ACTRN12613001347752RecruitingPhase 3
A randomized controlled trial of patients with IBD attending specialist clinics comparing de novo combination allopurinol and thiopurine versus thiopurine and placebo (ie standard practice) in terms of objective and clinical outcomes at six months
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Eastern Health
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •Age 18 - 80 years
- •Confirmed UC or CD diagnosis
- •Evidence for active disease as determined by baseline faecal calprotectin > or = 150µg/g and/or SCCAI > or = 4 (for UC) or HBI > or = 5 (for CD) at baseline screening visit
- •Require commencement of thiopurine therapy according to the patient’s treating physician
- •Stable doses of other IBD medications (standardized prednisolone weaning schedule only, maintenance biologics only, aminosalicylates at same dose only) for three months prior to enrolment
Exclusion Criteria
- •Unable to understand adequate English
- •Unable to give informed consent
- •Pregnancy or breastfeeding, or planning to become pregnant and breast feed during the study period
- •Medical comorbidities including concurrent sepsis, advanced chronic liver disease, malignancy, haematological disorders causing one or more cytopenias, or any other medical condition that the investigators feel would preclude study entry
- •Previous serious adverse reaction to a thiopurine or allopurinol
- •Low thiopurine methyltransferase (TPMT) activity at baseline visit (<5 U/ml) or TPMT homozygous genotype (TPMTL/ TPMTL) if previously tested
- •Unable to tolerate two weeks of either azathioprine 50mg or mercaptopurine 25mg (or half these doses if TPMT intermediate metaboliser or TPMT genotype 1*/3*)
- •Stage 4 or worse chronic kidney disease (an eGFR <30mL/min/1.73m2)
Investigators
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