NCT02005848

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

Phase II Study to Evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kamada, Ltd. · Industry
• Sex: All
• Age: 8 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• New Onset Type-1 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Alpha-1 Antitrypsin
OTHER	Placebo	Placebo

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2013-12-09
• Last updated: 2018-10-11

Locations

4 sites across 1 country: Israel