Pivotal phase 3 study of Alpha-1 antitrypsin in the patients with Alpha-1 Antitrypsin Deficiency (AATD).

Trial Profile

Pivotal phase 3 study of Alpha-1 antitrypsin in the patients with Alpha-1 Antitrypsin Deficiency (AATD).

Planning
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2017

At a glance

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

    • 13 Nov 2017 Kamada expects a response from the FDA in regards to the proposed protocol and will submit additional data at the beginning of 2018.
    • 13 Nov 2017 According to a Kamada media release, this trial expected to begin in the second half of 2018, after FDA approval.
    • 20 Jul 2017 According to a Kamada media release, the study is planned to include approximately 200-300 patients.
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