Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Completed · Phase 3
Conditions studied: Hepatitis B, Chronic
In brief
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 (OLT) due to HBV infection.
Key facts
- Study ID
- NCT00395018
- Run by
- Bristol-Myers Squibb
- People needed
- 109
- Starts
- 2007-04-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2012-05-31
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Northwestern University — Chicago, Illinois, United States
- Tulane University Hospital & Clinic — New Orleans, Louisiana, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University Of Nebraska Medical Center — Omaha, Nebraska, United States
- University Of Rochester Medical Center — Rochester, New York, United States
- University Of Cincinnati Medical Center — Cincinnati, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Baylor University Medical Center — Dallas, Texas, United States
- Baylor College Of Medicine — Houston, Texas, United States
- Local Institution — Buenos Aires, Buenos Aires, Argentina
- Local Institution — Woolloongabba, Queensland, Australia
- Local Institution — Heidelberg, Victoria, Australia
- Local Institution — Fortaleza, Ceará, Brazil
- Local Institution — Porto Alegre, Rio Grande do Sul, Brazil
- Local Institution — São Paulo, São Paulo, Brazil
- Local Institution — Clichy, France
- Local Institution — Paris, France
- Local Institution — Villejuif, France
- Local Institution — Bologna, Italy
- Local Institution — Roma, Italy
- Local Institution — Roma, Italy
- Local Institution — Torrette Di Ancona, Italy
- Local Institution — Seoul, South Korea
- Local Institution — Seoul, South Korea
- Local Institution — Seoul, South Korea
Full record on ClinicalTrials.gov
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