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Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01046799
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : November 5, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Liver Transplantation Hepatitis B Liver Disease Drug: Entecavir Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2008
Primary Completion Date : June 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Arms and Interventions

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 Name: Baraclude


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046799


Locations
Germany
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01046799     History of Changes
Other Study ID Numbers: 2008-005976-28
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents