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An Open-label and Multicenter Phase Ib/II Clinical Trial to Evaluate the Safety, Immunogenicity, PK/PD Profile of SS109 and NovoSeven® Following a Single Dose, and the Preliminary Efficacy and Safety of SS109 During On-demand Treatment in Hemophilia Patients With Coagulation Factor VIII or IX Inhibitors

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Trial Profile

An Open-label and Multicenter Phase Ib/II Clinical Trial to Evaluate the Safety, Immunogenicity, PK/PD Profile of SS109 and NovoSeven® Following a Single Dose, and the Preliminary Efficacy and Safety of SS109 During On-demand Treatment in Hemophilia Patients With Coagulation Factor VIII or IX Inhibitors

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Jul 2024

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At a glance

  • Drugs Eptacog alfa (Primary) ; SS 109 (Primary)
  • Indications Haemophilia A; Haemophilia B
  • Focus Pharmacokinetics
  • Sponsors Jiangsu Gensciences

Most Recent Events

  • 19 Jul 2024 Status changed from recruiting to completed.
  • 17 Jun 2024 Planned primary completion date changed from 31 May 2024 to 31 Jul 2024.
  • 28 Feb 2024 Planned End Date changed from 31 May 2024 to 31 Jul 2024.

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