se of Ajunctive Allopurinol in Azathioprine/6-Mercaptopurine Non-responders to Optimize 6-Thioguanine Nucleotide Production and Improve Clinical Outcomes in Patients with Inflammatory Bowel Disease (IBD).

Phase 3

Completed

• Conditions: Inflammatory Bowel Disease (IBD); Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12611000363987
• Lead Sponsor: The Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Adult inflammatory bowel disease patients (both Crohn’s disease and ulcerative colitis) taking thiopurine immunomodulators (azathioprine or 6- mercaptopurine) and fulfilling all 3 of the following criteria will be eligible:

A) Patient is not in a corticosteroid-free remission. Remission is defined as a Harvey Bradshaw Index (HBI) = 4 for Crohn's Disease (CD) and a Simple Clinical Colitis Activity Index (SCCAI) = 2 for Ulcerative Colitis (UC).

B) Patient is metabolizing thiopurines preferentially to produce 6-MMP instead of 6-TGN, with 6-MMP > 5,000 pmol/8 x 108 Red Blood Count (RBC) and 6-TGN < 235 pmol/8 x 108 Red Blood Count (RBC).

C) Patient has an adequate initial white blood cell count (WBC) to tolerate the anticipated White Blood Count (WBC) reduction after the addition of allopurinol: White Blood Count(WBC) = 4.5 x109/L.

Additionally, patients or their legal guardians must be willing and able to sign the written, informed consent document.

(Patients will be eligible for screening as soon as their metabolite profile identifies them to be shunting towards 6-MMP production, meaning a full 12 week trial of thiopurine therapy is not required prior to screening).

Exclusion Criteria

1. Suspected or known intolerance or allergy to allopurinol.

2. Concomitant therapy with the following immune modified and biologic agents will not be allowed within the following time intervals from the screening visit:
a. Cyclosporine- 4 weeks
b. Infliximab- 4 weeks
c. Any investigational study drug - 4 weeks.

3. Patients, or legal guardians, unable to give informed consent.
4. Pregnant and breast-feeding patients

5. TPMT heterozygous (TPMTH / TPMTL ) and TPMT homozygous low patients (TPMTL/ TPMTL ).

Study & Design

• Study Type: Interventional
• Study Design: Not specified