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

Hepatitis B Virus Associated Liver Disease Clinical Trial

Official title: Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus Associated Liver Disease
• Liver Diseases

• NCT number: NCT01421212
• Study type: Interventional
• Source: Biotest Pharmaceuticals Corporation
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1999
• Completion date: February 2002