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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
  • 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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    449 result(s) found for: Intravenous immunoglobulin. Displaying page 7 of 23.
    EudraCT Number: 2011-000914-21 Sponsor Protocol Number: 161003 Start Date*: 2012-02-13
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFECTIVENESS OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% SOLUTION (IGIV, 10%) FOR THE TREATMENT OF MILD TO MODERATE A...
    Medical condition: Mild to moderate Alzheimer’s disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000118-31 Sponsor Protocol Number: CCTU0145 Start Date*: 2017-01-16
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    Full Title: A randomised phase II double-blinded placebo-controlled trial of intravenous immunoglobulins and rituximab in patients with antibody-associated psychosis (SINAPPS2)
    Medical condition: Antibody associated Psychosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-002293-39 Sponsor Protocol Number: BIOIMMUN Start Date*: 2017-10-10
    Sponsor Name:ORIOL BESTARD
    Full Title: MULTICENTER, RANDOMIZED STUDY, TO EVALUATE THE EFFECTIVENESS OF INDIVIDUALIZATION OF IMMUNOLOGICAL RISK BASED ON SELECTIVE BIOMARKERS (DISPARITY OF HLA EPLETS AND ELISPOT-γ) TO OPTIMIZE IMMUNOSUPPR...
    Medical condition: PROPHYLAXIS OF REJECTION AFTER KIDNEY TRANSPLANTATION
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002460-29 Sponsor Protocol Number: EASIC30505 Start Date*: 2005-09-12
    Sponsor Name:Rheumazentrum Ruhrgebiet.
    Full Title: An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC...
    Medical condition: Ankylosing spondylitis (AS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004375-40 Sponsor Protocol Number: NGAM-12 Start Date*: 2020-07-09
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (“...
    Medical condition: Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10008976 Chronic lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001613-33 Sponsor Protocol Number: IgM-FAT Start Date*: 2019-04-18
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: Efficacy and safety of adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. standard dose in patients with septic shock. A multicenter, intervention...
    Medical condition: Septic shock
    Disease: Version SOC Term Classification Code Term Level
    23.1 10021881 - Infections and infestations 10040580 Shock septic LLT
    23.1 10021881 - Infections and infestations 10040070 Septic shock PT
    23.1 10021881 - Infections and infestations 10040070 Septic shock PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005769-42 Sponsor Protocol Number: WUM-KH-AL1 Start Date*: 2023-04-13
    Sponsor Name:Warsaw Medical University/ Warszawski Uniwersytet Medyczny
    Full Title: PHASE II, MULTICENTER STUDY TO ASSESS SAFETY AND EFFICACY OF COMBINATION OF SARGRAMOSTIM WITH D-VCD THERAPY (DARATUMUMAB, CYCLOPHOSPHAMIDE, BORTEZOMIB, DEXAMETHASONE) IN UNTREATED PATIENTS WITH LIG...
    Medical condition: LIGHT CHAIN AMYLOIDOSIS (Amyloidosis AL)
    Disease: Version SOC Term Classification Code Term Level
    24.1 10021428 - Immune system disorders 10086183 AL amyloidosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-004692-19 Sponsor Protocol Number: 963 Start Date*: 2007-12-19
    Sponsor Name:Biotest AG
    Full Title: Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study...
    Medical condition: Congenital CMV infection after primary CMV infection during pregnancy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000206-38 Sponsor Protocol Number: 54767414MMY3012 Start Date*: 2017-10-04
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
    Medical condition: Multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) GR (Completed) ES (Ongoing) FR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001627-32 Sponsor Protocol Number: CVAY736Q12301 Start Date*: 2023-03-15
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or r...
    Medical condition: immune thrombocytopenia (ITP)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10005329 - Blood and lymphatic system disorders 10083842 Immune thrombocytopenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) NO (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) BE (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-004503-39 Sponsor Protocol Number: IG1104 Start Date*: 2015-01-28
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group clinical trial to assess the efficacy and safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF...
    Medical condition: Patients with Post-polio syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029205 - Nervous system disorders 10036239 Post polio syndrome PT
    17.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Prematurely Ended) DK (Prematurely Ended) NL (Completed) ES (Prematurely Ended) PL (Prematurely Ended) RO (Prematurely Ended) HU (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-001088-38 Sponsor Protocol Number: BAY80-6946/17833 Start Date*: 2015-12-09
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in p...
    Medical condition: Patients with relapsed indolent non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Completed) DK (Prematurely Ended) ES (Prematurely Ended) GB (Completed) FR (Completed) PL (Prematurely Ended) IE (Prematurely Ended) AT (Prematurely Ended) PT (Prematurely Ended) HU (Completed) SK (Prematurely Ended) GR (Completed) BG (Prematurely Ended) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004179-22 Sponsor Protocol Number: B1841009 Start Date*: 2015-04-06
    Sponsor Name:Wyeth, A Pfizer Company
    Full Title: A Study To Evaluate Pneumococcal Antipolysaccharide Antibody Concentrations in Subjects That Participated in the Wyeth Prevenar Safety and Immunogenicity Study 0887X-101518
    Medical condition: Pneumococcal Disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005679-18 Sponsor Protocol Number: GMX04 Start Date*: 2011-12-07
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents
    Medical condition: Primary immunodeficiency diseases
    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 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2004-000537-11 Sponsor Protocol Number: ZLB03_003CR Start Date*: 2004-12-01
    Sponsor Name:ZLB Behring AG
    Full Title: An open-label, multicenter study on the efficacy and safety of IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP)
    Medical condition: Immune thrombocytopenic purpura (ITP) is the most common autoimmune disease. It is a bleeding disorder characterized by decreased counts of circulating platelets and normal or increased numbers of ...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002531-29 Sponsor Protocol Number: VIS649-201 Start Date*: 2020-03-24
    Sponsor Name:Visterra, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy
    Medical condition: Immunoglobulin A (IgA) Nephropathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10021263 IgA nephropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-001163-30 Sponsor Protocol Number: ALID02307 Start Date*: 2015-05-11
    Sponsor Name:Genzyme, a Sanofi Company
    Full Title: A trial of antigen-specific immune tolerance induction in mucopolysaccharidosis I (MPS I) patients initiating enzyme replacement therapy with Aldurazyme® (laronidase)
    Medical condition: Mucopolysaccharidosis I
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10056886 Mucopolysaccharidosis I PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001275-23 Sponsor Protocol Number: OTL-101-5(17IC04) Start Date*: 2017-09-21
    Sponsor Name:Great Ormond Street Hospital for Children NHS Trust
    Full Title: Efficacy and safety of a cryopreserved formulation of autologous CD34+ haematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for human ADA gene in subjects with Severe Co...
    Medical condition: Adenosine deaminase (ADA) deficiency is an inherited disorder that damages the immune system and causes severe combined immunodeficiency (SCID). Children with SCID lack virtually all immune protect...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10066372 ADA deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-002882-20 Sponsor Protocol Number: Start Date*: 2019-04-17
    Sponsor Name:Imperial College London
    Full Title: A multicentre randomised controlled trial to assess the safety and efficacy of adding rituximab to standard of care in treating acute antibody-mediated rejection in kidney transplantation (Transpla...
    Medical condition: Renal Transplant antibody-mediated rejection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-003951-44 Sponsor Protocol Number: ΕΑΕ-2017/ΜΜ01 Start Date*: 2017-12-15
    Sponsor Name:Hellenic Society of Hematology
    Full Title: A Prospective, Multicenter, Non-comparative, Open-label, Phase II Study to Evaluate the Effects of Daratumumab Monotherapy on Bone Parameters in Patients with Relapsed and /or Refractory Multiple M...
    Medical condition: Relapsed and /or Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
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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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