Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
This study has been completed.
Sponsor:
Cangene Corporation
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT00722332
First received: July 23, 2008
Last updated: October 30, 2013
Last verified: October 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Liver Transplantation |
Biological: HepaGam B |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients |
Resource links provided by NLM:
Further study details as provided by Cangene Corporation:
Primary Outcome Measures:
- Efficacy of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | February 2008 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
HBV-related liver transplant patients
|
Biological: HepaGam B
Hepatitis B Immunoglobulin
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722332
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722332
Locations
| 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 | |
Sponsors and Collaborators
Cangene Corporation
More Information
| Responsible Party: | Cangene Corporation |
| ClinicalTrials.gov Identifier: | NCT00722332 History of Changes |
| Other Study ID Numbers: | HB-009 |
| Study First Received: | July 23, 2008 |
| Last Updated: | October 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cangene Corporation:
|
HBIG (Hepatitis B Immune Globulin) Chronic Hepatitis B Recurrence Liver Transplant |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Antiviral Agents Immunoglobulins Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016