7 results
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…
This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…
to investigate the safety and tolerability of pirfenidone in asbestosis patients
Primary: To assess the safety profile of selnoflast compared with that of placeboSecondary: - To evaluate the efficacy of selnoflast compared with that of placebo- To assess the pharmacokinetic properties of selnoflast and metabolite(s) as…
The objective of the study is to assess the safety and tolerability, and to characterize the pharmacokinetics (PK) and pharmacodynamics (e.g., Cerebrospinal fluid [CSF] levels of IL-1β, TSPO positron emission tomography [PET] imaging) of selnoflast…
The primary objective is to compare the objective response rate (ORR) per Response Assessment in Neuro Oncology (RANO) criteria assessed by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy in…