NCT01497145已完成2 期
A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety of KRN321 in Adult Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The proportion of subjects achieving a erythroid response
研究概览
简要总结
This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
- •Serum EPO concentration ≤ 500 mIU/mL
- •Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations
排除标准
- •Previous bone marrow or hematopoietic stem cell transplantation
- •History of pure red cell aplasia
- •Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
- •Those who have increased risk of thrombosis during the study
- •Uncontrolled diabetes mellitus
- •Concurrent active infection or chronic inflammatory disease
- •Other causes of anemia
- •Previous or concurrent active malignancies other than MDS
结局指标
主要结局
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety
次要结局
未报告次要终点
研究者
研究点 (2)
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