CPC111 IN SICLKE CELL CRISIS--STAGES 1, 2, & 3

CPC111 处于 SICLKE 细胞危机中——第 1、2 阶段

• 批准号: 6274104
• 负责人: BRIAN K ADLER
• 金额: $ 2.59万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-26 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274104
• 关键词: adenosine triphosphate; blood disorder chemotherapy; clinical research; clinical trial phase I; dosage; drug screening /evaluation; erythrocytes; fructose biphosphatase; human subject; human therapy evaluation; sickle cell crisis

The purpose of this study is to provide an intervention that will help shorten the duration of the painful crisis. Fructose-1,6-diphosphate (FDP) is a phosphorylated sugar that is present naturally in the human body. Its anaerobic metabolism proceeds by way of glycolysis and yields 4 mol ATP per mol of FDP which is twice the yield of glucose. If FDP can help the red cell resist the stimulus to form the sickle shape, by increasing the intracellular availability of ATP, then administration of FDP early in a crisis could shorten its duration. Four to eight subjects will be entered in stage two/three. In stage two/three subjects are given one infusion over thirty minutes q 6 hours over 72 hours. Stage three is an open label infusion q 6 hours for an additional 1-7 days. The duration of Stage 3 will vary from patient to patient. To date, we have enrolled 7 patients. We were recently notified that the sponsoring company has closed enrollment after reaching their desired number of study subjects from among the various centers, therefore we will not be enrolling any more patients on this protocol.

这项研究的目的是提供一种干预措施， 缩短痛苦危机的持续时间。 果糖-1，6-二磷酸 (FDP)是一种天然存在于人体内的磷酸化糖， 身体 它的厌氧代谢通过糖酵解进行， 4 mol ATP/mol FDP，这是葡萄糖产量的两倍。 如果FDP能够 帮助红细胞抵抗刺激形成镰刀形状， 增加ATP的细胞内可用性，然后施用 危机早期的FDP可以缩短危机持续时间。 四到八个科目 将进入第二或第三阶段。 在第二/三阶段， 每6小时输注一次，每次30分钟，每次72小时。第三阶段是 开放标签输注，每6小时一次，再持续1-7天。持续时间 第3阶段的治疗方法因患者而异。 到目前为止，我们已经招募了7名患者。 我们最近接到通知， 赞助公司在达到他们的期望后关闭了注册 来自各中心的研究受试者数量，因此我们将 不能再招募更多的病人了