Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 1999

Primary Completion Date

February 28, 2002

Study Completion Date

February 28, 2002

Conditions
Hepatitis B Virus Associated Liver Disease
Interventions
BIOLOGICAL

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."

Trial Locations (11)

10029

Mount Sinai Medical Center, New York

10032

New York-Presbyterian Hospital Columbia-Presbyterian Medical Center, New York

23298

Medical College of Virginia Commenwealth University, Richmond

27599

The University of North Carolina Hospitals, Chapel Hill

32224

Mayo Clinic Jacksonville, Jacksonville

32610

University of Florida, Gainesville

33136

Jackson Memorial Hospital / University of Miami, Miami

48109

The University of Michigan Health System, Ann Arbor

55905

Rochester Methodist Hospital, Rochester

60612

Rush-Presbyterian - St. Luke's Medical Center, Chicago

94143

University of California, San Francisco, San Francisco

All Listed Sponsors
lead

Biotest Pharmaceuticals Corporation

INDUSTRY