JPRN-jRCT2080221677未知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
Kyowa Hakko Kirin Co., Ltd.0 个研究点开始时间: 2011年12月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
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
研究者
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