Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Study Overview
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Brief Summary
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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.

Conditions
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Liver Transplantation, Hepatitis B

Intervention / Treatment
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* Drug: lamivudine adefovir entecavir HBIG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lamivudine<br> | Drug: lamivudine adefovir entecavir HBIG<br>* 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<br>|
| Active Comparator: lamivudine and adefovir<br> | Drug: lamivudine adefovir entecavir HBIG<br>* 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<br>|
| Active Comparator: entecavir<br> | Drug: lamivudine adefovir entecavir HBIG<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serological markers of HBV | Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA. | every three month after liver transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV recurrence, entecavir