NCT00802139已完成4 期
A Prospective, Randomized, Multi-centered Trial to Compare the Efficacy and Safety of Intravenous Iron Sucrose (Venoferrum®) With Oral Iron Acetyl-transferrin Hydroglycerin (Bolgre®) in Pregnant Women With Iron Deficiency Anemia
JW Pharmaceutical3 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Change of plasma hemoglobin level
研究概览
简要总结
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •30~32nd weeks pregnant women aged over 18 years
- •Women who have Hb level of more than 10.0g/dL a week before study initiation
- •Patients who agree to participate in this study in writing
排除标准
- •Patients who have participated in another clinical study in recent 3 months
- •Patients who are prone to acute hemorrhage during pregnancy
- •Patients who have shown intolerance to iron therapy
- •Hemolytic anemia, hemoglobinopathies (thalassemia, sickle cell)
- •Bleeding tendency, hypersplenism
- •Chronic heart failure, Class II-IV heart disease, uncontrolled arterial hypertension (DBP ≥ 115mmHg), deep vein thrombosis, thrombocytosis, chronic renal disease
- •Severe renal failure patients (2.5 times or more higher plasma creatinine level than high limit of normal state)
- •Patients with severe liver dysfunction (2.5 times or more higher AST or ALT than high limit of normal state)
- •Patients with doubled or more CK level than high limit of normal state
- •Patients who are regarded as ineligible for this study by investigator
研究组 & 干预措施
venoferrum group
Experimental
干预措施: venoferrum(iron sucrose) (Drug)
Bolgre group
Active Comparator
干预措施: Bolgre (Iron acetyl-transferase) (Drug)
结局指标
主要结局
Change of plasma hemoglobin level
时间窗: 5 week
次要结局
- Target Hb achievement rate(11g/dL), Transferrin saturation(%), Ferritin(ng/mL), TIBC(ug/dL), MCV(fl), MCH(pg) and change in reticulocyte counts(5 week)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
不适用
Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic ShockSeptic ShockNCT05726825Hannover Medical School274
撤回
不适用
AmnioExcel® Plus vs SOC in the Management of Diabetic Foot UlcersDiabetic Foot UlcerNCT05024656Integra LifeSciences Corporation
尚未招募
2 期
A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux EsophagitisReflux EsophagitisEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesGastroesophageal RefluxEsophagitisNCT05604261Xuanzhu Biopharmaceutical Co., Ltd.156
终止
不适用
PArtial REbreathing for Migraine With Aura 1Migraine With AuraNCT05546385Rehaler142
已完成
3 期
Study of Efficacy and Safety of MEXIDOL® in Ischemic Stroke TherapyIschemic StrokeNCT02793687Pharmasoft150