Clinical trial NCT01421212: 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
Official title: Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis B Virus Associated Liver Disease
Keywords: Liver Transplantation
Liver Disease
Hepatitis B
Hepatitis B Infection
Hepatitis B Associated Liver Disease
HBV
Lead sponsor: Biotest Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.
measure: Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation.
Secondary outcomes:
measure: Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital / University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush-Presbyterian - St. Luke's Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: The University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Rochester Methodist Hospital
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital Columbia-Presbyterian Medical Center
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina Hospitals
state: North Carolina
city: Richmond
country: United States
facility: Medical College of Virginia Commenwealth University
state: Virginia
Study officials:
affiliation: Mayo Clinic
name: Rolland C. Dickson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco, CA
name: Norah A. Terrault, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
name: Donald Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
name: Terence Angtuaco, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Medical Center, New York, NY
name: Patricia Sheiner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University, Richmond, VA
name: Velimir A. Luketic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill, NC
name: Michael Fried, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia-Presbyterian Medical Center, New York, NY
name: Robert S. Brown, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rochester Methodist Hospital, Rochester, MN
name: Michael Ishitani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Consuelo Soldevila-Pico, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan, Ann Arbor, MI
name: Anna Lok, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami, Miami, FL
name: Rajender Reddy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: