drugset / Trial / NCT02005848
Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) \[Glassia®\] in the Treatment of New Onset Type-1 Diabetes. The study objectives are: * To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes * To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.
Timeline
- Start
- 2014-04
- Primary completion
- 2017-02
- Completion
- 2017-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 60 mg/kg | Intravenous |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 120 mg/kg | Intravenous |