Hepatic histology of IBD patients following one year of combination therapy with allopurinol and low-dose conventional thiopurines

Phase 4

Completed

• Conditions: hepatotoxicity; liver injury; 10017969; 10019654

• Registration Number: NL-OMON37756
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

Combination therapy of allopurinol and low dose thiopurine therapy for more than 1 year
Crohn's disease or ulcerative colitis
Adult patients

Exclusion Criteria

Anaemia (Hb< 6.5 mmol/l), thrombopenia (<50x10*9/l), contra-indications to undergo a liver biopsy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Histological assessed nodular regenerative hyperplasia of the liver</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Histological changes after at least 1 year of combination therapy of<br /><br>allopurinol and low dose azathioprine and 6-mercaptopurine<br /><br>Endosonographically determined liver and spleen size and liver appearance<br /><br>Standard laboratory variables, including liver tests and full blood count<br /><br>Thiopurine metabolites: 6-TGN and 6-MMP determined in erythrocytes</p><br>