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

May 11, 2018 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiang Gao, MD,PhD
  • Phone Number: +86-020-38663423
  • Email: hill.sea@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510065
        • Recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
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.
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.
No Intervention: control group
optimize the thiopurine use by coventional strategy without konwing NUDT15 genotype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference of incidence of leucopenia ADR
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborators

Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

October 8, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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