Status:
UNKNOWN
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Zhejiang University
Conditions:
Liver Transplantation
Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
NA
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 la...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01139203
Start Date
August 1 2009
Last Update
June 28 2010
Active Locations (1)
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1
Shanghai First People's Hospital
Shanghai, China, 200000