PACTR202208531640912尚未招募2 期
A Phase 2/3, Randomized, Multicenter Study of GBT021601 Administered Orally to Participants with Sickle Cell Disease and an Open- Label Pharmacokinetics Study in Pediatric Participants with Sickle Cell Disease.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Part A, Part B, and Part C:
- •Male or female with SCD
- •Participants with stable hemoglobin value
- •Participants on HU should be on stable dose for at least 90 days prior to signing ICF
- •Participants with SCD ages 12 to 65 years, inclusive
- •Participants with more than or equal to 2 and less than or equal to 10 VOCs inclusive, within 12 months of Screening
排除标准
- •Part A, Part B, and Part C:
- •Participants who had more than 10 VOC within 12 months of screening
- •Female participant who is breastfeeding or pregnant
- •Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1
- •Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF
研究者
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