CLINICAL TRIAL: A MULTI-CENTER, OPEN-LABEL, CONTINUATION TRIAL OF LYMPHOSTAT-B A

临床试验：LYMPHSTAT-B A 的多中心、开放标签、持续试验

• 批准号: 8167241
• 负责人: Cynthia Aranow
• 金额: $ 0.04万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167241
• 关键词: Adverse event; Antibodies; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Funding; Grant; Human; Immunoglobulins; Institution; Monoclonal Antibodies; Patients; Pharmaceutical Preparations; Research; Research Personnel; Resources; Safety; Source; Study Subject; Systemic Lupus Erythematosus; United States National Institutes of Health; open label; phase 2 study; response

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. This is an open label study of a human immune globulin monoclonal antibody (LymphoStat-B Antibody)which has demonstrated activity in patients with systemic lupus erythematosus. The study subjects will all have completed an initial phase 2 study in which they received the same drug [thus the tolerability and any adverse events that have occurred will be known]. The purpose of the study is to determine long term efficacy and safety of the treatment agent. This multi-center, open-label, continuation trial is directed at subjects who achieved a satisfactory response in the Phase 2 study (LBSL02).

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。 这是一项针对人免疫球蛋白单克隆抗体（LymphoStat-B Antibody）的开放标签研究，该抗体已在系统性红斑狼疮患者中表现出活性。研究对象都将完成初始 2 期研究，其中他们接受相同的药物[因此耐受性和发生的任何不良事件将被知晓]。 该研究的目的是确定治疗剂的长期疗效和安全性。这项多中心、开放标签、持续试验针对的是在 2 期研究 (LBSL02) 中取得满意反应的受试者。