NCT06961435

An Analysis of the Relationship Between the Genetic Polymorphisms of Plasminogen Activator Inhibitor-1 and Ulcerative Colitis in Chinese Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 900 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

From January 2019 to February 2025, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the associations of plasminogen activator inhibitor-1 (PAI-1) gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of PAI-1 gene variations on the clinical response of vedolizumab (VDZ) treatment in UC patients.

Detailed description

From January 2019 to February 2025, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of PAI-1 gene polymorphisms between UC group and normal control group, as well as the effects of PAI-1 gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of UC patients.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
BIOLOGICAL	Vedolizumab	Intravenous injection of VDZ (300mg/time) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of VDZ every 8 weeks to maintain treatment.

Timeline

• Start date: 2019-01-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2025-05-08
• Last updated: 2025-05-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study