Status:
COMPLETED
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (O...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00395018
Start Date
April 1 2007
End Date
March 1 2011
Last Update
May 31 2012
Active Locations (32)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States, 70112
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
University Of Nebraska Medical Center
Omaha, Nebraska, United States, 68198