4 results
Part 1 (phase 1b): to identify a dose of AMG 655 in combination with doxorubicin that is safe and tolerated as determined by the incidence of dose limiting toxicity Part 2 (phase2): To estimate the efficacy, as measured by progression-free survival…
Primary:* To assess the safety and tolerability of LAM-001 administered daily by dry powder inhaler (DPI) for 14 days in patients with lymphangioleiomyomatosis (LAM) (Period 1).* To assess the longer-term safety and tolerability of LAM-001…
The primary objective of the study is to evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs in the 3 months following implantation. Secondary objectives are related to safety and efficacy:• To…
The objective of this study is to investigate whether an interatrial shunt device is superior to sham procedure in prevention of: (1) incidence of and time to cardiovascular mortality through 12-24 months; (2) incidence of and time to heart…