EUCTR2008-003591-22-ES进行中（未招募）1 期
A multi-centre, randomised, prospective, single-blinded, controlled study to investigate the efficacy and safety of a standardised maintenance dosage regimen of intravenous ferric carboxymaltose (FERINJECT®) versus placebo in patients with iron deficiency caused by inflammatory bowel disease Estudio aleatorizado, multicéntrico, prospectivo, simple ciego y controlado para investigar la eficacia y la seguridad de una pauta de dosis de mantenimiento normalizada de carboximaltosa férrica (FERINJECT®) administrada por vía intravenosa en comparación con placebo en pacientes con déficit de hierro causado por enfermedad inflamatoria intestinal
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
- 200
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
- •Patients will be entered into this study only if they meet all of the following criteria:
- •Signed informed consent.
- •Non-anaemic patients treated in the FERGI CORRECTION study (Hb =12 g/dL female, =13 g/dL male), independent of ferritin value.
- •Normal levels of vitamin B12 and folic acid.
- •Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be entered into this study if they meet any of the following criteria:
- •Chronic alcohol abuse (alcohol consumption >20 g/day).
- •Presence of portal hypertension with oesophageal varices.
- •History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
- •Known hypersensitivity to FERINJECT®.
- •History of acquired iron overload.
- •Myelodysplastic syndrome.
- •Pregnancy or lactation.
- •Known active infection, clinically significant overt bleeding, active malignancy.
- •Known chronic renal failure.
- •Surgery with relevant blood loss (defined as Hb drop <2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.
- •Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) >3 times the upper limit of normal range.
- •Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Inability to fully comprehend and/or perform study procedures in the investigator’s opinion.
- •Participation in any other interventional study (except correction study) within 1 month prior to screening.
- •Body weight <35 kg.
- •Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.
研究者
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