drugset / Trial / NCT01304537

Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus

NCT01304537

Phase 1/2 Completed 24 enrolled Kamada, Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its anti-inflammatory properties. AAT is an acute stress reactant protein that increases during inflammation. In T1DM inflammation serves a major role in disease progression.

Timeline

Start
2011-06
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 40 mg/kg Intravenous
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 60 mg/kg Intravenous
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 80 mg/kg Intravenous