Calendario›GRFS›180 mg

180 mg

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

Ensayo de Grifols SA en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 2

Estado

Interrumpido

Participantes

76

previstos

Centros

36

Fin del objetivo primario

ene 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2014.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Wk 52 primary endpoint results would be unaffected by follow-up data so trial was discontinued prior to wk 104. No safety data was collected after wk 52.».

Qué mide

Change From Baseline in Mixed Meal Tolerance Test (MMTMT) Stimulated C-peptide 2 Hour Area Under the Concentration-time Curve (AUC) (Baseline, Week 52 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM). Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed enrollment will be opened to the child cohort. The purpose of this study is to evaluate the safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.

Más ensayos de GRFS

Todos los de GRFS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02093221), actualizada en ago 2018.