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: 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
- 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.