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Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

This study has been completed.
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: November 4, 2014
Last verified: November 2014
  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:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: November 4, 2014
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
Liver Diseases
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Entecavir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014