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

This study is currently recruiting participants.

Verified July 2012 by Cangene Corporation

Sponsor:

Information provided by (Responsible Party):

Cangene Corporation

ClinicalTrials.gov Identifier:

NCT00722332

First received: July 23, 2008

Last updated: July 23, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 23, 2008

Last Updated Date

July 23, 2012

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pharmacokinetic profile of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00722332 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety and Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hepatitis B
Liver Transplantation

Intervention ^ICMJE

Biological: HepaGam B

Hepatitis B Immunoglobulin

Other Name: HepaGam B

Study Arm (s)

Experimental: 1

HBV-related liver transplant patients

Intervention: Biological: HepaGam B

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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 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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christine Hall, PhD	(204) 275-4248	chall@cangene.com
Contact: Priya Uppin, MSc	(204) 275 4531	puppin@cangene.com

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00722332

Other Study ID Numbers ^ICMJE

HB-009

Has Data Monitoring Committee

Responsible Party

Cangene Corporation

Study Sponsor ^ICMJE

Cangene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Cangene Corporation

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top