High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)

PHASE3CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Primary Immunodeficiency Disease
Interventions
BIOLOGICAL

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.

Trial Locations (6)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY