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Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks

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Trial Profile

Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2025

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At a glance

  • Drugs Complement C1 inhibitor protein (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Sponsors Octapharma

    • Most Recent Events

    • 10 Apr 2025 Planned End Date changed from 1 Dec 2026 to 1 Jun 2027.
    • 10 Apr 2025 Planned primary completion date changed from 1 Dec 2026 to 1 Jun 2027.
    • 09 Jul 2024 Planned End Date changed from 1 Dec 2025 to 1 Dec 2026.

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