Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

October 30, 2013 updated by: Cangene Corporation
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X3J4
  • United States
    • California
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90033
      • Palo Alto, California, United States, 94304
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • New Jersey
      • Newark, New Jersey, United States, 07101
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
      • New York, New York, United States, 10029
    • Ohio
      • Cleaveland, Ohio, United States, 44195
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77030

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • HBsAg-positive candidates for HBV-related liver transplant
  • Treatment with antiviral therapy before transplantation as per treating physician's recommendation. (NOTE: It is expected that most patients will receive Lamivudine or Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)

Exclusion Criteria:

  • Multi-organ transplantation recipients
  • Liver re-transplantation except for primary non-function
  • Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at baseline visit (CT scan, MRI).
  • Patients requiring an OLT (Orthotopic Liver Transplant)due to fulminant hepatitis B
  • OLT patients receiving a liver graft from a donor that is positive for HBsAg
  • Patients using interferon pre-transplant (as interferon cannot be used post-transplant)
  • History of IgA (immunoglobulin A) deficiency
  • History of hypersensitivity to blood products.
  • HIV or HCV positive
  • Use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
  • Pregnancy or planned pregnancy during the course of the 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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
HBV-related liver transplant patients
Biological: HepaGam B
Hepatitis B Immunoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of HepaGam B in combination with antiviral therapy
Time Frame: 15 month follow-up
15 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy
Time Frame: 15 month follow-up
15 month follow-up

Collaborators and Investigators

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

Sponsor

Cangene Corporation

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

February 1, 2008

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB-009

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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