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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42663

Enrollment

250

Registered

2015-10-26

Start date

2015-12-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

chronic inflammatory bowel disease Crohn's disease ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

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 = 2x upper normal range) • Reduced renal function at baseline (creatinine >= 2x upper normal range MDRD> 60ml / min)

Design outcomes

Primary

Measure	Time frame
- Hepatotoxicteit - T1 level of 6-MMPR Using a diagnostic test the following outcomes are calculated: Positive-predictive-value Negative predictive value Specificity Sensitivity	—

Secondary

Measure	Time frame
- Gastrointestinal symptoms (nausea, vomiting, anorexia) - Leukopenia - T1 level of 6-TGN	—

Countries

Netherlands

Outcome results