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Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients With Congenital Afibrinogenemia

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Trial Profile

Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients With Congenital Afibrinogenemia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 04 Apr 2022

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At a glance

  • Drugs Fibrinogen (Primary)
  • Indications Afibrinogenaemia
  • Focus First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Grifols

    • Most Recent Events

    • 26 Nov 2020 This trial has been Discontinued in Italy, according to European Clinical Trials Database record.
    • 17 Mar 2020 Status changed from recruiting to completed.
    • 29 Jan 2018 Planned End Date changed from 1 Jan 2018 to 1 Dec 2019.

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