Shire Human Genetic Therapies AB

Primary objective: To evaluate the safety of Ripuga in Chinese Fabry disease naïve subjects by evaluating the incidence of treatment-emergent serious adverse events (TEAEs) throughout the study. Secondary objectives: 1. To evaluate other safety parameters of Ripuga; 2. To evaluate the efficacy of Ripuga on renal function parameters (estimated glomerular filtration rate [eGFR]); 1) To evaluate the efficacy of Ripuga on other renal function variables, pain, and pharmacodynamic (PD) markers (plasma lyso-Gb3); 2) To evaluate hearing changes in subjects aged <18 years; 3) To evaluate the pharmacokinetics (PK) of Ripuga in Chinese Fabry disease naïve subjects.