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

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55534

Enrollment

114

Registered

2009-09-07

Start date

2009-09-29

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatotoxicity liver injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: anaemia (Hb

Design outcomes

Primary

Measure	Time frame
The primary endpoint is histological assessed NRH	—

Secondary

Measure	Time frame
- liver stiffness assesed by Fibroscan (if available) - endosonographically determined liver and spleen size and liver appearance - Standard laboratory tests, including liver tests and full blood count.	—

Countries

Netherlands

Outcome results