Status:
COMPLETED
Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
16-64 years
Phase:
PHASE3
Brief 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.
Detailed 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 we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00643071
Start Date
September 1 2006
End Date
May 1 2008
Last Update
August 26 2014
Active Locations (6)
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1
Chūbu, Japan
2
Hokkaido, Japan
3
Kansai, Japan
4
Kanto, Japan