A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases

PHASE3CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Primary Immunodeficiency Diseases
Interventions
BIOLOGICAL

NewGam

The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as minimum trough levels of serum immunoglobulin G (IgG) was above 5 g/L. If serum IgG trough levels 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 (7)

63104

Dr. Alan Knutsen, St Louis

Unknown

Sudir Gupta, MD, Irvine

Isaac Melamed, MD, Centennial

James Moy, MD, Chicago

William Smits, MD, Fort Wayne

Ai Lan Kobayashi, MD, Papillion

Hans Ochs, MD, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Octapharma

INDUSTRY