Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

HepNet Study House, German Liverfoundation20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Transplantation Hepatitis B Liver Disease

Interventions

EntecavirDRUG

Entecavir monotherapy after short-term HBIg therapy for patients transplanted for hepatitis B induced end-stage liver disease; in case of prior lamivudine treatment, tenofovir will be added to the reinfection prophylaxis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

University Clinic Essen

Essen, Germany

Hannover Medical School

Hanover, Germany

University Hospital Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

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

Time frame: one year

Secondary Outcomes

hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation

Time frame: two years

Data from ClinicalTrials.gov

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