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Alphanate

Alphanate in Immune Tolerance Induction Therapy

Ensayo de Grifols SA en Hemophilia A, Congenital (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

2

previstos

Centros

20

Fin del objetivo primario

sep 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2018.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Terminated due to limited enrollment (non-safety related decision)».

Qué mide

Percentage of Participants Who Achieved Complete Immune Tolerance Within 33 Months of Initiation of Immune Tolerance Induction (ITI) Treatment Phase (del registro, en inglés) (hasta 32,5 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate. The study consists of 2 phases: * An ITI Treatment Phase in which all eligible participants will receive ITI treatment with alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, participants will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a participants has achieved partial immune tolerance, the participants will enter a 12-month Prophylactic Phase. * A 12-month Prophylactic Phase for all participants who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of alphanate. Due to limited enrollment, this study was early terminated.

Más ensayos de GRFS

Todos los de GRFS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03095287), actualizada en oct 2021.