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
Information source: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B Virus (HBV) Associated Liver Disease.
Intervention: Hepatitis B Immune Globulin (Boca HBVIg) (Biological)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Biotest Pharmaceuticals Corporation Official(s) and/or principal investigator(s):
Rolland C. Dickson, M.D., Principal Investigator, Affiliation: Mayo Clinic, Jacksonville, FL
Norah A. Terrault, M.D., MPH, Principal Investigator, Affiliation: University of California, San Francisco, CA
Donald Jensen, M.D., Principal Investigator, Affiliation: Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
Terence Angtuaco, M.D., Principal Investigator, Affiliation: Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
Patricia Sheiner, M.D., Principal Investigator, Affiliation: Mount Sinai Medical Center, New York, NY
Velimir A. Luketic, M.D., Principal Investigator, Affiliation: Virginia Commonwealth University, Richmond, VA
Michael Fried, M.D., Principal Investigator, Affiliation: University of North Carolina, Chapel Hill, NC
Robert S. Brown, M.D., MPH, Principal Investigator, Affiliation: Columbia-Presbyterian Medical Center, New York, NY
Michael Ishitani, M.D., Principal Investigator, Affiliation: Rochester Methodist Hospital, Rochester, MN
Consuelo Soldevila-Pico, M.D., Principal Investigator, Affiliation: University of Florida
Anna Lok, M.D., Principal Investigator, Affiliation: University of Michigan, Ann Arbor, MI
Rajender Reddy, M.D., Principal Investigator, Affiliation: University of Miami, Miami, FL
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.
Clinical Details
Official title: Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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: Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of California, San Francisco, San Francisco, California 94143, United States
University of Florida, Gainesville, Florida 32610, United States
Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States
Jackson Memorial Hospital / University of Miami, Miami, Florida 33136, United States
Rush-Presbyterian - St. Luke's Medical Center, Chicago, Illinois 60612, United States
The University of Michigan Health System, Ann Arbor, Michigan 48109, United States
Rochester Methodist Hospital, Rochester, Minnesota 55905, United States
Mount Sinai Medical Center, New York, New York 10029, United States
New York-Presbyterian Hospital Columbia-Presbyterian Medical Center, New York, New York 10032, United States
The University of North Carolina Hospitals, Chapel Hill, North Carolina 27599, United States
Medical College of Virginia Commenwealth University, Richmond, Virginia 23298, United States
Additional Information
Starting date: November 1999
Last updated: August 19, 2011
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