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

Primary Purpose

Thiopurine-induced Leukopenia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pre-genotype NUDT15 and optimize azathioprine dosage

About this trial

This is an interventional prevention trial for Thiopurine-induced Leukopenia

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm 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.

optimize the thiopurine use by coventional strategy without konwing NUDT15 genotype

Outcomes

Primary Outcome Measures

difference of incidence of leucopenia ADR

Secondary Outcome Measures

Full Information

NCT ID

NCT02929706

First Posted

October 8, 2016

Last Updated

May 11, 2018

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborators

Sir Run Run Shaw Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02929706

Brief Title

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

Official Title

Effectiveness of Thiopurine Dose Optimization by NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborators

Sir Run Run Shaw Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thiopurine-induced Leukopenia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

No Intervention

Arm Description

optimize the thiopurine use by coventional strategy without konwing NUDT15 genotype

Intervention Type

Genetic

Intervention Name(s)

Pre-genotype NUDT15 and optimize azathioprine dosage

Intervention Description

Primary Outcome Measure Information:

Title

difference of incidence of leucopenia ADR

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Gao, MD,PhD

Phone

+86-020-38663423

hill.sea@163.com

Facility Information:

Facility Name

The Sixth Affiliated Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510065

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kang Chao, MD,PhD

Phone

+86-20-38663423

chaokang@126.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

34563096

Citation

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.

Results Reference

derived

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

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