drugset / Trial / NCT02796937
Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
NaSingle-groupOpen-labelTreatment
Summary
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).
Timeline
- Start
- 2016-07
- Primary completion
- 2028-09
- Completion
- 2029-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 60 mg/kg | Intravenous |