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

Completed

• Conditions: chronic inflammatory bowel disease; Crohn's disease; ulcerative colitis; 10017969

• Registration Number: NL-OMON42663
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

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

• Known hypersensitivity to active substance or any of the excipients
• Leukocytes <3 x 10^9 /l on baseline
• Hepatic impairment at baseline (AST, ALT, y Gt or AF >= 2x upper normal range)
• Reduced renal function at baseline (creatinine >= 2x upper normal range MDRD> 60ml / min)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Hepatotoxicteit<br /><br>- T1 level of 6-MMPR<br /><br><br /><br>Using a diagnostic test the following outcomes are calculated:<br /><br>Positive-predictive-value<br /><br>Negative predictive value<br /><br>Specificity<br /><br>Sensitivity</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Gastrointestinal symptoms (nausea, vomiting, anorexia)<br /><br>- Leukopenia<br /><br>- T1 level of 6-TGN</p><br>