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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Aug 2019

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At a glance

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

    • 25 Feb 2019 C1-INH(f) and C4 antigen concentration results from three trials (NCT01912456, NCT01576523, NCT02316353) were presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 31 Aug 2018 Biomarkers information updated
    • 24 Mar 2018 Results of development of population pharmacokinetic pharmacodynamics model and use of this model to assess the relationship between C1INH functional activity levels and the risk of attacks in patients presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
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