6 results
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
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…
Primary objectives1. What is the effect of stopping mesalazine in the maintenance setting of patients with quiescent CD?2. Can subgroups of CD patients, for example based on prior treatment (medical vs. surgical), localization of disease, disease…
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 compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.