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SMT + PE-A 5% · APACHE

Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%

Ensayo de Grifols SA en insuficiencia hepatica aguda sobre cronica.

Fase

Fase 3

Estado

Interrumpido

Participantes

274

previstos

Centros

30

Fin del objetivo primario

abr 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2019.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to corporate business reasons only (non-safety related decision)».

Qué mide

Tiempo hasta la muerte sin un trasplante hepatico previo durante 90 dias despues de la aleatorizacion (hasta el dia 90)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.

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Ficha completa en ClinicalTrials.gov (NCT03702920), actualizada en may 2026.