Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 9, 2010
November 4, 2014
March 2008
June 2014   (final data collection date for primary outcome measure)
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01046799 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir
Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Transplantation
  • Hepatitis B
  • Liver Disease
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
Experimental: Entecavir
Intervention: Drug: Entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01046799
2008-005976-28
No
HepNet Study House, German Liverfoundation
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
HepNet Study House, German Liverfoundation
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP