NCT06382519

Thalidomide Therapy for VEOIBD

Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 28 Days – 6 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease

Detailed description

Very early onset inflammatory bowel disease (VEOIBD) refers to IBD diagnosed before 6 years of age. VEOIBD comprises a distinct subset of pediatric IBD characterized by stronger genetic predisposition, predominant colonic involvement, more extensive inflammation, more severe course, and peculiar response to treatments. Previous studies have been demonstrated that thalidomide, an oral molecule with immunomodulatory, antiangiogenic, and TNF-suppressing properties, is an effective and safe treatment for adults and children with IBD refractory to conventional therapies. This study is aimed to evaluate the efficacy and tolerance of thalidomide in VEOIBD.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Thalidomide	thalidomide, dose 1.5-2.5mg/kg.d, orally taken before bedtime.

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-04-24
• Last updated: 2025-05-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study