Abstract

This is a Phase II randomized blind, parallel group, multicenter, therapeutic equivalence trial. The Primary Immune Deficiency (PID) patients will be randomly assigned to one of the two treatment groups: experimental IGIV (IGIV-C, 10%) or control IGIV (IGIV-S/D, 10%). A total of 152 patients will be enrolled with a confirmed diagnosis of Primary Immune Deficiency and who are on stable IVUG replacement therapy for at least three months prior to entry into the trial. Nine infusions, with one of the study drugs, will be every three to four weeks for nine months. Patients will remain on the fixed individual replacement dose and dose interval established prior to entry into the study.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR012248-04
Application #
6408689
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1997-09-30
Project End
2001-11-30
Budget Start
Budget End
Support Year
4
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Albert Einstein College of Medicine
Department
Type
DUNS #
009095365
City
Bronx
State
NY
Country
United States
Zip Code
10461

  Publications

Ezzati, Ali; Katz, Mindy J; Lipton, Michael L et al. (2016) Hippocampal volume and cingulum bundle fractional anisotropy are independently associated with verbal memory in older adults. Brain Imaging Behav 10:652-9
Huang, Ying; Van Horn, Linda; Tinker, Lesley F et al. (2014) Measurement error corrected sodium and potassium intake estimation using 24-hour urinary excretion. Hypertension 63:238-44
Mossavar-Rahmani, Yasmin; Tinker, Lesley F; Huang, Ying et al. (2013) Factors relating to eating style, social desirability, body image and eating meals at home increase the precision of calibration equations correcting self-report measures of diet using recovery biomarkers: findings from the Women's Health Initiative. Nutr J 12:63
Esterson, Yonah B; Zhang, Kehao; Koppaka, Sudha et al. (2013) Insulin sensitizing and anti-inflammatory effects of thiazolidinediones are heightened in obese patients. J Investig Med 61:1152-60
Prentice, Ross L; Neuhouser, Marian L; Tinker, Lesley F et al. (2013) An exploratory study of respiratory quotient calibration and association with postmenopausal breast cancer. Cancer Epidemiol Biomarkers Prev 22:2374-83
Wylie-Rosett, Judith; Aebersold, Karin; Conlon, Beth et al. (2013) Health effects of low-carbohydrate diets: where should new research go? Curr Diab Rep 13:271-8
Cai, Guiqing; Atzmon, Gil; Naj, Adam C et al. (2012) Evidence against a role for rare ADAM10 mutations in sporadic Alzheimer disease. Neurobiol Aging 33:416-417.e3
Wang, Zhaoming; Parikh, Hemang; Jia, Jinping et al. (2012) Y chromosome haplogroups and prostate cancer in populations of European and Ashkenazi Jewish ancestry. Hum Genet 131:1173-85
Kenny, Eimear E; Pe'er, Itsik; Karban, Amir et al. (2012) A genome-wide scan of Ashkenazi Jewish Crohn's disease suggests novel susceptibility loci. PLoS Genet 8:e1002559
Kehlenbrink, S; Koppaka, S; Martin, M et al. (2012) Elevated NEFA levels impair glucose effectiveness by increasing net hepatic glycogenolysis. Diabetologia 55:3021-8

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