7 results
* The primary objective of this study is to investigate the effect of rifampicin on the pharmacokinetics (PK) of olaparib following oral dosing of the tablet formulation in patients with advanced solid tumours.* The secondary objectives are to…
To study the effect of alleviation of obstructive cholestasis by biliary drainage with or without rifampicin on serum bilirubin levels, quality of life, itch intensity, and serum and/or biliary bile salt, ATX, LPA, FGF-19 and biliary HCO3- levels in…
To assess the effectivity and safety of 1.0 molar gadobutrol (Gadovist®) for breast MRI
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
The objective of the trial is to assess the efficacy and safety of nintedanib in the treatment ofSSc with ILD at a dose of 150 mg bid compared to placebo.
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. Additional efficacy and safety endpoints will be collected to explore potential long-term effects.Please see…