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…
Primary objectives of the study are:• Arm 1 and Arm 3 (PTPs): to characterize the long-term safety profile of rVIII SingleChain with respect to inhibitor development in PTPs.• Arm 2 (PUPs): • To characterize the safety with respect to inhibitor…
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-…