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

January 17, 2019 updated by: Biotest Pharmaceuticals Corporation

Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital / University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian - St. Luke's Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Rochester Methodist Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10032
        • New York-Presbyterian Hospital Columbia-Presbyterian Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina Hospitals
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Medical College of Virginia Commenwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotest Pharmaceuticals Corporation

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi-4204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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