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

• Conditions: Chronic Hepatitis B Virus, Transplant; MedDRA version: 9.1Level: LLTClassification code 10019731Term: Hepatitis B

• Registration Number: EUCTR2006-000453-22-IT
• Lead Sponsor: Bristol_myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-09
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Signed written informed consent; 2. Orthotopic liver transplant (OLT) patients with end-stage liver disease due to chronic HBV infection; 3. HBV DNA <172 IU/ml (approximately <1000 copies/ml) by PCR prior to OLT: fifty (50)subjects with HBV DNA by PCR of <50 IU/ml (approximately 300 copies/ml) at the time of OLT and twenty (20) subjects with HBV DNA by PCR of >= 50 IU/ml and <172 IU/ml (approximately 300 copies/ml and 1000 copies/ml) at the time of OLT; 4. Patients with a pre-OLT diagnosis of hepatocellular carcinoma (HCC) may be enrolled ONLY if there is no evidence of extrahepatic spread, tumor is solitary and =< 6.5 cm in diameter or there are up to three nodules =< 4.5 cm in diameter each, and total tumor is =< 8cm.26; 5. Detectable HBsAg at screening and for at least 24 weeks prior to screening; 6. Patients eligible for OLT according to protocol- specified criteria, in the investigators judgment, are anticipated to receive transplant within 90 days; 7. Male and female adults (>= 18 years of age or minimum age of consent in a given country)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after the last dose of investigational product 2.WOCBP using a prohibited contraceptive method. At this time there are no known controindicated contraceptives to entecavir 3. Women who are pregnant or breastfeeding 4. Women with a positive pregnancy test or enrollment or prior to investigational product administration 5. Sexually active fertile men not using effective birth control if their partners are WOCBP 6. Patients with HCC who do not meet inclusion criteria or require systemic chemotherapy 7. Recipient of ABO blood group incompatible organ 8. Multi-organ or retransplant recipient 9. Donor cold ischemia time >20 hours 10. Co-infection with human immunodeficiency virus (HIV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), or hepatitis C virus (HCV) 11. Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication) 12. Currently abusing illegal drugs or alcohol sufficient,in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis 13. Other serious medical conditions that might preclude completion of this study 14. HBV DNA >= 172 UI/ml (approximately >=1000 copies/ml) by PCR prior to OLT 15. Serum alpha fetoprotein level > 100 ng/ml. If the alpha fetoprotein level is between 21 and 100 ng/ml and if ultrasonography or computerized tomograohy(CT) of the liver performed prior to the first dse of study medication does not demonstrate a focal lesion suggestive of carcinoma 16. Known history of allergy to nucleoside analogues 17. Unstable dose schedule (less than 4 weeks) for chronic medications. A consistent dosing schedule is recommended for the duration of study 18. Poor peripheral venous access 19. Unable to tolerate oral medication 20. Prisoners or subjects who are compulsorily detained

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified