drugset / Trial / NCT02929706
Pre-genotype NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease
Unknown
400 enrolled
Sixth Affiliated Hospital, Sun Yat-sen University
Sir Run Run Shaw Hospital · collab
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
Publications
- Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
- Chao K, Huang Y, Zhu X, Tang J, Wang X, Lin L, Guo H, Zhang C, Li M, Yang Q, Huang J, Ye L, Hu P, Huang M, Cao Q, Gao X. Randomised clinical trial: dose optimising strategy by NUDT15 genotyping reduces leucopenia during thiopurine treatment of Crohn's disease. Aliment Pharmacol Ther. 2021 Nov;54(9):1124-1133. doi: 10.1111/apt.16600. Epub 2021 Sep 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |