DATABASE ON PTS WHO RECEIVE ORTHOTOPIC LIVER TRANSPLANTATION FOR HEP B

接受乙型肝炎原位肝移植的患者数据库

• 批准号: 7604998
• 负责人: VELIMIR A LUKETIC
• 金额: $ 0.42万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-20 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604998
• 关键词: Accounting; Address; Blood; Cessation of life; Charge; Clinic Visits; Clinical Trials; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Consent; Consent Forms; Data; Databases; Development; Disputes; Dose; Drug resistance; Funding; Grant; Hepatitis B; Immunoglobulins; Infection; Institution; Intravenous; Lamivudine; Liver; Liver diseases; Maintenance; Monitor; Oral; Participant; Patients; Pharmacotherapy; Prevention; Purpose; Qualifying; Rate; Recurrence; Research; Research Personnel; Research Subjects; Resources; Running; Sampling; Serum; Source; Staging; Tissue Sample; Tissues; Transplant Recipients; United States; United States National Institutes of Health; Visit; liver transplantation; prevent; prospective; research study; therapy duration; willingness

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是建立一个观察数据库，收集在参与中心接受原位肝移植 (OLT) 治疗乙型肝炎的所有患者的术前和术后信息。 在美国，乙型肝炎每年导致 4,000-5,000 人死亡。 原位肝移植为患有终末期肝病的患者提供了唯一的希望。 肝病的治疗仍存在争议。 OLT 治疗乙型肝炎的早期结果较差，复发率超过 80%。 然而，最近的研究发现，持续高剂量IV（静脉注射）乙型肝炎免疫球蛋白（HBIG）可以将再感染率降低至20%以下。 然而，高剂量HBIG非常昂贵（第一年的总费用可能超过10万美元），并且对于OLT之前出现复制性感染的患者疗效较低。 拉米夫定是一种口服治疗乙型肝炎的药物，最近被批准用于治疗乙型肝炎，多项研究表明拉米夫定可以预防 OLT 后乙型肝炎复发，但随着治疗时间的延长，会产生耐药性。由于 HBIG 和拉米夫定具有不同的作用机制，因此联合治疗可能比单独使用任一药物更有效。 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 OLT 后药物治疗来预防乙型肝炎。这项研究的目的是开发和维护一个观察数据库，以捕获所有参与中心的所有乙型肝炎移植患者的数据。 该数据库将使研究人员能够解决任一重点临床试验中未包含的研究问题，并收集不符合或不同意参加任一临床试验的乙型肝炎患者的信息。 该数据库将由三个部分组成：1）来自图表审查的回顾性数据，2）前瞻性收集的数据，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获得研究概况，并被要求签署知情同意书以表明他们的参与意愿。 然后，参与者将在正常就诊期间接受监测。 在日常访问期间可能会采集额外的血液或组织样本，并将这些样本发送到 PI 实验室进行分析。