Back to resultsProphylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
Primary Purpose
Liver Transplantation, Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lamivudine adefovir entecavir HBIG
Sponsored by
About this trial
This is an interventional prevention trial for Liver Transplantation focused on measuring HBV recurrence, entecavir
Eligibility Criteria
Inclusion Criteria:
- patients into the transplant waiting list with HBV-related liver disease.
- HBsAg-positive.
- serum HBV-DNA negative.
- no HCV, HDV and HIV co-infection.
- without renal dysfunction.
- No lamivudine, adefovir and entecavir drug allergy history.
- no HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Exclusion Criteria:
- patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
- HBsAg-negative.
- serum HBV-DNA positive.
- HCV, HDV and HIV co-infection.
- patients with severe renal dysfunction or failure.
- lamivudine, adefovir and entecavir drug allergy history.
- HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Sites / Locations
- Shanghai First People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
lamivudine
lamivudine and adefovir
entecavir
Arm Description
Outcomes
Primary Outcome Measures
serological markers of HBV
Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.
Secondary Outcome Measures
Full Information
NCT ID
NCT01139203
First Posted
June 7, 2010
Last Updated
June 25, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT01139203
Brief Title
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Zhejiang University
4. Oversight
5. Study Description
Brief Summary
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Hepatitis B
Keywords
HBV recurrence, entecavir
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lamivudine
Arm Type
Active Comparator
Arm Title
lamivudine and adefovir
Arm Type
Active Comparator
Arm Title
entecavir
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lamivudine adefovir entecavir HBIG
Intervention Description
lamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly
Primary Outcome Measure Information:
Title
serological markers of HBV
Description
Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.
Time Frame
every three month after liver transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients into the transplant waiting list with HBV-related liver disease.
HBsAg-positive.
serum HBV-DNA negative.
no HCV, HDV and HIV co-infection.
without renal dysfunction.
No lamivudine, adefovir and entecavir drug allergy history.
no HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Exclusion Criteria:
patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
HBsAg-negative.
serum HBV-DNA positive.
HCV, HDV and HIV co-infection.
patients with severe renal dysfunction or failure.
lamivudine, adefovir and entecavir drug allergy history.
HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-Hai Peng, MD PHD
Phone
0086-021-63240090
Ext
3132
Email
pengpzh@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Li, MD
Phone
0086-021-63240090
Ext
3136
Email
transplant@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, MD PHD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Hai Peng, MD PHD
Phone
0086-021-63240090
Ext
3132
Email
pengpzh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tao Li, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19373086
Citation
Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.
Results Reference
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PubMed Identifier
18825721
Citation
Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.
Results Reference
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PubMed Identifier
17890261
Citation
Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.
Results Reference
background
PubMed Identifier
19852566
Citation
Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.
Results Reference
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Learn more about this trial
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
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