A Multi-center, Randomized, Double-blind, Crossover Study to Assess the Safety and Pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) Compared to Prolastin®-C in Subjects With Alpha₁-Antitrypsin Deficiency

Trial Profile

A Multi-center, Randomized, Double-blind, Crossover Study to Assess the Safety and Pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) Compared to Prolastin®-C in Subjects With Alpha₁-Antitrypsin Deficiency

Completed
Phase of Trial: Phase II/III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Alpha 1-antitrypsin (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Pharmacokinetics
  • Sponsors Grifols
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 24 May 2017 Primary endpoint of AUC(0-7 Days) based on antigenic content has been met, according to results presented at the 113th International Conference of the American Thoracic Society.
    • 24 May 2017 Results presented at the 113th International Conference of the American Thoracic Society
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