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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

Primary Purpose

Hepatitis B Virus Associated Liver Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hepatitis B Immune Globulin (Boca HBVIg)

About this trial

This is an interventional prevention trial for Hepatitis B Virus Associated Liver Disease focused on measuring Liver Transplantation, Liver Disease, Hepatitis B, Hepatitis B Infection, Hepatitis B Associated Liver Disease, HBV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California, San Francisco
University of Florida
Mayo Clinic Jacksonville
Jackson Memorial Hospital / University of Miami
Rush-Presbyterian - St. Luke's Medical Center
The University of Michigan Health System
Rochester Methodist Hospital
Mount Sinai Medical Center
New York-Presbyterian Hospital Columbia-Presbyterian Medical Center
The University of North Carolina Hospitals
Medical College of Virginia Commenwealth University

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT01421212

First Posted

August 18, 2011

Last Updated

January 17, 2019

Sponsor

Biotest Pharmaceuticals Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01421212

Brief Title

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

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

November 1999 (undefined)

Primary Completion Date

February 2002 (Actual)

Study Completion Date

February 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotest Pharmaceuticals Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B Virus Associated Liver Disease

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Hepatitis B Immune Globulin (Boca HBVIg)

Other Intervention Name(s)

Nabi-HB, HepaGam B, Hepatitis B Immune Globulin, HBIG

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.

Title

Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation.

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: