Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

This study has been completed.

First Received on November 1, 2006. Last Updated on April 7, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00395018

Purpose

The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus in subjects who receive an orthotopic liver transplant (OLT).

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: Entecavir	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Liver Transplantation

Drug Information available for: Entecavir Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Recurrence of hepatitis B virus (HBV) as measured by HBV DNA by PCR ≥ 50 IU/mL (approximately ≥ 300 copies/mL) [ Time Frame: at 72 weeks post liver transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serological endpoints will be assessed as counts and proportions. [ Time Frame: at 72 weeks post liver transplant ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	April 2007
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1	Drug: Entecavir Tablets, Oral, 1 mg, once daily, up to 72 weeks Other Names: Baraclude BMS-200475

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant
Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening

Exclusion Criteria:

Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395018

Show 32 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00395018 History of Changes
Other Study ID Numbers:	AI463-109
Study First Received:	November 1, 2006
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Chronic Hepatitis B Virus, Liver Transplant

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Encephalitis, Herpes Simplex
Virus Diseases
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections

DNA Virus Infections
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Herpesviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Antiviral Agents
Entecavir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012