Pre-genotype NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease

Effectiveness of Thiopurine Dose Optimization by NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02929706

Enrollment

400

Registered

2016-10-11

Start date

2016-07-31

Completion date

2018-08-31

Last updated

2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thiopurine-induced Leukopenia

Brief summary

NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory bowel disease (IBD) cohort.The present study aim to explor the following questions:can optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine use and optimise dosage according to the genotype.While the subjects in the control group follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.

Detailed description

We included patients diagnosis of IBD (\>18 yrs old) with indication of the use of thiopurine.Group A (intervention): AZA dose optimization by testing for NUDT15 R139C- testing results will be informed.Group B (control):AZA dose optimization according to standard guideline - testing results will not be informed.The participants will be followed for 9 month. The incidence of adverse events and efficacy will be analyzed.

Interventions

GENETICPre-genotype NUDT15 and optimize azathioprine dosage

Pre-genotype NUDT15 and optimize azathioprine dosage.The wild type use azathioprine(Imuran，2-2.5mg/kg/d),the CT genotype use half dose of azathioprine（Imuran，1-1.5mg/kg/d).The TT genotype avoid use of azathioprine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

Healthy volunteers

Inclusion criteria

* diagnosis of IBD with indication of the use of thiopurine

Exclusion criteria

* Contraindication of thiopurine * Previous use of thiopurine * co-treatment with 5-ASA or allopurinol

Design outcomes

Primary

Measure	Time frame
difference of incidence of leucopenia ADR	1 year

Countries

China

Contacts

Primary ContactXiang Gao, MD,PhD

hill.sea@163.com+86-020-38663423

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026