8 results
The primary objective is to measure the frequency of unexpected critical errors* of the Accu-Chek Combo® encountered during everyday normal use. (*Unexpected critical errors are device related events that may result in an adverse or serious adverse…
Primary Objective: To determine the safety and efficacy of 6000 IU C1-INH in patients with subarachnoid hemorrhage (SAH)Primary hypothesis: The hypothesis is that random assignment to C1-INH in SAH will lead to a reduction in delayed cerebral…
Primary: To evaluate the long-term safety of repeated subcutaneous(SC) administrations of lanadelumab in adolescents and adults with nonhistaminergicangioedema with normal C1-INH
The purpose of this investigation is to confirm long-term clinical performance and safety of the InterStim Micro System. The primary objectives of the study will evaluate data at 3 months post-implant; however, subjects will be followed for 2 years…
Primary Objective: To determine the safety and efficacy of 6000 IU Cinryze in patients with moderate and severe TBI (GCS <13 with a clinical indication for ICP measurements).Primary hypothesis: The hypothesis is that random assignment to…
The objectives of this study:• To generate the proof of concept for lanadelumab for treatment of symptoms of COVID-19 disease • To demonstrate its safety after intravenous administration.
The aim of the present *proof-of-principle* study is to test in patients suffering from AIHA whether co-administration of C1-inh improves the recovery of RBC transfusion by the inhibition of the activation of the classical pathway of complement. In…
Primary: To evaluate the efficacy of repeated subcutaneous (SC) administrations of lanadelumab in preventing angioedema attacks in adolescents (12 to <18 years of age) and adults with non-histaminergic angioedema with normal C1-INH.Secondary…