A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema.

Trial Profile

A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Jun 2017

At a glance

  • Drugs Alpha 1-antitrypsin (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Kamada
  • Most Recent Events

    • 22 Jun 2017 According to a Kamada media release, Kamada has withdrawn the MAA for its proprietary inhaled alpha-1 antitrypsin therapy for the treatment of AATD with the EMA.
    • 28 Mar 2016 Results published in a Kamada media release.
    • 28 Mar 2016 According to a Kamada media release, the company has submitted an MAA to the EMA for inhaled alpha-1 antitrypsin (AAT) therapy as a treatment for AAT deficiency (AATD). The filing was validated by the EMA.
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