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

Biotest

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatitis B Virus Associated Liver Disease

Treatments

Biological: Hepatitis B Immune Globulin (Boca HBVIg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01421212

Nabi-4204

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be 18 years old or greater, either male or female, of any ethnic background.
Be positive for HBsAg. Patients may be either positive or negative for anti-HDV, HBeAg, and HBV DNA (non-PCR assay).
Be diagnosed with HBV-induced liver disease including either:
HBsAg positive cirrhosis, or
HBsAg positive and presence of hepatocellular carcinoma (HCC) with no evidence of vascular invasion or extrahepatic spread, and either:
a single tumor no larger than 5 cm in diameter, or
no more than three tumors, the largest of which is no greater than 3 cm in diameter.
Have received at least one dose of Lamivudine 100 mgs po qd prior to transplantation.
Fulfill UNOS minimal listing criteria.
Have received approval for liver transplantation at the respective participating center and are listed as Status 2 or 3 and felt to be within three months of liver transplantation.
If requiring retransplantation for primary graft nonfunction or hepatic artery thrombosis, retransplantation must take place within the first four weeks of the initial transplant with no evidence of recurrent hepatitis B.
Be able and willing to give written informed consent. In patients with Grade 3 or 4 hepatic encephalopathy, a legal guardian must be available to provide consent. In the case of a minor, a parent or guardian must provide consent.
If a woman of childbearing potential, have a negative serum beta HCG pregnancy test within 14 days prior to starting Lamivudine therapy and within 14 days prior to transplant and agree to practice contraception during the study (a total of 36 weeks).

Exclusion criteria

Eligible patients must not:
Require retransplantation for recurrent hepatitis B.
Have chronic hepatitis B liver disease with a history of breakthrough infection on Lamivudine
Have other causes of liver disease including chronic hepatitis C.
Have HCC and do not meet Inclusion Criterion #3, or who require systemic chemotherapy.
Be seropositive for HIV infection.
Be using experimental devices or receiving experimental drugs.
Be participating in any other clinical treatment trial with an investigational drug within 30 days prior to liver transplantation or plan to receive another investigational drug during this study.