Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Dueto Chronic Hepatitis B Virus Infection.Estudio de la actividad antiviral de entecavir en pacientes que reciben trasplante hepático por infección crónica con el virus de la hepatitis BRevised Protocol 01, incorporating Amendment 02 (Version 1.0 Date 20-Nov-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0 Date 20-Nov-2006).

• Conditions: CHRONIC HEPATITIS B VIRUS,TRANSPLANTHepatitis Cronica por viris B, Transplante; MedDRA version: 8.1Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)

• Registration Number: EUCTR2006-000453-22-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-24
• 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 diameter 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 (>=16 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
contraindicated contraceptives to entecavir.
3) Women who are pregnant or breastfeeding
4) Women with a positive pregnancy test on 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 hrs
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 IU/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, it must be repeated. If the repeat alpha fetoprotein level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose 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