3 results
the objective of the current study is to evaluate the safety and efficacy of enzyme therapy in the Dutch population of patients with MPS I, II and VI; to compare this to the natural course of these diseases; to make an inventory of the direct and…
The primary objective is to show a difference in responder rates between the study product (T4020) and the vehicle : a reduction of 50% or more in keratitis/ulcer area from baseline (inclusion visit = V2 = Day 0) assessed at Day 28 (Visit 6).
Primary Study Objectives:Safety objective: assessment of procedure related mortality up to 30 days post-procedure.Performance objective: demonstration of the ability of Valvosoft to modify the structure of the calcified valve leaflets to improve…