Glassia (alpha1-proteinase inhibitor (Human)) / Takeda 
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 0 Diseases   2 Trials   2 Trials   86 News 


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  • ||||||||||  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.
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Journal:  Intravenous Alpha-1 Antitrypsin Therapy for Critically Ill COVID-19 Patients. (Pubmed Central) -  Jul 15, 2022   
    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. 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.
  • ||||||||||  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 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. Recruiting --> Active, not recruiting
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Oct 9, 2020   
    P3,  N=34, Completed, 
    Other approaches are needed to validate any benefit of augmentation therapy. Active, not recruiting --> Completed
  • ||||||||||  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, 
    Recruiting --> Active, not recruiting 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
  • ||||||||||  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 2020 --> Apr 2019 | Trial primary completion date: Mar 2020 --> Apr 2019 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
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD (clinicaltrials.gov) -  Jun 3, 2018   
    P2/3,  N=1, Terminated, 
    N=14 --> 20 N=168 --> 1 | Trial completion date: Jul 2019 --> May 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2018 --> May 2018; The decision to discontinue the study was based on business reasons.
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion date, Trial primary completion date:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Apr 27, 2018   
    P3,  N=36, Recruiting, 
    N=168 --> 1 | Trial completion date: Jul 2019 --> May 2018 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2018 --> May 2018; The decision to discontinue the study was based on business reasons. Trial completion date: May 2019 --> May 2020 | Trial primary completion date: May 2019 --> May 2020
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment closed:  A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD (clinicaltrials.gov) -  Mar 14, 2018   
    P2/3,  N=168, Active, not recruiting, 
    Trial primary completion date: Jan 2018 --> Dec 2019 Suspended --> 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) -  Feb 23, 2018   
    P3,  N=36, Recruiting, 
    Suspended --> Active, not recruiting Trial primary completion date: Feb 2018 --> May 2019 | Trial completion date: Feb 2018 --> May 2019
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Journal:  Response of Steroid-Refractory Acute GVHD to α1-Anti-Trypsin. (Pubmed Central) -  Feb 18, 2018   
    In a phase I/II open-label single-center study, we administered AAT (Glassia; Baxalta/Kamada, New Ziona, Israel) as salvage therapy to 12 patients with steroid-refractory acute graft-versus-host disease (GVHD)...These findings show that AAT is well tolerated and has efficacy in the treatment of steroid-refractory severe acute GvHD. Further studies are warranted.
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion:  Phase II Study to Evaluate the Efficacy and Safety of Glassia (clinicaltrials.gov) -  Feb 1, 2018   
    P2,  N=71, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial primary completion date:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Sep 11, 2017   
    P3,  N=36, Recruiting, 
    Active, not recruiting --> Completed Trial primary completion date: Sep 2017 --> Feb 2018
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Clinical:  A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD (clinicaltrials.gov) -  Jul 11, 2017   
    P2/3,  N=168, Suspended, 
    Trial primary completion date: Sep 2017 --> Feb 2018 Initiation date: Nov 2016 --> Apr 2017 | Recruiting --> Suspended
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial completion, Trial primary completion date:  Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD) (clinicaltrials.gov) -  May 24, 2017   
    P1/2,  N=14, Completed, 
    Initiation date: Nov 2016 --> Apr 2017 | Recruiting --> Suspended Active, not recruiting --> Completed | Trial primary completion date: Jul 2017 --> Jan 2017
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Clinical:  A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD (clinicaltrials.gov) -  Dec 15, 2016   
    P2/3,  N=168, Recruiting, 
    Recruiting --> Active, not recruiting | N=24 --> 14 Not yet recruiting --> Recruiting
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment closed, Phase classification, Enrollment change, Trial primary completion date:  Phase II Study to Evaluate the Efficacy and Safety of Glassia (clinicaltrials.gov) -  Jun 10, 2016   
    P2,  N=71, Active, not recruiting, 
    Initiation date: May 2016 --> Jan 2017 Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P2 | N=192 --> 71 | Trial primary completion date: Apr 2016 --> Jan 2017
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    Enrollment open:  Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency (clinicaltrials.gov) -  Apr 29, 2016   
    P4,  N=138, Recruiting, 
    Trial primary completion date: Jun 2016 --> Dec 2016 Not yet recruiting --> Recruiting
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
    New P4 trial:  Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency (clinicaltrials.gov) -  Mar 30, 2016   
    P4,  N=138, Not yet recruiting, 
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Enrollment open:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Mar 14, 2016   
    P3,  N=36, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda
    Trial initiation date:  GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) -  Dec 30, 2015   
    P3,  N=36, Not yet recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Sep 2015 --> Feb 2016
  • ||||||||||  Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
    Enrollment change, Trial termination:  Safety and Efficacy of (?1Proteinase Inhibitor, ?1PI) in HIV Disease (clinicaltrials.gov) -  Dec 10, 2014   
    P2/3,  N=12, Terminated, 
    Initiation date: Feb 2012 --> Nov 2013 N=20 --> 12 | Recruiting --> Terminated; Blinded review of the data suggested no significant diferences in outcomes.
  • ||||||||||  Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
    Trial primary completion date:  Safety and Efficacy of (?1Proteinase Inhibitor, ?1PI) in HIV Disease (clinicaltrials.gov) -  Jun 27, 2014   
    P2/3,  N=20, Recruiting, 
    N=20 --> 12 | Recruiting --> Terminated; Blinded review of the data suggested no significant diferences in outcomes. Trial primary completion date: Mar 2013 --> Jul 2014