Clinical trial NCT03719118: Tailored Therapeutic Model According to the Expression of Genes in Inflammatory Bowel Disease Patients
Official title: Effectiveness of Tailored Therapeutic Model According to the Expression of Genes Related to Immunomodulator-induced Myelosuppression in Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 215
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of myelosuppression
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Medical Research Institute
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Severance Hospital
name: Jae Hee Cheon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang JY, Park SJ, Jung ES, Jung SA, Moon CM, Chun J, Park JJ, Kim ES, Park Y, Kim TI, Kim WH, Cheon JH. Genotype-based Treatment With Thiopurine Reduces Incidence of Myelosuppression in Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2010-2018.e2. doi: 10.1016/j.cgh.2019.08.034. Epub 2019 Aug 22.