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

Vifor (International) Inc.0 个研究点目标入组 423 人开始时间: 2007年10月23日最近更新: 2012年3月19日

研究概览

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•Patients of 18 years and above with iron deficiency anaemia (haemoglobin [Hb] <11 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 21-23.
•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

•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.

发起方