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CompletedNCT00722332Updated Nov 1, 2013

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

A Phase 4 interventional study of HepaGam B in Hepatitis B and Liver Transplantation, sponsored by Cangene Corporation. Completed at 16 sites in 2 countries. Per ClinicalTrials.gov, last updated 2013-11-01.

Sponsored by Cangene Corporation · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis B
  • Liver Transplantation

Keywords

  • HBIG (Hepatitis B Immune Globulin)
  • Chronic Hepatitis B Recurrence
  • Liver Transplant
03

In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 9 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Cangene Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    1

    HBV-related liver transplant patients

    Biological: HepaGam B

Interventions

  • BiologicalHepaGam B

    Hepatitis B Immunoglobulin

06

What researchers measure

Primary outcomes

  1. Efficacy of HepaGam B in combination with antiviral therapy

    Time frame: 15 month follow-up

Secondary outcomes

  1. Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy

    Time frame: 15 month follow-up

07

Study locations

16 sites
  • Los Angeles, California 90033, United States
  • Los Angeles, California 90095, United States
  • Palo Alto, California 94304, United States
  • Atlanta, Georgia 30322, United States
  • Chicago, Illinois 60611, United States
  • Burlington, Massachusetts 01805, United States
  • Minneapolis, Minnesota 55455, United States
  • Newark, New Jersey 07101, United States
  • New York, New York 10016, United States
  • New York, New York 10029, United States
  • New York, New York 10032, United States
  • Cleaveland, Ohio 44195, United States
  • Pittsburgh, Pennsylvania 15213, United States
  • Dallas, Texas 75246, United States
  • Houston, Texas 77030, United States
  • Montreal, Quebec H2X3J4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00722332
Lead sponsor
Cangene Corporation
Responsible party
Sponsor
First posted
Jul 25, 2008
Start date
Feb 2008
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Nov 1, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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