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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 4 of 4.
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    EudraCT Number: 2011-001508-37 Sponsor Protocol Number: 113681 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine, when administered as primary vaccination integrated int...
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria, immunization against hepatitis B)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005223-90 Sponsor Protocol Number: PULSE-PAH-004 Start Date*: 2016-07-12
    Sponsor Name:Bellerophon Pulse Technologies LLC
    Full Title: A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS W...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) PT (Prematurely Ended) BE (Prematurely Ended) CZ (Prematurely Ended) NL (Prematurely Ended) AT (Prematurely Ended) HR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-020558-33 Sponsor Protocol Number: 997HA301 Start Date*: 2011-04-14
    Sponsor Name:Biogen Idec Hemophilia, Inc.
    Full Title: A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in ...
    Medical condition: Severe hemophilia A - defined as <1 IU/dL (<1%) endogenous FVIII
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10056493 Haemophilia A without inhibitors PT
    14.1 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed) FR (Ongoing) DE (Completed) BE (Completed) ES (Completed) AT (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001512-28 Sponsor Protocol Number: COVIM Start Date*: 2021-05-11
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: Immunogenicity of COVID-19 vaccines in medical staff and special risk populations
    Medical condition: SARS-CoV-2 immunogenicity
    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: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002643-18 Sponsor Protocol Number: REDUCE Start Date*: 2018-09-04
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: REDUCE - Multicenter, prospective, randomized study investigating the efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily in comparison to standard triple immunosu...
    Medical condition: Immunosuppression after kidney transplantion in elderly patients ≥65 years of age
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021428 - Immune system disorders 10062016 Immunosuppression PT
    20.0 10021428 - Immune system disorders 10054990 Immunodeficiency secondary to organ transplantation LLT
    20.0 100000004863 10074474 Transplantation complications HLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) AT (Prematurely Ended) ES (Prematurely Ended) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002004-10 Sponsor Protocol Number: 15-007 Start Date*: 2016-10-13
    Sponsor Name:Jazz Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Un...
    Medical condition: Prevention of Hepatic Veno-Occlusive Disease following Hematopoietic Stem Cell Transplant
    Disease: Version SOC Term Classification Code Term Level
    19.0 10019805 - Hepatobiliary disorders 10047207 Veno-occlusive liver damage LLT
    19.0 10019805 - Hepatobiliary disorders 10047217 Venoocclusive syndrome of the liver LLT
    19.0 10019805 - Hepatobiliary disorders 10047216 Venoocclusive liver disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) BE (Completed) DE (Prematurely Ended) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-005697-71 Sponsor Protocol Number: 060402 Start Date*: 2006-01-26
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 3/4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous Infu...
    Medical condition: Subjects with Severe or Moderately Severe Hemophilia A (baseline factor VIII (FVIII) level <= 2% of normal) hemophilia A undergoing major orthopedic surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) BE (Completed) PT (Completed) ES (Completed) HU (Completed) NL (Completed) GB (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-021162-30 Sponsor Protocol Number: Wil-24 Start Date*: 2011-12-20
    Sponsor Name:Octapharma AG
    Full Title: Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate®) In Subjects With Inherited Von Willebrand Disea...
    Medical condition: Surgery in Inherited Von Willebrand Disease (VWD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000966-12 Sponsor Protocol Number: EL-004 Start Date*: 2019-11-18
    Sponsor Name:Eloxx Pharmaceuticals Inc
    Full Title: A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis...
    Medical condition: Cystic fibrosis (CF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004864-38 Sponsor Protocol Number: P05411 Start Date*: 2009-10-02
    Sponsor Name:Schering Plough Research Institute, A Division of Schering Corporation
    Full Title: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    13.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    13.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    13.1 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) BE (Completed) FR (Completed) PT (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016069-27 Sponsor Protocol Number: DORIPED3003 Start Date*: 2010-05-28
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
    Medical condition: Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) LV (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-016719-39 Sponsor Protocol Number: 050901 Start Date*: 2010-04-07
    Sponsor Name:Baxter Innovations GmbH
    Full Title: IMMUNINE – Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors i...
    Medical condition: To expose up to 50 patients aged 12-64 years, and approximately 20 pediatric patients up to 11 years of age with severe or moderately severe hemophilia B to IMMUNINE for a period of approximately 2...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10010331 - Congenital, familial and genetic disorders 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001598-10 Sponsor Protocol Number: PB1046-PT-CL-0004 Start Date*: 2020-01-24
    Sponsor Name:PhaseBio Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adu...
    Medical condition: Symptomatic Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) GR (Prematurely Ended) ES (Prematurely Ended) BG (Prematurely Ended) AT (Prematurely Ended) PL (Prematurely Ended) RO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-000804-18 Sponsor Protocol Number: TDE-PH-304 Start Date*: 2007-02-15
    Sponsor Name:United Therapeutics Corporation
    Full Title: An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with : 1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 ...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) NL (Completed) AT (Completed) FR (Completed) BE (Completed) IT (Completed) DE (Completed) SE (Completed) PT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-019544-39 Sponsor Protocol Number: 20090072 Start Date*: 2010-10-04
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease
    Medical condition: Crohn’s disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10011408 Crohns disease aggravated LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-005771-39 Sponsor Protocol Number: RVLO221-02 Start Date*: 2023-03-16
    Sponsor Name:Revolo Biotherapeutics Ltd
    Full Title: A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    23.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-014295-21 Sponsor Protocol Number: 998HB102 Start Date*: 2010-05-06
    Sponsor Name:Biogen Idec Hemophilia Inc.
    Full Title: B-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc fusion protein (rFIXFc) in the Prevention and Treat...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10053754 Hemophilia B without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) FR (Completed) PL (Completed) BE (Completed) IT (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2010-020881-53 Sponsor Protocol Number: 20100008 Start Date*: 2011-01-18
    Sponsor Name:Amgen Inc
    Full Title: A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10013099 Disease Crohns LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016720-31 Sponsor Protocol Number: 250901 Start Date*: 2010-06-09
    Sponsor Name:Baxter Innovations GmbH [...]
    1. Baxter Innovations GmbH
    2. Baxter Healthcare Corporation
    Full Title: BAX 326 (recombinant Factor IX): A Phase 1/3 Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, Immunogenicity in Previously Treated Patients with Severe (FIX...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) BG (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000891-12 Sponsor Protocol Number: 212149 Start Date*: 2021-10-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei an...
    Medical condition: Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10040550 Shigella infections HLT
    20.0 10021881 - Infections and infestations 10054178 Shigella infection PT
    20.0 10021881 - Infections and infestations 10040542 Shigella LLT
    20.0 10021881 - Infections and infestations 10040547 Shigella flexneri LLT
    20.0 10021881 - Infections and infestations 10040551 Shigella sonnei LLT
    20.1 10021881 - Infections and infestations 10004016 Bacterial diarrhoea PT
    20.0 10017947 - Gastrointestinal disorders 10012735 Diarrhoea PT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (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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