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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01421212
First received: August 18, 2011
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Hepatitis B Virus (HBV) Associated Liver Disease.
Biological: Hepatitis B Immune Globulin (Boca HBVIg)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biotest Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation. [ Designated as safety issue: No ]
  • Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine. [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 1999
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421212

Locations
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
Investigators
Principal Investigator: Rolland C. Dickson, M.D. Mayo Clinic, Jacksonville, FL
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
  More Information

No publications provided

Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01421212     History of Changes
Other Study ID Numbers: Nabi-4204
Study First Received: August 18, 2011
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biotest Pharmaceuticals Corporation:
Liver Transplantation
Liver Disease
Hepatitis B
Hepatitis B Infection
Hepatitis B Associated Liver Disease
HBV

Additional relevant MeSH terms:
Hepatitis
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
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014