Liver toxicity of azathioprine and 6-mercaptopurine in IBD patients.

Liver toxicity of azathioprine and 6-mercaptopurine in IBD patients. - Liver toxicity of azathioprine and 6-mercaptopurine

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31453

Enrollment

120

Registered

2008-05-29

Start date

2008-06-10

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Nodular regenerative hyperplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: IBD patients 18 years or older who have been treated at least 5 years with azathioprine and/or 6-mercaptopurine who give permission for ultrasound guided liverbiopsy and MRI

Exclusion criteria

Exclusion criteria: anaemia (Hb 1.5), ascites. exclusioncriteria for MRI: pacemaker, ICD, metal intracerebral clips, known allergy for contrast agents that are used, claustrophobia.

Design outcomes

Primary

Measure	Time frame
prevalence of NRH (histologically) with percutaneous liver biopsy prevalence of NRH with MRI, uing the Seiderer protocol, sensitivity and specificity compared to histology.	—

Secondary

Measure	Time frame
Secundary goals are the correlation between NRH and the cumulative dose of azathioprin and 6-mercaptopurin and the correlation between NRH and the 6-TGN levels. Other secundary goals are the correlation between radiological and histological findings and correlation between radiological or histological findings and blood constituents (livertests and thrombocytes).	—

Countries

Netherlands

Outcome results