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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Alpha-1 Antitrypsin 40mg (AAT, Glassia®)

Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.

DRUG

Alpha-1 Antitrypsin 60mg (AAT, Glassia®)

Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.

DRUG

Alpha-1 Antitrypsin 80mg (AAT, Glassia®)

Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.

Trial Locations (2)

49202

Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes at Schneider Children's Medical Center of Israel, Petah Tikva

70300

Assaf Haroffeh Medical Center, Ẕerifin

All Listed Sponsors
lead

Kamada, Ltd.

INDUSTRY

NCT01304537 - Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter