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Clinical trials for Primary immunodeficiency disorders

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
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    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 ).  
     
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    80 result(s) found for: Primary immunodeficiency disorders. Displaying page 1 of 4.
    1  2  3  4  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: 2022-004155-13 Sponsor Protocol Number: BMS_IM101-931 Start Date*: 2023-04-20
    Sponsor Name:Universitätsklinikum Freiburg
    Full Title: Study to investigate the restoring of an immunological balance during therapy with abatacept Abatacept restores immune system equilibrium (ARISE)
    Medical condition: CVID patients confirmed according to ESID/PAGID criteria or related disorders which fulfill the diagnostic criteria for CVID and interstitial lung disease or granuloma diagnosed by chest CT positiv...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10021449 Immunodeficiency common variable PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    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: 2016-001480-36 Sponsor Protocol Number: 2015_31 Start Date*: 2016-07-11
    Sponsor Name:Centre Hospitalier Régional et Universitaire de Lille
    Full Title: Assessment of the IgG trough level in subjects with primary immunodeficiency switching from standard subcutaneous immunoglobulin (SCIG) to every other week HyQvia
    Medical condition: Primary immunodeficiencies
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    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: 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: 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: 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: 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: 2015-002491-24 Sponsor Protocol Number: BMS-IM101-563 Start Date*: 2016-05-11
    Sponsor Name:Universitätsklinikum Freiburg, vertreten durch den Leitenden Ärztlichen Direktor
    Full Title: Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease
    Medical condition: CVID patients confirmed according to ESID/PAGID criteria or related disorders which fulfill the diagnostic criteria for CVID and interstitial lung disease or granuloma diagnosed by chest CT positiv...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10022611 Interstitial lung disease PT
    18.1 10021428 - Immune system disorders 10021449 Immunodeficiency common variable PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000673-68 Sponsor Protocol Number: 16IC17 Start Date*: 2018-10-09
    Sponsor Name:Great Ormond Street Hospital for Children NHS Trust
    Full Title: Phase I/II study of lentiviral gene transfer for SCID-X1 with low dose targeted busulfan
    Medical condition: Severe combined immunodeficiency disorder (SCID) is a heterogeneous group of inherited disorders characterized by a profound reduction or absence of T lymphocyte function, resulting in lack of both...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10069566 Severe combined immunodeficiency syndrome LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 2013-000620-34 Sponsor Protocol Number: IGSC-1103 Start Date*: 2013-08-05
    Sponsor Name:LFB Biotechnologies
    Full Title: A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes
    Medical condition: Primary Immunofediciency (PID) syndromes
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004870 10036700 Primary immunodeficiency syndromes HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) GB (GB - no longer in EU/EEA)
    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: 2016-001631-12 Sponsor Protocol Number: IgPro10_3004 Start Date*: 2017-01-30
    Sponsor Name:CSL Behring KK
    Full Title: Prospective open-label single-arm study of the pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency
    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 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: 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: 2009-017346-32 Sponsor Protocol Number: 201228 Start Date*: 2010-03-15
    Sponsor Name:Fondazione Telethon
    Full Title: A PHASE I/II CLINICAL TRIAL OF HAEMATOPOIETIC STEM CELL GENE THERAPY FOR THE WISKOTT-ALDRICH SYNDROME
    Medical condition: Wiskott-Aldrich Syndrom
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000972-40 Sponsor Protocol Number: IM101-774 Start Date*: 2020-06-09
    Sponsor Name:Universitätsklinikum Freiburg
    Full Title: Safety and Efficacy of abatacept (s.c.) in patients with CTLA4 insufficiency or LRBA deficiency
    Medical condition: Patients with a molecular confirmed diagnosis of CTLA4 (cytotoxic T-lymphocyte-associated Protein 4) (haplo)-insufficiency or LRBA (Lipopolysaccharide-Responsive and Beige-like An¬chor) deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10021449 Immunodeficiency common variable PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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
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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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