Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis.

Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis. - Efficacy and safety of LCAP with tacrolimus for ulcerative colitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026767

Enrollment

Registered

2017-04-01

Start date

2017-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: UC patients who satisfy the following all conditions (1) treated by tacrolimus (2) treated by the maximum dose 5-ASA (3) >=16 years old,=<85 years old when agree the participation of this research (4) Disease extent: total or left-sided

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Clinical response rate (Lichtiger score, DAI score)	—

Secondary

Measure	Time frame
(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	—

Countries

Japan

Contacts

Public ContactShunichi Yanai

Iwate Medical University Division of Gastroenterology, Department of Internal Medicine

syanai@iwate-med.ac.jp019-651-5111

Outcome results