Flag of the European Union EU Clinical Trials Register Help

Clinical trials for X-linked 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   43865   clinical trials with a EudraCT protocol, of which   7286   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    22 result(s) found for: X-linked Agammaglobulinemia. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-005015-82 Sponsor Protocol Number: NGAM-05 Start Date*: 2012-01-10
    Sponsor Name:Octapharma AG
    Full Title: Clinical study to evaluate the safety and tolerability of immunoglobulin intravenous (human) 10% (NewGam) administered at high infusion rates to patients with primary immunodeficiency diseases (ext...
    Medical condition: primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10049485 Bruton's agammaglobulinemia LLT
    14.1 10021428 - Immune system disorders 10010112 Common variable immunodeficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-011434-10 Sponsor Protocol Number: NGAM-01 Start Date*: 2010-03-02
    Sponsor Name:OCTAPHARMA AG
    Full Title: CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
    Medical condition: Primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    12.0 10010112 Common variable immunodeficiency LLT
    12.0 10049485 Bruton's agammaglobulinemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-000792-16 Sponsor Protocol Number: GAMr-29 Start Date*: 2012-06-14
    Sponsor Name:OCTAPHARMA AG
    Full Title: “CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES”
    Medical condition: primary immunodeficiency disease (PID)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10049485 Bruton's agammaglobulinemia LLT
    14.1 10021428 - Immune system disorders 10010112 Common variable immunodeficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023483-41 Sponsor Protocol Number: I10E-0718 Start Date*: 2011-03-01
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID)
    Medical condition: a primary immunodeficiency as defined by the ESID and validated by a reference centre : • X-linked agammaglobulinemia (XLA) • Common variable immunodeficiency (CVID)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004870 10010112 Common variable immunodeficiency LLT
    14.1 100000004870 10036700 Primary immunodeficiency syndromes HLT
    14.1 100000004870 10001471 Agammaglobulinemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2006-006522-25 Sponsor Protocol Number: ZLB06_005CR Start Date*: 2007-02-01
    Sponsor Name:CSL Behring AG
    Full Title: A multicenter study on the efficacy and safety of Vivaglobin® in Previously Untreated Patients (PUPs) with Primary Immunodeficiency (PID)
    Medical condition: Patients with PID diseases as Common Variable Immunodeficiency (CVID) or X-linked agammaglobulinemia ( XLA), age 1 to 70 years
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010112 Common variable immunodeficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended) BE (Completed) GR (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-003221-30 Sponsor Protocol Number: D5290C00008 Start Date*: 2021-10-22
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ ...
    Medical condition: RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003772-23 Sponsor Protocol Number: ZLB05_006CR Start Date*: 2015-04-14
    Sponsor Name:CSL Behring AG
    Full Title: A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)
    Medical condition: Primary Immune Deficiency (Common Variable Immunodeficiency and X-linked agammaglobulinemia)
    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: 2008-000830-30 Sponsor Protocol Number: ZLB07_002CR Start Date*: 2008-07-10
    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 (IgPro20 EU Extension Study)
    Medical condition: PID (primary immuno deficiency)
    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) ES (Completed) FR (Completed) SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-012036-32 Sponsor Protocol Number: IGNG-0724 Start Date*: 2009-07-30
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: SAFETY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, WHEN ADMINISTERED TO PRIMARY IMMUNODEFICIENT PATIENTS, AT A PROGRESSIVELY INCREASED FLOW RATE
    Medical condition: PRIMARY IMMUNODEFICIENCY
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064859 Primary immunodeficiency syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-001410-17 Sponsor Protocol Number: IGNG-0629 Start Date*: 2007-05-31
    Sponsor Name:LFB SA
    Full Title: LONG-TERM SAFETY AND EFFICACY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, ADMINISTERED IN CURRENT PRACTICE TO PRIMARY IMMUNODEFICIENT PATIENTS
    Medical condition: Primary Immunodeficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064859 Primary immunodeficiency syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019249-25 Sponsor Protocol Number: 981 Start Date*: 2010-08-12
    Sponsor Name:Biotest AG
    Full Title: An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infu...
    Medical condition: Primary immunodeficiency disease (PID)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010509 Congenital hypogammaglobulinemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    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: 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: 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: 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: 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 (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 27 02:11:45 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA