EUCTR2011-003121-94-NL进行中（未招募）不适用
A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by a High Dosing Regimen in Subjects with Inflammatory Bowel Disease (PROMISE) - P-Monofer-IBD-02
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
- 30
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. Subjects with age = 18 years
- •2. Subjects diagnosed with IBD either in remission or active
- •3. Hb < 12 g/dL for women and Hb < 13 g/dL for men
- •4. Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L
- •5. Willingness to participate after signing informed consent
- •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 5
排除标准
- •1. Patient judged by the physician to be in need of surgery due to Crohn's disease or ulcerative colitis within the next 2 months
- •2. Anaemia predominantly caused by factors other than IDA
- •3. Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- •4. Known hypersensitivity to any excipients of iron isomaltoside 1000
- •5. History of multiple allergies
- •6. Decompensated liver cirrhosis or active viral hepatitis (defined as Alanine Aminotransferase (ALAT) > 3 times upper limit of normal)
- •7. Acute and/or chronic infections
- •8. Body weight < 50 kg
- •9. Rheumatoid arthritis with symptoms or signs of active joint inflammation
- •10. Pregnancy and nursing. In order to avoid pregnancy, women have to be postmenopausal, surgically sterile, or use one of the following contraceptives during the whole study period and 5 days after the study has ended (i.e. 5 times plasma biological half-life of the investigational medicinal product): intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
- •11. Blood transfusion within the previous 12 weeks
- •12. Subjects with a history of asthma, allergic eczema, or other atopic allergy
- •13. Planned elective surgery during the study
- •14. Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range
- •15. Participation in any other clinical study within 3 months prior to Screening
- •16. IV iron treatment within 8 weeks prior to Screening
- •17. Oral iron treatment within 1 week prior to Screening
- •18. ESA treatment within 8 weeks prior to Screening
- •19. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study
研究者
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