Validation hepatotoxicity-predictor-algorithm for patients with thiopurine drugs; A prospective observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26269

Enrollment

200

Registered

2015-10-08

Start date

2015-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

thiopurine drugs hepatotoxicity

Interventions

no interventions. prospective observational study

Eligibility

Inclusion criteria

Inclusion criteria: • age > 18 years • patient agrees to take part in the study (signed informed consent) • Diagnosis: IBD (UC, CD, IBD-UC) • patients that start with thiopurine drugs (azathioprine or mercaptopurine)

Exclusion criteria

Exclusion criteria: • Known hypersensitivity to active substance or any of the excipients • Leukocytes 60ml / min)

Design outcomes

Primary

Measure	Time frame
hepatotoxicity	—

Secondary

Measure	Time frame
leukopenia GI-complaints	—

Contacts

Public ContactS.A.W. van Moorsel

Zuyderland MC

f.vanmoorsel@orbisconcern.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)