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Clinical trials for Bethesda System

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    19 result(s) found for: Bethesda System. Displaying page 1 of 1.
    EudraCT Number: 2015-004063-36 Sponsor Protocol Number: CELIM-RCD-002 Start Date*: 2016-02-22
    Sponsor Name:Celimmune LLC
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients with Type II Refractory Celiac Disease, an In Situ Sm...
    Medical condition: Type II Refractory Celiac Disease (RCD-II)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-002136-40 Sponsor Protocol Number: 261203 Start Date*: Information not available in EudraCT
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 y...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Prematurely Ended) ES (Completed) CZ (Prematurely Ended) AT (Completed) HU (Completed) DE (Completed) NL (Prematurely Ended) BE (Completed) NO (Completed) DK (Completed) FI (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003456-20 Sponsor Protocol Number: ITN084AD Start Date*: 2020-02-17
    Sponsor Name:Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease
    Full Title: Grass Pollen Sublingual Tablet Immunotherapy plus Dupilumab for Induction of Tolerance in Adults with Moderate to Severe Seasonal Allergic Rhinitis.
    Medical condition: Moderate to Severe Seasonal Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004870 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003647-19 Sponsor Protocol Number: CELIM-NRCD-001 Start Date*: 2016-02-22
    Sponsor Name:Celimmune LLC
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients with Celiac Disease.
    Medical condition: Celiac disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2021-000608-39 Sponsor Protocol Number: 21-ItolDC-028-01 Start Date*: 2022-09-20
    Sponsor Name:Idogen AB
    Full Title: An open-label, multi-center, first in human, phase 1/2a trial to evaluate the safety and preliminary efficacy of autologous tolerogenic dendritic cells ex vivo loaded with recombinant Factor VIII (...
    Medical condition: Treatment of patients with Hemophilia A who have developed inhibitory antibodies to clotting Factor VIII and have failed Immune Tolerance Induction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adults Gender: Male
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022991-29 Sponsor Protocol Number: SMR/0211OBD-1033 Start Date*: 2011-02-01
    Sponsor Name:Sucampo Pharma Americas, Inc.
    Full Title: A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Patients with Opioid-induced Bowel Dysfunction
    Medical condition: Opioid-induced Bowel Dysfunction
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10061247 Intestinal functional disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) SE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-000985-21 Sponsor Protocol Number: Bay14-2222/12800 Start Date*: 2009-12-07
    Sponsor Name:Bayer HealthCare Pharmaceuticals Inc
    Full Title: Randomized, controlled, parallel, prospective trial to evaluate the effect of secondary prophylaxis with rFVIII therapy in severe hemophilia A adult and/or adolescent subjects, as applicable, compa...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2011-002065-37 Sponsor Protocol Number: BAY86-5028 / 14371 Start Date*: 2011-09-12
    Sponsor Name:Bayer HealthCare AG
    Full Title: Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal ...
    Medical condition: Contraception
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10010808 Contraception PT
    Population Age: Adolescents, Under 18 Gender: Female
    Trial protocol: SE (Completed) FI (Completed) NL (Completed) AT (Completed) BE (Completed) DE (Completed) DK (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2015-005524-26 Sponsor Protocol Number: GBI1406 Start Date*: 2016-07-29
    Sponsor Name:Grifols Biologicals Inc.
    Full Title: A Multicenter Phase 2 Open-Label, Single-Arm, Prospective, Interventional Study of Plasma-Derived Factor VIIIIVWF Alphanate® in Immune Tolerance Induction Therapy in Subjects with Congenital Hemoph...
    Medical condition: Inhibitors in patients with severe Congenital Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004851 10018847 Haematological disorders HLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000300-42 Sponsor Protocol Number: 03AR0298 Start Date*: 2013-01-18
    Sponsor Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Full Title: A long-term outcome study with the IL-1 receptor antagonist Anakinra/Kineret® in patients with Neonatal onset multisystem inflammatory disease (Nomid/Cinca syndrome)
    Medical condition: neonatal onset multisystem inflammatory disease (NOMID/CINCA)
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-004168-24 Sponsor Protocol Number: BETHESDaCD Start Date*: 2023-12-29
    Sponsor Name:Medical University of Warsaw
    Full Title: Evaluation of the efficacy of topical treatment with budesonide in children with Crohn's disease located in the esophagus and/or stomach and/or duodenum - BETHESDa
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001179-21 Sponsor Protocol Number: 11-EI-0263 Start Date*: 2018-01-17
    Sponsor Name:The National Eye Institute
    Full Title: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Branch Retinal Vein Occlusions
    Medical condition: Branch Retinal Vein Occlusion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-001143-12 Sponsor Protocol Number: 11-EI-0264 Start Date*: 2018-01-09
    Sponsor Name:The National Eye Institute
    Full Title: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Central Retinal Vein Occlusions
    Medical condition: Central Retinal Vein Occlusion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-003072-37 Sponsor Protocol Number: 8HA01EXT Start Date*: 2012-01-18
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episode...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    19.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) BE (Completed) GB (Completed) DE (Completed) AT (Completed) ES (Completed) IT (Completed) IE (Completed) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004271-22 Sponsor Protocol Number: INSIGHTPROTOCOL006 Start Date*: 2015-02-25
    Sponsor Name:Regents of the University of Minnesota
    Full Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
    Medical condition: Infleunza
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) ES (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2020-001052-18 Sponsor Protocol Number: 010 Start Date*: 2020-03-25
    Sponsor Name:Regents of the University of Minnesota
    Full Title: A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European U...
    Medical condition: Influenza COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022005 Influenza viral infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) GB (Completed) DE (Completed) GR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-005674-11 Sponsor Protocol Number: ADVL1412 Start Date*: 2015-04-08
    Sponsor Name:National Cancer Institute
    Full Title: A PHASE 1/2 STUDY OF NIVOLUMAB (IND# 124729) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH RECURRENT OR REFRACTORY SOLID TUMORS AS A SINGLE AGENT AND IN COMBINATION WITH IPILIMUMAB
    Medical condition: •Childhood Solid Neoplasm •Recurrent Childhood Rhabdomyosarcoma •Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor •Recurrent Neuroblastoma •Recurrent Osteosarcoma •Recurrent ...
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10031296 Osteosarcoma recurrent PT
    17.1 10005329 - Blood and lymphatic system disorders 10025319 Lymphomas Hodgkin's disease HLGT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066595 Neuroblastoma recurrent PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015564 Ewing's sarcoma recurrent PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039027 Rhabdomyosarcoma recurrent PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001247-39 Sponsor Protocol Number: CV185-362 Start Date*: 2017-04-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart ...
    Medical condition: Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019273 Heart disease congenital PT
    20.0 10007541 - Cardiac disorders 10007636 Cardiomyopathy PT
    20.0 10007541 - Cardiac disorders 10019276 Heart disease, unspecified LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    20.0 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) FI (Completed) AT (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003468-30 Sponsor Protocol Number: SAG/0211PFC-1131 Start Date*: 2014-09-24
    Sponsor Name:Sucampo Pharma Europe Ltd.
    Full Title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional...
    Medical condition: functional constipation in paediatric patients
    Disease: Version SOC Term Classification Code Term Level
    18.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) ES (Prematurely Ended) NL (Completed) PL (Completed) FR (Ongoing)
    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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