NCT01046799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

6.3 years

First QC Date

January 9, 2010

Last Update Submit

November 4, 2014

Conditions

Liver TransplantationHepatitis BLiver Disease

Keywords

hepatitis Bliver transplantationshortterm HBIglamivudine resistance

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (1)

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

    two years

Study Arms (1)

Entecavir

EXPERIMENTAL
Drug: Entecavir

Interventions

EntecavirDRUG

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

Also known as: Baraclude
Entecavir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver transplantation for hepatitis B induced endstage liver disease
  • absence of coinfection with HIV and HCV
  • female and male patients \>= 18 years of age

You may not qualify if:

  • any evidence of other causes for endstage liver disease
  • patients that do not fulfill the criteria for liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Clinic Essen

Essen, Germany

Location

Hannover Medical School

Hanover, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

MeSH Terms

Conditions

Hepatitis BLiver Diseases

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisDigestive System Diseases

Study Officials

  • Michael P Manns, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Heiner Wedemeyer, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2010

First Posted

January 12, 2010

Study Start

March 1, 2008

Primary Completion

June 1, 2014

Study Completion

October 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

DE(3)