EUCTR2012-005783-10-DK进行中（未招募）不适用
A Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Red Blood Cell transfusion in Women with Severe Postpar-tum Iron Deficiency Anaemia - P-Monofer-PP-02
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
- 20
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
- •A subject will be eligible for inclusion in the study if they fulfil the following criteria:
- •1.PPH > 1000 mL
- •2.Hb = 5.5 and = 8.0 g/dL (= 3.5 and = 5.0 mmol/L)
- •3.Willingness to participate and signed the informed consent form
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will NOT be eligible for inclusion in this study if they fulfil any of the following criteria:
- •1.Women aged < 18 years
- •2.Multiple births
- •3.Peripartum RBC transfusion
- •4.Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- •5.Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- •6.Women with a history of active asthma within the last 5 years or a history of multiple allergies
- •7.Known decompensated liver cirrhosis or active hepatitis
- •8.Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syn-drome (defined according to Dansk Selskab for Obstetrik og Gynækologi guidelines)
- •9.Active acute infection assessed by clinical judgement
- •10.Rheumatoid arthritis with symptoms or signs of active joint inflammation
- •11.History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- •12.Not able to read, speak and understand the Danish language
- •13.Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
- •14.Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
研究者
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