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Clinical trial

Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease

ID
Name
Thal in VEOIBD
Description
This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease
Trial arms
Trial start
2024-05-15
Estimated PCD
2025-12-31
Trial end
2026-12-31
Status
Not yet recruiting
Treatment
Thalidomide
thalidomide, dose 1.5-2.5mg/kg.d, orally taken before bedtime.
Size
40
Primary endpoint
endoscopic response rate
week 52
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample, stool samples and biopsy samples during endoscopy'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-04-24

1 organization

1 product

1 indication

Organization
Children's Hospital of Fudan University
Product
Thalidomide
Indication
Inflammatory Bowel Disease