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An Open-Label, Multicenter Evaluation of the Pharmacokinetics Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW117) in Patients With Severe Hemophilia A.

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Trial Profile

An Open-Label, Multicenter Evaluation of the Pharmacokinetics Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW117) in Patients With Severe Hemophilia A.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs FRSW 107 (Primary) ; Octocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Jiangsu Gensciences

    • Most Recent Events

    • 06 Sep 2023 Randomized has been removed from the design term as this trial is now an Non-Randomized trial, Primary endpoints has been amended.
    • 15 Jun 2023 Results reporting pharmacokinetic and adverse events data from two groups (S1 group; n=6; at dose 25 IU/kg and S2 group; n=7; at dose 50 IU/kg) presented at the 28th Congress of the European Haematology Association
    • 27 Jun 2022 Status changed from active, no longer recruiting to completed.

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