Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Transplantation Hepatitis B Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

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

Interventions

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Entecavir

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

Intervention Type DRUG

Other Intervention Names

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Baraclude

Eligibility Criteria

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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