NCT01895218已完成3 期
A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Physical fatigue
研究概览
简要总结
The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
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
- •Women with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
- •Willingness to participate and signed the informed consent form
排除标准
- •Women aged < 18 years
- •Multiple births
- •Peripartum RBC transfusion
- •Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- •Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- •Women with a history of active asthma within the last 5 years or a history of multiple allergies
- •Known decompensated liver cirrhosis and active hepatitis
- •Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
- •Active acute infection assessed by clinical judgement
- •Rheumatoid arthritis with symptoms or signs of active joint inflammation
- •History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- •Not able to read, speak and understand the Danish language
- •Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
- •Any other medical condition that, in the opinion of the 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
研究组 & 干预措施
Iron isomaltoside 1000 (Monofer®)
Experimental
干预措施: Iron isomaltoside 1000 (Drug)
Standard medical Care
Active Comparator
干预措施: Standard medical Care (Other)
结局指标
主要结局
Physical fatigue
时间窗: From exposure to 12 weeks post-exposure
The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
次要结局
- Change in Hb concentration(From exposure to week 1, 3, 8 and 12 post-exposure)
- Change in concentrations of p-ferritin(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in Fatigue symptoms(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in postpartum depression symptoms(From exposure to 12 weeks post-exposure)
- Breastfeeding(From exposure to 12 weeks post-exposure)
- RCB transfusions(From exposure to 12 weeks post-exposure)
- Adverse drug reactions (ADRs)(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in concentrations of reticulocyte count(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in concentrations of transferrin saturation (TSAT)(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in concentrations of p-iron(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in concentrations of p-transferrin(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in concentrations of mean reticulocyte haemoglobin content (CHr)(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
- Change in haematology parameters(From exposure to day 3, week 1, 3, 8 and 12 post-exposure)
研究者
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