5 results
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…
Primary objectives:* To explore the comparative bioavailability between 12.5 mg of Risperdal® Consta® prepared from a 25 mg dose strength of Risperdal® Consta® EU-sourced, and 12.5 mg of Risperdal® Consta® prepared from a 12.5 mg dose strength…
Primary: To evaluate the efficacy of tisagenlecleucel therapy as measured by overall response rate by investigator assessment.Secondary: Duration of response, event free survival, relapse free survival, overall survival, safety, kinetics,…
In this study we will investigate the pharmacodynamics of the compound Cofact, whereby the Cofact that will be used in this study is a modified version of the existing compound Cofact. The effect on the physiologic functions will be evaluated by…
To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease progression / stable disease at or after the week 12 assessment; or death at any time.