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Clinical trials for Gastrointestinal tract disorders congenital

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   44412   clinical trials with a EudraCT protocol, of which   7421   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 ).  
     
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    9 result(s) found for: Gastrointestinal tract disorders congenital. Displaying page 1 of 1.
    EudraCT Number: 2015-003369-27 Sponsor Protocol Number: REGAIN Start Date*: 2016-07-01
    Sponsor Name:Universitätsklinikum Freiburg
    Full Title: A Phase I-IIa trial on low-dose IL-2 (Aldesleukin) treatment for immunological dysregulation in common variable immunodeficiency (CVID)
    Medical condition: autoimmune enteropathy (AIE) in common variable immunodeficiency (CVID).
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021428 - Immune system disorders 10021449 Immunodeficiency common variable PT
    19.0 100000004856 10017922 Gastroenteropathy NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000906-31 Sponsor Protocol Number: IgPro10_2001 Start Date*: 2020-05-22
    Sponsor Name:CSL Behring GmbH
    Full Title: A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Sy...
    Medical condition: efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10012977 Diffuse systemic sclerosis LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) FR (Completed) PL (Prematurely Ended) BE (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004136-30 Sponsor Protocol Number: DEALSZ-2018-001 Start Date*: 2019-07-02
    Sponsor Name:Charité - Universitätsmedizin Berlin Klinik für Dermatologie und Allergologie
    Full Title: An Open-Label, Pilot Study to assess the effect of Lanadelumab on the clinical signs and symptoms of Hereditary angioedema with normal C1-inhibitor
    Medical condition: Lanadelumab in patients with Hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074782 Hereditary angioedema breakthrough attack LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002621-98 Sponsor Protocol Number: SHP643-302 Start Date*: 2022-08-19
    Sponsor Name:Takeda
    Full Title: A Phase 3 Multi-center, Open-label Study to Evaluate the Efficacy and Safety of Lanadelumab (SHP643) in Japanese Subjects with Hereditary Angioedema
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10075280 Hereditary angioedema attack LLT
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002093-42 Sponsor Protocol Number: SHP643-301 Start Date*: 2020-02-04
    Sponsor Name:Shire (Shire is now part of Takeda)
    Full Title: SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (...
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    23.1 10010331 - Congenital, familial and genetic disorders 10075280 Hereditary angioedema attack LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002911-13 Sponsor Protocol Number: RB15.098 Start Date*: 2015-09-15
    Sponsor Name:CHRU de Brest
    Full Title: A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mu...
    Medical condition: Cystic Fibrosis treated by 'roscovitine' in subjects homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-012842-21 Sponsor Protocol Number: PR-005 Start Date*: 2010-09-20
    Sponsor Name:Aptalis Pharma US Inc.
    Full Title: Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficien...
    Medical condition: Exocrine pancreatic insufficiency associated with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10015674 Exocrine pancreas conditions HLGT
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) BG (Completed) BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2016-004479-35 Sponsor Protocol Number: VX16-661-115 Start Date*: Information not available in EudraCT
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or...
    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: Children, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) DK (Completed) BE (Completed) DE (Completed) GB (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-002977-24 Sponsor Protocol Number: 209538 Start Date*: 2019-04-03
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: A Phase IIA, open-label study to evaluate the immunogenicity and safety of sequential use of GSK's investigational vaccine GSK3277511A when administered to healthy smokers and ex-smokers aged 50 to...
    Medical condition: Healthy volunteers (chronic obstructive pulmonary disorder [COPD]))
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FI (Completed) FR (Completed) IT (Completed)
    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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