NCT01139203

Brief Summary

Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

June 28, 2010

Status Verified

August 1, 2009

Enrollment Period

3.3 years

First QC Date

June 7, 2010

Last Update Submit

June 25, 2010

Conditions

Liver TransplantationHepatitis B

Keywords

HBV recurrenceentecavir

Outcome Measures

Primary Outcomes (1)

  • serological markers of HBV

    Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.

    every three month after liver transplantation

Study Arms (3)

lamivudine

ACTIVE COMPARATOR
Drug: lamivudine adefovir entecavir HBIG

lamivudine and adefovir

ACTIVE COMPARATOR
Drug: lamivudine adefovir entecavir HBIG

entecavir

ACTIVE COMPARATOR
Drug: lamivudine adefovir entecavir HBIG

Interventions

lamivudine adefovir entecavir HBIGDRUG

lamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly

entecavirlamivudinelamivudine and adefovir

Eligibility Criteria

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

You may qualify if:

  • patients into the transplant waiting list with HBV-related liver disease.
  • HBsAg-positive.
  • serum HBV-DNA negative.
  • no HCV, HDV and HIV co-infection.
  • without renal dysfunction.
  • No lamivudine, adefovir and entecavir drug allergy history.
  • no HBV-YMDD mutation for patients who have a long-term use of lamivudine.

You may not qualify if:

  • patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
  • HBsAg-negative.
  • serum HBV-DNA positive.
  • HCV, HDV and HIV co-infection.
  • patients with severe renal dysfunction or failure.
  • lamivudine, adefovir and entecavir drug allergy history.
  • HBV-YMDD mutation for patients who have a long-term use of lamivudine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai First People's Hospital

Shanghai, 200000, China

RECRUITING

Related Publications (4)

  • Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.

    PMID: 19373086BACKGROUND

  • Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.

    PMID: 18825721BACKGROUND

  • Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.

    PMID: 17890261BACKGROUND

  • Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.

    PMID: 19852566BACKGROUND

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zhi-Hai Peng, MD PHD

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Zhi-Hai Peng, MD PHD

CONTACT

0086-021-63240090pengpzh@hotmail.com

Tao Li, MD

CONTACT

0086-021-63240090transplant@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 8, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2012

Last Updated

June 28, 2010

Record last verified: 2009-08

Locations

CN(1)