外用沙利度胺治疗cGVHD口腔炎的疗效及机制评价-猫眼课题宝

外用沙利度胺治疗cGVHD口腔炎的疗效及机制评价

批准号：

7594630

负责人：

jane fall-dickson

金额：

$16.0万

依托单位：

NATIONAL INSTITUTE OF NURSING RESEARCH

依托单位国家：

美国

项目类别：

财政年份：

资助国家：

美国

项目状态：

未结题

起止时间：

至

来源：

https://reporter.nih.gov/project-details/7594630

关键词：

Age Biological Factors Blood Clinic Clinical Clinical Services Clinical Trials Data Monitoring Committees Clinical assessments Data Development Drug Formulations Effectiveness Gel Heart Inflammation Inflammatory Response Institutes Lung Monitor Mouthwash National Cancer Institute Natural History Oral Diagnosis Outcome Pathogenesis Patients Pharmacologic Substance Placebos Play Population Protocols documentation Punch Biopsy Purpose Randomized Controlled Clinical Trials Research Personnel Role Safety Schedule Stomatitis Testing Thalidomide Topical application Tumor Necrosis Factor-alpha United States Food and Drug Administration United States National Institutes of Health chronic graft versus host disease clinical efficacy cytokine efficacy evaluation human TNF protein inclusion criteria novel oral condition prospective tool

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中文摘要

翻译

这项研究的数据和安全监测计划已经得到NINR数据和安全监测委员会的批准。2007年6月26日，FDA最终批准了沙利度胺局部凝胶IND 76,793的使用。招聘计划于2007年10月在NIH临床中心开始。除了国家心脏、肺和血液研究所副研究员、医学博士Richard Childs提供的患者群体外，cGVHD患者还将通过国家癌症研究所(NCI)赞助的位于NIH临床中心的每周cGVHD诊所进行转介，该诊所由NCI赞助的cGVHD自然病史方案“决定cGVHD患者预后的临床和生物因素的前瞻性评估”(04-C-0281)主持。外用沙利度胺由美国国立卫生研究院临床中心药物开发服务处准备。

英文摘要

The data and safety monitoring plan for the study has been approved by the NINR Data and Safety Monitoring Board. The FDA gave final clearance for use of thalidomide topical gel IND 76, 793, on June 26, 2007. Recruitment is scheduled to start October 2007 at the NIH Clinical Center. In addition to the patient population provided by Richard Childs, MD, Associate Investigator, National Heart, Lung, and Blood Institute, cGVHD patients will be referred through the weekly National Cancer Institute (NCI) sponsored cGVHD Clinic at the NIH Clinical Center, under the auspices of the NCI-sponsored cGVHD natural history protocol "Prospective Assessment of Clinical and Biological Factors Determining Outcomes in Patients with cGVHD" (04-C-0281). Topical thalidomide is prepared by the Pharmaceutical Development Service, Clinical Center, NIH.

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