EUCTR2015-003069-28-DK进行中（未招募）1 期
An open label trial evaluating the pharmacokinetics and safety of an intravenously administered single dose of Feramyl® 200 mg, 500 mg or 1500 mg vs. Ferinject® 500 mg in patients suffering from anaemia following cardiac surgery - Feramyl® PK and safety trial in patients suffering from anaemia following cardiac surgery
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- All
入选标准
- •1. Signed informed consent given prior to any trial procedures performed
- •2. Male or female aged = 18years at the time of signing the informed consent
- •3. Cardiac surgery performed and the subject has a low mortality risk according to Euro SCORE II < 6 %
- •4. Anaemia defined as haemoglobin:
- •- a.200 mg and 500 mg treatment groups: Below 13.0 g/dl (8.1 mmol/L) for males and 12.0 g/dl (7.3 mmol/L) for females and TSAT < 20 %
- •- b.1500 mg treatment group: Below 8.1 g/dl (5 mmol/L) if bodyweight is 70-74 kg; Below 8.5 g/dl (5.3 mmol/L) if body weight is 75-79 kg; Below 9.4 g/dl (5.8 mmol/L) if body weight is 80-84 kg; Below 9.8 g/dl (6.1 mmol/L) if body weight is 85-89 kg; Below 10.3 g/dl (6.4 mmol/L) if body weight is 90 kg or above
- •5. Blood pressure < 145 mmHg/95 mmHg
- •6. Willing and able to comply with the protocol according to the investigators judgement
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Body weight less than 50 kg
- •2.Currently experiencing an ongoing bleeding >50 ml/h for the last 3 hours before start of infusion
- •3.Unexplained anaemia or anaemia due to other aetiology; untreated Vitamin B12 or folate deficiency or hemoglobinopathy
- •4.Anticipated medical need for erythropoetin during the trial period
- •5.Known hypersensitivity to iron, hydroxyethylstarch or any excipients of the investigational products
- •6.Known drug allergy, immunological or inflammatory diseases, severe asthma, eczema or atopy
- •7.Preoperative anaemia treatment within 3 months prior to screening
- •8.Ferritin > 800 ng/ml
- •9.Imminent dialysis
- •10.Infection (T > 38.5°C or subject on non-prophylactic antibiotics)
- •11.Chronic liver disease or screening ALAT or ASAT above three times the upper limit of the normal range
- •12.Renal disease defined as proteinuria and s-creatinine > 150 µmol/l
- •13.Primary hematologic disease
- •14.Known malignant disease/cancer within the last 5 years
- •15.Insulin treated diabetes
- •16.Rheumatoid arthritis with active joint inflammation
- •17.History (current or past) of drug or alcohol abuse
- •18.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods as required by local regulations and practice
- •19.Known or suspected of not being able to comply with the trial protocol (e.g. due to psychological disorders or other conditions).
- •20.Receipt of any investigational medicinal products within the last 90 days
研究者
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