8 results
The main objective of this study is to define the optimal dose of fluorescent tracer for intraoperative detection of tumor delineation during breast cancer surgery.
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
Primary objectives -To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor…
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The study will be performed in 2 parts, Part 1 and Part 2. Part 2 has been clinically completed. The remainder of this document concerns Part 1 only. The purpose of Part 1 of this study is to determine the reversal of the blood thinning effects of…
- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689
Image guided surgery in sinonasal inverted papilloma by targeting vascular endothelial growth factor
The main objective is to study if the conjugate bevacizumab-IRDye800CW accumulates more in sinonasal inverted papilloma than in normal sinonasal mucosa, with a TBR of *2 as cutoff value.
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…