TRIAL OF RITUXIMAB FOR CHRONIC, SEVERE IDIOPATHIC THROMBOCYTOPENIC PURPURA

利妥昔单抗治疗慢性、重度特发性血小板减少性紫癜的试验

• 批准号: 7374964
• 负责人: DONALD MAHONEY
• 金额: $ 0.74万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374964
• 关键词: TRIAL; RITUXIMAB; CHRONIC; SEVERE; IDIOPATHIC

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 trial will test the hypothesis that Ritusimab will extend the remission period for subjects with refractory pediatric ITP. Primary 1. Efficacy:To evaluate the effectiveness of rituximab in severe or refractory pediatric ITP, with response defined as follows: platelet count 50,000/mL on four measures spanning 28 days starting at 9 - 12 weeks (day 57 - day 84) (i.e., once established during the 9 - 12 week timeframe, the response would be defined as beginning at the first one of these measures). All measurements must be independent of supportive care, as follows: 1) no IVIG administration within 7 days of the first measure or at any time between measures, 2) no initiation of a 4-day corticosteroid pulse within 7 days of the first measure or at any time between measures, and 3) no platelet transfusions administered within 7 days of the first measure or at any time between measures.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。该试验将检验利妥昔单抗将延长难治性儿科 ITP 受试者的缓解期的假设。主要 1. 功效：评估利妥昔单抗治疗严重或难治性儿科 ITP 的有效性，响应定义如下：从第 9 - 12 周（第 57 天 - 第 84 天）开始，跨越 28 天的四项测量，血小板计数达到 50,000/mL（即，一旦在 9 - 12 周的时间范围内建立，响应将被定义为从这些措施中的第一个开始）。所有测量必须独立于支持性护理，如下：1) 第一次测量后 7 天内或测量之间的任何时间没有 IVIG 给药，2) 第一次测量后 7 天内没有开始 4 天皮质类固醇脉冲，或测量之间的任何时间，以及 3) 第一次测量后 7 天内或测量之间的任何时间不进行血小板输注。