drugset / Trial / NCT01421212

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

NCT01421212 ↗

Phase 1/2 Completed 30 enrolled Biotest Pharmaceuticals Corporation
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
1999-11
Primary completion
2002-02
Completion
2002-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Boca HBVIg Protein / enzyme biologic 5000 iu Intravenous
Subject Boca HBVIg Protein / enzyme biologic 10000 iu Intravenous