LBCTR2019010169招募中1 期
Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
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
- Open (masking not used)
入排标准
- 年龄范围
- 0 至 5（—）
- 性别
- All
入选标准
- •Key inclusion criteria include
- •Estimated glomerular filtration rate (eGFR) at Screening = 30 mL/min normalized to 1.73 m2 body surface area (BSA).
- •Average spot Uox-to-creatinine ratio at Screening above 2 times the 95th percentile for age based on Matos et al, 1999:
- •o > 0.44 mol/mol in participants < 6 months
- •o > 0.34 mol/mol in participants from 6 months to <12 months
- •o > 0.26 mol/mol in participants 12 months to < 2 years
- •o > 0.20 mol/mol in participants from 2 to < 3 years and
- •o > 0.16 mol/mol in participants from 3 to 5 years
排除标准
- •Key exclusion criteria include
- •Renal or hepatic transplantation (prior or planned within the study period)
- •Plasma oxalate (Pox) > 30 µmol/L at Screening
- •Documented evidence of clinical manifestations of severe systemic oxalosis (including preexisting retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
研究者
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