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: 20 Jul 2017

At a glance

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

    • 20 Jul 2017 According to a Kamada media release, the study is planned to include approximately 200-300 patients.
    • 20 Jul 2017 According to a Kamada media release, Company has submitted to the U.S. Food and Drug Administration (FDA) for review a proposed pivotal Phase 3 protocol for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy (Inhaled AAT) for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).
    • 29 Jun 2017 New trial record
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