Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Shanghai Jiao Tong University School of Medicine

Status: Unknown

Conditions: Liver Transplantation; Hepatitis B

Treatments: Drug: lamivudine adefovir entecavir HBIG

Study type: Interventional

Funder types: Other

Identifiers

NCT01139203

SH20100601

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients into the transplant waiting list with HBV-related liver disease.
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

1. patients with HBV-related hepatocellular carcinoma beyond Milan 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

lamivudine

Active Comparator group

Treatment:

Drug: lamivudine adefovir entecavir HBIG

lamivudine and adefovir

Active Comparator group

Treatment:

Drug: lamivudine adefovir entecavir HBIG

entecavir

Active Comparator group

Treatment:

Drug: lamivudine adefovir entecavir HBIG