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  • ||||||||||  Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Kineret (anakinra) / SOBI, Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
    The Unfortunate Trifecta: Tuberculosis, EBV, and CMV Induced Hemophagocytic Lymphohistiocytosis (Marriott Marquis San Diego Marina, Pacific Ballroom 15-17 (Ground Floor, North Tower)) -  Feb 20, 2024 - Abstract #ATS2024ATS_8170;    
    Case report: A 52-year-old male with history of end-stage renal disease underwent deceased donor kidney transplant two years prior to presentation and was maintained on mycophenolate, tacrolimus, and prednisone...Broad infectious workup resulted in CMV and EBV viremia, treated with intravenous valganciclovir and cytogam...High clinical suspicion for HLH (H-score 218, 93-96% probability) prompted therapy with dexamethasone and anakinra (IL-1 blocker) following biopsy...Globally, cases of MTB induced HLH have a 54% survival rate, with diagnostic delay resulting in delay of appropriate antimicrobials and worse outcomes. These diagnostic delays warrant consideration of empiric MTB therapy for immunocompromised patients under suspicion for HLH.
  • ||||||||||  A Case of Idiopathic Pneumonia Syndrome in a Patient With Recent Stem Cell Transplant (San Diego Convention Center, Area H (Hall H, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_5651;    
    Early recognition and intervention are crucial for achieving favorable outcomes in these challenging cases. This also highlights the importance of treating possible infectious etiologies while awaiting workup and when unable to rule out certain infections.
  • ||||||||||  VariZIG (varicella zoster immune globulin) / Kamada
    Journal:  Case Report: Hospital-Acquired Chickenpox in a Healthcare Setting. (Pubmed Central) -  Jan 8, 2024   
    Further study of approaches including traditional antiviral agents, passive humoral immunotherapy (such as CytoGam) is needed. No abstract available
  • ||||||||||  Zemaira (human alpha-1 antitrypsin intravenous) / CSL Behring, Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    Journal:  Purified Versus Plasma Alpha-1 Antitrypsin Effects on Cellular Activities. (Pubmed Central) -  Dec 18, 2023   
    By adding purified exogenous alpha-1 antitrypsin (AAT) to peripheral blood mononuclear cells in 20% autologous serum and measuring AAT-induced cellular adherence, it was determined that purified AAT differs from plasma AAT. The known association of AAT with lipoproteins and the negative feedback between AAT and low-density lipoprotein (LDL) suggest that purification may separate AAT from a plasma component such as LDL that participates in their normal plasma functions.
  • ||||||||||  cyclophosphamide / Generic mfg.
    Trial completion, Trial completion date:  Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma (clinicaltrials.gov) -  Jan 31, 2023   
    P3,  N=53, Completed, 
    The known association of AAT with lipoproteins and the negative feedback between AAT and low-density lipoprotein (LDL) suggest that purification may separate AAT from a plasma component such as LDL that participates in their normal plasma functions. Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Dec 2022
  • ||||||||||  VariZIG (varicella zoster immune globulin) / Kamada, WinRho SDF (rho(d) immune globulin (human)) / Kamada
    Journal:  Human immune globulin treatment controls Zika viremia in pregnant rhesus macaques. (Pubmed Central) -  Jul 23, 2022   
    No adverse fetal or infant outcomes were identified in the treated animals, yet the placebo control treated animals also did not have signs related to congenital Zika syndrome (CZS). Human immune globulin may be a viable prophylaxis and treatment option for ZIKV infection during pregnancy, however, more studies are required to fully assess the impact of this treatment to prevent CZS.
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Journal:  Intravenous Alpha-1 Antitrypsin Therapy for Critically Ill COVID-19 Patients. (Pubmed Central) -  Jul 15, 2022   
    Human immune globulin may be a viable prophylaxis and treatment option for ZIKV infection during pregnancy, however, more studies are required to fully assess the impact of this treatment to prevent CZS. No abstract available
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    Clinical, Journal:  Comparative biochemical efficacy analysis of an alpha-proteinase inhibitor (Glassia®) in patients with alpha-1 antitrypsin deficiency. (Pubmed Central) -  Jun 9, 2022   
    P2/3
    For functional A1PI, the GMR (90% CI) was 98.7 (92.5-105.4) for baseline corrected and 107.8% (102.3-113.5) for uncorrected concentrations. In conclusion, the biochemical efficacy of Glassia using the endpoints of plasma antigenic and functional A1PI trough concentrations at steady state was comparable with Prolastin in patients with AATD.
  • ||||||||||  KedRAB (human rabies immune globulin) / Kamada, Kedrion
    Journal:  Epidemiology of rabies immune globulin use in paediatric and adult patients in the USA: a cross-sectional prevalence study. (Pubmed Central) -  Apr 28, 2022   
    Paediatric patients represent a significant proportion of the patient population receiving RIG, and are associated with higher prevalence of codes reporting repair of larger, more complex wounds in highly innervated anatomical regions. Dosing and administration of RIG must be informed by animal bite wound characteristics; clinicians should understand the differences between presentations in adults and children and treat accordingly.
  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment closed:  Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov) -  Nov 22, 2021   
    P2,  N=20, Active, not recruiting, 
    In combination with the established safety profile for CMVIG, these results suggest that prophylactic CMVIG treatment in patients undergoing solid organ transplantation may be beneficial, particularly in those at high risk of CMV infection or disease. Recruiting --> Active, not recruiting
  • ||||||||||  danazol oral / Generic mfg.
    Assessing Clinical Outcomes in Patients Undergoing Splenectomy for Immune Thrombocytopenia: A Real World Perspective (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4828;    
    We did not note differences in splenectomy outcomes across patients of different Backgrounds or with comorbidities, confirming that these should not play a role in treatment decisions. Patients who failed to respond to steroids and/or IVIG had lower response rates to splenectomy as has been previously hypothesized, though these represented a very small subset of our study population.
  • ||||||||||  Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
    Trial completion:  A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) -  Sep 22, 2021   
    P3,  N=399, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  KedRAB (human rabies immune globulin) / Kamada, Kedrion
    Clinical, Journal:  Safety and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure. (Pubmed Central) -  Jul 7, 2021   
    We report the safety, efficacy, and immunogenicity of a phase 4, prospective, 2-center, open-label, single-arm clinical trial evaluating human rabies immunoglobulin (HRIG150; KEDRAB 150 IU/mL) as part of PEP in patients (aged <17) with suspected or confirmed rabies exposure, where PEP was indicated...These results demonstrate that HRIG150 is well tolerated and effective in pediatric patients as a component of PEP. To the authors' knowledge, this study is the first to establish pediatric safety and efficacy of HRIG in the US.
  • ||||||||||  VariZIG (varicella zoster immune globulin) / Emergent Biosolutions
    [VIRTUAL] Prevention of varicella zoster virus infection among adult immunocompromised patients by VariZIG () -  May 8, 2021 - Abstract #ECCMID2021ECCMID_216;    
        Conclusions This study demonstrates the efficacy and safety of VariZIG as PEP in one of the largest cohorts of immunocompromised adults to date . No early case of varicella infection was found following exposure, supporting the current recommendations of VariZIG administration.
  • ||||||||||  Kamada Anti-SARS-CoV-2 / Kedrion, Kamada
    Trial completion:  Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19 (clinicaltrials.gov) -  Jan 5, 2021   
    P1/2,  N=12, Completed, 
    These data indicate that VARIZIG may reduce severity of varicella in immunocompromised children and adults. Recruiting --> Completed
  • ||||||||||  Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
    Enrollment change:  A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) -  Oct 19, 2020   
    P3,  N=399, Active, not recruiting, 
    Recruiting --> Completed N=800 --> 399
  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion date, Trial primary completion date:  Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov) -  Sep 2, 2020   
    P2,  N=20, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Jan 2020 --> Jan 2022 | Trial primary completion date: Dec 2019 --> Dec 2021
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment closed:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Apr 28, 2020   
    P3,  N=34, Active, not recruiting, 
    Further studies are warranted to determine the impact and proposed mechanism of action of AAT in β-cell preservation. Recruiting --> Active, not recruiting
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion date, Trial primary completion date:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Dec 20, 2019   
    P3,  N=36, Recruiting, 
    VARIZIG was well-tolerated and safe in high-risk participants. Trial completion date: May 2020 --> Aug 2020 | Trial primary completion date: May 2020 --> Aug 2020
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    Enrollment change:  Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency (clinicaltrials.gov) -  Oct 8, 2019   
    P3,  N=7, Terminated, 
    Trial completion date: May 2020 --> Aug 2020 | Trial primary completion date: May 2020 --> Aug 2020 N=22 --> 7
  • ||||||||||  VariZIG (varicella zoster immune globulin) / Emergent Biosolutions
    Review, Journal:  Chickenpox: An update. (Pubmed Central) -  Jun 22, 2019   
    A tetravalent measles-mumps-rubella-chickenpox vaccine, used in the United States, has a good tolerability in spite of the occurrence of fever and febrile seizures. Routine vaccination would contribute to make savings in France, by reducing direct and indirect costs of chickenpox.
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion date, Trial primary completion date:  Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation (clinicaltrials.gov) -  Feb 28, 2019   
    P2,  N=30, Active, not recruiting, 
    Routine vaccination would contribute to make savings in France, by reducing direct and indirect costs of chickenpox. Trial completion date: Dec 2020 --> Apr 2019 | Trial primary completion date: Mar 2020 --> Apr 2019
  • ||||||||||  Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
    Trial completion date:  A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) -  Jan 30, 2019   
    P3,  N=800, Active, not recruiting, 
    Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Apr 2019 --> Dec 2019 Trial completion date: Dec 2018 --> Aug 2021
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    Phase classification, Enrollment change, Trial completion date, Trial initiation date, Trial termination, Trial primary completion date:  Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency (clinicaltrials.gov) -  Nov 26, 2018   
    P3,  N=22, Terminated, 
    Trial completion date: Dec 2018 --> Aug 2021 Phase classification: P4 --> P3 | N=138 --> 22 | Trial completion date: Jul 2021 --> Sep 2018 | Initiation date: Jun 2016 --> Nov 2016 | Recruiting --> Terminated | Trial primary completion date: Jul 2021 --> Sep 2018
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment change:  Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD) (clinicaltrials.gov) -  Oct 30, 2018   
    P1/2,  N=20, Completed, 
    Phase classification: P4 --> P3 | N=138 --> 22 | Trial completion date: Jul 2021 --> Sep 2018 | Initiation date: Jun 2016 --> Nov 2016 | Recruiting --> Terminated | Trial primary completion date: Jul 2021 --> Sep 2018 N=14 --> 20
  • ||||||||||  Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada
    Enrollment closed, Trial primary completion date:  A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (clinicaltrials.gov) -  Jun 14, 2018   
    P3,  N=800, Active, not recruiting, 
    N=14 --> 20 Recruiting --> Active, not recruiting | Trial primary completion date: May 2018 --> Nov 2018