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Teplizumab · TEPLI-REAL

Description of Patients With Type 1 Diabetes Treated With Teplizumab

Ensayo de Sanofi en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

no aplica

Estado

Completado

Participantes

110

previstos

Centros

27

Fin del objetivo primario

ago 2025

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en feb 2025.

Qué mide

Participant demographic characteristics at teplizumab initiation (At Day 1 (first dose of teplizumab)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroType 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment. Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06892002), actualizada en ago 2025.