TRIAL OF RITUXIMAB FOR CHRONIC, SEVERE IDIOPATHIC THROMBOCYTOPENIC PURPURA

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本试验将检验Ritusiumab将延长难治性儿童ITP受试者的缓解期的假设。小学一年级。有效性：评价利妥昔单抗在重度或难治性儿童ITP中的有效性，应答定义如下：从9 - 12周开始（第57天-第84天），在28天的4次测量中血小板计数50，000/mL（即，一旦在9 - 12周的时间范围内确定，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治疗，如下所示：1）在首次测量的7天内或测量之间的任何时间没有IVIG给药，2）在首次测量的7天内或测量之间的任何时间没有开始4天皮质类固醇脉冲，3）在首次测量的7天内或测量之间的任何时间没有输注血小板。

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.