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

Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643071

Enrollment

Registered

2008-03-26

Start date

2006-09-30

Completion date

2008-05-31

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis, Tacrolimus, FK506, Treatment outcome

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 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.

Interventions

DRUGTacrolimus

Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 64 Years

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 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

Design outcomes

Primary

Measure	Time frame
Improvement of Disease Activity Index score (DAI score)	12 weeks

Secondary

Measure	Time frame
Patients impression	12 weeks
Amount of steroid	12 weeks
Changes of DAI score ( Total & each item)	2 weeks
Changes of clinical severity and symptom	12 weeks
Endoscopic finding	12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026