Iron therapy in IBD patients with normal levels of haemoglobin and chronic fatigue

ISTITUTO CLINICO HUMANITAS0 个研究点开始时间: 2012年3月7日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•- Man and women, 18 years of age or older. - Female subjects must utilize a highly effective method of birth control throughout the study. - At least 12-month history of IBD. - Inactive Crohn’s disease or Ulcerative colitis (HB: <5, Mayo Clinical Score: = 2) since at least 6 months - Chronic fatigue symptoms (Mfi-20 > 13). - Concurrent stable doses of 5-aminosalicylate, azathioprine, methotrexate or anti TNFa. - Iron deficiency: ferritin< 100 ng/ml or ferritin 100-300 ng/ml when transferring saturation (TSAT) < 20%.
•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 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Known hypersensitivity to iron sucrose or to its excipients. - Pregnancy: women with childbearing potential must not become pregnant during the study. - Clinically active IBD and /or C-reactive protein >2.5. - Comorbidity possibly resulting in (additional) fatigue (e.g., kidney or adrenal insufficiency, autoimmune diseases, malignancy, depression, a recent viral infection, or psychotrauma psychic diseases, included depression. - Anaemia (Hb:< 12.5 in male and < 11.5 in female

发起方

ISTITUTO CLINICO HUMANITAS