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A Phase 1,Randomized, Single-blind, Placebo-controlled, Single Dose, Dose-escalated Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Profile of Subcutaneous Administration of a Long-acting Recombinant Factor VIIa in Healthy Adult Males

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Trial Profile

A Phase 1,Randomized, Single-blind, Placebo-controlled, Single Dose, Dose-escalated Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Profile of Subcutaneous Administration of a Long-acting Recombinant Factor VIIa in Healthy Adult Males

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Factor VIIa-CTP (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Adverse reactions
  • Sponsors OPKO Health
  • Most Recent Events

    • 03 May 2018 Status changed from recruiting to completed.
    • 09 Nov 2017 Planned End Date changed from 1 May 2017 to 1 May 2018.
    • 09 Nov 2017 Planned primary completion date changed from 1 Apr 2017 to 1 Mar 2018.

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