6 results
The study objectives are to determine the incidence rate of FVIII inhibitors, frequency of adverse events (AEs), and serious adverse events (SAEs) associated with the use of CSL627, to evaluate the PK of 50 IU/kg CSL627, and to evaluate the efficacy…
Aim of this study is to see if the use of an anti-adhesive medical device, the FlexiSurge, is safe to use against adhesions that arise after open abdominal surgery.
To evaluate the efficacy of rVIII-SingleChain in the treatment of major andminor bleeding events based on the investigator*s 4-point assessment scale
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 (…
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 (…