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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719118
• Other study ID #: 4-2015-0812
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 5, 2018

Study information

• Verified date: October 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 5, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Genetic:
• genotyping for three genes (TPMT, NUDT15 and FTO)
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

Other:
• non-genotyping
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.

Locations

Country	Name	City	State
Korea, Republic of	Ewha Medical Research Institute	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of myelosuppression		1 year