Prevention of Recurrent Hepatitis B After Liver Transplantation

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00059267
• Collaborator: University of Michigan (Other)
• Enrollment: 317
• Location: 1
• Actual Duration (Months): 80
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B; Cirrhosis; Acute Liver Failure; Hepatocellular Carcinoma	Drug: HBIG, Epivir, Hepsera

Study Design

• Study Type: Observational
• Actual Enrollment: 317 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevention of Recurrent Hepatitis B After Liver Transplantation
• Actual Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• University of Michigan

Investigators

• Principal Investigator: Anna S Lok, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• ClinicalTrials.gov Identifier: NCT00059267
• Other Study ID Numbers: NIH HBV-OLT (completed); U01DK057577
• First Posted: Apr 23, 2003
• Last Update Posted: Oct 18, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis; Liver Failure; Liver Failure, Acute; Adefovir dipivoxil

Study Results

No Results Posted as of Oct 18, 2017