5 results
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
• To assess contraceptive efficacy, vaginal bleeding patterns (cycle control),general safety and acceptability of the NOMAC-E2 COC in a large group ofwomen aged 18-50 years.
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
To evaluate the effects on ovarian function with the NOMAC/E2 COC in a group of women aged 18-35 years.