4 results
The primary objective of this study is to evaluate the safety and performance of the Permaseal device for left ventricular transapical access and closure and to gain data that will lead to CE-Mark approval for the Permaseal device.
The purpose of the study is to investigate how quickly and to what extent flurbiprofen is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered via a FTS. Furthermore, the pharmacokinetics of FTS will be…
To characterize the safety, tolerability, and recommended phase 2 dose (RP2D) of each combination partner used with ruxolitinib (Part 1)To evaluate the preliminary efficacy of each novel ruxolitinib combination treatment arm (Parts 2 & 3)
To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease at 12 months