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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   44019   clinical trials with a EudraCT protocol, of which   7318   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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    7,320 result(s) found. Displaying page 1 of 366.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2009-010722-19 Sponsor Protocol Number: BI71023_3001 Start Date*: 2009-11-04
    Sponsor Name:CSL Behring LLC
    Full Title: A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII Deficiency Estudio prospectivo, multicéntrico, con et...
    Medical condition: Congenital Factor XIII deficiency Deficiencia congénita de factor XIII
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016083 Factor XIII deficiency LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002823-27 Sponsor Protocol Number: GAVALAGG Start Date*: 2016-11-17
    Sponsor Name:INFECTOPHARM Arzneimittel GmbH
    Full Title: Placebo-kontrollierte, multizentrische, randomisierte, doppelblinde Phase III-Studie zur Verbesserung der gastrointestinalen Verträglichkeit einer per-oralen Antibiotikatherapie durch add-on-Gabe v...
    Medical condition: Verbesserung der gastrointestinalen Verträglichkeit einer per-oralen Antibiotikatherapie
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10055956 Antibiotic-associated diarrhoea LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-016731-34 Sponsor Protocol Number: CRO1413 Start Date*: 2010-01-08
    Sponsor Name:Imperial College
    Full Title: Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised double blind controlled trial of Nutritional Evaluation and Optimisation in Neonates.
    Medical condition: Preterm birth
    Disease: Version SOC Term Classification Code Term Level
    12.0 10036594 Premature birth LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002345-39 Sponsor Protocol Number: Göteborg University Start Date*: 2006-02-16
    Sponsor Name:NOPHO NHL-group
    Full Title: B-NHL BFM 04
    Medical condition: B-cell lymphoma or B-ALL in children up to 18 years of age
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-014892-31 Sponsor Protocol Number: MAIVECMOPAIN Start Date*: 2009-11-10
    Sponsor Name:ErasmusMC - Sophia
    Full Title: Morphine intravenous vs. Paracetamol intravenous in children on ECMO
    Medical condition: Patients treated with Extra Corporal Membrane Oxygenation (ECMO) receive morphine as standardised analgesic drug. Morphine is associated with several side effects. In these patients a non-opioid dr...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024387-17 Sponsor Protocol Number: CPI-CL-012 Start Date*: 2012-05-16
    Sponsor Name:Cumberland Pharmaceuticals Inc.
    Full Title: A Multi-center, Randomized, Open-Label, Parallel, Active-Comparator, Multiple Dose Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Pediatric Patients
    Medical condition: fever
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-000069-41 Sponsor Protocol Number: THCHOG-2008-01 Start Date*: 2008-04-09
    Sponsor Name:Erasmus MC
    Full Title: Regulation of colloid osmotic pressure during cardiopulmonary bypass in infants: prospective randomised trial
    Medical condition: Regulation of COP during CPB in infants
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001674-32 Sponsor Protocol Number: NordiNet-IOS Start Date*: 2009-04-29
    Sponsor Name:Novo Nordisk Farma Oy
    Full Title: NordiNet International Outcome Study (NordiNet IOS)
    Medical condition: Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    16.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2013-002847-28 Sponsor Protocol Number: CRLX030A2208 Start Date*: 2014-06-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Multicenter, open-label, dose escalation study to evaluate safety, tolerability and pharmacokinetics of RLX030 in addition to standard of care in pediatric patients from birth to <18 years of age, ...
    Medical condition: acute heart failure
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10000803 Acute heart failure LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005508-14 Sponsor Protocol Number: 08/0171 Start Date*: 2010-02-09
    Sponsor Name:University College london
    Full Title: A phase 3 randomized, placebo-controlled blinded investigation of six weeks vs. six months of oral valgancoclovir therapy in infants with symtomatic congenital cytomegalovirus infection. DMID # 06-...
    Medical condition: Symptomatic Congenital Cytomegalovirus.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010430 Congenital cytomegalovirus infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002328-34 Sponsor Protocol Number: KB056 Start Date*: Information not available in EudraCT
    Sponsor Name:KEDRION S.P.A
    Full Title: Efficacy and safety evaluation of Kedrion Fibrin Sealant as an adjuvant for the control of hemostasis in pediatric patients undergoing abdominal or orthopedic surgery. Multicenter, randomized, cont...
    Medical condition: Paediatric patients undergoing abdominal or orthopedic surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10067439 Haemostasis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001515-31 Sponsor Protocol Number: NEOMERO-1 Start Date*: 2011-08-25
    Sponsor Name:FONDAZIONE PENTA ONLUS
    Full Title: EFFICACY, PHARMACOKINETICS AND SAFETY OF MEROPENEM IN INFANTS BELOW 90 DAYS OF AGE (INCLUSIVE) WITH CLINICAL OR CONFIRMED LATE-ONSET SEPSIS: A EUROPEAN MULTICENTER RANDOMISED PHASE III TRIAL
    Medical condition: late onset sepsis in the neonate and infant up to 90 days of age
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10053840 Bacterial sepsis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) GR (Completed) LT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-002686-36 Sponsor Protocol Number: 20053 Start Date*: 2005-09-19
    Sponsor Name:Všeobecná fakultní nemocnice v Praze
    Full Title: Developmental pharmacokinetics and pharmacogenetics aspects of analgosedation by tramadol of newborns, infants and older children treated at the intensive care unit
    Medical condition: children requiring analgosedation with tramadol
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004820-41 Sponsor Protocol Number: MK-7625A-035 Start Date*: 2017-08-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropen...
    Medical condition: Complicated intra-abdominal infection (cIAI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) ES (Completed) HU (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004538-40 Sponsor Protocol Number: BC-5429 Start Date*: 2020-11-20
    Sponsor Name:Ghent University Hospital
    Full Title: A multicentric randomised controlled clinical trial to study the impact of bedside model-informed precision dosing of vancomycin in critically ill children.
    Medical condition: Gram positive infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004704-19 Sponsor Protocol Number: MK-7625A-036 Start Date*: 2019-08-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    Full Title: A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nos...
    Medical condition: Nosocomial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted) EE (Trial now transitioned) Outside EU/EEA GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000201-69 Sponsor Protocol Number: D5290C00005 Start Date*: 2019-08-13
    Sponsor Name:MedImmune, LLC
    Full Title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-...
    Medical condition: The prevention of medically attended RSV LRTI.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) LV (Completed) GB (GB - no longer in EU/EEA) SE (Completed) DE (Completed) BG (Completed) CZ (Completed) EE (Completed) HU (Completed) LT (Ongoing) PL (Completed) FI (Completed) AT (Completed) FR (Ongoing) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004571-12 Sponsor Protocol Number: ANRS160RalFE Start Date*: 2014-02-06
    Sponsor Name:Inserm-ANRS
    Full Title: Evaluation of the pharmacokinetic properties and the tolerance of raltegravir during the third trimester of pregnancy
    Medical condition: HIV and pregnancy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10073025 Prevention of mother to child transmission of HIV infection LLT
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003842-34 Sponsor Protocol Number: MK-5592-127 Start Date*: Information not available in EudraCT
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formul...
    Medical condition: Invasive Fungal Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10017533 Fungal infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) Outside EU/EEA BE (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    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)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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