PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL

儿科羟基脲 III 期临床试验

• 批准号: 6347007
• 负责人: ZORA R ROGERS
• 金额: $ 8.47万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6347007
• 关键词: blood disorder chemotherapy; chemoprevention; clinical research; human subject; human therapy evaluation; hydroxyurea; infant human (0-1 year); longitudinal human study; multiple organ failure; pathologic process; preschool child (1-5); sickle cell anemia

BABY HUG is a randomized, double-blind, placebo-controlled trial to determine if hydroxyurea can prevent the onset of chronic end organ damage in young children with sickle cell anemia. BABY HUG follows the successful completion of two other sickle cell disease trials, the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) and the Pediatric Hydroxyurea (PED HUG) Trial. Approximately 200 children, ages six months to 24 months, with sickle cell disease will be recruited to receive either hydroxyurea or placebo. The children will be screened at trial start-up for signs of abnormal brain, renal, pulmonary, and splenic function, and for developmental milestones. They will then be randomly assigned to receive hydroxyurea or a placebo and followed with yearly studies of chronic end organ damage of the major organ systems.

BABY HUG是一项随机、双盲、安慰剂对照试验，旨在确定羟基脲是否可以预防镰状细胞贫血幼儿慢性终末器官损伤的发生。BABY HUG是在成功完成另外两项镰状细胞病试验之后推出的，这两项试验分别是镰状细胞性贫血（MSH）中羟基脲的多中心研究和儿科羟基脲（PED HUG）试验。将招募大约200名患有镰状细胞病的6个月至24个月的儿童接受羟基脲或安慰剂治疗。在试验启动时，将对儿童进行筛查，以确定是否存在脑、肾、肺和脾功能异常的体征以及发育里程碑。然后，他们将被随机分配接受羟基脲或安慰剂，并随后进行主要器官系统慢性终末器官损伤的年度研究。