Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
IGIV-C, a novel intravenous immunoglobulin: Evaluation of safety, efficacy, mechanisms of action, and impact on quality of life
Thrombosis and Haemostasis, Volume 91, No. 4, Year 2004
Notification
URL copied to clipboard!
Description
The general safety and efficacy of intravenous immunoglobulin (IGIV) as treatment for idiopathic thrombocytopenic purpura (ITP) has been well-studied. The current study compares the safety and efficacy of a novel IGIV (IGIV-C; Gamunex®, 10%) with a licensed solvent/detergent-treated product (IGIV-S/D; Gamimune®N, 10%) in treatment of ITP. Ninety-seven pediatric and adult patients with acute and chronic ITP were treated in a multi-center, prospective, randomized, double-blind parallel group, non-inferiority trial at 26 international sites. Baseline data (age, duration of ITP, platelet counts, previous treatment) were comparable between groups. Patients were treated with 1 g/kg/day of IGIV-C or IGIV-S/D for 2 days. The primary endpoint, proportion of patients whose platelet counts increased from ≤20 × 109/L to ≥50 × 109/L within 7 days after dosing, was achieved by 35/39 (90%) and 35/42 (83%) of patients treated with IGIV-C and IGIV-S/D, respectively. A secondary endpoint, maintaining platelet counts ≥50 × 109/L for ≥7 days, was achieved by 29/39 (74%) of IGIV-C and 25/42 (60%) IGIV-S/D treated patients. Compared with IGIV-S/D, fewer patients treated with IGIV-C received corticosteroids beyond day 7 (p = 0.02). Efficacy was independent of the presence of isoantibodies or blood type, supporting mechanisms of effect different from anti-D treatments. Adverse events were generally mild and occurred with similar frequency in each group. Viral safety monitoring for HIV, HCV, HBV and Parvovirus B19 showed no seroconversions on study. In conclusion, IGIV-C is as safe and efficacious as IGIV-S/D in treatment of ITP. © 2004 Schattauer GmbH, Stuttgart.
Authors & Co-Authors
Bussel, James Bruce
United States, New York
New York Presbyterian Hospital
Eldor, Amiram
Israel, Tel Aviv-yafo
Tel Aviv Sourasky Medical Center
Kelton, John G.
Canada, Hamilton
Mcmaster University Medical Centre
Varon, David
Israel, Jerusalem
Hadassah University Medical Centre
Brenner, Benjamin R.
Israel, Haifa
Rambam Health Care Campus Israel
Gillis, Shmuel
Israel, Jerusalem
Hadassah University Medical Centre
Angiolillo, Anne
United States, Washington, D.c.
Childrens National Health System
Kulkarni, Roshni
United States, East Lansing
Michigan State University
Abshire, Thomas C.
United States, Atlanta
Emory University
Kelleher, Jack
United States, Whippany
Bayer Corporation, Usa
Luke, Kung Hung
Canada, Ottawa
Children's Hospital of Eastern Ontario, Ottawa
Whitlock, Pierre
Canada, Moncton
Oncology Centre
Richard, Leon
Canada, Moncton
Oncology Centre
Ritchie, Bruce C.
Canada, Edmonton
University of Alberta
Wilson, Jonathan
Canada, Toronto
Humber River Hospital
Warrier, Indira
United States, Detroit
Children's Hospital of Michigan
Cherrick, Irene
United States, Syracuse
Upstate Medical University Hospital
Blanchard, Kerry
United States, Shreveport
Lsu Health Sciences Center - Shreveport
Hall, Scott
United States, Stanford
Stanford Healthcare
Aledort, Louis M.
United States, New York
The Mount Sinai Medical Center
Kessler, Craig M.
United States, Washington, D.c.
Georgetown University Medical Center
Cooper, Herbert
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Gonzalez, M. Francisco
United States, Columbia
University of South Carolina
Owen, William
United States, Norfolk
Children's Hospital of the King's Daughters Health System
Blayney, Douglas W.
United States, Pomona
Wilshire Oncology Medical Group
Bodensteiner, David
United States, Kansas City
University of Kansas Medical Center
Karabus, Cyril D.
South Africa, Cape Town
Red Cross War Memorial Children's Hospital
Vaithilingum, Manickavallie
South Africa, Durban
Addington Hospital
Statistics
Citations: 53
Authors: 28
Affiliations: 26
Identifiers
Doi:
10.1160/th03-10-0650
ISSN:
03406245
Research Areas
Disability
Infectious Diseases
Study Design
Cohort Study