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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   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).

    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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    2,292 result(s) found. Displaying page 1 of 115.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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: 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: 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: 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: 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: 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: 2015-004155-43 Sponsor Protocol Number: PA-CL-PED-01 Start Date*: 2016-05-04
    Sponsor Name:Vifor Fresenius Medical Care Renal Pharma France
    Full Title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and...
    Medical condition: Control of serum phosphorus levels in paediatric and adolescent subjects with chronic kidney disease (CKD).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    20.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-002411-34 Sponsor Protocol Number: 20140315 Start Date*: 2019-01-28
    Sponsor Name:Amgen Inc.
    Full Title: Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Sec...
    Medical condition: Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2015-002252-27 Sponsor Protocol Number: TED-C14-006 Start Date*: 2016-09-19
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age with Short Bowel Syndrome who are Dependent ...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004904-50 Sponsor Protocol Number: GWEP15100 Start Date*: Information not available in EudraCT
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study.
    Medical condition: Infantile Spasms
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002926-35 Sponsor Protocol Number: 080716CT Start Date*: 2017-01-16
    Sponsor Name:Alder Hey Children's Foundation NHS Trust
    Full Title: Pharmacokinetics of post-operative Cefuroxime in infants undergoing cardiac surgery
    Medical condition: post operative paediatric cardiac patients
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10053840 Bacterial sepsis PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-002729-39 Sponsor Protocol Number: C-07-40 Start Date*: 2017-11-07
    Sponsor Name:Alcon Research Ltd
    Full Title: An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in the USA
    Medical condition: Bacterial conjunctivitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061784 Conjunctivitis bacterial PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000251-74 Sponsor Protocol Number: SFY10718 Start Date*: 2017-03-20
    Sponsor Name:Sanofi
    Full Title: An open-label, uncontrolled 4-week study to assess the safety, efficacy and pharmacokinetics of Allegra® (dry syrup formulation) 15 mg or 30 mg twice daily in pediatric patients with atopic dermat...
    Medical condition: Atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001008-49 Sponsor Protocol Number: NV22155 Start Date*: 2016-09-30
    Sponsor Name:F. Hoffmann-La Roche AG
    Full Title: A randomized, multicenter trial of oseltamivir doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days in influenza patients with pandemic (H1N1) 2009
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002146-72 Sponsor Protocol Number: CC-5013-AML-002 Start Date*: 2017-07-03
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomide (REVLIMID®) in Pediatric Subjects from 1 to ≤ 18 Years of Age with Relapse...
    Medical condition: Leukemia, Myeloid
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012984 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2019-002836-10 Sponsor Protocol Number: C3291002 Start Date*: 2019-08-22
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 4, Multicenter, Open Label Safety Study Of Crisaborole Ointment 2% In Children Aged 3 Months To Less Than 24 Months With Mild To Moderate Atopic Dermatitis
    Medical condition: Atopic Dermatitis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004753-33 Sponsor Protocol Number: CSLCT-QIV-15-03 Start Date*: 2016-12-15
    Sponsor Name:Seqirus GmbH
    Full Title: A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-li...
    Medical condition: Prophylaxis for influenza virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004316-18 Sponsor Protocol Number: 2006-05 Start Date*: 2017-11-21
    Sponsor Name:Jazz Pharmaceuticals
    Full Title: Defibrotide for Patients with Hepatic Veno-occlusive Disease (VOD): A Treatment IND Study
    Medical condition: Hepatic Veno-Occlusive Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10047207 Veno-occlusive liver damage LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults 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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