PBGM01 Delivered into the Cisterna Magna of Pediatric Su...
    Medical condition: GM1 gangliosidosis (GM1) is an autosomal recessive disorder that results from mutations in the human galactosidase beta 1 gene (GLB1), which encodes beta-galactosidase (β-gal).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-004898-32 Sponsor Protocol Number: SAM103848 Start Date*: 2016-12-08
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50...
    Medical condition: Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-001133-40 Sponsor Protocol Number: AT1001-025 Start Date*: 2020-01-06
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Fabry Subjects with Amenable GLA Variants and Severe Renal Impairment
    Medical condition: Fabry Subjects with Amenable GLA Variants and Severe Renal Impairment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-002109-20 Sponsor Protocol Number: AAV2-hRPE65v2-301 Start Date*: 2016-10-24
    Sponsor Name:Spark Therapeutics, Inc.
    Full Title: A Safety and Efficacy Study in Subjects with Leber Congenital Amaurosis (LCA) Using Adeno-Associated Viral Vector to Deliver the Gene for Human RPE65 to the Retinal Pigment Epithelium (RPE) [AAV2-h...
    Medical condition: Leber Congenital Amaurosis (LCA)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10070667 Leber's congenital amaurosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004900-44 Sponsor Protocol Number: SF114570 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl peroxide/Clindamycin gel and Tazarotene cream when used in combination in the Treat...
    Medical condition: Acne Vulgaris
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000263-32 Sponsor Protocol Number: V260-028 Start Date*: 2017-03-07
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Rotavirus Reassortant Vaccine in Chinese Healthy Adults, Children and Infants
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002849-30 Sponsor Protocol Number: CCTL019B2101J/CHP-959 Start Date*: 2017-11-16
    Sponsor Name:University of Pennsylvania
    Full Title: A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leuk...
    Medical condition: Chemotherapy resistant or refractory CD19+ B-cell Leukemia and Lymphoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-005111-40 Sponsor Protocol Number: CN138-178 Start Date*: 2017-04-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Flexible- Dosed Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents with Autistic Disorder
    Medical condition: Autistic Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000611-17 Sponsor Protocol Number: LTS12745 Start Date*: 2017-08-28
    Sponsor Name:Alfresa Pharma Corporation and Sanofi KK
    Full Title: A Long term study of M071754 - A open-label study in patients with infantile spasms.
    Medical condition: Patients diagnosed with infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000608-14 Sponsor Protocol Number: 1.0/170119 Start Date*: Information not available in EudraCT
    Sponsor Name:Tartu University Hospital
    Full Title: Prospective validation of individualized Bayesian dose optimization tool DosOpt for Vancomycin treatment in neonates.
    Medical condition: In neonatal population wide inter-and intra-individual variability of pharmacokinetics makes extremely difficult to ensure optimal exposure of vancomycin with standard regimens. On average >50% of ...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003248-34 Sponsor Protocol Number: IMPAACTP1110 Start Date*: 2016-11-02
    Sponsor Name:NIAID and NICHD
    Full Title: A PHASE I TRIAL TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF RALTEGRAVIR IN HIV-1-EXPOSED NEONATES AT HIGH RISK OF ACQUIRING HIV-1 INFECTION
    Medical condition: New born babies at risk of acquiring HIV from their infected mothers.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053529 Vertical human immunodeficiency virus transmission LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004680-39 Sponsor Protocol Number: AUTO3-PA1 Start Date*: 2017-06-21
    Sponsor Name:Autolus Limited
    Full Title: A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 in Paediatric and Adult Patients with R...
    Medical condition: Acute lymphoblastic leukaemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001678-40 Sponsor Protocol Number: CACZ885N2301E2 Start Date*: 2017-05-15
    Sponsor Name:Novartis pharma AG
    Full Title: An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes
    Medical condition: Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004318-82 Sponsor Protocol Number: CTBM100CUS03 Start Date*: 2017-05-15
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    20.0 100000004862 10021860 Infection Pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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