Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis

Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis - Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021896

Enrollment

Registered

2016-04-13

Start date

2014-05-09

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

Ulcernative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with moderate to severe ulcerative colitis

Exclusion criteria

Exclusion criteria: Patients who contraindicate for tacrolimus. Patients who contraindicate for tacrolimus.

Design outcomes

Primary

Measure	Time frame
Efficacy rate after 12 weeks(partial DAI score and Lichtiger score)	—

Secondary

Measure	Time frame
1, Remission rate after 12 weeks 2, DAI score and Lichtiger score after 12 weeks 3, Endoscopic remission rate after 12 weeks(mucosal healing) 4, The condition of reactivation(Presence or absence of reactivation and time to reactivation) 5, Safety(Presence or absence of adverse eventes and abnormality of laboratory values) 6, Efficacy of steroid taper 7, Influences efficacy of factor for patient background and therapy 8, Relationship with gene polymorphism of CYP3A5 and efficacy of tacrolimus and trough levels	—

Measure

Time frame

1, Remission rate after 12 weeks 2, DAI score and Lichtiger score after 12 weeks 3, Endoscopic remission rate after 12 weeks(mucosal healing) 4, The condition of reactivation(Presence or absence of reactivation and time to reactivation) 5, Safety(Presence or absence of adverse eventes and abnormality of laboratory values) 6, Efficacy of steroid taper 7, Influences efficacy of factor for patient background and therapy 8, Relationship with gene polymorphism of CYP3A5 and efficacy of tacrolimus and trough levels

—

Countries

Japan

Contacts

Public ContactFumihito Hirai

Fukuoka University Chilushi Hospital Department of Gastroenterology

fuhirai@cis.fukuoka-u.ac.jp092-921-1011

Outcome results