EUCTR2019-003202-27-FR进行中（未招募）1 期
Assessment of the eFficacy, the onset-of-Action and the Safety of Tot'héma ® in adults with moderate iron deficiency anaemia - FAST
aboratoire Innotech Internationnal0 个研究点目标入组 270 人开始时间: 2020年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
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
- •Selection criterion
- •1. Patient with moderate anaemia defined as 8 g/dL = haemoglobin level = 9 g/dL on the last hematological test performed within 7 days before screening visit
- •Inclusion criteria
- •1. Adult men and women (=18 years)
- •2. Patient with a confirmation of moderate anaemia defined as 8 g/dL = haemoglobin level = 9 g/dL on the last hematological test performed within 7 days before inclusion visit
- •3. Patient with ferritin blood level < lower limit of laboratory standard for this biological parameter on the last hematological test performed within 7 days before inclusion visit
- •4. Patient who has read, understood, dated and signed the informed consent form
- •5. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates
- •6. Patient is registered with a national health insurance scheme or is covered by such a scheme
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Patient for whom an oral iron supplementation is not indicated or not recommended according to Investigator’s opinion
- •2. C-Reactive Protein > 10 mg/L on the last hematological test performed within 7 days before inclusion visit
- •3. Patient with benign or malignant neoplastic tumour
- •4. Patient presenting gastrointestinal disorders incompatible with study treatment compliance
- •5. Pregnant or breastfeeding woman
- •6. Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception – per investigator’s judgment
- •7. Patient with surgery scheduled to occur during the treatment period
- •8. Patient allergic or hypersensitive to any of the components of Tot'héma® ampoule
- •9. Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism
- •10. Patient with active digestive bleeding (such as digestive ulcer)
- •11. Patient having taken iron supplementation, iron-based IV therapy or mineral supplementation with iron within the 15 days prior to the inclusion visit (V2)
- •12. Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency
- •13. Patient with acute malaria crisis within 15 days prior to inclusion
- •14. Patient with a positive Faecal Occult Blood Test (FOBT)
- •15. Patient with HIV infection
- •16. Unreliable patients, including non-observant patients, patients with known alcoholism or drug abuse, or with a history of a serious psychiatric disorder, as well as patients who are reluctant to give informed consent or to comply with protocol requirement.
- •17. Patient with a family relationship to a person at the investigator’s site or at the Sponsor or at the CRO.
- •18. Participant involved in another interventional or observational clinical trial or who participated in another interventional clinical trial within four weeks before inclusion.
研究者
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