Type 1 Diabetes Clinical Trial
Official title:
Open Label Study (Extension 001)to Evaluate Long Term Treatment Effect of the Safety, Tolerability and Efficacy of Intervenous ALPHA-1 ANTITRYSIN (AAT)Glasia™ in Type 1 Diabetes Mellitus (Extension to KAMADA AAt 008, PHASE I/II Study)
At a previous study the investigators have assessed the safety and efficacy of treatment
with AAT(Alpha 1 Antitrypsin)in newly diagnosed type 1 diabetes subjects aiming at beta
cells preservation .
Since treatment with AAT is expected to be a chronic treatment; stopping treatment will
probably result in eventual loss of the preserved beta-cell function. Indeed, other
investigational drugs aiming at beta cells preservation have shown that patients who were
initially treated and maintained their initial beta-cell function, required continuation of
treatment or they lost the beta-cell function.
Therefore, in this extension study, patients who were previously treated with AAT and
maintained clinically significant beta-cell function are offered a continuation of
treatment, since they are likely to benefit from use of the medication.
The proposed study is aimed to assess the long term effect of AAT in subjects with type 1
diabetes mellitus: safety and tolerability of treatment, and effect on beta-cell function.
Subjects who have completed all visits of the 008 study will be offered to participate in
the extension study.
The study will be consist off two main arms as following:
Arm 1: Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2 nmol/L will
continue treatment with AAT for up to 18 treatments according to the dosage group they were
allocated to in the 008 study.
Arm 2:
Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L and
subjects with peak stimulated C -peptide secretion ≥ 0.2 nmol/L who are reluctant to receive
additional study drug.
Clinical follow up for all subjects in both arms will be for 3 years
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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