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

New Onset Type-1 Diabetes Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• New Onset Type-1 Diabetes

• NCT number: NCT02005848
• Study type: Interventional
• Source: Kamada, Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Completion date: February 2017