EUCTR2010-023788-16-DK进行中（未招募）1 期
A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-anemic Patients Undergoing Elective or Sub-Acute CABG, Valve Replacement or a Combination thereof. - P-Monofer-CABG-01
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •In order to be suitable for inclusion in the study, the subjects meet the following criteria:
- •1. Men and women over 18 years.
- •2. Non-anemic Patients undergoing elective or subacute CABG, heart valve replacement or a combination thereof.
- •3. Women: Hb = 12.0 g / dl (7.45 mmol / l), men: Hb = 13.0 g / dl (8.1 mmol / l).
- •4. Willingness to participate after informed consent.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Individuals who meet one or more of the following criteria are unsuitable for inclusion in the study:
- •1. Participants who have received blood transfusion within 30 days prior to screening, and / or during the elective CABG or subacute, heart valve replacement, or a combination thereof.
- •2. Iron Overload or disturbances in utilization of iron (eg. Haemochromatosis and haemosiderosis)
- •3. Serum ferritin> 800 ng / ml.
- •4. Known hypersensitivity to any of the excipients of the study drug.
- •5. Multiple allergies in medical history.
- •6. Decompensated cirrhosis and hepatitis.
- •7. Alanine aminotransferase (ALT)> 3 times upper limit of normal.
- •8. Acute infections (after clinical assessment).
- •9. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •10. The patient is pregnant or breast-feeding. (To exclude pregnancy, women must be postmenopausal (at least 12 months since the last menstrual period) or sterilized or, for women of childbearing potential, use one of the following methods of contraception throughout the trial and for a period after termination representing at least 5 biological plasma half-lives of study drug: P contraceptives, intrauterine devices, parenteral contraception with depot effect (prolonged release formulation with progestin), subdermal implant, vaginal ring or transdermal patches).
- •11. Participation in another clinical trial, in a period prior to screening corresponding to less than 5 half-lives of the experimental drug.
- •12. Untreated Vitamin B12 or folate deficiency.
- •13. Another iv or oral iron therapy within 4 weeks prior to screening visit.
- •14. Erythropoietin treatment within 4 weeks prior to screening visit.
- •15. Impaired renal function defined by se-creatinine> 150µmol / l
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood DonorsFemale first-time bloddonors with iron deficiencyMedDRA version: 18.1Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851EUCTR2012-001529-28-DKPharmacosmos A/S
进行中（未招募）
不适用
Clinical Study on Amore-Male Sexual Wellness Drink of Sipwise Beverages in Sexual Wellness in MalesCTRI/2021/04/032849Sipwise Beverages Private Limited
进行中（未招募）
不适用
Clinical Study on Amore-Female Sexual Wellness Drink of Sipwise Beverages in Sexual Wellness in Females.CTRI/2021/04/032884Sipwise Beverages Private Limited
进行中（未招募）
2 期
A Trial of MitoQ for the Treatment of People with Parkinson's DiseaseParkinson's diseaseNeurological - DementiasACTRN12606000218594Antipodean Pharmaceuticals, Inc120
已完成
不适用
Clinical Study on Nichi Glucan to treat Diabetes with/without High Cholesterol and Lipid Levels.CTRI/2019/06/019855Enerflo Singapore Pvt Ltd157