8 results
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 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…
The main objective of this open-label, randomized clinical trial is to asses whether patient-controlled analgesia with remifentanil is more efficious and equally safe as pethidine as analgesic strategy during ultrasound-guided transvaginal oocyte…
To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
To investigate if there is a clinically important different effect of atropine on haemodynamic variables, tissue oxygenation or microcirculation during anaesthesia with either sufentanil and propofol or with remifentanil and propofol.
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated…
Primary:To assess the non-inferiority of the sedative properties of continuous intravenous (i.v.) clonidine compared to continuous i.v. midazolam in mechanically ventilated children and adolescents (0 - <18 years) admitted to a paediatric…
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…