Inflammatory Bowel DiseasesNCT06913998
The Prevalence and Impacts of Nudix Hydrolase 15 (NUDT15) Gene Variants in Taiwanese Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Neutropenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Neutropenia, Nudt15 Deficiency
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Dec 2023to Nov 2026
- How long will I take part?
- 2 Years
- 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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study included participants who are diagnosed with inflammatory bowel disease at National Taiwan University Children's Hospital and agree to have blood test for NUDT15 gene evaluation.
Who may be able to join
- Participants who are diagnosed with inflammatory bowel disease.
Who cannot join
- Participants who refused to have blood test for NUDT15 gene evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jia-Feng Wu, MD,PhD, +886-2-2312-3456 ext. 270352, wjf@ntu.edu.tw
About this study
The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.
Read the detailed description
In inflammatory bowel disease (IBD), thiopurines play an important role in maintenance of steroid-free remission but possess risk of life-threatening neutropenia, which is associated with gene variants of NUDT15 in Asians. In order to better incorporate thiopurines in clinical practice, the investigators aim to summarize the prevalence and impacts of NUDT15 variation in IBD in Taiwan. The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.
- Conditions
- Inflammatory Bowel Diseases, Neutropenia, Nudt15 Deficiency
- Medical subject headings
- Inflammatory Bowel Diseases, Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutropenia
Neutropenia is defined as absolute neutrophil count <1500/microL, and severe neutropenia is defined as absolute neutrophil count <500/microL.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start27 Dec 2023
- Primary completionJan 2026 (estimated)
- Study completionNov 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 National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913998
- Sponsor's protocol ID
- 202309124RINB
- Status last verified
- Nov 2024
- First submitted
- 30 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Impacts of Nudix Hydrolase 15 (NUDT15) Gene Variants in Taiwanese Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06913998
- Acronym / sponsor ID
- 202309124RINB
- Conditions
- Inflammatory Bowel Diseases, Neutropenia, Nudt15 Deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.
Detailed description
In inflammatory bowel disease (IBD), thiopurines play an important role in maintenance of steroid-free remission but possess risk of life-threatening neutropenia, which is associated with gene variants of NUDT15 in Asians. In order to better incorporate thiopurines in clinical practice, the investigators aim to summarize the prevalence and impacts of NUDT15 variation in IBD in Taiwan. The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study included participants who are diagnosed with inflammatory bowel disease at National Taiwan University Children's Hospital and agree to have blood test for NUDT15 gene evaluation.
Key inclusion criteria (1 listed)
- Participants who are diagnosed with inflammatory bowel disease.
Key exclusion criteria (1 listed)
- Participants who refused to have blood test for NUDT15 gene evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neutropenia
Time frame: 2 years
Neutropenia is defined as absolute neutrophil count <1500/microL, and severe neutropenia is defined as absolute neutrophil count <500/microL.
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 8 Apr 2025.
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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.
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 and Neutropenia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 8 Apr 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 Taiwan. 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 Wei-Ting Chen, MD (+886-2-2312-3456 ext. 270352, DBE98@tepch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutropenia (time frame: 2 years). 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 8 Apr 2025.