NCT00722332CompletedPhase 4
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Cangene Corporation16 sites in 2 countries9 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 16
- Primary Endpoint
- Efficacy of HepaGam B in combination with antiviral therapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- 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
Outcomes
Primary Outcomes
Efficacy of HepaGam B in combination with antiviral therapy
Time Frame: 15 month follow-up
Secondary Outcomes
- Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy(15 month follow-up)
Investigators
Study Sites (16)
Loading locations...
Similar Trials
Completed
Not Applicable
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110EChronic Hepatitis BNCT01813487Genexine, Inc.6
Completed
Phase 2
Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast CancerBreast CancerNCT00670982Harold J. Burstein, MD, PhD29
Completed
Phase 2
Herombopag Added to Cyclosporine in Non Severe Aplastic AnemiaNon Severe Aplastic AnemiaUntreatedNCT05660785Institute of Hematology & Blood Diseases Hospital, China54
Completed
Phase 2
A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.Colorectal CancerNCT01159171Hoffmann-La Roche50
Unknown
Phase 2
Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCLExtranodal NK/T-cell LymphomaNCT04337593Beijing Tongren Hospital20