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Myozyme®

Immune Tolerance Induction Study

Ensayo de Sanofi en Pompe Disease · Glycogen Storage Disease Type II (GSD-II) · Glycogenesis 2 Acid Maltase Deficiency (del registro, en inglés).

Fase

Fase 4

Estado

Interrumpido

Participantes

4

previstos

Centros

5

Fin del objetivo primario

feb 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2008.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study was conducted to fulfill a post marketing commitment (PMC 6). FDA acknowledged fulfillment of PMC.».

Qué mide

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (From Baseline up to 18 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAn exploratory, open-labeled study of participants with Pompe disease, who had previously received Myozyme® (alglucosidase alfa) treatment, to evaluate the efficacy, safety and clinical benefit of 2 Immune Tolerance Induction (ITI) regimens in combination with Myozyme®. Eligible participants who were then receiving Myozyme® therapy were enrolled into the study, and were followed for a minimum of 18 months on-study (a 6-month ITI treatment module and a 12-month follow-up module on Myozyme® alone). Eligible participants were followed for a minimum of 18 months on treatment or, if a participant was \<6 months of age at the time of enrollment, until the participant was 2 years of age. Both cross-reacting immunologic material (CRIM)-negative and CRIM-positive participants were eligible for Regimen A depending if they met the required criteria. Regimen B, however, was limited to CRIM-negative participants.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00701701), actualizada en mar 2022.