EUCTR2011-001593-25-HU进行中（未招募）1 期
An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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.Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
- •2.Life expectancy beyond 18 months by Investigator’s judgement.
- •3.Willingness to participate after informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
- •2.Any major protocol deviation in Lead-in Study.
- •3.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 (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches].
- •4.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.
- •5.Patients with a Harvey-Bradshaw Index > 8 or Partial Mayo Score (excluding Endoscopy Sub-score) > 6 at End of Study Visit of Lead-in Study.
研究者
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This long-term follow-up study will assess the ability to maintain a stable haemoglobin (iron containing molecule in the blood) and safety profile of iron isomaltoside 1000 (Monofer®) in Inflammatory Bowel Disease subjects with iron deficiency anemia.EUCTR2011-001593-25-ATPharmacosmos A/S50
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