Overview of Aralast Clinical Trial (RETAIN) for New-Onset T1DM
FEvIR ResearchStudy - A Research Trial of Aralast in New
A research study titled RETAIN was conducted regarding Aralast for New Onset Diabetes.
Summary
This study assesses whether the drug Aralast NP, an Alpha-1 Antitrypsin (AAT) formulation, can slow the progression of new-onset Type 1 Diabetes Mellitus (T1DM). Part I focused on dose-escalation studies to evaluate pharmacokinetics (PK), pharmacodynamics (PD), and safety.
Details
This research, titled 'Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (ITN041AI),' is a clinical trial (RETAIN) targeting patients with new-onset T1DM. The primary goal was to assess if the AAT formulation could help slow the progression of T1DM. Part I involved dose-escalation studies focusing on pharmacokinetics (PK), pharmacodynamics (PD), and safety. Different dosing regimens were established for age groups (16-35 years, 8-15 years). Notably, the study was ultimately terminated due to 'lack of mechanistic signal' and 'competing industry studies.' The data is presented via a FHIR ResearchStudy Viewer, highlighting the use of standardized structures (FHIR) for managing and sharing clinical trial information in healthcare interoperability.
Technology Note
FHIR（Fast Healthcare Interoperability Resources）は医療データ交換の国際標準。このエントリの関連技術: FHIR
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