A2ALL LADR PROTOCOL:PRE-TRNSPLNT TRTMNT TO PRVNT RCURRNCE OF HEPC AFT LVR TRNSPL

A2ALL LADR 协议：PRE-TRNSPLNT TRTMNT 到 HEPC AFT LVR TRNSPL 的 PRVNT 复发

• 批准号: 7604428
• 负责人: Gregory Thomas Everson
• 金额: $ 0.81万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604428
• 关键词: Affect; Anemia; Blood; Blood Cell Count; Blood Circulation; Blood Platelets; Chronic Hepatitis C; Clinical; Computer Retrieval of Information on Scientific Projects Database; Count; Dose; Erythropoietin; Funding; Genotype; Goals; Grant; Granulocyte Colony-Stimulating Factor; Growth Factor; Hemoglobin; Hepatitis C; Hepatitis C virus; Infection; Institution; Interferons; Lead; Leukocytes; Liquid substance; Liver; Liver diseases; Malignant neoplasm of liver; Oral cavity; Participant; Patients; Pharmaceutical Preparations; Protocols documentation; Purpose; Research; Research Personnel; Resources; Ribavirin; Solutions; Source; Stream; Time; Transplantation; United States Food and Drug Administration; United States National Institutes of Health; Viral; Virus; Virus Diseases; Week; analog; base; day; interferon therapy; liver transplantation; peginterferon alfa-2b; prevent

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. Chronic hepatitis C is a long-lasting viral infection affecting the liver that may lead to permanent liver damage and, occasionally, to liver cancer. It rarely disappears by chance, but may be cleared from the bloodstream in some patients by interferon therapy, with or without a second anti-viral agent called ribavirin. The combination of peginterferon alpha and ribavirin has recently been shown to be more effective than prior available treatments in clearing the virus from the blood, and therefore getting rid of the infection. There are several different types of Hepatitis C virus and they are called genotypes. The purpose of this study is to determine how safe and how effective treatment with combination peginterferon alfa-2b plus ribavirin is in preventing the return of hepatitis C after transplant. The results from patients in genotype 1, 4, 5, or 6 who receive treatment will be compared to the results of patients in the same genotypes who do not receive treatment; if the participant has one of these genotypes they have 2 chances out of 3 to receive the treatment. All patients with genotypes 2 or 3 will receive treatment as the treatment benefit is higher with these genotypes. Peginterferon alfa-2b (PEGINTRONTM) is a form of interferon that lasts a long time in the blood stream and is given once a week. Ribavirin is taken orally (by mouth) twice a day, as a liquid solution in variable amounts with an average dose of approximately 2 teaspoons/dose (10 to 15 ml). Subjects who are treated in this study will receive both PEGINTRONTM + ribavirin. NOTE: not all patients who join this study will receive treatment. Peginterferon alfa-2b was approved by the Food and Drug Administration for treatment of hepatitis C in 2001, and Ribavirin was approved for use with Peginterferon alfa-2b in August, 2001. Because the participants have advanced liver disease and are awaiting liver transplantation, they may be less able to tolerate full doses of both peginterferon and ribavirin. For this reason the starting doses of both drugs will begin low and then doses will be increased based on their tolerance to the treatment. One of the clinical problems encountered in patients with advanced liver disease are low blood cell counts, specifically low white cells, low platelets, and low hemoglobin (anemia). If a participant has excessively low blood counts or develops them on treatment they may receive additional treatment, called growth factors (erythropoietin analogue (EPO) or granulocyte-colony stimulating factor (G-CSF)). The goal of using growth factors is to keep their blood counts high enough so that they can be treated with adequate doses of peginterferon and ribavirin.

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。 慢性丙型肝炎是一种影响肝脏的长期病毒感染，可能导致永久性肝损伤，有时甚至导致肝癌。 它很少会偶然消失，但在某些患者中，可以通过干扰素治疗（使用或不使用称为利巴韦林的第二种抗病毒药物）从血流中清除。最近显示，聚乙二醇干扰素α和利巴韦林的组合在清除血液中的病毒方面比现有的治疗方法更有效，从而消除感染。 丙型肝炎病毒有几种不同类型，它们被称为基因型。 本研究的目的是确定聚乙二醇干扰素 alfa-2b 加利巴韦林联合治疗在预防移植后丙型肝炎复发方面的安全性和有效性。 接受治疗的基因型1、4、5或6患者的结果将与未接受治疗的相同基因型患者的结果进行比较；如果参与者具有这些基因型之一，他们就有三分之二的机会接受治疗。所有基因型 2 或 3 的患者都将接受治疗，因为这些基因型的治疗效果更高。 聚乙二醇干扰素 alfa-2b (PEGINTRONTM) 是干扰素的一种形式，可在血流中持续很长时间，每周给药一次。 利巴韦林每天口服两次，为不同剂量的液体溶液，平均剂量约为 2 茶匙/剂量（10 至 15 毫升）。 本研究中接受治疗的受试者将同时接受 PEGINTRONTM + 利巴韦林治疗。 注意：并非所有参加本研究的患者都会接受治疗。 聚乙二醇干扰素α-2b于2001年被美国食品和药物管理局批准用于治疗丙型肝炎，利巴韦林于2001年8月被批准与聚乙二醇干扰素α-2b一起使用。 由于参与者患有晚期肝病并正在等待肝移植，因此他们可能无法耐受全剂量的聚乙二醇干扰素和利巴韦林。 因此，两种药物的起始剂量将开始较低，然后根据其对治疗的耐受性增加剂量。 晚期肝病患者遇到的临床问题之一是血细胞计数低，特别是白细胞低、血小板低和血红蛋白低（贫血）。 如果参与者的血细胞计数过低或在治疗中出现这种情况，他们可能会接受额外的治疗，称为生长因子（促红细胞生成素类似物 (EPO) 或粒细胞集落刺激因子 (G-CSF)）。 使用生长因子的目的是保持他们的血细胞计数足够高，以便他们可以接受足够剂量的聚乙二醇干扰素和利巴韦林治疗。