Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Immunologic Deficiency Syndrome
Interventions
DRUG

Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™

IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.

Trial Locations (11)

23219

Children's Hospital of Richmond, Richmond

33408

Allergy Associates of the Palm Beaches, North Palm Beach

Rush University Medical Center, Chicago

35233

University of Alabama Hospital, Birmingham

43235

Optimed Research, LTD, Columbus

52242

University of Iowa Hospitals and Clinics, Iowa City

75230

Dallas Allergy Immunology, Dallas

75231

AARA Research Center, Dallas

98225

Bellingham Asthma, Allergy & Immunology Clinic, Bellingham

M4V1R2

Gordon Sussman Clinical Research Inc., Toronto

M5G1X8

The Hospital for Sick Children, Toronto

Sponsors
All Listed Sponsors
collaborator

Atlantic Research Group

OTHER

lead

Green Cross Corporation

INDUSTRY