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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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    • 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   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 4 of 23.
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    EudraCT Number: 2007-007134-19 Sponsor Protocol Number: GAM10-04 Start Date*: 2009-01-14
    Sponsor Name:Octapharma AG
    Full Title: Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer...
    Medical condition: mild to moderate Alzheimer´s disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 2013-002290-21 Sponsor Protocol Number: GMX07 Start Date*: 2014-04-30
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary...
    Medical condition: Primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2018-001605-93 Sponsor Protocol Number: 3151-201-008 Start Date*: 2019-07-01
    Sponsor Name:AstraZeneca AB
    Full Title: A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) FR (Completed) CZ (Prematurely Ended) ES (Prematurely Ended) BG (Prematurely Ended) AT (Prematurely Ended) HU (Prematurely Ended) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-004318-14 Sponsor Protocol Number: NEOD001-201 Start Date*: 2016-06-13
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction
    Medical condition: Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in bo...
    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: DE (Prematurely Ended) GB (Completed) GR (Completed) ES (Prematurely Ended) AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004918-32 Sponsor Protocol Number: Study No.: 960 Start Date*: 2006-04-11
    Sponsor Name:Biotest AG
    Full Title: A monocentre, open-label, prospective study investigating the effects of the human normal immunoglobulin Intratect®/ BT 681 for intravenous administration on clinical efficacy, safety, and laborato...
    Medical condition: Chronic idiopathic pain syndromes (fibromyalgia, myofascial pain, complex regional pain syndrome)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10033371 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003194-22 Sponsor Protocol Number: APHP200009 Start Date*: Information not available in EudraCT
    Sponsor Name:Assistance Publique – Hôpitaux de Paris (AP-HP)
    Full Title: A RANDOMIZED PHASE III MULTICENTER TRIAL COMPARING THE EFFICACY AND SAFETY OF ANAKINRA VERSUS INTRAVENOUS IMMUNOGLOBULIN (IVIG) RETREATMENT, IN PATIENTS WITH KAWASAKI DISEASE WHO FAILED TO RESPOND ...
    Medical condition: Anakinra treatment is expected to reduce the early and long-term mortality of patients with Kawasaki Disease (KD), by a rapid and sustained effect on vascular inflammation.
    Disease:
    Population Age: Infants and toddlers, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004433-17 Sponsor Protocol Number: 124210 Start Date*: 2020-02-18
    Sponsor Name:MRC CTU at UCL
    Full Title: Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary arte...
    Medical condition: Kawasaki Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) EE (Completed) SE (Completed) FI (Completed) ES (Ongoing) DE (Completed) NL (Completed) IT (Completed) AT (Completed) CZ (Completed)
    Trial results: (No results available)
    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: 2011-005586-21 Sponsor Protocol Number: GMX02 Start Date*: 2011-12-07
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura
    Medical condition: Idiopathic thrombocytopenic purpura.
    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, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-003430-33 Sponsor Protocol Number: IgPro10_4002 Start Date*: 2018-09-19
    Sponsor Name:CSL Behring
    Full Title: Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP
    Medical condition: Pediatric Chronic inflammatory demyelinating polyneuropathy (CIDP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061811 Demyelinating polyneuropathy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2015-002345-64 Sponsor Protocol Number: 181501 Start Date*: 2015-11-12
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion with Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects with Immunoglobulin A Nephropathy (IgAN)
    Medical condition: IgA Nephropathy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000826-36 Sponsor Protocol Number: P160905J Start Date*: 2018-05-17
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Efficacy and safety of immunoglobulin associated with rituximab versus rituximab alone in Childhood-Onset steroid-dependent nephrotic syndrome
    Medical condition: Childhood-Onset steroid-dependent nephrotic syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10029164 Nephrotic syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004664-18 Sponsor Protocol Number: NEOD001-OLE251 Start Date*: 2017-08-08
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
    Medical condition: The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) GR (Completed) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000545-40 Sponsor Protocol Number: FELZ01 Start Date*: 2021-08-01
    Sponsor Name:Medical University of Vienna
    Full Title: Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection – A Phase 2 Pilot Trial
    Medical condition: Late active or chronic active antibody-mediated rejection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003534-32 Sponsor Protocol Number: MOM-M254-001 Start Date*: 2019-01-03
    Sponsor Name:Momenta Pharmaceuticals, Inc.
    Full Title: A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura
    Medical condition: Immune thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004851 10074667 Immune thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) HU (Completed) PL (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-006854-29 Sponsor Protocol Number: CLIgAN Start Date*: 2022-09-28
    Sponsor Name:Fondazione Schena - Centro Europeo della Ricerca sulle Malattie Renali
    Full Title: A multicentre, prospective, open-label, randomized CLinical study to evaluate the effect of personalized therapy on patients with Immunoglobulin A Nephropathy (CLIgAN)
    Medical condition: Idiopathic IgA nephropathy (IgAN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001790-86 Sponsor Protocol Number: PIX306 Start Date*: 2012-12-24
    Sponsor Name:CTI Biopharma, Corp.
    Full Title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or a...
    Medical condition: Treatment of Patients with Aggressive B-cell Non-Hodgkin Lymphoma , who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10012820 Diffuse large B-cell lymphoma NOS LLT
    19.1 100000004864 10067070 Follicular B-cell non-Hodgkin's lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) FR (Completed) HU (Completed) IT (Completed) CZ (Completed) DK (Prematurely Ended) BG (Prematurely Ended) PL (Completed) BE (Completed) AT (Completed) SK (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2010-020167-20 Sponsor Protocol Number: KB047 Start Date*: 2010-10-19
    Sponsor Name:KEDRION
    Full Title: Pharmacokinetics, efficacy, tolerability and safety evaluation of the therapy with subcutaneous immunoglobulin in the treatment of hypo or agammaglobulinaemic patients. Open label phase II/III study
    Medical condition: Hypogammaglobulinaemia or agammaglobulinaemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060384 LLT
    9.1 10001471 LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-004155-13 Sponsor Protocol Number: BMS_IM101-931 Start Date*: 2023-04-20
    Sponsor Name:Universitätsklinikum Freiburg
    Full Title: Study to investigate the restoring of an immunological balance during therapy with abatacept Abatacept restores immune system equilibrium (ARISE)
    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
    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)
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