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

Completed · Phase 1/Phase 2

Conditions studied: Hepatitis B Virus Associated Liver Disease

In brief

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.

Key facts

Study ID

NCT01421212

Run by

Biotest Pharmaceuticals Corporation

People needed

30

Starts

1999-11-01

Expected to finish

2002-02-01

Last updated by the study team

2019-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Jackson Memorial Hospital / University of Miami — Miami, Florida, United States
• Rush-Presbyterian - St. Luke's Medical Center — Chicago, Illinois, United States
• The University of Michigan Health System — Ann Arbor, Michigan, United States
• Rochester Methodist Hospital — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• New York-Presbyterian Hospital Columbia-Presbyterian Medical Center — New York, New York, United States
• The University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Medical College of Virginia Commenwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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