Prevention of Recurrent Hepatitis B After Liver Transplantation

Hepatocellular Carcinoma Clinical Trial

Official title:

Prevention of Recurrent Hepatitis B After Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059267
• Other study ID #: NIH HBV-OLT (completed)
• Secondary ID: U01DK057577
• Status: Completed
• Phase: N/A
• First received: April 22, 2003
• Last updated: October 16, 2017
• Start date: March 2001
• Est. completion date: November 2007

Study information

• Verified date: October 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Related Conditions & MeSH terms

• Acute Liver Failure
• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatocellular Carcinoma
• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• HBIG, Epivir, Hepsera

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Degertekin B, Han SH, Keeffe EB, Schiff ER, Luketic VA, Brown RS Jr, Emre S, Soldevila-Pico C, Reddy KR, Ishitani MB, Tran TT, Pruett TL, Lok AS; NIH HBV-OLT Study Group. Impact of virologic breakthrough and HBIG regimen on hepatitis B recurrence after li — View Citation