CTRI/2009/091/000983已完成3 期
A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia Study ID: P-Monofer-IBD-01 - Nil
Pharmacosmos AS0 个研究点目标入组 350 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 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
入排标准
入选标准
- •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.
排除标准
- •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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