399
Participants
Start Date
April 30, 2012
Primary Completion Date
October 31, 2019
Study Completion Date
June 30, 2021
CMV hyperimmune globulin
The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
Placebo
The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
Columbia University, New York
Magee Womens Hospital of UPMC, Pittsburgh
Hospital of the University of Pennsylvania, Philadelphia
University of North Carolina - Chapel Hill, Chapel Hill
Duke University, Durham
University of Alabama - Birmingham, Birmingham
Ohio State University, Columbus
Case Western Reserve-Metrohealth, Cleveland
Northwestern University, Chicago
University of Texas - Southwestern Medical Center, Dallas
University of Texas - Houston, Houston
University of Texas - Galveston, Galveston
University of Colorado Denver, Aurora
University of Utah Medical Center, Salt Lake City
Stanford University, Stanford
Brown University, Providence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER