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

NCT01421212 | Completed Phase 1

• 1 other identifier: Nabi-4204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 11

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.

Conditions

Hepatitis B Virus Associated Liver Disease

Keywords

Liver Transplantation; Liver Disease; Hepatitis B; Hepatitis B Infection; Hepatitis B Associated Liver Disease; HBV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

Interventions

Hepatitis B Immune Globulin (Boca HBVIg) BIOLOGICAL

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.

Also known as: Nabi-HB, HepaGam B, Hepatitis B Immune Globulin, HBIG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biotest Pharmaceuticals Corporation: lead

Study Sites (11)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Jackson Memorial Hospital / University of Miami

Miami, Florida, 33136, United States

Location

Rush-Presbyterian - St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Rochester Methodist Hospital

Rochester, Minnesota, 55905, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

New York-Presbyterian Hospital Columbia-Presbyterian Medical Center

New York, New York, 10032, United States

Location

The University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Medical College of Virginia Commenwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Liver Diseases; Hepatitis B

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 22, 2011
• Study Start: November 1, 1999
• Primary Completion: February 1, 2002
• Study Completion: February 1, 2002
• Last Updated: January 22, 2019

Record last verified: 2011-08

Locations

US (11)