10 results
Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…
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…
To assess the normalization (reversal) of coagulation assays upon administration of two dosages of Prothrombin Complex Concentratre (PCC, Cofact®) in healthy volunteers treated with either rivaroxaban or apixaban
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
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 (…
To evaluate whether the efficacy in terms of progression free survival (PFS) of second-line tepotinib in combination with gefitinib is superior to pemetrexed+cisplatin/carboplatin in subjects with T790M negative, MET+ locally advanced or metastatic…
To test whether the clinical outcome of lower fixed dose of PCC is superior to higher variable dose of PCC, for VKA related bleeding in a randomized setting. Secondary objectives include the comparison of INR after administration of PCC, time to…
To investigate in a randomized controlled trial, whether giving Cofact pre-operatively can reduce the bloodloss and transfusion requirements during orthotopic liver transplantation. Also we investigate the safety of Cofact in this patient population…
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
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 (…