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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
  • 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   44380   clinical trials with a EudraCT protocol, of which   7392   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 2 of 4.
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    EudraCT Number: 2022-003621-21 Sponsor Protocol Number: TAK-771-3005 Start Date*: 2022-12-06
    Sponsor Name:Takeda
    Full Title: A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients with Primary Immunodeficiency Disease (PID)
    Medical condition: 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: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2016-000468-41 Sponsor Protocol Number: CCDZ173X2201E1 Start Date*: 2016-07-19
    Sponsor Name:Pharming Technologies B.V.
    Full Title: An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinos...
    Medical condition: APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) NL (Prematurely Ended) IE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000481-38 Sponsor Protocol Number: 161102 Start Date*: 2012-06-28
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treatment with Immune Globulin (Human), 10% in Subjects with Primary Immunodeficiency Diseases – A Stu...
    Medical condition: Primary Immunodeficiency Diseases
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021428 - Immune system disorders 10036700 Primary immunodeficiency syndromes HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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: 2020-004734-37 Sponsor Protocol Number: NORM-01 Start Date*: 2021-12-14
    Sponsor Name:Octapharma Pharmazeutika Prod.Ges.m.b.H
    Full Title: Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with p...
    Medical condition: Primary Immunodeficiency Diseases
    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 (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    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: 2019-002343-14 Sponsor Protocol Number: RAG1-2019-01 Start Date*: 2020-09-25
    Sponsor Name:Leiden University Medical Center
    Full Title: PHASE I/II CLINICAL TRIAL OF AUTOLOGOUS HEMATOPOIETIC STEM CELL GENE THERAPY FOR RAG1-DEFICIENT SEVERE COMBINED IMMUNODEFICIENCY
    Medical condition: Patients with severe combined immunodeficiency (SCID) based on a genetic defect in the Recombinase Activating Gene 1 (RAG1)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003438-26 Sponsor Protocol Number: 161504 Start Date*: 2017-02-14
    Sponsor Name:Baxalta US Inc.
    Full Title: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases
    Medical condition: Primary Immunodeficiency Disease (PIDD)
    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: GB (GB - no longer in EU/EEA) SE (Completed) DK (Completed) CZ (Completed) SK (Completed) FR (Completed) GR (Completed) HU (Completed)
    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: 2021-003327-15 Sponsor Protocol Number: TIDAM Start Date*: 2022-02-21
    Sponsor Name:Erasmus MC
    Full Title: An open-label, 8-week, proof of concept trial on thymosin-α1 (thymalfasin) in the treatment of primary antibody deficiency (PAD) associated mood disorders (TIDAM18).
    Medical condition: Primary immunodeficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002999-13 Sponsor Protocol Number: SCGAM-06 Start Date*: 2019-07-16
    Sponsor Name:Octapharma
    Full Title: CLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH PRIMARY IMMUNODEF...
    Medical condition: primary immunodeficiency
    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, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-000961-36 Sponsor Protocol Number: KB057 Start Date*: 2013-11-15
    Sponsor Name:Kedrion SpA
    Full Title: Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study.
    Medical condition: Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021428 - Immune system disorders 10054979 Secondary immunodeficiency PT
    16.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    16.1 10005329 - Blood and lymphatic system disorders 10021245 Idiopathic thrombocytopenic purpura PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019459-23 Sponsor Protocol Number: 170903 Start Date*: 2011-01-18
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
    Medical condition: Primary Immunodeficiency Diseases
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed) HU (Completed) SE (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2022-003622-45 Sponsor Protocol Number: TAK-771-3004 Start Date*: 2022-12-06
    Sponsor Name:Takeda
    Full Title: A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects with Primary Immunodeficiency Diseases (PID)
    Medical condition: Primary Immunodeficiency Diseases (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: Outside EU/EEA
    Trial results: View results
    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: 2012-002491-14 Sponsor Protocol Number: Sepsis_IFNg Start Date*: 2012-11-08
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: The effects of interferon-gamma on sepsis-induced immunoparalysis, a randomised double-blind placebo-controlled pilot (Phase IIIb) study
    Medical condition: Sepsis-induced immunoparalysis (SIRS, Sepsis, Septic shock)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10018065 - General disorders and administration site conditions 10062357 SIRS LLT
    14.1 10018065 - General disorders and administration site conditions 10061218 Inflammation PT
    14.1 10021881 - Infections and infestations 10040047 Sepsis PT
    14.1 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    14.1 10021881 - Infections and infestations 10040070 Septic shock PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000274-20 Sponsor Protocol Number: GNT-WAS-03 Start Date*: 2014-05-14
    Sponsor Name:Genethon
    Full Title: LONG TERM SAFETY FOLLOW UP OF PATIENTS ENROLLED IN THE PHASE I/II CLINICAL TRIAL OF HAEMATOPOIETIC STEM CELL GENE THERAPY FOR THE WISKOTT-ALDRICH SYNDROME(GTG 002-07 AND GTG 003-08)
    Medical condition: Wiskott-Aldrich syndrome (WAS) is a rare X-linked immunodeficiency caused by mutations in a single gene ,the Wiskott-Aldrich Syndrome Protein (WASP). WAS is characterised by micro-thrombocytopeni...
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10047992 Wiskott-Aldrich syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005927-19 Sponsor Protocol Number: GESIDA11920 Start Date*: 2022-05-17
    Sponsor Name:Fundación SEIMC-GESIDA
    Full Title: Phase IV, randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir alafe...
    Medical condition: Human immunodeficiency virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10053500 Human immunodeficiency virus transmission PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003741-29 Sponsor Protocol Number: MARAND-X Start Date*: 2017-04-05
    Sponsor Name:A.S.L. TO 2
    Full Title: MARAND-X Study: MARaviroc-based Treatment Switch in HIV-positive Patients with HAND: Consequences of Reducing Antiretroviral-associated NeurotoXicity
    Medical condition: HIV-infection, HIV-associated neurocognitive disorders
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10001516 AIDS-dementia complex LLT
    20.0 100000004848 10002725 Anti-HIV positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003876-22 Sponsor Protocol Number: CCDZ173X2201 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CD...
    Medical condition: APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) NL (Completed) IE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
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