clinical trial · NCT05054387
China Post-marketing Surveillance (PMS) Study of Fabrazyme®
Genzyme, a Sanofi Company·phase4·completed·n = 22
Fabry DiseaseAgalsidase beta
brief summary
This is a 54-week Phase 4, open label, single arm study to evaluate the safety and the efficacy of Fabrazyme (agalsidase beta) as enzyme replacement therapy (ERT) in Chinese participants with Fabry Disease.
started
Oct 13, 2021
primary completion
Mar 9, 2023
completion
Mar 9, 2023
last updated
Sep 11, 2025
detailed description
Study participation for each patient will be total of 54 weeks which will include 4 weeks of screening, 48 weeks of treatment period and 2 weeks of post study treatment observation
official title
A Phase 4, Open Label, Safety and Efficacy Study of Fabrazyme® (Agalsidase Beta) as Enzyme Replacement Therapy in Chinese Participants With Fabry Disease
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol