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Recruiting

Thalidomide Therapy for VEOIBD

NCT06382519 · Children's Hospital of Fudan University
In plain English

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Official title
Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease
About this study
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.
Eligibility criteria
Inclusion Criteria: * diagnosed with inflammatory bowel disease * disease onset less than 6 years old * Pediatric Crohn's disease Activity Index (PCDAI)\>30 or Pediatric Ulcerative Colitis Activity Index (PUCAI)\>35 * patients and their legal guardians were willing to receive thalidomide treatment and participate in this study. Exclusion Criteria: * liver dysfunction * allergy to thalidomide * with Neuropathy * with thrombosis * thalidomide treatment in the previous 30 days * biologics treatment in the previous 8 weeks * not suitable participated in this study
Study design
Enrollment target: 40 participants
Age groups: child
Timeline
Starts: 2024-05-15
Estimated completion: 2026-12-31
Last updated: 2025-05-22
Interventions
Drug: Thalidomide
Primary outcomes
  • endoscopic response rate (week 52)
Sponsor
Children's Hospital of Fudan University · other
Contacts & investigators
ContactYing Huang · contact · yhuang815@163.com · 021-64931727
InvestigatorYing Huang · principal_investigator, Children's Hospital of Fudan University
All locations (1)
Lin WangRecruiting
Shanghai, Shanghai Municipality, China
Thalidomide Therapy for VEOIBD · TrialPath