EUCTR2007-001517-41-BG进行中（未招募）不适用
Comparative study of the efficacy and tolerability of iron polymaltose complex film-coated tablets with folic acid (Maltofer® Fol film-coated tablets) compared to a generic iron sulphate product in pregnant women with iron-deficiency anaemia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 423
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients of 18 years and above with iron deficiency anaemia
- •(haemoglobin [Hb] <11.0 g/dL and ferritin =30 µg/L).
- •Mean corpuscular volume (MCV) <100 fL.
- •Gestational weeks 15–23. Patients will be stratified according to their
- •gestational age at inclusion in the following categories: 15-17, 18-20 and
- •Signed informed consent.
- •Patient is willing and able to comply with all study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Iron overload (e.g., haemochromatosis, haemosiderosis).
- •Disturbances in iron utilisation (e.g., lead anaemia, sidero achrestic
- •anaemia, thalassaemia).
- •Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or
- •haemolytic anaemia).
- •Anaemia related to blood loss, haemoglobinopathies, rheumatic and other
- •chronic diseases, autoimmune diseases, malignancies, bone marrow
- •diseases, enzyme defects and drug induced anaemia.
- •Known hypersensitivity to iron polymaltose complex film-coated tablets
- •(Maltofer® Fol film-coated tablets) or to iron sulphate or to any excipients.
- •Participation in another clinical study during the study and 4 weeks prior
- •to the study.
- •Preeclampsia.
- •Acute infectious diseases, parasitosis.
- •Tested positive for human immunodeficiency virus (HIV) or hepatitis B
- •surface (HBs) antigen as confirmed by prior assessment at beginning of
- •pregnancy (if prior assessments are not available, tests for HIV and HBs
- •have to be performed at screening).
- •History of alcohol or drug abuse.
- •Non-responder to oral iron products.
- •Severe diseases of liver, kidney, cardiovascular system, gastrointestinal
- •tract, psychological disorders and other which in the investigator’s opinion
- •makes participation in study unacceptable.
- •Intake of iron-containing preparations (including multi-vitamin
- •preparations containing iron), 14 days prior to the first dosing day or
- •intake of iron-containing preparations other than the study medication
- •during the study.
研究者
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