Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Not Applicable

• Conditions: Liver Transplantation; Hepatitis B
• Interventions: Drug: lamivudine adefovir entecavir HBIG

• Registration Number: NCT01139203
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Submitted: 2010-06-25
• Last Update Posted: 2010-06-28
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lamivudine	lamivudine adefovir entecavir HBIG	-
lamivudine and adefovir	lamivudine adefovir entecavir HBIG	-
entecavir	lamivudine adefovir entecavir HBIG	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai First People's Hospital; 🇨🇳 Shanghai, China