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Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

NCT01046799 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • HepNet Study House, German Liverfoundation

    lead NETWORK

Principal Investigators

  • Michael P Manns, MD · Hannover Medical School

  • Heiner Wedemeyer, MD · Hannover Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2014-06-30
Completion
2014-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01046799 on ClinicalTrials.gov