An open-label uncontrolled study of Immunopure with ulcerative colitis

JRCT ID: jRCTs032210590

Registered date:01/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ulcerative colitis
• Date of first enrollment: 01/02/2022
• Target sample size: 11
• Study type: Interventional

Intervention(s)

Leukocyte depletion therapy using Immunopure.
Treatment conditions are blood flow rate (QB) of 30 mL/min, total treatment time of 60 minutes, treatment volume of 1800 mL, and the procedure is performed at least once and up to 10 times.

Outcome(s)

• Primary Outcome: Amount of change in TNF-alpa before and after the first treatment
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Shibuya Tomoyoshi
• Source(s) of Monetary Support: NIKKISO CO., LTD.,NIKKISO CO., LTD.