EUCTR2016-001772-30-IT进行中（未招募）1 期
Clinical burden of anemia in inflammatory bowel disease: Role of Iron Deficiency And iron Replacement Therapy, therapeutic trial - NA
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO0 个研究点目标入组 300 人开始时间: 2021年6月1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
- 300
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
- •Have given written informed consent to participate
- •Be aged 18 years and over
- •Have IBD and IDA with or without inflammation
- •Have a BMI >16
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Patients with hypersensitivity to the IMPs, to other iron containing products and to sucrose or benzil alcohol
- •Pregnancy, lactation and women of childbearing potential (WOCBP) not willing to use highly efficient contraceptive measures
- •history of erythropoietin treatment within 4 weeks prior to recruitment;
- •alcohol abuse, liver cirrhosis, active hepatitis or signs of liver disease with a Child-Pugh class B or C;
- •chronic renal failure stage 4 or higher
- •major surgery in the previous 3 months;
- •significant overt bleeding,
- •acute severe anemia with hemodynamic instability;
- •active malignancy
- •any hematologic disease causing anemia;
- •known active infection;
- •known human immunodeficiency virus, HCV and HBV infections;
- •evidence of tubercular (TB) infection
研究者
相似试验
Unknown
3 期
Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic TrialInflammatory Bowel DiseasesIron Deficiency AnemiaNCT04587141Fondazione IRCCS Policlinico San Matteo di Pavia300
Unknown
4 期
Anemia in Inflammatory Bowel DiseaseBowel Diseases, InflammatoryAnemiaNCT02760940Federal University of Juiz de Fora200
已完成
不适用
Clinical Burden of Anemia in Inflammatory Bowel Disease (RIDART1)AnemiaNCT02872376Fondazione IRCCS Policlinico San Matteo di Pavia740
终止
3 期
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF TherapyInflammatory Bowel DiseaseNCT01428843Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives60
已完成
不适用
Relationship between anemia and small bowel lesion in dialysis patientssmall intestinal lesionJPRN-UMIN000035821Osaka Medical College39