NCT02731534已完成3 期
Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia
Zeria Pharmaceutical0 个研究点目标入组 238 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 主要终点
- Maximum change in Hb value
研究概览
简要总结
The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with iron deficiency anemia
排除标准
- •Patients with anemia caused by conditions other than iron deficiency
- •Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
- •Patients with liver, kidney or circulatory system disease
- •Patients with a history or present illness that is a malignant tumor or autoimmune disease
- •Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
- •Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
研究组 & 干预措施
Z-213
Experimental
干预措施: Z-213 (Drug)
Saccharated Ferric Oxide
Active Comparator
干预措施: Saccharated Ferric Oxide (Drug)
结局指标
主要结局
Maximum change in Hb value
时间窗: 12 weeks
次要结局
- Proportion of subjects with normalization in Hb value(12 weeks)
- Change in Hb value(12 weeks)
- Proportion of responders(12 weeks)
- Proportion of cumulative dosage(12 weeks)
- Incidence of Adverse Events(12 weeks)
- Incidence of Adverse Drug Reactions(12 weeks)
- Dosing period and the number of doses(12 weeks)
研究者
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