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

Thiopurine-induced Leukopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929706
• Other study ID #: 20160704
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiang Gao, MD,PhD
• Phone: +86-020-38663423
• Email: hill.sea[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Leukopenia
• Thiopurine-induced Leukopenia

Intervention

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.

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of incidence of leucopenia ADR		1 year