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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   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 3 of 4.
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    EudraCT Number: 2011-004483-30 Sponsor Protocol Number: GS-US-236-0115 Start Date*: 2012-01-20
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF)...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) AT (Completed) PT (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004963-56 Sponsor Protocol Number: GS-US-236-0121 Start Date*: 2012-01-25
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) AT (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005508-33 Sponsor Protocol Number: MC-FludT.16/NM Start Date*: 2014-09-29
    Sponsor Name:medac Gesellschaft für klinische Spezialpräparate mbH
    Full Title: Clinical phase II trial to compare Treosulfan-based conditioning therapy with Busulfan-based conditioning prior to allogeneic haematopoietic stem cell transplantation (HSCT) in paediatric patients ...
    Medical condition: Male and female children with non-malignant diseases requiring myeloablative conditioning treatment with following allogeneic haematopoietic stem cell transplantation (allo-HSCT) – i.e. primary imm...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10021606 Inborn errors of metabolism NEC HLT
    20.0 100000004870 10036700 Primary immunodeficiency syndromes HLT
    20.0 100000004850 10018903 Haemoglobinopathies congenital HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) CZ (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002489-34 Sponsor Protocol Number: AV-APL-B-002-22 Start Date*: 2023-02-09
    Sponsor Name:Pharma Mar, S.A.
    Full Title: A Multicentre, Open label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin versus Control in Immunocompromi...
    Medical condition: Immunocompromised Adult Patients with Symptomatic COVID-19 requiring Hospital Care
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Prematurely Ended) PT (Prematurely Ended) PL (Completed) IT (Prematurely Ended) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-000905-29 Sponsor Protocol Number: RENOIR Start Date*: 2022-04-12
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies
    Medical condition: Covid-19 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10047438 Viral infectious disorders HLGT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003563-36 Sponsor Protocol Number: ACQUIVAS Start Date*: 2018-07-30
    Sponsor Name:Cambridge University Hospital NHS Foundation Trust and University of Cambridge
    Full Title: ACQUIVAS - Acquired immunodeficiency in ANCA associated vasculitis (AAV)
    Medical condition: Pneumococcal vaccine responses in ANCA associated vasculitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10050894 Anti-neutrophil cytoplasmic antibody positive vasculitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-019411-37 Sponsor Protocol Number: FE999906CS11 Start Date*: 2010-08-30
    Sponsor Name:FERRING Arzneimittel GmbH
    Full Title: A Prospective, Open Label, Randomised, Parallel Group Trial Comparing the Effects of Highly Purified Menotrophin and Recombinant Follicle Stimulating Hormone (rFSH, Follitropin alpha) Administered ...
    Medical condition: Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10021926 Infertility PT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    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: 2004-000478-30 Sponsor Protocol Number: AC-052-364 Start Date*: 2004-10-28
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in pat...
    Medical condition: Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. T...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) ES (Completed) CZ (Completed) GB (Completed) BE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002688-32 Sponsor Protocol Number: 1602T0832 Start Date*: 2017-11-07
    Sponsor Name:Shionogi Ltd.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared with Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients with Influenza at High Risk of Infl...
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022005 Influenza viral infections HLT
    20.1 100000004862 10022002 Influenza A virus infection LLT
    20.1 100000004862 10022003 Influenza B virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) HU (Completed) GB (Completed) PL (Completed) BG (Completed) ES (Completed) BE (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-001693-28 Sponsor Protocol Number: CONE-01 Start Date*: 2020-02-06
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: Prospective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with con...
    Medical condition: Hereditary angioedema type I and type II
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    21.0 10010331 - Congenital, familial and genetic disorders 10080956 Hereditary angioedema type I LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080960 Hereditary angioedema type II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002052-14 Sponsor Protocol Number: EURO-HIT-HLH Start Date*: 2011-06-07
    Sponsor Name:AZIENDA OSPEDALIERA MEYER
    Full Title: EURO-HIT-HLH European cooperative pilot study for testing Hybrid ImmunoTherapy for Hemophagocytic LymphoHistiocytosis
    Medical condition: Familial hemophagoytic lymphohistiocytosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10005329 Blood and lymphatic system disorders SOC
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003382-17 Sponsor Protocol Number: 1439A-021 Start Date*: 2015-08-12
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naï...
    Medical condition: Human Immunodeficiency Virus-1 infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) PT (Completed) DK (Completed) NL (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-003250-34 Sponsor Protocol Number: IVI-ERA-2011 Start Date*: 2011-12-13
    Sponsor Name:IVI Madrid
    Full Title: Endometrial receptivity with different support protocols for the luteal phase in ovarian stimulation cycles in which final oocyte maturation is carried out with GnRH analogues. Analysis by endometr...
    Medical condition: Ovarian Hyperstimulation Syndrome (OHSS)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038604 - Reproductive system and breast disorders 10033266 Ovarian hyperstimulation syndrome PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004365-27 Sponsor Protocol Number: EDP-305-101 Start Date*: 2018-12-17
    Sponsor Name:Enanta Pharmaceuticals Inc.
    Full Title: A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Non-Alcoholic Steatohep...
    Medical condition: Non-alcoholic Steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10029530 Non-alcoholic fatty liver PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004547-77 Sponsor Protocol Number: RN03-CP-0001 Start Date*: 2020-06-09
    Sponsor Name:ReNeuron Ltd
    Full Title: First-in-human Phase I/IIa, Open-Label, Prospective Study of the Safety and Tolerability of Subretinally Transplanted Human Retinal Progenitor Cells (hRPC) in Subjects with Retinitis Pigmentosa (RP)
    Medical condition: Retinitis Pigmentosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-002131-34 Sponsor Protocol Number: GS-US-357-1394 Start Date*: 2015-05-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Men and women, ages 18 through 75 years, with a diagnosis of idiopathic PAH, heritable PAH or PAH associated with connective tissue disease (PAH-CTD), congenital heart defects (repaired), drug and ...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Completed) ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-001937-40 Sponsor Protocol Number: EORTC 16032-18031 Start Date*: 2005-05-19
    Sponsor Name:European Organisation for Research and Treatment of Cancer
    Full Title: Randomized, open phase II study of immunization with the recombinant MAGE-3 protein combined with adjuvant AS02B or AS15 in patients with unresectable and progressive metastatic cutaneous melanoma
    Medical condition: Unresectable and progressive metastatic cutaneous melanoma
    Disease: Version SOC Term Classification Code Term Level
    7.0 10027155 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003329-32 Sponsor Protocol Number: CS0866-A-U301 Start Date*: 2015-07-28
    Sponsor Name:Daiichi Sankyo Pharma Development
    Full Title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
    Medical condition: Hypertension
    Disease: Version SOC Term Classification Code Term Level
    18.0 10047065 - Vascular disorders 10020772 Hypertension PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-002741-18 Sponsor Protocol Number: GS-US-611-6273 Start Date*: 2022-12-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
    Medical condition: Coronavirus disease 2019 (COVID-19) in patients who have a high risk of developing serious or severe illness
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) HU (Completed) ES (Ongoing) BG (Completed) IT (Completed)
    Trial results: View results
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