Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
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This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in responders.
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Ages Eligible for Study:
16 Years to 64 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Moderate to severe refractory UC patients
Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding
Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction
Mild or fulminant type
Renal failure patients, hepatic failure patients
Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
Patients who received LCAP or GCAP within 2 weeks prior to entry
Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry.
Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.