A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
Status:
Withdrawn
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug
to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects the
cells that are thought to be involved in the development of type 1 diabetes mellitus (T1DM,
T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the effect
of Aralast NP on preserving beta cell function and to determine if the intervention would
slow the progression of type 1 diabetes.
Part I of this trial (NCT 01183468) was an open-label, safety and dose level study consisting
of two groups. After completion of Part I, including a satisfactory safety review, enrollment
in Part II was to begin. Part II was designed as a two-arm, double-blind, placebo-controlled
clinical trial, and participants were to be randomly assigned to either the Aralast NP
treatment or placebo group.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Immune Tolerance Network (ITN) Juvenile Diabetes Research Foundation
Treatments:
Alpha 1-Antitrypsin Protease Inhibitors Protein C Inhibitor