NCT03055559已完成不适用
Oral Iron Repletion With Globifer Forte® After 12 Weeks of Treatment
Gedeon Richter Slovakia, s.r.o.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte
研究概览
简要总结
The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥ 18 ≤ 60 years of age
- •Signed written informed consent
- •Hb ≥ 8 ≤ 10g/dl for
排除标准
- •History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
- •Known hypersensitivity to oral iron preparations.
- •Diseases, which an iron supplementation is not allowed or contraindicated.
- •Patients on current oral or intravenous iron supplementation
- •History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
- •Patients who have had iron supplementation within the last 30 days.
- •Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.
- •Inability to comprehend study protocol
- •Participation in another clinical trial (currently or within the last 30 days)
结局指标
主要结局
Proportion of patients with a clinical relevant increase of the haemoglobin level treatment with GlobiFer Forte
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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