13 results
Primary objective: - To determine the feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to identify dysplasia and/or malignant lesions in patients with Barrett*s esophagus. - To evaluate the safety of EMI-…
Primary Objective:To describe the total apparent CYP3A mediated clearance (Cl/F) of midazolam in the paediatric intensive care population from the age of 0 to 6 years, as surrogate marker of intestinal and hepatic CYP3A activity.Secondary Objectives…
The primary objective of this study is to determine the safety and feasibility of fluorescence molecular endoscopy using the fluorescent tracer bevacizumab-800CW for identification of pathological complete response after neoadjuvant…
PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…
The aim of this study is to determine whether LNP023 is effective and safe for the treatment of PNH. LNP023 is compared to the Standard of Care (SOC) anti-C5 antibody treatment. The primary objectives are to:• Demonstrate superiority of LNP023…
The primary objective of this study is to determine the feasibility and safety of quantitative fluorescence endoscopy using the fluorescent tracer durvalumab-680LT to get insight in the PD-L1 expression before and after neoadjuvant therapy in…
The primary objective of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, andefficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).
To evaluate the efficacy of ravulizumab compared with placebo to reduceproteinuria in adult participants with LN or IgAN.
Main objective:To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) profile.Secondary objectives:• To assess the efficacy of…
Part 1 - To determine the efficacy of oral BCX9930 monotherapy administered for 24 weeks, compared to continued complement component 5 (C5) inhibitor therapy, in subjects with paroxysmal nocturnal hemoglobinuria (PNH) with an inadequate response to…
To assess the efficacy of ravulizumab versus placebo in the treatment of adult and adolescent participants with HSCT-TMA.
The primary objective of this pilot intervention study is to gain insight into vedolizumab distribution and to identify vedolizumab target cells in the inflamed gut, by performing in- and ex-vivo imaging using a tracer consisting of fluorescently…
Primary:To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in…