NCT06935942

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 906 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

From January 2020 to January 2025, a total of 311 CD patients and 495 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of PAI-1 were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of PAI-1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Multi-model logistic regression was used to explore the effect of PAI-1 gene variation on the clinical response of CD patients in the treatment of UST at week 8.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	Ustekinumab - Standard Dosage	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study