CTRI/2011/12/002304已完成3 期
A Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer®) administered by 500 mg IV bolus injection or 1000 mg intravenous infusion to subjects with Inflammatory Bowel Disease - none
Pharmacosmos AS0 个研究点目标入组 16 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
- 16
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 Crohnâ??s disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis).
- •3.Weight above 50 kg.
- •4.Hb <12 g/dL.
- •5.Transferrin saturation (TfS) <20%.
- •6.Life expectancy beyond 12 months by investigatorâ??s judgment.
- •7.Willingness to participate after informed consent
排除标准
- •1.Anaemia predominantly caused by factors other 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).
- •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 normal limit).
- •9.History of immunocompromise and/or history of Hepatitis B and/or C.
- •10.Active acute or chronic infections [assessed by clinical judgement and if deemed necessary by investigator, supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)].
- •11.Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •12.Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), 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 (5 days) of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
- •13.Extensive active bleeding necessitating blood transfusion
- •14.Planned elective surgery during the study
- •15.Participation in any other clinical study within 3 months prior to screening
- •16.Untreated Vitamin B12 or folate deficiency
- •17.Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit
- •18.Erythropoietin treatment within 4 weeks prior to screening visit
- •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. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
研究者
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