NCT02929706

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thiopurine-induced Leukopenia

Interventions

Type	Name	Description
GENETIC	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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-05-01
• Completion: 2018-08-01
• First posted: 2016-10-11
• Last updated: 2018-05-17

Locations

1 site across 1 country: China