4 results
To assess the effectivity and safety of 1.0 molar gadobutrol (Gadovist®) for breast MRI
Part 1:- To assess the PK of a single iv microdose (<=30 nmol) of recombinant human placental alkaline phosphatase (hRESCAP);- To assess if microdosing is a suitable technique to predict the PK of recombinant proteins using hRESCAP as model…
Main objective:To assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis (LN)Secondary objective:To assess the safety and tolerability of Orelvo…
Primary Objective* To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. Secondary Objectives* To assess the…