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

Information source: Cangene Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B; Liver Transplantation

Intervention: HepaGam B (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Cangene Corporation

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.

Clinical Details

Official title: Evaluation of HepaGam B in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients

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

Primary outcome: Efficacy of HepaGam B in combination with antiviral therapy

Secondary outcome: Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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 10032, United States

New York, New York 10029, United States

New York, New York 10016, United States

Cleaveland, Ohio 44195, United States

Pittsburgh, Pennsylvania 15213, United States

Montreal, Quebec H2X3J4, Canada

Dallas, Texas 75246, United States

Houston, Texas 77030, United States

Additional Information

Starting date: February 2008
Last updated: October 30, 2013

Page last updated: August 20, 2015

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