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NCT Number: NCT06913998

The Prevalence and Impacts of Nudix Hydrolase 15 (NUDT15) Gene Variants in Taiwanese Inflammatory Bowel Disease

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Diseases Agranulocytosis Cytopenia Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Leukocyte Disorders Leukopenia Neutropenia Nudt15 Deficiency

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Jia-Feng Wu, MD,PhD

CONTACT

[email protected]

+886-2-2312-3456 ext. 270352

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are diagnosed with inflammatory bowel disease.

Exclusion criteria

  • Participants who refused to have blood test for NUDT15 gene evaluation.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia-Feng Wu, MD, PhD

CONTACT

[email protected]

+886-2-2312-3456 ext. 270352

Wei-Ting Chen, MD

CONTACT

[email protected]

+886-2-2312-3456 ext. 270352

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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