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Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

This study is currently recruiting participants.
Verified December 2012 by HepNet Study House, German Liverfoundation
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation
ClinicalTrials.gov Identifier:
NCT01046799
First received: January 9, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: September 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046799

Contacts
Contact: Michael P Manns, MD +495115320 ext 3305 manns.michael@mh-hannover.de

Locations
Germany
University Clinic Essen Not yet recruiting
Essen, Germany
Contact: Guido Gerken, MD     +49 - 201 - 723-0 ext 3610     guido.gerken@uk-essen.de    
Contact: Susanne Beckebaum         susanne.beckebaum@uni-essen.de    
Principal Investigator: Guido Gerken, MD            
Sub-Investigator: Susanne Beckebaum, MD            
Hannover Medical School Recruiting
Hannover, Germany
Contact: Michael P Manns, MD     +49511532-0 ext 3305     manns.michael@mh-hannover.de    
Principal Investigator: Michael P Manns            
Principal Investigator: Heiner Wedemeyer, MD            
Sub-Investigator: Karsten Wursthorn, MD            
University Hospital Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Christoph Eisenbach, MD     +49 6221 - 56 - 0 ext 38849     Christoph_Eisenbach@med.uni-heidelberg.de    
Sponsors and Collaborators
HepNet Study House, German Liverfoundation
Hannover Medical School
Investigators
Principal Investigator: Michael P Manns, MD Hannover Medical School
Principal Investigator: Heiner Wedemeyer, MD Hannover Medical School
  More Information

No publications provided

Responsible Party: HepNet Study House, German Liverfoundation
ClinicalTrials.gov Identifier: NCT01046799     History of Changes
Other Study ID Numbers: 2008-005976-28
Study First Received: January 9, 2010
Last Updated: December 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013