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Clinical trials for Agammaglobulinemia

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    36 result(s) found for: Agammaglobulinemia. Displaying page 2 of 2.
    « Previous 1  2 
    EudraCT Number: 2014-003605-15 Sponsor Protocol Number: IgPro20_3001 Start Date*: 2015-02-26
    Sponsor Name:CSL Behring AG
    Full Title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (PID)
    Medical condition: Primary Immune Deficiency (PID)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003607-30 Sponsor Protocol Number: ZLB04_009CR Start Date*: 2015-02-26
    Sponsor Name:CSL Behring AG
    Full Title: A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunode...
    Medical condition: Primary Immune Deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-006745-13 Sponsor Protocol Number: ZLB06_001CR Start Date*: 2007-07-11
    Sponsor Name:CSL Behring AG
    Full Title: A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency
    Medical condition: PID (Primary Immunodeficiency)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064859 Primary immunodeficiency syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FR (Completed) ES (Completed) SE (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-003652-52 Sponsor Protocol Number: 991 Start Date*: 2016-09-29
    Sponsor Name:Biotest AG
    Full Title: An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as repl...
    Medical condition: Replacement therapy in patients with primary immunodeficiency disease (PID)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-002611-27 Sponsor Protocol Number: GAM10-03 Start Date*: 2008-10-27
    Sponsor Name:Octapharma AG
    Full Title: Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID)
    Medical condition: Primary Immundeficiency Diseases (PID)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064859 Primary immunodeficiency syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002290-21 Sponsor Protocol Number: GMX07 Start Date*: 2014-04-30
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary...
    Medical condition: Primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2016-003799-33 Sponsor Protocol Number: IgPro20_4004 Start Date*: 2017-01-30
    Sponsor Name:CSL Behring LLC
    Full Title: An open-label multicenter study to evaluate the safety and tolerability of higher infusion parameters of immune globulin subcutaneous (human), 20% liquid (Hizentra®) in subjects with primary immuno...
    Medical condition: Primary immunodeficiency
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005679-18 Sponsor Protocol Number: GMX04 Start Date*: 2011-12-07
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents
    Medical condition: Primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10005329 Blood and lymphatic system disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2021-000515-24 Sponsor Protocol Number: NL76470.078.21 Start Date*: 2021-02-15
    Sponsor Name:Erasmus University Medical Center
    Full Title: Vaccination Against Covid in Primary Immune Deficiencies
    Medical condition: Patients with primary immunodeficiency disease, also known as inborn errors pf immunity, are vaccinated against COVID-19 using COVID-19 Vaccine Moderna. The vaccine has been approved for use in the...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10036700 Primary immunodeficiency syndromes HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004491-31 Sponsor Protocol Number: M12-420 Start Date*: 2015-02-03
    Sponsor Name:Abbott Japan Co., Ltd
    Full Title: Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004351-39 Sponsor Protocol Number: FARM8MXYFL Start Date*: 2011-10-28
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: Phase II, randomized, double arm, multi-center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with...
    Medical condition: primary immunodefciency patients with COPD and frequent exacerbations
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10029978 Obstructive chronic bronchitis with acute exacerbation LLT
    14.1 10021428 - Immune system disorders 10013289 Disorders involving the immune mechanism LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003554 Asthma aggravated LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005001-26 Sponsor Protocol Number: 20-773/M Start Date*: 2021-12-24
    Sponsor Name:UMC Utrecht
    Full Title: Influencing Progression of Airway Disease in Primary Antibody Deficiency
    Medical condition: Primary antibody deficiency: - Unclassified antibody deficiency (unPAD) - IgA deficiency - Specific polysaccharide antibody deficiency (SPAD) - IgG subclass deficiency (IgSD) - Common variable immu...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006621-22 Sponsor Protocol Number: COVIC-19-G Start Date*: 2022-02-14
    Sponsor Name:DRK-Blutspendedienst Baden-Württemberg - Hessen gGmbH
    Full Title: A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19 as model of early treatment in a pandemia with a new path...
    Medical condition: Clinically Vulnerable Individuals with Mild COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.1 10022891 - Investigations 10084355 COVID-19 virus test positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001496-32 Sponsor Protocol Number: KB070 Start Date*: 2020-10-01
    Sponsor Name:KEDRION S.P.A
    Full Title: A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected...
    Medical condition: Pediatric Patients Affected by Primary Immunodeficiency Disease.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) PT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003290-15 Sponsor Protocol Number: GTI1503 Start Date*: 2016-05-12
    Sponsor Name:Grifols Therapeutics Inc.
    Full Title: A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency
    Medical condition: Primary Immunodeficiency (PI) diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    20.0 10021428 - Immune system disorders 10045792 Unspecified disorder of immune mechanism LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) ES (Completed) DE (Completed) PL (Completed) HU (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-002378-95 Sponsor Protocol Number: D7000C00001 Start Date*: 2023-06-21
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy, and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions ...
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DK (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) SE (Prematurely Ended)
    Trial results: (No results available)
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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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