An open-label uncontrolled study of Immunopure with ulcerative colitis
- Conditions
- ulcerative colitisD003093
- Registration Number
- JPRN-jRCTs032210590
- Lead Sponsor
- Shibuya Tomoyoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 11
1)The participant is over 20 years old and under 80 years old.
2)The participant was diagnosed with ulcerative colitis 3 months before screening.
3) The participant with steroid dependence / resistance / unwished is moderate.
4)The participant provides written informed consent before the commencement of any study related procedure.
1)The participant is lactating, breastfeeding, or pregnant.
2)The participant has a serious liver disease or heart disease.
3)The participant has a low white blood cell count (less than 3,000 / mm3).
4)The participant has low platelet counts (less than 100,000 / mm3).
5)The participant has a history of hypersensitivity to anticoagulants.
6)The participant is judged to be inappropriate as a participant by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in TNF-alpa before and after the first treatment
- Secondary Outcome Measures
Name Time Method Safety (adverse events, clinical examination values, vital signs), Remission rate, Effective rate, change Change in Lichtiger index score, Cchange in CRP , and LRG, leukocyte, platelet rRemoval rate and change in leukocyte and platelet at baseline, 15-min and the end of treatment, and Rremoval rate and change in inflammatory cytokine at baseline, 15-min and the end of treatment