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

Astellas

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00643071

F506-CL-1108

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 patients

Sex

All

Ages

16 to 64 years old

Volunteers

No Healthy Volunteers

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

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