Fibryga (fibrinogen concentrate (human)) / Octapharma 
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  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    Journal:  Differences in coagulation-relevant parameters: Comparing cryoprecipitate and a human fibrinogen concentrate. (Pubmed Central) -  Sep 3, 2023   
    The tested HFC is a more reliable fibrinogen and FXIII source for accurate dosing compared with cryoprecipitate. Cryoprecipitate appears considerably less predictable for bleeding management due to wide variation in pro- and anticoagulation factors, the presence of PMPs, and the potential to elevate VWF and FVIII to prothrombotic levels.
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    Trial completion, Trial completion date, Trial primary completion date, Surgery:  Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients (clinicaltrials.gov) -  May 11, 2023   
    P4,  N=30, Completed, 
    This study contributes to evidence supporting fibrinogen concentrate for bleeding control/prevention in real-world clinical practice, particularly for patients with acquired fibrinogen deficiency. Recruiting --> Completed | Trial completion date: Dec 2023 --> May 2023 | Trial primary completion date: Aug 2023 --> Mar 2023
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    Enrollment open, Trial completion date, Trial primary completion date, Surgery:  Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients (clinicaltrials.gov) -  Oct 27, 2021   
    P4,  N=30, Recruiting, 
    These results may have implications for the choice of fibrinogen concentrate and dosing. Not yet recruiting --> Recruiting | Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Aug 2021 --> Aug 2023
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    Clinical data, Trial completion, Real-world evidence, Real-world:  Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data (clinicaltrials.gov) -  May 13, 2021   
    P=N/A,  N=200, Completed, 
    HFC was efficacious for on-demand treatment of bleeding and as surgical prophylaxis, with a favorable safety profile, in patients with congenital afibrinogenemia. Recruiting --> Completed
  • ||||||||||  Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer, Fibryga (fibrinogen concentrate (human)) / Octapharma
    Enrollment open, Head-to-Head:  FiiRST-2: Factor In the Initial Resuscitation of Severe Trauma 2 Patients (clinicaltrials.gov) -  Apr 4, 2021   
    P4,  N=350, Recruiting, 
    Despite differences in PK and dosing, HFC was efficacious for on-demand BE treatment and surgical prophylaxis in CFD patients across age groups. Not yet recruiting --> Recruiting
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    Enrollment open, Trial completion date, Trial primary completion date:  Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency (clinicaltrials.gov) -  Mar 5, 2021   
    P=N/A,  N=25, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Oct 2027 | Trial primary completion date: Jan 2024 --> Oct 2027
  • ||||||||||  Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer, Fibryga (fibrinogen concentrate (human)) / Octapharma
    Trial completion date, Trial initiation date, Trial primary completion date, Head-to-Head:  FiiRST-2: Factor In the Initial Resuscitation of Severe Trauma 2 Patients (clinicaltrials.gov) -  Dec 19, 2020   
    P4,  N=350, Not yet recruiting, 
    Efficacy was comparable for adult, adolescent and paediatric patients, with a favourable safety profile. Trial completion date: Jun 2023 --> Jan 2024 | Initiation date: Oct 2020 --> Jan 2021 | Trial primary completion date: May 2023 --> Dec 2023
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    [VIRTUAL] Human Fibrinogen Concentrate for Bleeding Prophylaxis During Surgery in Paediatric Patients with Congenital Fibrinogen Deficiency () -  Dec 18, 2020 - Abstract #GTH2021GTH_239;    
    Efficacy of HFC (Fibryga® Octapharma) in surgical prophylaxis was assessed at the end of surgery by the surgeon and post-operatively by the haematologist using a four-point objective scale (Excellent, Good, Moderate, None), and by an Independent Data Monitoring & Endpoint Adjudication Committee (IDMEAC)...No allergic/hypersensitivity reactions or deaths were observed. Conclusion HFC administration for bleeding prophylaxis during surgery was efficacious for this ultra-rare disease in a paediatric population with congenital afibrinogenemia and showed a favourable safety profile.
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    [VIRTUAL] Coagulation Parameters Associated With Fibrinogen Concentrate Or Cryoprecipitate Treatment Of Surgical Bleeding () -  Oct 17, 2020 - Abstract #ASA2020ASA_478;    
    The FORMA-05 coagulation parameter analyses showed broad overlap between HFC and cryoprecipitate, with satisfactory maintenance of clot quality, FXIII and thrombin generation parameters in both treatment groups. This analysis demonstrates that treatment with HFC can maintain fibrinogen levels that are reduced due to blood loss, consumption and dilution, leading to successful efficacy in patients with acquired fibrinogen deficiency undergoing CRS for PMP.
  • ||||||||||  Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer, Fibryga (fibrinogen concentrate (human)) / Octapharma
    New P4 trial, Head-to-Head:  FiiRST-2: Factor In the Initial Resuscitation of Severe Trauma 2 Patients (clinicaltrials.gov) -  Aug 31, 2020   
    P4,  N=350, Not yet recruiting, 
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    Clinical data, Trial completion date, Trial primary completion date, Real-world evidence, Real-world:  Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data (clinicaltrials.gov) -  Aug 14, 2020   
    P=N/A,  N=264, Recruiting, 
    Use of HFC was associated with favorable efficacy outcomes and no safety concerns were identified. Trial completion date: Mar 2020 --> Mar 2021 | Trial primary completion date: Mar 2020 --> Mar 2021
  • ||||||||||  RiaSTAP (fibrinogen concentrate (human)) / CSL Behring, Fibryga (fibrinogen concentrate (human)) / Octapharma
    Preclinical, Journal:  Comparison of Two Different Fibrinogen Concentrates in an in vitro Model of Dilutional Coagulopathy. (Pubmed Central) -  May 2, 2020   
    Fibrinogen levels were more increased by high-dose substitution of both preparations. Based on this data it can be stated that both fibryga® and Haemocomplettan® had the same performance in our in vitro model except for CTEXTEM and thrombin time.
  • ||||||||||  Fibryga (fibrinogen concentrate (human)) / Octapharma
    FIBRYGA FOR MANAGEMENT OF CONGENITAL FIBRINOGEN DEFICIENCY WITH SEVERE BLEEDING COMPLICATIONS () -  Apr 3, 2020 - Abstract #ASPHO2020ASPHO_145;    
    Management varies depending on the severity of bleeding complications. Here we describe the case of an 8-year-old boy with congenital quantitative fibrinogen deficiency and a history of severe bleeding complications effectively managed with scheduled FIBRYGA prophylaxis.