Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis

Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis - Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005314

Enrollment

Registered

2011-03-25

Start date

2011-03-01

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

Patients receive GCAP eleven times at most, twice per a week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderate, severe and fulminating active ulcerative colitis

Exclusion criteria

Exclusion criteria: -Granulocyte count is not more than 2,000/mm3 -Serious infectious disease -Proctitis -Use of enema, suppository(Mesalazine,sulfasalazine stroids) within last 2 weeks -Introduce or increase the dosage of Mesalazine,sulfasalazine within the last 4 weeks -Introduce or increase the dosage of Steroids (intravenous infusion,oral) within the last 2 weeks -Use of total parental nutrition within last 4 weeks -Introduce or increase the dosage of Cycrosporine,tacrolimus within the last 4 weeks -Introduce or increase the dosage of 6-mercaptopurine, azathioprine within the last 4 weeks -Use of Infliximab with in last 6 weeks -Use of GCAP,LCAP with in last 8 weeks -History of colectomy

Design outcomes

Secondary

Measure	Time frame
-Remission rate(Mayo and CAI score) -Efficacy(Mayo and CAI score) -Expression of mRNA level of inflammatory cytokines and regenerating factors in mucosa	—

Primary

Measure	Time frame
Mucosal healing rate(Endoscopic Score of Mayo index)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026