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

NCT01304537 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-06-09

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Kamada, Ltd.

    lead INDUSTRY

Principal Investigators

  • Mariana Rachmiel, B.Med.Sc · Assaf Haroffeh Medical Center, Zerifin, Israel

  • Yael Lebenthal, MD · Institute for Endocrinology & Diabetes, Schneider Children's Medical Center, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01304537 on ClinicalTrials.gov