Inflammatory Bowel DiseasesNCT06382519
Thalidomide Therapy for VEOIBD
An observational study of Inflammatory Bowel Diseases, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease Read more about this study
- Who is it for?
- Ages 28 days to 6 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with very early onset inflammatory bowel disease who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lin Wang
Shanghai, Shanghai Municipality, 201102
Ying Huang, 02164931727, yhuang815@163.com
About this study
Official title: Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease
This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease
Read the 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
- Being tested
- Thalidomide
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
thalidomide, dose 1.5-2.5mg/kg.d, orally taken before bedtime.
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic response rate
The Simple Endoscopic Score for Crohn Disease decreased 50% compared with baseline OR Mayo score 0-1 (higher scores mean a worse outcome)
Measured: week 52
Secondary outcomes (6)
clinical response rate
Inflammatory bowel disease mainly contains Crohn's disease and ulcerative colitis. If the patient was diagnosed with Crohn's disease, we use the Pediatric Crohn's disease Activity Index score to evaluate the clinical response, which is defined as Pediatric Crohn's disease Activity Index decreased more than 12.5 compared with baseline. If the patient was diagnosed with ulcerative colitis, we use the Pediatric Ulcerative Colitis Activity Index score to evaluate the clinical response, which is defined as Pediatric Ulcerative Colitis Activity Index score decreased more than 20 compared with baseline. The Pediatric Crohn's disease Activity Index score varies from 0 to 100 and the Pediatric Ulcerative Colitis Activity Index score varies from 0 to 85 (higher scores mean a worse outcome).
Measured: week8, week26, week52
biomarker remission rate
biomarker remission is defined as not only C-reactive protein less than 8mg/L, but also fecal calprotectin less than 100ug/g.
Measured: week8, week26, week52
growth development
weight and height Z score (higher scores mean a better outcome)
Measured: week52
clinical remission rate with steroid-free
If the patient was diagnosed with Crohn's disease, this outcome is defined as the Pediatric Crohn's disease Activity Index score less than 10 without steroid treatment. If the patient was diagnosed with ulcerative colitis, this outcome is defined as the Pediatric Ulcerative Colitis Activity Index score less than 10 without steroid treatment.
Measured: week26
adverse event
The rate of the potential adverse events were monitored during the intervention.
Measured: within one year
treatment persistence
the time between the start and the last dose of thalidomide
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start15 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382519
- Sponsor's protocol ID
- Thal in VEOIBD
- Status last verified
- May 2025
- First submitted
- 11 Apr 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06382519
- Acronym / sponsor ID
- Thal in VEOIBD
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 days to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with very early onset inflammatory bowel disease who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- liver dysfunction
- allergy to thalidomide
- with Neuropathy
- with thrombosis
- thalidomide treatment in the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomidethalidomide, dose 1.5-2.5mg/kg.d, orally taken before bedtime. | Drug | – |
Primary outcome
endoscopic response rate
Time frame: week 52
The Simple Endoscopic Score for Crohn Disease decreased 50% compared with baseline OR Mayo score 0-1 (higher scores mean a worse outcome)
6 secondary outcomes
clinical response rate
Time frame: week8, week26, week52
biomarker remission rate
Time frame: week8, week26, week52
growth development
Time frame: week52
clinical remission rate with steroid-free
Time frame: week26
adverse event
Time frame: within one year
treatment persistence
Time frame: within one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Huang principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Huang (021-64931727, yhuang815@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic response rate (time frame: week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.