Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"
Summary
To evaluate different doses of "Kamada-AAT for Inhalation" on the levels of alpha 1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to assess the safety of the treatment in subjects with AAT Deficiency.
Timeline
- Start
- 2014-04
- Primary completion
- 2016-02
- Completion
- 2016-05
Outcome
Met primary endpoint
registry analysis (superiority test); Kamada-AAT for Inhalation, 80mg vs Placebo; p = 0.0005; Wilcoxon (Mann-Whitney) NCT02001688 ↗
registry analysis (superiority test); Kamada-AAT for Inhalation, 160mg vs Placebo; p = 0.020; Wilcoxon (Mann-Whitney) NCT02001688 ↗
registry analysis (superiority test); Kamada-AAT for Inhalation, 160mg vs Placebo; p = 0.0193; Wilcoxon (Mann-Whitney) NCT02001688 ↗
release “meeting the primary endpoint of the Company's U.S. Phase 2 clinical trial of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy” kamada.com ↗
release “our U.S. Phase 2 study of inhaled Alpha-1 Antitrypsin (AAT) for the treatment of AAT Deficiency met its primary endpoint” kamada.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 80 mg | Inhaled |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 160 mg | Inhaled |