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

Hepatic histology of IBD patients following one year of combination therapy with allopurinol and low-dose conventional thiopurines - 1 years NRH of allopurinol and AZA/6MP

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37756
Enrollment
22
Registered
2012-04-04
Start date
2012-06-21
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

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Anaemia (Hb

Design outcomes

Primary

MeasureTime frame
Histological assessed nodular regenerative hyperplasia of the liver

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)