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An Open-label, Randomized Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema

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Trial Profile

An Open-label, Randomized Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2023

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At a glance

  • Drugs Complement C1 inhibitor protein (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Sponsors CSL Behring

    • Most Recent Events

    • 28 Sep 2020 According to a CSL Behring media release, based on NCT02316353 and NCT01912456, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older.
    • 16 Mar 2020 Results assessing factors associated with reduced response to C1-Inhibitor in patients with hereditary Angioedema presented at the 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 16 Mar 2020 Results of subgroup analysis assessing efficacy of subcutaneous C1-inhibitor in open label extension study of 'COMPACT' trial presented at the 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
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