drugset / Trial / NCT02929706

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

NCT02929706

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2016-07
Primary completion
2018-05
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 1 mg/kg
Subject Azathioprine Small molecule 1.5 mg/kg
Subject Azathioprine Small molecule 2 mg/kg
Subject Azathioprine Small molecule 2.5 mg/kg

Indications