5 results
Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…
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*…
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 objective is:* To determine the overall response rate (ORR) of 4 weekly infusions of obinutuzumab monotherapy (Induction I) in patients with rituximab-refractory follicular lymphoma.The secondary objectives are:* To determine the…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.