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Phase 2b Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of a Subcutaneous Prophylaxis Treatment Regimen of CB2679d, in Adult Subjects With Hemophilia B

Trial Profile

Phase 2b Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of a Subcutaneous Prophylaxis Treatment Regimen of CB2679d, in Adult Subjects With Hemophilia B

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Dec 2019

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At a glance

  • Drugs Dalcinonacog alfa (Primary) ; Dalcinonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Therapeutic Use
  • Sponsors Catalyst Biosciences
  • Most Recent Events

    • 27 Nov 2019 Planned End Date changed from 29 Jan 2020 to 30 Apr 2020.
    • 27 Nov 2019 Planned primary completion date changed from 29 Nov 2019 to 28 Feb 2020.
    • 07 Nov 2019 According to a Catalyst Biosciences media release, the company has completed 28-day SQ dosing and 30-day washout and safety follow-up of two subjects in the study. Factor IX levels in these two subjects exceeded the efficacy endpoint of >12% activity and no ADAs or inhibitors were detected. Enrollment is ongoing and the Company anticipates reporting final data in the first half of 2020.
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