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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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7,366 result(s) found. Displaying page 289 of 369.
    EudraCT Number: 2017-000421-13 Sponsor Protocol Number: 1913 Start Date*: 2017-07-27
    Sponsor Name:Erasmus MC
    Full Title: Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial
    Medical condition: Congenital diaphragmatic hernia with pulmonary hypertension
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) NO (Prematurely Ended) AT (Prematurely Ended) SE (Ongoing) BE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-003775-20 Sponsor Protocol Number: HGT-MLD-071 Start Date*: 2013-09-11
    Sponsor Name:Shire Human Genetics Therapies Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
    Full Title: An Open-label Extension of Study HGT-MLD-070 Evaluating Long Term Safety and Efficacy of Intrathecal Administration of HGT-1110 in Patients with Metachromatic Leukodystrophy
    Medical condition: Treatment of Metachromatic Leukodystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10067609 Metachromatic leukodystrophy PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000133-40 Sponsor Protocol Number: 2016-2369 Start Date*: 2016-05-25
    Sponsor Name:Gustave Roussy
    Full Title: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
    Medical condition: Relapsed or refractory tumors in children
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003956-37 Sponsor Protocol Number: IGG-PRINTO-002 Start Date*: 2006-09-26
    Sponsor Name:Istituto Giannina Gaslini
    Full Title: Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednison...
    Medical condition: Juvenile Dermatomyositis at onset
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) IT (Ongoing) DK (Completed) BE (Completed) SE (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-003737-29 Sponsor Protocol Number: BUU-5/EEA Start Date*: Information not available in EudraCT
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophi...
    Medical condition: Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10064220 Eosinophilic esophagitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PT (Completed) NL (Completed) GR (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-002754-22 Sponsor Protocol Number: TCC-201 Start Date*: 2019-11-01
    Sponsor Name:Ascendis Pharma Growth Disorders A/S
    Full Title: ACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP admin...
    Medical condition: Achondroplasia (ACH) in prepubertal children
    Disease: Version SOC Term Classification Code Term Level
    25.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) DK (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003467-26 Sponsor Protocol Number: NN7769-4516 Start Date*: 2021-11-30
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors
    Medical condition: Haemophilia A Haemophilia A with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed) IT (Completed) ES (Ongoing) PT (Completed) LT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004224-38 Sponsor Protocol Number: CNTO1275PUC3001 Start Date*: 2021-02-25
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in...
    Medical condition: Moderately to Severely Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) HU (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) Outside EU/EEA BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004496-31 Sponsor Protocol Number: CNTO148UCO3003 Start Date*: 2018-11-07
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Pa...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) ES (Ongoing) FR (Trial now transitioned) NL (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003775-19 Sponsor Protocol Number: EFC16461 Start Date*: 2020-09-23
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: Master protocol of three randomized, double-blind, placebo-controlled, multi center, parallel-group studies of dupilumab in patients with chronic spontaneous urticaria (CSU) who remain symptomatic ...
    Medical condition: Chronic spontaneous urticaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) HU (Completed) GB (GB - no longer in EU/EEA) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-003317-25 Sponsor Protocol Number: LTS14424 Start Date*: 2018-05-04
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: One year study to evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA LT (Completed) HU (Completed) PL (Completed) IT (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003577-25 Sponsor Protocol Number: 1907V921F Start Date*: Information not available in EudraCT
    Sponsor Name:Shionogi B.V.
    Full Title: A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment w...
    Medical condition: Opioid induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Prematurely Ended) IT (Completed) NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003422-32 Sponsor Protocol Number: AMoRe2017 Start Date*: 2018-04-25
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH
    Full Title: INTERNATIONAL MULTICENTER, OPEN-LABEL, PHASE 2 STUDY TO TREAT MOLECULAR RELAPSE OF PEDIATRIC ACUTE MYELOID LEUKEMIA WITH AZACITIDINE
    Medical condition: Intravenous azacitidine 100 mg/m2, Days 1 to 7 of a 28-day cycle for up to 3 cycles initially. In case of decline of MRD during azacitidine treatment additional cycles are allowed (maximum 6 cycl...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Prematurely Ended) SE (Completed) BE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000704-28 Sponsor Protocol Number: GCP#05.01.020 Start Date*: 2016-06-16
    Sponsor Name:Gamida Cell Ltd
    Full Title: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord...
    Medical condition: High risk haematological malignancies
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    19.0 100000004864 10000886 Acute myeloid leukemia LLT
    19.0 100000004864 10009015 Chronic myeloid leukemia LLT
    19.0 100000004864 10028534 Myelodysplastic syndrome NOS LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IT (Prematurely Ended) PT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004438-93 Sponsor Protocol Number: CT-ORZY-NPC-002 Start Date*: 2016-05-09
    Sponsor Name:Orphazyme A/S
    Full Title: Arimoclomol prospective double blind, randomised, placebo-controlled study in patients diagnosed with Niemann Pick disease type C
    Medical condition: Niemann Pick disease type C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) IT (Completed) PL (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-001747-12 Sponsor Protocol Number: CSEG101B2201 Start Date*: 2019-05-24
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 2, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, with or without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups o...
    Medical condition: Sickle Cell Disease with Vaso-Occlusive Crisis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    20.1 10010331 - Congenital, familial and genetic disorders 10002077 Anaemia sickle cell LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Restarted) FR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021238-74 Sponsor Protocol Number: SP0994 Start Date*: Information not available in EudraCT
    Sponsor Name:UCB BIOSCIENCES GmbH
    Full Title: A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, FOLLOW UP STUDY EVALUATING THE LONG TERM SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) IN COMPARISON WITH CONTROLLED-RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), ...
    Medical condition: Epilepsy; partial onset or generalized tonic clonic seizures
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) BE (Completed) SE (Completed) FI (Completed) PT (Completed) GB (Completed) CZ (Completed) SK (Completed) PL (Completed) IT (Completed) LV (Completed) LT (Completed) GR (Completed) BG (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002217-59 Sponsor Protocol Number: 63623872FLZ3002 Start Date*: 2018-05-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, ...
    Medical condition: Influenza A Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10022002 Influenza A virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended) LV (Prematurely Ended) EE (Completed) LT (Prematurely Ended) FR (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) SK (Prematurely Ended) HU (Prematurely Ended) BE (Completed) BG (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002156-84 Sponsor Protocol Number: 63623872FLZ3001 Start Date*: 2018-05-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, a...
    Medical condition: Influenza A Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10022002 Influenza A virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) LV (Prematurely Ended) LT (Prematurely Ended) FR (Prematurely Ended) DE (Prematurely Ended) SK (Prematurely Ended) BE (Completed) CZ (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended) PL (Prematurely Ended) GB (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019765-28 Sponsor Protocol Number: SP0993 Start Date*: 2011-02-08
    Sponsor Name:UCB BIOSCIENCES GmbH
    Full Title: A MULTICENTER, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200M...
    Medical condition: Epilepsy, partial onset or generalised tonic-clonic seizures.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) CZ (Completed) FI (Completed) SE (Completed) HU (Completed) ES (Completed) PT (Completed) PL (Completed) SK (Completed) GB (Completed) GR (Completed) IT (Completed) LV (Completed) LT (Completed) BG (Completed) 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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