NCT05843916 - Switch Over Study of Biosimilar AGA for Fabry Disease | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 13, 2022

Primary Completion Date

December 1, 2023

Study Completion Date

December 1, 2023

Conditions

Fabry Disease

Interventions

DRUG

Recombinant human alpha galactosidase A (agalsidase beta)

All participants will receive 2 doses of Fabrazyme® with approximately 14 days between them. The dose will be 1 mg/kg of body mass every 2 weeks

DRUG

Recombinant human alpha-galactosidase A (agalsidase beta)

All participants will receive AGA BETA BS for 54 weeks. The dose will be 1 mg/kg of body mass every 2 weeks

Trial Locations (4)

RECRUITING

Centro Médico Santa María de la Salud, San Isidro

RECRUITING

Instituto de Nefrología Pergamino S.R.L, Pergamino

RECRUITING

Instituto de Investigaciones Clínicas Quilmes, Buenos Aires

RECRUITING

Clínica Universitaria Reina Fabiola, Córdoba