Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols 
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 24 Diseases   3 Trials   3 Trials   31 News 
  • ||||||||||  Privigen (human immune globulin intravenous 10%) / CSL Behring, Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Rapid desensitization to intravenous immunoglobulins (Poster Zone C) -  Apr 30, 2023 - Abstract #EAACI2023EAACI_1610;    
    Flebogamma Undiluted IDTs yielded a positive result with Plangamma
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Enrollment closed, Trial completion date, Trial primary completion date:  FORCE: Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma (clinicaltrials.gov) -  Oct 6, 2022   
    P2/3,  N=210, Active, not recruiting, 
    Active, not recruiting --> Terminated Suspended --> Active, not recruiting | Trial completion date: Sep 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Trial suspension:  FORCE: Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma (clinicaltrials.gov) -  Jan 28, 2022   
    P2/3,  N=210, Suspended, 
    Suspended --> Active, not recruiting | Trial completion date: Sep 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022 Recruiting --> Suspended
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Trial completion date, Trial primary completion date:  FORCE: Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma (clinicaltrials.gov) -  Aug 18, 2021   
    P2/3,  N=210, Recruiting, 
    Recruiting --> Suspended Trial completion date: Dec 2022 --> Sep 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
  • ||||||||||  Journal:  Anti-SARS-CoV-2 Antibodies Within IVIg Preparations: Cross-Reactivities With Seasonal Coronaviruses, Natural Autoimmunity, and Therapeutic Implications. (Pubmed Central) -  Mar 16, 2021   
    Pre-pandemic IVIg donors have either natural autoantibodies or pre-pandemic cross-reactive antibodies against antigenic protein fragments conserved among the "common cold" - related coronaviruses. The findings are important in: (a) assessing true anti-SARS-CoV-2-IgG seroprevalence avoiding false positivity in IVIg-receiving patients; (b) exploring potential protective benefits in patients with immune-mediated conditions and immunodeficiencies receiving acute or chronic maintenance IVIg therapy, and (c) validating data from a recent controlled study that showed significantly lower in-hospital mortality in the IVIg- treated group.
  • ||||||||||  Trial completion:  Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) -  Mar 10, 2021   
    P2,  N=100, Completed, 
    The findings are important in: (a) assessing true anti-SARS-CoV-2-IgG seroprevalence avoiding false positivity in IVIg-receiving patients; (b) exploring potential protective benefits in patients with immune-mediated conditions and immunodeficiencies receiving acute or chronic maintenance IVIg therapy, and (c) validating data from a recent controlled study that showed significantly lower in-hospital mortality in the IVIg- treated group. Active, not recruiting --> Completed
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Trial completion date, Trial primary completion date:  FORCE: Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma (clinicaltrials.gov) -  May 6, 2020   
    P2/3,  N=210, Recruiting, 
    Studies to confirm the utility of IVIG preparations for COVID-19 management may be warranted. Trial completion date: Jun 2021 --> Dec 2022 | Trial primary completion date: Jan 2021 --> Jun 2022
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    AMBAR (Alzheimer’s Management By Albumin Replacement) Phase 2B/3 Trial: complete clinical, biomarker and neuroimaging results () -  Oct 16, 2019 - Abstract #CTAD2019CTAD_64;    
    P2/3
    The distribution of AEs over time showed an accumulation of events during the conventional TPE period with a progressive decrease during the LVPE period. Percentage of patients with infections was higher in patients treated with PE-A without IVIG (62.8%), not only than those treated with high dose and low dose albumin + IVIG (39.2 and 39.5%, respectively) but also than those in the placebo arm (41.8%).
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Trial completion:  AMBAR: A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease (clinicaltrials.gov) -  Jul 31, 2019   
    P2/3,  N=347, Completed, 
    Percentage of patients with infections was higher in patients treated with PE-A without IVIG (62.8%), not only than those treated with high dose and low dose albumin + IVIG (39.2 and 39.5%, respectively) but also than those in the placebo arm (41.8%). Active, not recruiting --> Completed
  • ||||||||||  Flebogamma 5% DIF (human immune globulin intravenous 5%) / Grifols
    Enrollment closed, Trial primary completion date:  AMBAR: A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease (clinicaltrials.gov) -  Aug 2, 2017   
    P2/3,  N=350, Active, not recruiting, 
    Trial primary completion date: Dec 2017 --> Jan 2021 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Dec 2017