Tailored Therapeutic Model According to the Expression of Genes in Inflammatory Bowel Disease Patients

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Medical Research Institute, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

20-80 years old
Patients who were diagnosed as having IBD based on clinical, endoscopic, radiographic, and histological assessments,
Patients who were planned to start thiopurines for the first time for the treatment of IBD.

Exclusion criteria

Patients who had previous use of thiopurine
Those who had abnormal laboratory findings prior to screening, including white blood cell (WBC) count < 3,000/μL, platelet (PLT) count < 100/μL, or elevation of aminotransferase more than twice the upper normal limits
Those who were diagnosed other infectious diseases at the time of screening or receiving antibiotics within the previous 7 days;
Those who were pregnant or lactating.

Treatment and study plan

genotyping for three genes (TPMT, NUDT15 and FTO)

Genetic

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

non-genotyping

Other

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.

Primary outcomes

Cumulative incidence of myelosuppression

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Effectiveness of Tailored Therapeutic Model According to the Expression of Genes Related to Immunomodulator-induced Myelosuppression in Inflammatory Bowel Disease Patients

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Oct 25, 2018
Registry last updated: Oct 25, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed