Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01139203

Enrollment

300

Registered

2010-06-08

Start date

2009-08-31

Completion date

Unknown

Last updated

2010-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Liver Transplantation

Keywords

HBV recurrence, entecavir

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.

Interventions

DRUGlamivudine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactZhi-Hai Peng, MD PHD

pengpzh@hotmail.com0086-021-63240090

Backup ContactTao Li, MD

transplant@126.com0086-021-63240090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026