ong-term hepatotoxicity of azathioprine, 6-mercaptopurine and 6-thioguanine in IBD patients

Phase 4

Recruiting

• Conditions: hepatotoxicity; liver injury; 10017969; 10019654

• Registration Number: NL-OMON55534
• 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: Recruiting
• Sex: Not specified
• Target Recruitment: 114

Inclusion Criteria

Crohns disease or ulcerative colitis; age between 18 and 70 years; AZA , 6-MP
or 6-TG therapy for more than five years succesively; written informed consent

Exclusion Criteria

anaemia (Hb<6.5mmol/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>The primary endpoint is histological assessed NRH </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- liver stiffness assesed by Fibroscan (if available)<br /><br>- endosonographically determined liver and spleen size and liver appearance<br /><br>- Standard laboratory tests, including liver tests and full blood count.</p><br>