4 results
CORE PERIODPrimary:* Evaluate the safety and tolerability of up to 24 weeks of AG-348 administration in patients with pyruvate kinase deficiency (PK deficiency).Secondary:* Evaluate the pharmacokinetics (PK) of AG-348 and the metabolite AGI-8702.*…
Primary Efficacy Objective The primary efficacy objective is to determine the long-term efficacy of NCAP (Neurostimulation of the Cholinergic Anti-inflammatory Pathway) delivered by the implanted device as assessed by the Crohn*s Disease Activity…
Primary Efficacy ObjectiveThe primary efficacy objective is to determine the effect of NCAP delivered by the implanted device on clinical signs and symptoms of Crohn*s disease, as assessed by the Crohn*s Disease Activity Index (CDAI)Secondary…
Primary Objective: The primary objective of this study is to assess lung volume measured by EIT and minute ventilation measured by the ventilator during CMV and FCV at the ICU. This will allow for an adequate powercalculation for future studies.…