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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421212
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : January 22, 2019
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Associated Liver Disease Biological: Hepatitis B Immune Globulin (Boca HBVIg) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine
Study Start Date : November 1999
Actual Primary Completion Date : February 2002
Actual Study Completion Date : February 2002

Intervention Details:
  • Biological: Hepatitis B Immune Globulin (Boca HBVIg)

    Phase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses).

    Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study.

    Other Names:
    • Nabi-HB
    • HepaGam B
    • Hepatitis B Immune Globulin
    • HBIG

Primary Outcome Measures :
  1. Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.
  2. Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation.

Secondary Outcome Measures :
  1. Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421212

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Jackson Memorial Hospital / University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Rush-Presbyterian - St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Michigan
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Rochester Methodist Hospital
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
New York-Presbyterian Hospital Columbia-Presbyterian Medical Center
New York, New York, United States, 10032
United States, North Carolina
The University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
United States, Virginia
Medical College of Virginia Commenwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Biotest Pharmaceuticals Corporation
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Principal Investigator: Rolland C. Dickson, M.D. Mayo Clinic
Principal Investigator: Norah A. Terrault, M.D., MPH University of California, San Francisco, CA
Principal Investigator: Donald Jensen, M.D. Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
Principal Investigator: Terence Angtuaco, M.D. Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
Principal Investigator: Patricia Sheiner, M.D. Mount Sinai Medical Center, New York, NY
Principal Investigator: Velimir A. Luketic, M.D. Virginia Commonwealth University, Richmond, VA
Principal Investigator: Michael Fried, M.D. University of North Carolina, Chapel Hill, NC
Principal Investigator: Robert S. Brown, M.D., MPH Columbia-Presbyterian Medical Center, New York, NY
Principal Investigator: Michael Ishitani, M.D. Rochester Methodist Hospital, Rochester, MN
Principal Investigator: Consuelo Soldevila-Pico, M.D. University of Florida
Principal Investigator: Anna Lok, M.D. University of Michigan, Ann Arbor, MI
Principal Investigator: Rajender Reddy, M.D. University of Miami, Miami, FL
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Responsible Party: Biotest Pharmaceuticals Corporation Identifier: NCT01421212    
Other Study ID Numbers: Nabi-4204
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: August 2011
Keywords provided by Biotest Pharmaceuticals Corporation:
Liver Transplantation
Liver Disease
Hepatitis B
Hepatitis B Infection
Hepatitis B Associated Liver Disease
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs