Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

November 4, 2014 updated by: HepNet Study House, German Liverfoundation

Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany
        • University Clinic Essen
      • Hannover, Germany
        • Hannover Medical School
      • Heidelberg, Germany
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Entecavir
Drug: 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
Other Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HepNet Study House, German Liverfoundation

Collaborators

Hannover Medical School

Investigators

  • Principal Investigator: Michael P Manns, MD, Hannover Medical School
  • Principal Investigator: Heiner Wedemeyer, MD, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

January 9, 2010

First Submitted That Met QC Criteria

January 9, 2010

First Posted (ESTIMATE)

January 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-005976-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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