Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
NCT ID: NCT01139203
Last Updated: 2010-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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lamivudine
lamivudine adefovir entecavir HBIG
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
lamivudine and adefovir
lamivudine adefovir entecavir HBIG
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
entecavir
lamivudine adefovir entecavir HBIG
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
Interventions
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lamivudine adefovir entecavir HBIG
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
Eligibility Criteria
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Inclusion Criteria
2. HBsAg-positive.
3. serum HBV-DNA negative.
4. no HCV, HDV and HIV co-infection.
5. without renal dysfunction.
6. No lamivudine, adefovir and entecavir drug allergy history.
7. no HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Exclusion Criteria
2. HBsAg-negative.
3. serum HBV-DNA positive.
4. HCV, HDV and HIV co-infection.
5. patients with severe renal dysfunction or failure.
6. lamivudine, adefovir and entecavir drug allergy history.
7. HBV-YMDD mutation for patients who have a long-term use of lamivudine.
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Principal Investigators
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Zhi-Hai Peng, MD PHD
Role: STUDY_CHAIR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai First People's Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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SH20100601
Identifier Type: -
Identifier Source: org_study_id
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