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Clinical trials for Immune System Diseases AND Acquired Immunodeficiency Syndrome

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.
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    14 result(s) found for: Immune System Diseases AND Acquired Immunodeficiency Syndrome. Displaying page 1 of 1.
    EudraCT Number: 2014-000307-26 Sponsor Protocol Number: CeTMAd-VIH-2014 Start Date*: 2016-06-09
    Sponsor Name:Iniciativa Andaluza en Terapias Avanzadas-Fundación Pública Andaluza Progreso y Salud
    Full Title: Clinical trial Phase I/II, test of concept, double blind, randomized, controlled with placebo, to evalue the safety and efficiency of the treatment with expanded adult mesenchymal stem cells from a...
    Medical condition: Infection for HIV with controlled viral load and immunological discordant response
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10001509 AIDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    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: 2012-001766-15 Sponsor Protocol Number: MBL2012 Start Date*: 2013-02-12
    Sponsor Name:Fundación Pública Andaluza para la Gestion de la Investigación en Salud de Sevilla
    Full Title: Impact of azithromycin as an immunomodulator in patients with recurrent pneumonia and deficit of mannose-binding LECITHIN (MBL2012)
    Medical condition: Pediatric patients with recurrent pneumonia and MBL deficiency.
    Disease: Version SOC Term Classification Code Term Level
    15.1 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    15.1 100000004862 10010120 Community acquired pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    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: 2012-005727-32 Sponsor Protocol Number: MD2012.02 Start Date*: 2013-07-25
    Sponsor Name:Sanquin Blood Supply Foundation
    Full Title: Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml
    Medical condition: Primary a- or hypogammaglobulinemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004870 10010112 Common variable immunodeficiency LLT
    14.1 100000004850 10010509 Congenital hypogammaglobulinemia LLT
    14.1 100000004850 10071133 Congenital agammaglobulinemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    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: 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: 2015-002491-24 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: 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: 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: (No results available)
    EudraCT Number: 2011-001982-42 Sponsor Protocol Number: J004 Start Date*: 2012-08-02
    Sponsor Name:Guy's & St. Thomas' NHS Foundation Trust
    Full Title: Investigation of a novel intervention in Acute HIV infection (AHI) on long term latent HIV reservoir size: A pilot study of antiretroviral therapy plus immunoglobulin in AHI
    Medical condition: Acute HIV Infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10000811 Acute infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002245-37 Sponsor Protocol Number: TMC114FD2HTX1005 Start Date*: 2020-01-22
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Ala...
    Medical condition: Healthy Volunteers; Human immunodeficiency virus type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003396-18 Sponsor Protocol Number: TMC114FD2HTX1007 Start Date*: 2020-12-23
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Ten...
    Medical condition: Healthy Volunteers; Human immunodeficiency virus type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002017-22 Sponsor Protocol Number: 63723283LUC1001 Start Date*: 2016-11-16
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with A...
    Medical condition: Advanced Stage Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Ongoing) GB (GB - no longer in EU/EEA) IT (Completed)
    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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