30
Participants
Start Date
November 30, 1999
Primary Completion Date
February 28, 2002
Study Completion Date
February 28, 2002
Hepatitis B Immune Globulin (Boca HBVIg)
"Phase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses).~Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study."
Mount Sinai Medical Center, New York
New York-Presbyterian Hospital Columbia-Presbyterian Medical Center, New York
Medical College of Virginia Commenwealth University, Richmond
The University of North Carolina Hospitals, Chapel Hill
Mayo Clinic Jacksonville, Jacksonville
University of Florida, Gainesville
Jackson Memorial Hospital / University of Miami, Miami
The University of Michigan Health System, Ann Arbor
Rochester Methodist Hospital, Rochester
Rush-Presbyterian - St. Luke's Medical Center, Chicago
University of California, San Francisco, San Francisco
Lead Sponsor
Biotest Pharmaceuticals Corporation
INDUSTRY