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Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

This study has been completed.
Hannover Medical School
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation Identifier:
First received: January 9, 2010
Last updated: November 4, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Liver Transplantation
Hepatitis B
Liver Disease
Drug: Entecavir
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study

Resource links provided by NLM:

Further study details as provided by HepNet Study House, German Liverfoundation:

Primary Outcome Measures:
  • prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy [ Time Frame: one year ]

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

Estimated Enrollment: 20
Study Start Date: March 2008
Study Completion Date: October 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Baraclude


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01046799

University Clinic Essen
Essen, Germany
Hannover Medical School
Hannover, Germany
University Hospital Heidelberg
Heidelberg, Germany
Sponsors and Collaborators
HepNet Study House, German Liverfoundation
Hannover Medical School
Principal Investigator: Michael P Manns, MD Hannover Medical School
Principal Investigator: Heiner Wedemeyer, MD Hannover Medical School
  More Information

Responsible Party: HepNet Study House, German Liverfoundation Identifier: NCT01046799     History of Changes
Other Study ID Numbers: 2008-005976-28
Study First Received: January 9, 2010
Last Updated: November 4, 2014

Keywords provided by HepNet Study House, German Liverfoundation:
hepatitis B
liver transplantation
shortterm HBIg
lamivudine resistance

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents processed this record on April 28, 2017