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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Boca HBVIg | Protein / enzyme biologic | 5000 iu | Intravenous |
| Subject | Boca HBVIg | Protein / enzyme biologic | 10000 iu | Intravenous |