Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00722332 |
Recruitment Status :
Completed
First Posted : July 25, 2008
Last Update Posted : November 1, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B Liver Transplantation | Biological: HepaGam B | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
HBV-related liver transplant patients
|
Biological: HepaGam B
Hepatitis B Immunoglobulin |
- Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ]
- Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722332
United States, California | |
Los Angeles, California, United States, 90033 | |
Los Angeles, California, United States, 90095 | |
Palo Alto, California, United States, 94304 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Burlington, Massachusetts, United States, 01805 | |
United States, Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New Jersey | |
Newark, New Jersey, United States, 07101 | |
United States, New York | |
New York, New York, United States, 10016 | |
New York, New York, United States, 10029 | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Cleaveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Dallas, Texas, United States, 75246 | |
Houston, Texas, United States, 77030 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H2X3J4 |
Responsible Party: | Cangene Corporation |
ClinicalTrials.gov Identifier: | NCT00722332 |
Other Study ID Numbers: |
HB-009 |
First Posted: | July 25, 2008 Key Record Dates |
Last Update Posted: | November 1, 2013 |
Last Verified: | October 2013 |
HBIG (Hepatitis B Immune Globulin) Chronic Hepatitis B Recurrence Liver Transplant |
Hepatitis A Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |