Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Hepatitis B Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01139203
• Other study ID #: SH20100601
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2010
• Last updated: June 25, 2010
• Start date: August 2009

Study information

• Verified date: August 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Zhi-Hai Peng, MD PHD
• Phone: 0086-021-63240090
• Email: pengpzh[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Liver Transplantation

Intervention

Drug:
• lamivudine 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

Locations

Country	Name	City	State
China	Shanghai First People's Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (4)

Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614. Review. — View Citation

Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599. Review. — View Citation

Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32. Review. — View Citation

Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serological markers of HBV	Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.	every three month after liver transplantation	No