Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
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Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.
Condition or disease
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.
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Layout table for eligibility information
Ages Eligible for Study:
16 Years to 64 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Severe refractory UC patients who meets the following criteria
Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding
Steroid resistant or dependent
Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study
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