LBCTR2019080217已完成3 期
A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 至 65（—）
- 性别
- All
入选标准
- •Male or female study participants with sickle cell disease
- •- Participant has had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.
- •- Age 12 to 65 years
- •- Hemoglobin (Hb) =5.5 and =10.5 g/dL during screening
- •- For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF
排除标准
- •- More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
- •- Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a RBC transfusion for any reason within 60 days of signing the ICF
- •- Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)
- •- Hepatic dysfunction characterized by alanine aminotransferase (ALT)>4 x ULN
- •- Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit; calculated by the central laboratory) <30mL/min/1.73m2 or on chronic dialysis
研究者
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