Prevention of Hepatitis B Virus Reinfection After Liver T... | NCT01046799

Studies
Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

NCT01046799

Sponsor

HepNet Study House, German Liverfoundation

Status

Completed

Last Update Posted

Nov 5, 2014Estimated

Enrollment

20Estimated

Phase

Phase 3

Conditions

Liver Transplantation
Hepatitis B
Liver Disease

Interventions

Entecavir

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jun 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 9, 2010

First Submission Date that Met QC Criteria

Jan 9, 2010

First Posted Date

Jan 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2014

Last Update Posted Date

Nov 5, 2014Estimated

Name	Class
Hannover Medical School	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Entecavir	Experimental		Drug: Entecavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy		one year

Secondary Outcomes

Measure	Description	Time Frame
hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation		two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael P Manns, MD	Hannover Medical School	Principal Investigator
Heiner Wedemeyer, MD	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic Essen		Essen			Germany
Hannover Medical School

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B
D008107	Liver Diseases

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C413685	entecavir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided