5 results
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 the safety and tolerability of a nonadjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups;- To assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
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 whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.