NCT03719118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

October 23, 2018

Last Update Submit

October 23, 2018

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of myelosuppression

    1 year

Study Arms (2)

Genotyping group

EXPERIMENTAL

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

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

Non-genotyping group

ACTIVE COMPARATOR

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

Other: non-genotyping

Interventions

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

Genotyping group
non-genotypingOTHER

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.

Non-genotyping group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Severance Hospital

Seoul, 03722, South Korea

Location

Ewha Medical Research Institute

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31446180DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Genotype

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Jae Hee Cheon, MD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

January 1, 2016

Primary Completion

September 30, 2018

Study Completion

October 5, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

KR(5)