DATABASE ON PTS WHO RECEIVE ORTHOTOPIC LIVER TRANSPLANTATION FOR HEP B

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是建立一个观察性数据库，以收集所有在参与中心接受原位肝移植（奥尔特）治疗B型肝炎的患者的术前和术后信息。B型肝炎在美国每年造成4，000 - 5，000人死亡。原位肝移植是终末期肝病患者的唯一希望。肝病的治疗方法仍有争议。肝奥尔特治疗B型肝炎的早期效果不佳，复发率大于80%。然而，最近的研究发现，持续大剂量静脉注射B型肝炎免疫球蛋白（HBIG）可将再感染率降至20%以下。然而，高剂量HBIG非常昂贵（第一年的总费用可超过$100，000），并且在奥尔特之前具有复制性感染的患者中疗效低。拉米夫定是一种口服治疗B型肝炎的药物，一些研究表明拉米夫定可以预防OLT后B型肝炎的复发，但随着治疗时间的延长，药物耐药性会增加。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。 本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OLT后药物治疗预防B型肝炎。本研究的目的是开发和维护一个观察性数据库，以采集所有参与中心所有因B型肝炎接受移植的患者的数据。该数据库将使研究人员能够解决未包括在任何一项重点临床试验中的研究问题，并收集不符合或不同意参加任何一项临床试验的B型肝炎患者的信息。 数据库将由三部分组成：1）来自病历审查的回顾性数据，2）前瞻性收集的数据，3）整个研究期间收集的血清和肝脏组织值。将向所有合格的研究受试者提供研究概述，并要求其签署知情同意书以表明其参与意愿。然后将在正常的临床访视期间对受试者进行监测。在常规访视期间可能会采集额外的血液或组织样本，并将这些样本送至PI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.