An interventional study of genotyping for three genes (TPMT, NUDT15 and FTO) and non-genotyping in Inflammatory Bowel Diseases, sponsored by Yonsei University. Completed at 5 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
This study is a randomized controlled study conducted at five tertiary university hospitals. Patients who are 20-80 years old, diagnosed as having Inflammatory Bowel Disease(IBD) and who are planned to start thiopurines for the first time for the treatment of IBD are enrolled. Patients are assigned to the genotyping group or to the non-genotyping group. The patients who carry any heterozygotic variant among the three genes receive 50 mg azathioprine (AZA) or 25 mg of 6-mercaptopurine, while those who have any homozygotic variant are recommended to take other alternative drugs. The patients who do not carry any genetic variant or are assigned in non-genotyping group receive the standard dose of thiopurines based on the conventional approach.
Patients in the non-genotyping group receive the standard dose of thiopurines based on the conventional approach.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 215 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
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Exclusion Criteria:
The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO)
Genetic: genotyping for three genes (TPMT, NUDT15 and FTO)
Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping.
Other: non-genotyping
Patients who carry any heterozygotic variants receive 50 mg AZA or 25 mg 6-mercaptopurine (6-MP), while those who have any homozygotic variants are recommended to take other alternative drugs instead of thiopurines
Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. Conventional regimen starts with 50 mg of AZA, then the dose is increased by 25 mg in every 1-2 weeks to 2.0-2.5 mg/kg along with regular monitoring of general blood tests including WBC counts.
Cumulative incidence of myelosuppression
Time frame: 1 year
Plan to share: Undecided — Undecided yet.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Yonsei University