Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

November 30, 2007

Study Completion Date

November 30, 2007

Conditions
Primary ImmunodeficiencyCommon Variable HypogammaglobulinemiaX-linked HypogammaglobulinemiaHypogammaglobulinemiaImmunodeficiency With Hyper-IgMWiskott-Aldrich Syndrome
Interventions
BIOLOGICAL

Gammaplex (Intravenous immunoglobulin)

GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously for 12 months.

Trial Locations (7)

14222

Childrens Hospital at Buffalo, Allergy Division, Buffalo

30342

Family Allergy and Asthma Center PC, Atlanta

33408

Allergy Associates of the Palm Beaches, North Palm Beach

60612

Rush University Medical Centre, University Consultants in Allergy & Immunology, Chicago

75063

Allergy, Asthma & Immunology Clinic, P.A., Irving

UCLA Medical Centre, Irving

989109-5235

University of Washington School of Medicine, Dept. of Pediatrics, Seattle

Sponsors
All Listed Sponsors
lead

Bio Products Laboratory

OTHER