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

NCT02005848 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-10-11

No results posted yet for this study

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.

Conditions

  • New Onset Type-1 Diabetes

Interventions

BIOLOGICAL

Alpha-1 Antitrypsin

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Kamada, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

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 NCT02005848 on ClinicalTrials.gov