Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis.
Not Applicable
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-UMIN000026767
- Lead Sponsor
- Iwate Medical University
- Brief Summary
We could not accumulate appropriate patients for this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who satisfy the folloing any conditions (1)disease extent: rectal (2)leukocyte count < 3,000mm3 or platelet count < 100,000mm3 (3)diagnosed with fulminant UC (4)with deep or wide range ulceration, serious bleeding, performation, or toxic megacolon. (5)With severe cardiovascular, liver, kidney, respiratory, metabolic, or nervous diseases (6)Taking Anti-Angiotensin Converting Enzyme Antibody (7)Newly administerd or increased dose of thioprines within 8 weeks prior to LCAP (8)Administerd biological agents or Cyclosporin within 8 weeks prior to LCAP
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response rate (Lichtiger score, DAI score)
- Secondary Outcome Measures
Name Time Method (1)comparison of the rate of DAI score improvement and mucosal healing with the past study. (2)UCEIS (3)change of the laboratory data (4)change of the dosage of corticosteroid. (5)the number and variety of adverse events