drugset / Trial / NCT02005848

Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes

NCT02005848

Phase 2 Completed 70 enrolled Kamada, Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 60 mg/kg Intravenous
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 120 mg/kg Intravenous