5 results
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…
Primary ObjectiveThe primary objective is to compare the annualized rates of bleeding episodes (ABR)between subjects receiving a prophylactic regimen of BAX 855 with an on-demandtreatment regimen.Secondary ObjectivesThe key secondary objective is to…
Primary Objective:Part 1:- To determine the MTD and recommended phase 2 dose (RP2D) of avapritinib.- To determine the safety and tolerability of avapritinib.Part 2:* To determine the overall response rate (ORR) by RECIST criteria at the MTD/RP2D of…
The objective of this pilot study is to investigate if glucose measurement on the vaginal wall can be an alternative for capillary and subcutaneous glucose measurement. The present study will look at the efficacy of an intravaginal device to measure…
The objective of this pilot study is to investigate the efficiency of a glucose monitor device placed in a tear fluid of human eye to measure glucose for up to 6 hours and its correlation to blood glucose values. Additionally, more information will…