Febuxostat-thiopurine combination therapy in patients with moderately severe inflammatory bowel disease

Phase 1

• Conditions: inflammatory bowel disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12612001107819
• Lead Sponsor: Prof Tim Florin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

i) moderately severe IBD
ii) patients who accumulate methylated thiopurine metabolites

Exclusion Criteria

i) allergic reaction to 6-mercaptopurine
ii) not so severe as to fit PBS criteria for anti-TNFa treatments
iii) TPMT < 0.3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
therapeutic drug monitoring of drug efficacy using concurrent monitoring of total 6-thioguanine (6TG) methyl 6-mercaptopurine (me6MMP) in red blood cells (method of Dervieux and Bouleau)<br> together with the ratio of mean red blood cell volume : white blood cell count in peripheral venous blood[1,2,4 weeks]

Secondary Outcome Measures

Name	Time	Method
drug combination efficacy by -<br><br>clinical measures of disease activity: Harvey Bradshaw for Crohn's or Simple severity of colitis index for ulcerative colitis as appropriate, together with C-reactive protein and requirement for and dose of steroid[1,2,4 weeks]