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Clinical trials for Globulin

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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    262 result(s) found for: Globulin. Displaying page 1 of 14.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2019-003459-12 Sponsor Protocol Number: RB-NAIT-01-01 Start Date*: 2020-08-11
    Sponsor Name:Rallybio, IPA, LLC
    Full Title: A Single-blind, Placebo-controlled, Single-center Study Investigating the Dose of Human Anti-Human Platelet Antigen (HPA)-1a Immune Globulin (NAITgam) Needed to Eliminate HPA-1a Positive Platelets ...
    Medical condition: prevention of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT In mothers negative for HPA-1a antigen, fetal platelets positive for HPA-1a antigen, may enter the mother’s circulation and induce pr...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10075151 Fetal and neonatal alloimmune thrombocytopenia LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003608-61 Sponsor Protocol Number: ZLB06_002CR Start Date*: 2015-01-05
    Sponsor Name:CSL Behring
    Full Title: A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
    Medical condition: Primary Immune Deficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-001623-38 Sponsor Protocol Number: 060103 Start Date*: 2004-11-05
    Sponsor Name:Baxter AG
    Full Title: Phase 3B Recombinant Antihemophilic Factor Manufactured and Formulated without added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060612 Hemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003609-14 Sponsor Protocol Number: ZLB07_001CR Start Date*: 2015-01-05
    Sponsor Name:CSL Behring
    Full Title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
    Medical condition: Primary Immune Deficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003409-13 Sponsor Protocol Number: IgPro20_3006 Start Date*: 2015-01-05
    Sponsor Name:CSL Behring
    Full Title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects with Primary Immunodeficiency
    Medical condition: Primary Immune Deficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002396-99 Sponsor Protocol Number: NN7170-4213 Start Date*: 2016-10-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: AT (Completed) DE (Completed) BG (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000501-21 Sponsor Protocol Number: 2003-12 Start Date*: 2005-04-30
    Sponsor Name:XTL Biopharmaceuticals
    Full Title: A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-B, a Mixture of Two Monoclonal Antibodies...
    Medical condition: Hepatic allograft recipients for treatment of hepatitis B virus infection.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002757-45 Sponsor Protocol Number: 11859 Start Date*: 2005-11-28
    Sponsor Name:Bayer HealthCare LLC/Biological Products
    Full Title: A prospective controlled study on the effect on bleeding events and joint function in young adults with severe hemophilia A after a 6 month prophylaxis treatment compared to on demand treatment
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    7.1 10018937 low
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006560-11 Sponsor Protocol Number: FARM7J4HCH Start Date*: 2009-02-24
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Prevention of human cytomegalovirus (HCMV) mother-to-fetus transmission by administration of virus-specific hyperimmune globulin to pregnant women with primary HCMV infection
    Medical condition: Pregnant women with primary HCMV infection.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023242-69 Sponsor Protocol Number: GENA-11 Start Date*: 2011-05-31
    Sponsor Name:Octapharma AG
    Full Title: Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01
    Medical condition: Severe haemophilia A (FVIII:C <1%)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2020-002542-16 Sponsor Protocol Number: INSIGHT013 Start Date*: 2020-09-30
    Sponsor Name:Office of Sponsored Projects, Regents of the University of Minnesota
    Full Title: An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the...
    Medical condition: COVID-19 (SARS-CoV-2) infection
    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: GB (GB - no longer in EU/EEA) GR (Completed) DK (Completed) DE (Completed)
    Trial results: View results
    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: 2017-002281-46 Sponsor Protocol Number: NN7008-4304 Start Date*: 2018-02-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated patients with moderate or severe Haemophilia A in India.
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004791-35 Sponsor Protocol Number: NN7008-4028 Start Date*: 2018-03-09
    Sponsor Name:Novo Nordisk A/S’
    Full Title: Efficacy and safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated Chinese patients with haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003821-40 Sponsor Protocol Number: NN7170-4345 Start Date*: 2017-02-15
    Sponsor Name:Novo Nordisk A/S
    Full Title: Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed) AT (Completed) BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004834-18 Sponsor Protocol Number: 060601 Start Date*: 2008-02-22
    Sponsor Name:Baxter Innovations GmbH
    Full Title: PHARMACOKINETIC COMPARISON OF ADVATE rAHF-PFM WITH RECOMBINATE rAHF IN PATIENTS WITH SEVERE HEMOPHILIA A: A PHASE IV, PROSPECTIVE, RANDOMIZED, CONTROLLED, CROSS-OVER, SINGLE CENTER STUDY
    Medical condition: The objective of this study is to further evaluate observations of decreased efficacy in subjects having been switched to Advate rAHF-PFM from Recombinate rAHF by comparing the pharmacokinetic para...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066439 Hemophilia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-004435-22 Sponsor Protocol Number: AVI-40-3 Start Date*: 2005-12-13
    Sponsor Name:OCTAPHARMA AG
    Full Title: INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE
    Medical condition: Previously untreated patients with severe (FVIII:C<2%) haemophilia A, no inhibitor activity prior to admission, no concomitant therapy with Interferon, patients registered for regular treatment at ...
    Disease: Version SOC Term Classification Code Term Level
    8.0 10016080 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: CZ (Completed) FR (Not Authorised)
    Trial results: View results
    EudraCT Number: 2010-023666-46 Sponsor Protocol Number: F8VR-1006 Start Date*: 2011-12-13
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES
    Medical condition: HAEMOPHILIA A
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-023921-39 Sponsor Protocol Number: NN7008-3893 Start Date*: 2011-04-27
    Sponsor Name:Novo Nordisk A/S
    Full Title: Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-005253-39 Sponsor Protocol Number: BAY14-2222/12684 Start Date*: 2015-01-21
    Sponsor Name:Bayer HealthCare AG
    Full Title: A Prospective Study to Evaluate the Effect of rFVIII-FS in Different Prophylactic Regimens on Bleeding Events Frequency and Development of Arthropathy in Previously Treated and Minimally Treated He...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    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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