Back to resultsPrevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
Primary Purpose
Liver Transplantation, Hepatitis B, Liver Disease
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation focused on measuring hepatitis B, liver transplantation, shortterm HBIg, lamivudine resistance
Eligibility 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
Sites / Locations
- University Clinic Essen
- Hannover Medical School
- University Hospital Heidelberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Entecavir
Arm Description
Outcomes
Primary Outcome Measures
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
Secondary Outcome Measures
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
Full Information
NCT ID
NCT01046799
First Posted
January 9, 2010
Last Updated
November 4, 2014
Sponsor
HepNet Study House, German Liverfoundation
Collaborators
Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01046799
Brief Title
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
Official Title
Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HepNet Study House, German Liverfoundation
Collaborators
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Hepatitis B, Liver Disease
Keywords
hepatitis B, liver transplantation, shortterm HBIg, lamivudine resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Entecavir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude
Intervention Description
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
Primary Outcome Measure Information:
Title
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
Time Frame
one year
Secondary Outcome Measure Information:
Title
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Manns, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heiner Wedemeyer, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Essen
City
Essen
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
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