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

Kamada, Ltd.4 sites in 1 country70 target enrollmentApril 2014

ConditionsNew Onset Type-1 Diabetes

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: New Onset Type-1 Diabetes
Sponsor: Kamada, Ltd.
Enrollment: 70
Locations: 4
Primary Endpoint: Beta cell function
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

February 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kamada, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject (or parent/guardian) willing and able to sign an informed consent
•Age 8-25 (inclusive) years
•Recently diagnosed with T1DM
•Basal C-peptide ≥ 0.2 pmol/mL
•Positive for at least one diabetes-related autoantibody
•Ability and consent to comply with completion of patient diary
•No significant abnormalities in serum hematology, serum chemistry
•No significant abnormalities in urinalysis
•No significant abnormalities in ECG
•For women of child bearing potential, non-pregnant, non-lactating female patients

Exclusion Criteria

•IgA deficient subjects
•Subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
•Subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
•Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
•Clinically significant intercurrent illnesses
•Pregnant or lactating women
•Current use of any medication known to influence glucose tolerance
•Current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.