Thalidomide Therapy for VEOIBD

NCT ID: NCT06382519

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thalidomide

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

28 Days

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ying HUANG

Head of gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ying Huang

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lin Wang

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ying Huang

Role: CONTACT

021-64931727

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ying Huang

Role: primary

02164931727

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Thal in VEOIBD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.