2 results
Approved WMOCompleted
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Approved WMOCompleted
The objective of the study is to investigate how quickly and to what extent balovaptan is absorbed and eliminated from the body (pharmacokinetics) when it is administered in combination with rifampicin. It will also be investigated to what extent…