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

Summary

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.

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.

Sponsors & Collaborators

• Biotest Pharmaceuticals Corporation

  lead INDUSTRY

Principal Investigators

• Rolland C. Dickson, M.D. · Mayo Clinic

• Norah A. Terrault, M.D., MPH · University of California, San Francisco, CA

• Donald Jensen, M.D. · Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL

• Terence Angtuaco, M.D. · Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL

• Patricia Sheiner, M.D. · Mount Sinai Medical Center, New York, NY

• Velimir A. Luketic, M.D. · Virginia Commonwealth University, Richmond, VA

• Michael Fried, M.D. · University of North Carolina, Chapel Hill, NC

• Robert S. Brown, M.D., MPH · Columbia-Presbyterian Medical Center, New York, NY

• Michael Ishitani, M.D. · Rochester Methodist Hospital, Rochester, MN

• Consuelo Soldevila-Pico, M.D. · University of Florida

• Anna Lok, M.D. · University of Michigan, Ann Arbor, MI

• Rajender Reddy, M.D. · University of Miami, Miami, FL

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-11-30

Primary Completion

2002-02-28

Completion

2002-02-28

Countries

• United States

Study Locations