5 results
The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…
Primary objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…
Primary objective:To assess the bioequivalence of single-dose velpatasvir administered as a fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) when given with cola + omeprazole 40mg (test 1/trt A) compared to velpatasvir…
The primary objective of this study is to evaluate the short term safety and tolerability, and pharmacokinetic properties of 2-IB when administered to adult patients after OHCA. Secondary objectives include safety and efficacy parameters at 30 days…
This study will be a prospective, placebo controlled, randomised phase 2 single centre study with the primary objective to evaluate the safety and tolerability of 2-IB when administered to patients with AIS due to LVO, treated with IVT and/or EVT.…