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Completed

NCT Number: NCT01046799

Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

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.

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Key information

Conditions

Liver Transplantation Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Disease Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Clinic Essen, Essen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entecavir

Drug

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 names: Baraclude

Primary outcomes

  1. prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy

    Time frame: one year

Secondary outcomes

  1. hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation

    Time frame: two years

Sponsors and collaborators

Lead sponsor

HepNet Study House, German Liverfoundation

Network

Collaborators

  • Hannover Medical School

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2010
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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