Skip to main content
OpenTrials
Completed

NCT Number: NCT00722332

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Liver Transplantation Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HepaGam B

Biological

Hepatitis B Immunoglobulin

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

Sponsors and collaborators

Lead sponsor

Cangene Corporation

Industry

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2008
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.