62
Participants
Start Date
September 30, 2003
Primary Completion Date
December 31, 2006
Study Completion Date
December 31, 2006
Omr-lgG-am
Omr-IgG-am™ 5% is provided in 100 ml bottles (5.0 grams) as a sterile solution containing 5% protein, 10% maltose and water for injection. This product is licensed in Israel, but not in the US.
Polygam® S/D
Polygam® S/D is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. When reconstituted (5%) with the supplied diluent (sterile water for injection, USP) Polygam® S/D contains approximately 50mg of protein per ml (approximately 90% is gamma globulin); 3mg/ml human albumin, 22.5 mg/ml glycine, 20 mg/ml glucose, 2mlg/ml polyethylene glycol (PEG), 1 mcg/ml tri-nbutyl phosphate, 1 mcg/ml octoxynol 9, and 100 mcg/ml polysorbate 80.
Placebo
Normal Saline.
Flushing Hospital Medical Center, Flushing
Lehigh Valley Hospital, Allentown
The Reading Hospital and Medical Center, West Reading
George Washington University Medical Center, Washington D.C.
Johns Hopkins University, Baltimore
University of Virginia, Charlottesville
University of South Alabama Medical Center, Mobile
Vanderbilt University, Nashville
University of Toledo, Toledo
University Hospitals of Cleveland, Cleveland
University Hospital, Cincinnati
Wright-Patterson Medical Center, Wright-Patterson AFB
University of Michigan, Ann Arbor
Wayne State University, Detroit
Avera Research Institute, Sioux Falls
Infectious Disease Consultations - Rapid City, Rapid City
Dakota Clinic at Innovis, Fargo
MeritCare Hospital, Fargo
St. Alexius Medical Center, Bismarck
Trinity Health - Hospital, Minot
Mercury Street Medical Group, Butte
Infectious Disease Specialists, PC, Missoula
Loyola University, Maywood
Saint Louis University, St Louis
University of Kansas Medical Center, Kansas City
Via Christi Regional Medical Center, Wichita
VA Medical Center - Omaha, Omaha
Creighton University, Omaha
Central Nebraska Medical Clinic, Broken Bow
McCook Clinic, PC, McCook
Great Plains Regional Medical Center, North Platte
Tulane University, New Orleans
University of Arkansas, Little Rock
The University of Texas Health Science Center at Tyler, Tyler
The University of Texas Health Science Center at Houston, Houston
Wilford Hall Medical Center, San Antonio
Exempla St. Joseph Hospital, Denver
University of Colorado, Denver
Idaho Falls Infectious Diseases, PLLC, Idaho Falls
St. Joseph's Hospital and Medical Center, Phoenix
Mayo Clinic Hospital, Phoenix
University of Arizona Health Sciences Center, Tucson
University of New Mexico, Albuquerque
University of Southern California, Los Angeles
Kaiser Permanente South Bay Medical Center, Harbor City
City of Hope National Medical Center, Duarte
Seton Medical Center, Daly City
University of California San Francisco, San Francisco
California Pacific Medical Center, San Francisco
Santa Rosa Kaiser Medical, Santa Rosa
University of California Davis Medical Center, Sacramento
Enloe Medical Center, Chico
Legacy Good Samaritan, Portland
University of Alabama at Birmingham, Birmingham
University of California Irvine, Orange
Indiana University, Indianapolis
University of Kentucky, Lexington
National Institutes of Health, Bethesda
Washington University in St. Louis, St Louis
University of Nebraska Medical Center, Omaha
Clara Maass Medical Center, Belleville
Memorial Hospital of RI, Pawtucket
Rhode Island Hospital, Providence
The University of Texas Southwestern Medical Center, Dallas
The University of Texas Medical Branch, Galveston
The University of Texas Health Science Center, San Antonio
University of Calgary, Calgary
University of Alberta, Edmonton
University of Manitoba, Winnipeg
National Institute of Allergy and Infectious Diseases (NIAID)
NIH