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