The Associations of Plasminogen Activator Inhibitor-1 Gene Polymorphisms With Crohn's Disease in Chinese Patients

NCT06935942 | Completed FDA Drug

• 1 other identifier: SAHoWMU-CR2025-01-212
• Study Type: observational
• Target: 906
• Locations: 1 country
• Sites: 1

Brief Summary

From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of PAI-1 gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• the genotypes of PAI-1

  multiplex polymerase chain reaction-ligase detection reaction technique

  Baseline

Secondary Outcomes (1)

• clinical response of ustekinumab (UST) treatment

  week 8

Study Arms (2)

CD patients

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous (SC) dose of 90 mg UST at 8 weeks. Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

Biological: Ustekinumab - Standard Dosage

normal controls

no biological agents treatment

Interventions

Ustekinumab - Standard Dosage BIOLOGICAL

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous dose of 90 mg UST at week 8.Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

CD patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between CD group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood.

You may qualify if:

• diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

You may not qualify if:

• rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Extract whole genome DNA from peripheral blood

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: January 1, 2020
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)