Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• 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

OR

• Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study

Exclusion Criteria:

• 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