A novel treatment for ulcerative colitis with purastat

JRCT ID: jRCTs032230119

Registered date:07/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 07/06/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): The study drug (Purastat) will be applied to the rectum under the lower gastrointestinal endoscope. A total of 3 subjects will be treated once and the safety results will be analyzed. After seeking the opinion of the efficacy and safety committee, the study drug will be administered to the remaining subjects every 4 weeks for a total of 3 doses.

Outcome(s)

Primary Outcome

Percentage improvement from baseline in Mayo endoscopic score at 2, 3, and 4 endoscopies and percentage of remission
Improvement: decrease in Mayo endoscopic score from baseline
Remission: After allowing for a decrease from baseline. 0 or 1 in Mayo endoscopic score

Secondary Outcome

Improvement from baseline and remission rate of the following endpoints after treatment: Clinical severity (partial mayo score)
Clinical severity (partial mayo score)
Improvement: decrease of at least 1 point from baseline
Remission: total of 2 points or less and none of the subscores exceed 1
Pathological severity (NANCY index)
Improvement: decrease of at least 1 point from baseline
Remission:After allowing for a decrease from baseline. NANCY index of 0 or 1

Change from baseline in the following endpoints after treatment (difference between pre and post values)
:Hb, CRP, LRG

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Ulcerative colitis between the ages of 18 and 85 at the time of enrollment
2) Patients with mild to moderate disease on the Partial Mayo score
3) Patients who understand the contents of the consent document and give free written consent

Exclude criteria

1) Those with concurrent infectious or drug-induced enteritis
2) Pregnant or possibly pregnant
3) Those who are breast-feeding
4) Patients with abnormal blood coagulation function
5) Patients with severe organ failure
6)History of hypersensitivity to peptide or protein preparations6) Other patients who are deemed unsuitable for registration by the physician in charge.
7)Those who are deemed unsuitable for registration by the physician in charge

Related Information

• Primary Sponsor: Hashimoto Yu
• Secondary Sponsor: Uraoka Toshio
• Source(s) of Monetary Support: 3D MATRIX