The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to prevent hepatitis B reinfection following liver transplantation in patients with end stage liver failure due to hepatitis B infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
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.
University of California, San Francisco
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Jackson Memorial Hospital / University of Miami
Miami, Florida, United States
Rush-Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States
The University of Michigan Health System
Ann Arbor, Michigan, United States
Rochester Methodist Hospital
Rochester, Minnesota, United States
Mount Sinai Medical Center
New York, New York, United States
New York-Presbyterian Hospital Columbia-Presbyterian Medical Center
New York, New York, United States
The University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
...and 1 more locations
Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.
Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation.
Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.
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