6 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…
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 doxepin hydrochloride 5% cream is more effective in reducing pruritus in burn patients than standard treatment (clemastine).
to evaluate whether Doxepin hydrochloride 5% cream versus a placebo cream significantly reduces pruritus in burn patients by comparing itch scores.
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
The clinical study objective is to demonstrate the acute and 12 months safety and performance of the Cryterion Cardiac Cryoablation System when used as intended.