3 results
The study is designed to clinically demonstrate device acute safety (Primary Endpoint) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).The main objectives of the study areU :1) Evaluate the Acute safety of the…
To find the optimal dose of neladenoson bialanate for the Phase III trial by detecting and characterizing a significant dose-response relationship in the two primary efficacy endpoints, absolute change from baseline in LVEF and log-transformed NT-…
To demonstrate the efficacy of repeated daily doses of 40 µg/kg/day and 120 µg/kg/day A4250 in children with progressive familial intrahepatic cholestasis (PFIC) Types 1 and 2, as determined by the following:* Proportion of patients experiencing at…