EUCTR2006-000453-22-ES进行中（未招募）不适用
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).
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- •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
研究者
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