Prevention of Recurrent Hepatitis B After Liver Transplantation

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00059267
Study type	Observational
Source	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status	Completed
Phase	N/A
Start date	March 2001
Completion date	November 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04209491` - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed	`NCT03963206` - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)	Phase 4
Completed	`NCT03268499` - TACE Emulsion Versus Suspension	Phase 2
Recruiting	`NCT05263830` - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting	`NCT05044676` - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting	`NCT05095519` - Hepatocellular Carcinoma Imaging Using PSMA PET/CT	Phase 2
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Completed	`NCT05068193` - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT03781934` - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations	Phase 1/Phase 2
Terminated	`NCT03655613` - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC	Phase 1/Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Completed	`NCT04401800` - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma	Phase 2
Withdrawn	`NCT05418387` - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona	N/A
Active, not recruiting	`NCT04039607` - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma	Phase 3
Terminated	`NCT03970616` - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma	Phase 1/Phase 2
Recruiting	`NCT06239155` - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04118114` - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors	Phase 2
Recruiting	`NCT03642561` - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE	Phase 2/Phase 3
Completed	`NCT03222076` - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer	Phase 2