DATABASE ON PTS WHO RECEIVE ORTHOTOPIC LIVER TRANSPLANTATION FOR HEP B

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是建立一个观察性数据库，以收集参与中心接受原位肝移植(OLT)治疗的所有乙肝患者的术前和术后信息。 在美国，乙肝每年造成4,000-5,000人死亡。原位肝移植为终末期肝病患者提供了唯一的希望。肝病的治疗方法仍然存在争议。肝移植治疗乙型病毒性肝炎的早期效果很差，复发率超过80%。然而，最近的研究发现，持续大剂量静脉注射乙肝免疫球蛋白(HBIG)可以将再感染率降低到20%以下。然而，大剂量HBIG非常昂贵(第一年的总费用可能超过100,000美元)，而且对OLT前复制感染的患者疗效较低。拉米夫定是一种口服疗法，最近被批准用于治疗乙肝，多项研究表明，拉米夫定可以预防原位肝移植术后乙肝的复发，但随着治疗时间的延长，耐药性会产生。由于HBIG和拉米夫定有不同的作用机制，联合治疗可能比单独使用任何一种药物更有效。 这项研究将与另外两项前瞻性临床试验同时进行，这两项试验采用不同剂量和组合的原位肝移植后药物治疗来预防乙肝。这项研究的目的是开发和维护一个观察性数据库，以捕获所有参与中心的所有乙肝移植患者的数据。该数据库将使研究人员能够解决两个重点临床试验中都没有包括的研究问题，并收集不符合或不同意参与这两个临床试验的乙肝患者的信息。该数据库将由三部分组成：1)图表回顾的回顾数据，2)前瞻性收集的数据，以及3)在整个研究过程中收集的血清和肝组织值。所有符合条件的研究对象都将被给予研究的概述，并被要求签署知情同意书，以表明他们愿意参与。然后，参与者将在正常的诊所就诊期间接受监测。在通常的探视过程中，可能会额外采集血液或组织样本，并将这些样本送到PI的实验室进行分析。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to establish an observational database to collect pre- and post- orthotopic liver transplant (OLT) information on all patients who receive OLT for hepatitis B at participating centers. Hepatitis B accounts for 4,000-5,000 deaths per year in the United States. Orthotopic liver transplantation offers the only hope for patients who develop end-stage liver disease. The treatment for liver disease is still disputed. Early results with OLT for hepatitis B were poor with recurrence rates of greater than 80%. However, recent studies have found that continuous high dose IV (intravenous) hepatitis B immune globulin (HBIG) can decrease the rate of reinfection to less than 20%. However, high dose HBIG is very expensive (total charges for the first year can exceed $100,000) and the efficacy is low in patients with replicative infection prior to OLT. Lamivudine, an oral treatment was recently approved for hepatitis B and several studies suggest that lamivudine can prevent recurrent hepatitis B post-OLT, however drug resistance develops with long duration of therapy. Because HBIG and lamivudine have different mechanisms of action, combination therapy may be more effective than either agent alone. This study will run concurrently with two other prospective clinical trial which administer different doses and combinations of post-OLT drug therapy for the prevention of hepatitis B. The purpose of this study is the development and maintenance of a observational database to capture data from all patients transplanted for hepatitis B at all participating centers. The database will enable the researchers to address research questions that are not included in either of the focused clinical trials and collect information on patients with hepatitis B that do not qualify or do not consent to participation in either clinical trial. The database will be comprised of three components: 1) retrospective data from a chart review, 2) prospectively collected data, and 3) serum and liver tissue values collected throughout the study. All eligible research subjects will be given an overview of the study and asked to sign the informed consent form to indicate their willingness for participation. Participants will then be monitored during their normal clinic visits. An extra blood or tissue samples may be taken during the usual visits and these samples sent to the PI's lab for analysis.