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

Sun Yat-sen University

Status: Unknown

Conditions: Thiopurine-induced Leukopenia

Treatments: Genetic: Pre-genotype NUDT15 and optimize azathioprine dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT02929706

20160704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

intervention group

Experimental group

Description:

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.

Treatment:

Genetic: Pre-genotype NUDT15 and optimize azathioprine dosage

control group

No Intervention group

Description:

optimize the thiopurine use by coventional strategy without konwing NUDT15 genotype