Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

Hepatitis B Clinical Trial

Official title:

Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046799
• Other study ID #: 2008-005976-28
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2010
• Last updated: November 4, 2014
• Start date: March 2008
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: HepNet Study House, German Liverfoundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Disease
• Liver Diseases
• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
Germany	University Clinic Essen	Essen
Germany	Hannover Medical School	Hannover
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
HepNet Study House, German Liverfoundation	Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy		one year	Yes
Secondary	hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation		two years	Yes