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Clinical trials for Intravenous immunoglobulin

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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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   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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    449 result(s) found for: Intravenous immunoglobulin. Displaying page 2 of 23.
    « Previous 1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2014-005496-87 Sponsor Protocol Number: 161403 Start Date*: 2015-10-15
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human...
    Medical condition: Chronic inflammatory demyelinating polyradiculoneuropathy
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10057645 Chronic inflammatory demyelinating polyradiculoneuropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DK (Completed) DE (Completed) SE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) NO (Completed) SK (Completed) GR (Completed) AT (Completed) PL (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002411-17 Sponsor Protocol Number: CIDP01 Start Date*: 2019-04-29
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic ...
    Medical condition: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10057645 Chronic inflammatory demyelinating polyradiculoneuropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DK (Completed) NL (Completed) DE (Completed) ES (Completed) FR (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2004-004465-15 Sponsor Protocol Number: Study No. 957 Start Date*: 2005-04-05
    Sponsor Name:Biotest AG
    Full Title: A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients wi...
    Medical condition: primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome
    Disease: Version SOC Term Classification Code Term Level
    7.0 10036700 HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2005-000840-10 Sponsor Protocol Number: KB 036 Start Date*: 2005-09-19
    Sponsor Name:KEDRION
    Full Title: Open Label Phase II Multicenter Study for the Evaluation of Pharmacokinetics of VENBIG (Human Immunoglobulin anti-Hepatitis B for Intravenous Use) and IMMUNOHBS (Human Immunoglobulin anti Hepatitis...
    Medical condition: Prevention of hepatitis B recurrence after liver transplantation in patients who carry the surface antigen of the hepatitis B virus.
    Disease: Version SOC Term Classification Code Term Level
    6.1 10019731 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005150-34 Sponsor Protocol Number: DRIP1.04 Start Date*: 2014-11-18
    Sponsor Name:Erasmus MC
    Full Title: Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy
    Medical condition: Chronic inflammatory demyelinating polyradiculoneuropathy.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004848 10035325 Plasma immunoglobulin G decreased LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    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: 2018-003149-41 Sponsor Protocol Number: IgPro20_2001 Start Date*: 2019-07-16
    Sponsor Name:CSL Behring GmbH
    Full Title: A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglob...
    Medical condition: Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10012977 Diffuse systemic sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002155-11 Sponsor Protocol Number: B5411003 Start Date*: 2021-06-09
    Sponsor Name:Pfizer Inc.
    Full Title: A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ACCESS THE EFFICACY AND SAFETY OF PF-06462700 ADMINISTERED INTRAVENOUSLY AT 40 MG/KG/DAY FOR 4 DAYS IN JAPANESE PARTICIPANTS WITH MODERATE AND ABOVE A...
    Medical condition: Moderate and above aplastic anemia
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-000058-73 Sponsor Protocol Number: LIPS Start Date*: 2012-09-14
    Sponsor Name:University of Liverpool [...]
    1. University of Liverpool
    2. Walton Centre NHS Foundation Trust
    Full Title: A multi-centre (UK) double-blind randomised parallel group placebo controlled trial to evaluate the efficacy, safety, and tolerability of Intravenous Immunoglobulin (IVIg) 0.5g/kg plus standard tre...
    Medical condition: Complex Regional Pain Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2009-013930-25 Sponsor Protocol Number: 2009-600 Start Date*: 2009-11-24
    Sponsor Name:Aarhus University Hospital, Department of Neurology
    Full Title: Randomiseret, dobbelt blindet placebokontrolleret undersøgelse af subkutan immunglobulinbehandling af kronisk inflammatorisk demyeliniserende polyradikuloneuropati (English: A randomized, double-...
    Medical condition: Chronic inflammatory demyelinating polyradiculoneuropathy
    Disease: Version SOC Term Classification Code Term Level
    12.0 10057645 Chronic inflammatory demyelinating polyradiculoneuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    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: 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: 2015-003653-17 Sponsor Protocol Number: 992 Start Date*: 2017-01-27
    Sponsor Name:Biotest AG
    Full Title: An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic...
    Medical condition: Chronic primary immune thrombocytopenia (ITP)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004851 10051057 Idiopathic thrombocytopenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-002997-35 Sponsor Protocol Number: OVG2014/05 Start Date*: 2015-02-06
    Sponsor Name:University of Oxford
    Full Title: A phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the management of children with encephalitis (The IgNiTE study)
    Medical condition: Encephalitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10014594 Encephalitis infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-000037-14 Sponsor Protocol Number: NEOD001-301 Start Date*: 2021-09-01
    Sponsor Name:Prothena Biosciences Limited
    Full Title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with ...
    Medical condition: AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, a...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-005215-98 Sponsor Protocol Number: IUWP2005.01 Start Date*: 2007-03-12
    Sponsor Name:Sanquin Plasma Products
    Full Title: Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.
    Medical condition: Established diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10021275 IgG subclass deficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003877-87 Sponsor Protocol Number: SCGAM-01 Start Date*: 2014-03-12
    Sponsor Name:Octapharma Pharmazeutika Prod.Ges.m.b.H
    Full Title: CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
    Medical condition: Primary immunodeficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) PL (Completed) SK (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: 2016-004766-26 Sponsor Protocol Number: NL58747 Start Date*: 2017-03-08
    Sponsor Name:Academic Medical Center
    Full Title: Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.
    Medical condition: idiopathic inflammatory myopathies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (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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