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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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    10,988 result(s) found. Displaying page 304 of 550.
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    EudraCT Number: 2017-001828-22 Sponsor Protocol Number: 101 Start Date*: Information not available in EudraCT
    Sponsor Name:Y-mAbs Therapeutics A/S
    Full Title: A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-omburtamab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
    Medical condition: Treatment of pediatric neuroblastoma patients with CNS relapse as evidenced by CNS/LM metastases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073130 Central nervous system neuroblastoma PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) ES (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-004406-25 Sponsor Protocol Number: IB1001-202 Start Date*: 2019-05-09
    Sponsor Name:IntraBio Ltd
    Full Title: Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A multinational, multicenter, open-label, rater-blinded Phase II study.
    Medical condition: GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)
    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: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-002773-21 Sponsor Protocol Number: 89Zr-TLX250-003 Start Date*: 2019-04-10
    Sponsor Name:TELIX International Pty Ltd
    Full Title: A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal ce...
    Medical condition: Patients with an indeterminate renal mass (IRM) detected on contrast-enhanced abdominal MR imaging or equivalent standard of care imaging, clinically suspicious for renal cell carcinoma and schedul...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA) BE (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2005-001621-29 Sponsor Protocol Number: 80804002 Start Date*: 2009-05-05
    Sponsor Name:Faculty of Medicine Carl Gustav Carus, University of Technology, Dresden
    Full Title: Pre-POINT (Primary Oral INsulin Trial) study A dose finding safety and immune efficacy study for primary mucosal insulin therapy in islet autoantibody negative children at high genetic risk for ty...
    Medical condition: pre-type 1 diabetes (islet autoimmunity in non-diabetic relatives of subjects with type 1 diabetes)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004552-38 Sponsor Protocol Number: CLGX818X2109 Start Date*: 2014-07-10
    Sponsor Name:Array BioPharma Inc.
    Full Title: A Phase II, Multi-center, Open-label Study of sequential LGX818/MEK162 combination followed by a Rational Combination With targeted agents After Progression, to overcome resistance in Adult Patient...
    Medical condition: Locally Advanced or Metastatic BRAF V600 Melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000953-38 Sponsor Protocol Number: MK-1986-014 Start Date*: 2018-02-07
    Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
    Medical condition: Treatment or prophylaxis against Gram-positive infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) GB (GB - no longer in EU/EEA) NO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004339-19 Sponsor Protocol Number: UTX-TGR-204 Start Date*: 2017-02-16
    Sponsor Name:TG Therapeutics
    Full Title: A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination with Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
    Medical condition: Chronic Lymphocytic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10008976 Chronic lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) ES (Ongoing) GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000309-64 Sponsor Protocol Number: AL-ACC-01 Start Date*: 2019-10-24
    Sponsor Name:Ayala Pharmaceuticals, Inc.
    Full Title: A Phase 2, Open-Label, Multi-Center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
    Medical condition: Adenoid cystic carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10053231 Adenoid cystic carcinoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-005306-49 Sponsor Protocol Number: MK-0683-092 Start Date*: 2008-09-03
    Sponsor Name:Department of Haematology, Herlev Hospital, University of Copenhagen
    Full Title: A Phase II Study of Vorinostat in Patients with Polycythaemia Vera and Essential Thrombocythaemia
    Medical condition: patients with polycythaemia vera or essential thrombocythaemia or myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036057 Polycythaemia vera LLT
    9.1 10015493 Essential thrombocythaemia LLT
    12.1 10028537 Myelofibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-005659-15 Sponsor Protocol Number: ACE-011-B-THAL-001 Start Date*: 2012-10-04
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2a, open-label, dose finding study to determine the safety and tolerability of sotatercept (ACE-011) in adults with beta (β)- thalassemia
    Medical condition: Subjects with red blood cell (RBC) transfusion dependent β-thalassemia major and β thalassemia intermedia, as well as non-transfusion dependent β-thalassemia intermedia will take part in this study.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10062923 Thalassemia intermedia LLT
    20.1 100000004850 10054661 Thalassemia major LLT
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2015-001997-16 Sponsor Protocol Number: VX15-770-124 Start Date*: Information not available in EudraCT
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Init...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003149-41 Sponsor Protocol Number: IgPro20_2001 Start Date*: 2019-07-16
    Sponsor Name:CSL Behring GmbH
    Full Title: A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglob...
    Medical condition: Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10012977 Diffuse systemic sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-005035-33 Sponsor Protocol Number: R2477-FOP-1623 Start Date*: 2017-08-15
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progres...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003118-42 Sponsor Protocol Number: D419EC00001 Start Date*: 2019-04-16
    Sponsor Name:AstraZeneca AB
    Full Title: Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patien...
    Medical condition: Advanced Solid Tumors and Hematological Malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    21.1 100000004864 10066481 Hematological malignancy LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Ongoing) ES (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004705-26 Sponsor Protocol Number: LPS15497 Start Date*: 2020-03-24
    Sponsor Name:Sanofi Aventis Groupe
    Full Title: A randomized double blind placebo controlled study evaluating the effect of dupilumab on sleep in adult patients with moderate to severe atopic dermatitis
    Medical condition: Atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012438 Dermatitis atopic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000337-39 Sponsor Protocol Number: 4658-102-OLE Start Date*: Information not available in EudraCT
    Sponsor Name:Sarepta Therapeutics, Inc
    Full Title: An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen in Patients with Duchenne Muscular Dystrophy Who Have Completed Study 4658-102
    Medical condition: Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: FR (Ongoing) BE (Prematurely Ended) GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002153-11 Sponsor Protocol Number: GS-LHON-CLIN-06 Start Date*: 2018-02-12
    Sponsor Name:GENSIGHT BIOLOGICS
    Full Title: Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REVERSE Phase III Clinical Trials
    Medical condition: Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10062951 Leber's hereditary optic atrophy neuropathy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003162-25 Sponsor Protocol Number: MEA116841 Start Date*: 2015-02-26
    Sponsor Name:GlaxoSmithKline Research Ltd
    Full Title: Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in...
    Medical condition: Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004867 10018701 Granulomatous disease LLT
    21.1 100000004866 10072580 Granulomatous polyangiitis LLT
    21.0 100000004864 10014956 Eosinophilic granuloma LLT
    20.1 100000004870 10014957 Eosinophilic granulomatous vasculitis LLT
    21.1 100000004866 10056218 Necrotising granulomatous vasculitis LLT
    21.1 100000004855 10068462 Eosinophilic asthma LLT
    21.1 100000004866 10036023 Polyangiitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-001526-59 Sponsor Protocol Number: CL2-95011-001 Start Date*: 2020-10-20
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study
    Medical condition: Primary Sjögren’s Syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10040767 Sjogren's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002623-14 Sponsor Protocol Number: GWSP18023 Start Date*: 2020-03-17
    Sponsor Name:GW Pharma Ltd
    Full Title: A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis
    Medical condition: Symptomatic relief of spasticity in Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) GB (GB - no longer in EU/EEA) RO (Ongoing)
    Trial results: View results
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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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