eukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial

Phase 2

• Conditions: lcerative Colitis

• Registration Number: JPRN-UMIN000004242
• Lead Sponsor: Department of Lower Gastroenterology, Hyogo College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-12-01
• Study Start: 2010-09-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria included therapy with cyclosporine, tacrolimus earlier than 4 weeks prior to start study, infliximab earlier than 8 weeks prior to start study. Also, patients with having granulocytopenia (neutrophil count <2,000/micro-liter), serious heart or kidney disease, coagulation disorder, history of hypersensitivity to heparin or heparin-induced thrombocytopenia, hypotension (<90/65mmHg) or uncontrolled hypertension (>180/ 120mmHg, despite medical therapy; anemia lower than 9.0g/dl in hemoglobin, and women being or wishing pregnant, were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is a non-relapsing ratio at 48 weeks, relapse is defined if a patient have to start PSL or increase the ongoing dosage, Clinical Activity Index (CAI) ≥ 5.

Secondary Outcome Measures

Name	Time	Method
To evaluate mucosal UC activity, colonoscopy is done in all patients before and after remission induction therapy. Also, patients who achieve sustained remission at week 48 have colonoscopy at the end of study.