Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

Phase 3

Completed

• Conditions: Hepatitis B; Liver Transplantation; Liver Disease
• Interventions: Drug: Entecavir

• Registration Number: NCT01046799
• Lead Sponsor: HepNet Study House, German Liverfoundation

Brief Summary

The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2010-01-09
• Study First Submitted QC: 2010-01-09
• Study First Posted: 2010-01-12
• Primary Completion: 2014-06
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• liver transplantation for hepatitis B induced endstage liver disease
• absence of coinfection with HIV and HCV
• female and male patients >= 18 years of age

Exclusion Criteria

• any evidence of other causes for endstage liver disease
• patients that do not fulfill the criteria for liver transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Entecavir	Entecavir	-

Primary Outcome Measures

Name	Time	Method
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy	one year

Secondary Outcome Measures

Name	Time	Method
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation	two years

Trial Locations

Locations (3)

University Clinic Essen; 🇩🇪 Essen, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany