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

Primary Purpose

Inflammatory Bowel Diseases

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

genotyping for three genes (TPMT, NUDT15 and FTO)

non-genotyping

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Severance Hospital
Ewha Medical Research Institute
Gangnam Severance Hospital
Korea University Hospital
Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Genotyping group

Non-genotyping group

Arm Description

The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO)

Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping.

Outcomes

Primary Outcome Measures

Cumulative incidence of myelosuppression

Secondary Outcome Measures

Full Information

NCT ID

NCT03719118

First Posted

October 23, 2018

Last Updated

October 23, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03719118

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

215 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genotyping group

Arm Type

Experimental

Arm Description

The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO)

Arm Title

Non-genotyping group

Arm Type

Active Comparator

Arm Description

Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping.

Intervention Type

Genetic

Intervention Name(s)

genotyping for three genes (TPMT, NUDT15 and FTO)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

non-genotyping

Intervention Description

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 Outcome Measure Information:

Title

Cumulative incidence of myelosuppression

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jae Hee Cheon, MD

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Ewha Medical Research Institute

City

Seoul

Country

Korea, Republic of

Facility Name

Gangnam Severance Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Korea University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Undecided yet.

Citations:

PubMed Identifier

31446180

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.

Results Reference

derived

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

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