5 results
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
to investigate the safety and efficacy of idarucizumab in reversing the anticoagulation effect of dabigatran, in patients who have uncontrolled bleeding or require emergency surgery or invasive procedures.
Primary (Cohort 1)* To compare the efficacy of zanubrutinib (BGB-3111) vs ibrutinib in subjects with MYD88MUT WMSecondary (Cohort 1) * To further compare the efficacy, clinical benefit, and anti-lymphoma effects of BGB-3111 vs ibrutinib in subjects…