EUCTR2017-002452-87-GB进行中（未招募）1 期
A randomized, double-blinded, comparative trial comparing the incidence of hypophosphatemia in relation to repeated treatment courses of iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease - hypophosphatemia following IV iron therapy in IDA due to IBD
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
- 120
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
- •Participants included:
- •1. are = 18 years
- •2. have been diagnosed with IBD
- •3 have a hemoglobin (Hb) value < 13 g/dL
- •4. have a body weight = 50 kg
- •5. have a serum ferritin value > 100 ng/mL
- •6. have an eGFR (estimated Glomerular filtration rate) of = 65 mL/min/1.73 m2
- •7. have a serum phosphate value of > 2.5 mg/dL
- •8. are when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly
- •9. have provided written informed consent to participate in the study
- •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 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Exclusion criteria included:
- •1. Anaemia (low red blood cell count) mainly caused by factors other than inflammatory bowel disease (IDA) according to Investigator's judgment
- •2. Haemoglobin (Hb) = 10 g/dL and body weight < 70 kg
- •3. Hemochromatosis or other iron storage disorders
- •4. Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
- •5. Previous serious hypersensitivity reactions to any intravenous (IV) iron compounds
- •6.Treatment with IV iron, erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, chemotherapy and/or an investigational drug within the last 30 days prior to screening
- •7. Planned surgery during the trial period
- •8.Alanine Aminotransferase (ALAT) and/or Aspartate Aminotransferase (ASAT) > 3 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)
- •9. Surgery under general anaesthesia within the last 30 days prior to screening
- •10. Any non-viral infection within the last 30 days prior to screening
- •11. Alcohol or drug abuse within the past 6 months
- •12. Untreated hyperparathyroidism
- •13. Kidney transplantation
- •14. Conditions that interfere with the participant's ability to understand the requirements of the trial and/or presumable non-compliance
- •15. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the participant’s disease management at risk or may result in the participants being unable to comply with the trial requirements
- •16. Pregnant or nursing women, and women of childbearing potential not using highly efficient contraception.
研究者
相似试验
进行中（未招募）
1 期
Occurrence of hypophosphataemia in patients with iron deficiency anemia caused by inflammatory bowel disease after treatment with iron isomaltoside or iron carboxymaltoseEUCTR2017-002452-87-DKPharmacosmos A/S120
进行中（未招募）
1 期
Occurrence of hypophosphataemia in patients with iron deficiency anemia caused by inflammatory bowel disease after treatment with ironisomaltoside or iron carboxymaltoseEUCTR2017-002452-87-DEPharmacosmos A/S120
进行中（未招募）
1 期
Occurrence of hypophosphataemia in patients with iron deficiency anemia caused by inflammatory bowel disease after treatment with iron isomaltoside or iron carboxymaltoseIron deficiency anemia in subject with inflammatory bowel diseaseMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: LLTClassification code 10079322Term: Anaemia of chronic inflammationSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2017-002452-87-SEPharmacosmos A/S120
进行中（未招募）
1 期
Occurrence of hypophosphataemia in patients with iron deficiency anemia caused by inflammatory bowel disease after treatment with ironisomaltoside or iron carboxymaltoseEUCTR2017-002452-87-ATPharmacosmos A/S120
尚未招募
4 期
Comparative trial of two gels in mild to moderate acneCTRI/2019/08/020563KPC Medical College and Hospital