Trial Details
Not RecruitingBasic Information
| Clinical ID | c3258 |
|---|---|
| Identifier | JPRN-UMIN000004242 |
| Trial Title | Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial - Leukocytapheresis as Maintenance of Remission in Patients with Inflammatory Bowel Disease |
| Trial URL | Visit Original Page |
Study Information
| Study Results | Yes |
|---|---|
| Conditions | Ulcerative Colitis |
| Interventions | The patients assigned to the True arm, each receives one Adacolumn GMA session every 4 weeks for up to 48 weeks. The circuit line was covered securely by a curtain to blind both the physician and the patients on the type of treatment. The patients assigned to the sham arm, each receives one extracorporeal procedure with the circuit blood lines without the Adacolumn every 4 weeks for up to 48 weeks. The circuit line was covered securely by a curtain to blind both the physician and the patients on the type of treatment. The patients assigned to the control arm, each receives conventional medications without any extracorporeal circulation. |
Participant Information
| Sponsor | Department of Lower Gastroenterology, Hyogo College of Medicine |
|---|---|
| City | - |
| Country/Region | Japan |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | INFANT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE2 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | 2009-12-01 |