The primary objective of the study is to validate a hepatotoxicity predictor algorithm in IBD patients who are starting treatment with azathioprine or mercaptopurine. This algorithm contains the determinants BMI, age, gender, and T1 level of 6-MMPR…
ID
Bron
Aandoening
thiopurine drugs
hepatotoxicity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
hepatotoxicity
Achtergrond van het onderzoek
This prospective observational study focus on validating the algorithm that predicts how likely it is that hepatotoxicity occurs in a patient who starts with azathioprine or mercaptopurine. The study will be conducted in collaboration with the Gastroenterology and Liver doctors and Gastroenterology Liver nurses from Zuyderland Medical Center and other participating hospitals.
Doel van het onderzoek
The primary objective of the study is to validate a hepatotoxicity predictor algorithm in IBD patients who are starting treatment with azathioprine or mercaptopurine. This algorithm contains the determinants BMI, age, gender, and T1 level of 6-MMPR. This algorithm is compiled using retrospective data from the study by Wong et al. For the validation prospective data is collected.
* Wong D.R., Thiopurines in Inflammatoory Bowel Diseases; New perspectives to optimise safety and efficacy, Chapter 7: Thiopurine-induced hepatotoxicity, 2015
Onderzoeksopzet
follow up is 12 weeks
Onderzoeksproduct en/of interventie
no interventions. prospective observational study
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5257 |
| NTR-old | NTR5547 |
| Ander register | : 15-T-148 |