2 results
Approved WMOPending
The primary objective is to evaluate the safety and efficacy of the PulseCath during support of patients with impaired ventricular function, for a period between 24 hours minimum and 14 days maximum. Safety will be assessed by the incidence of…
Approved WMOCompleted
Primary objectives of this study:1. Evaluate the efficacy after 26 weeks of Kuvan® treatment + Phe-restricted diet therapy in increasing dietary Phe tolerance, as compared to dietary therapy alone in <4 year-old infants and children with…