Inflammatory Bowel DiseasesNCT03719118
Tailored Therapeutic Model According to the Expression of Genes in Inflammatory Bowel Disease Patients
A study testing genotyping for three genes (TPMT, NUDT15 and FTO) and non-genotyping in people with Inflammatory Bowel Diseases, run by Yonsei University at 5 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- genotyping for three genes (TPMT, NUDT15 and FTO) and non-genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 1 Jan 2016to 5 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Severance Hospital
Seoul, 03722
Ewha Medical Research Institute
Seoul
Gangnam Severance Hospital
Seoul
Korea University Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Effectiveness of Tailored Therapeutic Model According to the Expression of Genes Related to Immunomodulator-induced Myelosuppression 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- genotyping for three genes (TPMT, NUDT15 and FTO), non-genotyping
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-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.
| Study group | Role | What they receive |
|---|---|---|
| Genotyping group | Experimental | The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO) Receives: 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. Receives: Other: non-genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of myelosuppression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jan 2016
- Primary completion30 Sep 2018
- Study completion5 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Hee Cheon, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719118
- Sponsor's protocol ID
- 4-2015-0812
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet.
Publications
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.
PubMed 31446180
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tailored Therapeutic Model According to the Expression of Genes Related to Immunomodulator-induced Myelosuppression in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT03719118
- Acronym / sponsor ID
- 4-2015-0812
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotyping group | Experimental | Genetic: genotyping for three genes (TPMT, NUDT15 and FTO)The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO) |
| Non-genotyping group | Active comparator | Other: non-genotypingPatients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Genetic | Genotyping group |
| non-genotypingPatients 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. | Other | Non-genotyping group |
Primary outcome
Cumulative incidence of myelosuppression
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Derived from this study: PubMed 31446180Chang 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.
- Individual participant dataSharing planned: Undecided. Undecided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Hee Cheon, MD principal investigator
Severance Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genotyping for three genes (TPMT, NUDT15 and FTO) and non-genotyping in people with Inflammatory Bowel Diseases, run by Yonsei University at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of myelosuppression (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03719118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.