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

Not Applicable

• Conditions: Thiopurine-induced Leukopenia
• Interventions: Genetic: Pre-genotype NUDT15 and optimize azathioprine dosage

• Registration Number: NCT02929706
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-10
• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-11
• Primary Completion: 2018-05
• Last Update Submitted: 2018-05-11
• Last Update Posted: 2018-05-17
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Pre-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.

Primary Outcome Measures

Name	Time	Method
difference of incidence of leucopenia ADR	1 year

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China