Ciclosporin and azathioprine treatment in severe ulcerative colitis: a double-blind controlled trial to evaluate short and long-term outcome

niversity of Nottingham (UK)0 个研究点目标入组 280 人开始时间: 2005年7月20日最近更新: 2015年1月13日

适应症

试验速览

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•Patients admitted to hospital with severe ulcerative colitis, who have been treated with intravenous corticosteroids for between 48 hours and 5 days, and still fulfil Truelove and Witts criteria for severe colitis.

•1. Positive stool culture for enteric pathogens or Clostridium difficile
•2. Cholesterol level below 3 mM
•3. Greater than 5 days treatment with intravenous corticosteroids
•4. Crohn's disease
•5. Bowel perforation, or obstructive symptoms not due substantially to active inflammation
•6. Pregnancy or lactation, or inability to take contraception during the trial
•7. Treatment with ciclosporin tacrolimus or infliximab in the three months prior to study entry
•8. Serious intercurrent infection or other active disease within three months prior to treatment
•9. History of concurrent malignancy, or evidence of colonic dysplasia
•10. Known human immunodeficiency virus (HIV) infection
•11. Toxic dilation of the colon or clinical condition where colectomy is highly likely
•12. Significant renal impairment (serum creatinine above 130 uM)
•13. Uncontrolled hypertension

发起方

niversity of Nottingham (UK)