A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Alpha-1 Antitrypsin (AAT) (Glassia
alpha-1 antitrypsin
beta cell preservation
children and adolescents
type 1 diabetes
Journal
International journal of molecular sciences
ISSN: 1422-0067
Titre abrégé: Int J Mol Sci
Pays: Switzerland
ID NLM: 101092791
Informations de publication
Date de publication:
29 Nov 2019
29 Nov 2019
Historique:
received:
03
11
2019
revised:
25
11
2019
accepted:
27
11
2019
entrez:
5
12
2019
pubmed:
5
12
2019
medline:
28
4
2020
Statut:
epublish
Résumé
Our aim was to assess the efficacy, safety, and tolerability of alpha-1 antitrypsin (AAT) as a therapeutic modality for β-cell preservation in patients with recent-onset type 1 diabetes. Seventy type 1 diabetes patients (37 males; mean age 13.1 ± 4.1years) were randomized to treatment with 22 infusions of AAT (Glassia
Identifiants
pubmed: 31795482
pii: ijms20236032
doi: 10.3390/ijms20236032
pmc: PMC6928874
pii:
doi:
Substances chimiques
Immunologic Factors
0
alpha 1-Antitrypsin
0
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Déclaration de conflit d'intérêts
The study design was carried out by the investigators and the sponsor’s representatives. Data collection and the statistical analysis of results were performed by the external CRO. Data interpretation and writing were carried out by the investigators and the sponsor’s representatives. E.C.L. is on the advisory board of Kamada. D.E., M.S., and N. T. are employees of Kamada. No other potential conflicts of interest relevant to this article are reported.
Références
Cell Mol Immunol. 2014 Jul;11(4):377-86
pubmed: 25000533
Diabetes. 2012 Aug;61(8):2066-73
pubmed: 22688329
J Pharmacol Exp Ther. 2016 Nov 7;359(3):482-490
pubmed: 27821710
Pharmacol Ther. 2009 Sep;123(3):292-309
pubmed: 19481569
J Clin Endocrinol Metab. 2014 Aug;99(8):E1418-26
pubmed: 24527714
Diabetes Res Clin Pract. 2013 May;100(2):203-9
pubmed: 23529064
Diabetologia. 2010 Oct;53(10):2198-204
pubmed: 20593162
J Leukoc Biol. 2009 May;85(5):886-95
pubmed: 19197072
Pediatr Diabetes. 2018 Aug;19(5):945-954
pubmed: 29473705
Proc Natl Acad Sci U S A. 2008 Oct 21;105(42):16236-41
pubmed: 18852465
Biochem Soc Trans. 2002 Apr;30(2):93-8
pubmed: 12023832
Diabetes. 2018 Aug;67(8):1481-1494
pubmed: 30030289
Nat Rev Immunol. 2010 Jul;10(7):501-13
pubmed: 20577267
Proc Natl Acad Sci U S A. 2012 Jan 10;109(2):564-9
pubmed: 22203983
Immunotherapy. 2018 Sep;10(13):1137-1148
pubmed: 30236025
Ann Intern Med. 1998 Apr 1;128(7):517-23
pubmed: 9518395
N Engl J Med. 2002 May 30;346(22):1692-8
pubmed: 12037148
Proc Natl Acad Sci U S A. 2005 Aug 23;102(34):12153-8
pubmed: 16093309
Pediatr Diabetes. 2016 Aug;17(5):351-9
pubmed: 26073583
Front Immunol. 2016 Dec 07;7:559
pubmed: 28003813
Stat Med. 2007 Feb 10;26(3):484-97
pubmed: 16625520
Proc Natl Acad Sci U S A. 2008 Oct 21;105(42):16242-7
pubmed: 18852471
Biol Blood Marrow Transplant. 2016 Sep;22(9):1596-1601
pubmed: 27223109
J Biol Chem. 2007 Mar 23;282(12):8573-82
pubmed: 17261591
Biochim Biophys Acta Gen Subj. 2018 Sep;1862(9):1852-1861
pubmed: 29857082