6 results
This trial is, along with establishment of the safety, tolerability and pharmacokinetics and -dynamics of CDZ173 in the target population, designed to select the optimal dose to normalize the function of the PI3K protein in patients with APDS/PASLI…
The primary objectives of the study are as follow:1) To assess usability and adherence to a T2T strategy implemented through a digital e-health tool website (i.e. do physicians work through all aspects of the website and take part in all the T2T…
In this study we will investigate how safe the new compound leniolisib is and how well it is tolerated by healthy male participants.We also investigate how quickly and to what extent leniolisib is absorbed, transported, and eliminated from the body…
The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with…
In this study we will compare leniolisib as capsules with leniolisib as tablets. We compare this in terms of how quickly and to what extent each form of leniolisib is absorbed, transported, and eliminated from the body (this is called…
Objective Endpoint• To assess the clinical safety and tolerability of leniolisib in pediatric patients (aged 4 to 11 years) with APDS• Incidence of treatment-emergent AEs (TEAEs), SAEs, and AEs leading to discontinuation of study drug• Change from…