3 results
Approved WMOCompleted
Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…
Approved WMOCompleted
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…
Approved WMOCompleted
To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.