EUCTR2009-012544-16-AT进行中（未招募）不适用
A phase III, randomized, comparative, open-label study of intravenous ironoligosaccharide (Monofer®) administered by infusions or repeated bolusinjections in comparison with oral iron sulphate in inflammatory boweldisease subjects with iron deficiency anaemia - Iron Oligosaccharide to patients with IBD and iron deficiency anaemia
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
- 350
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
- •Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following
- •1. Men and women, aged more than 18 years.
- •2. Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score
- •of less than or equal to 5 on the Harvey-Bradshaw index for Crohn’s disease and a Mayo score (subscore without
- •endoscopy) of less than or equal to 6 for ulcerative colitis).
- •3. Hb <12.0 g/dL (7.45 mmol/L).
- •4. Transferrin saturation (TfS) <20 %.
- •5. Life expectancy beyond 12 months.
- •6. Willingness to participate after informed consent.
- •(Serum ferritin has been chosen not to be inclusion criteria as the cut-off level is highly dependent upon the
- •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) yes
- •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 any of the following criteria apply:
- •1. Anaemia predominantly caused by other factors than iron deficiency anaemia.
- •2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
- •3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes
- •or to iron sulphate).
- •4. Known hypersensitivity to any excipients in the investigational drug products.
- •5. Subjects with a history of multiple allergies.
- •6. Active Intestinal Tuberculosis.
- •7. Active Intestinal amoebic infections.
- •8. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper limit normal).
- •9. Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive
- •protein (CRP)).
- •10. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •11. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women
- •of child bearing potential must use one of the following contraceptives during the whole study period and after
- •the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product:
- •Contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal
- •implantation, vaginal ring, and transdermal patches.
- •12. Extensive active bleeding necessitating blood transfusion.
- •13. Planned elective surgery during the study.
- •14. Participation in any other clinical study within 3 months prior to screening.
- •15. Intolerance to oral iron treatment.
- •16. Untreated B12 or folate deficiency.
- •17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- •18. Erythrypoietin treatment within 8 weeks prior to screening visit.
- •19. Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.
- •20. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for
- •the completion of the study or place the patient at potential risk from being in the study. Example, Uncontrolled
- •Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
- •21. History of immunocompromise, including positive HIV test result.
研究者
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