Abstract

Immunoglubulin for intravenous (IVIG) has been used for more than 15 years in patients with primary immunodeficiency diseases and has dramatically improved the health status of affected patients. In an effort to improve the quality, effectiveness, and safety of this product, IGIV-C, is purer than the previously licensed product, IGIV-S/D, more closely reflects the IgG subclass distribution found in plasma, and is treated with caprylate rather than solvent-detergent to inactivate viruses such as hepatitis. Preclinical analytical and in vivo animal models have demonstrated the similar physical, chemical and functional properties of IGIV-C to IGIV-S/D. This will be the first clinical trial to compare the pharmacokinetics and safety profile of IGIV-C with IGIV-S/D in patients with primary humoral immune deficiency.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000037-41
Application #
6416883
Study Section
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
41
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
University of Washington
Department
Type
DUNS #
135646524
City
Seattle
State
WA
Country
United States
Zip Code
98195

  Publications

Courcoulas, Anita P; King, Wendy C; Belle, Steven H et al. (2018) Seven-Year Weight Trajectories and Health Outcomes in the Longitudinal Assessment of Bariatric Surgery (LABS) Study. JAMA Surg 153:427-434
Field, Alison E; Inge, Thomas H; Belle, Steven H et al. (2018) Association of Obesity Subtypes in the Longitudinal Assessment of Bariatric Surgery Study and 3-Year Postoperative Weight Change. Obesity (Silver Spring) 26:1931-1937
O'Rourke, Robert W; Johnson, Geoffrey S; Purnell, Jonathan Q et al. (2018) Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes. Int J Obes (Lond) :
Cherrier, M M; Cross, D J; Higano, C S et al. (2018) Changes in cerebral metabolic activity in men undergoing androgen deprivation therapy for non-metastatic prostate cancer. Prostate Cancer Prostatic Dis 21:394-402
Duggan, Catherine; Baumgartner, Richard N; Baumgartner, Kathy B et al. (2018) Genetic variation in TNF?, PPAR?, and IRS-1 genes, and their association with breast-cancer survival in the HEAL cohort. Breast Cancer Res Treat 168:567-576
Han, Seung Jin; Boyko, Edward J; Kim, Soo Kyung et al. (2018) Association of Thigh Muscle Mass with Insulin Resistance and Incident Type 2 Diabetes Mellitus in Japanese Americans. Diabetes Metab J 42:488-495
Wander, Pandora L; Hayashi, Tomoshige; Sato, Kyoko Kogawa et al. (2018) Design and validation of a novel estimator of visceral adipose tissue area and comparison to existing adiposity surrogates. J Diabetes Complications 32:1062-1067
Purnell, Jonathan Q; Johnson, Geoffrey S; Wahed, Abdus S et al. (2018) Prospective evaluation of insulin and incretin dynamics in obese adults with and without diabetes for 2 years after Roux-en-Y gastric bypass. Diabetologia 61:1142-1154
King, Wendy C; Hinerman, Amanda S; Belle, Steven H et al. (2018) Comparison of the Performance of Common Measures of Weight Regain After Bariatric Surgery for Association With Clinical Outcomes. JAMA 320:1560-1569
Han, Seung Jin; Fujimoto, Wilfred Y; Kahn, Steven E et al. (2018) Change in visceral adiposity is an independent predictor of future arterial pulse pressure. J Hypertens 36:299-305

Showing the most recent 10 out of 563 publications