RecruitingNCT06382519

Thalidomide Therapy for VEOIBD

Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease


Sponsor

Children's Hospital of Fudan University

Enrollment

40 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 28 DaysMax Age: 6 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

DRUGThalidomide

thalidomide, dose 1.5-2.5mg/kg.d, orally taken before bedtime.


Locations(1)

Lin Wang

Shanghai, Shanghai Municipality, China

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NCT06382519


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