A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema

Trial Profile

A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2017

At a glance

  • Drugs Complement C1 inhibitor protein (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPACT
  • Sponsors CSL Behring
  • Most Recent Events

    • 23 Jun 2017 According to a CSL Behring media release, U.S. Food and Drug Administration (FDA) has approved HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients.This approval is supprted by the data from this trial.
    • 10 Jun 2017 Biomarkers information updated
    • 22 Mar 2017 Results published in the CSL Behring Media Release
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