21
Participants
Start Date
May 31, 2011
Primary Completion Date
September 30, 2012
Study Completion Date
September 30, 2012
NewGam
The initial dose and dosing interval for each participant was the dose and dosing interval the participant received at the end of the NGAM-01 study. The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as the minimum trough level of serum immunoglobulin G (IgG) was above 5 g/L. If the serum IgG trough level dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.
University of California Irvine, Irvine
Immunoe Research Center, Centennial
Rush Universtity Medical Center, Chicago
Cardinal Glennon Children's Hospital, St Louis
Midlands Pediatrics, Papillion
Seattle Children's Hospital, Seattle
Lead Sponsor
Octapharma
INDUSTRY