search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number22959
- NTR NumberNTR5547
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2015
- Secondary IDs15-T-148 
- Public TitleValidation hepatotoxicity-predictor-algorithm for patients with thiopurine drugs; A prospective observational study
- Scientific TitleValidation hepatotoxicity-predictor-algorithm for patients with thiopurine drugs; A prospective observational study
- ACRONYM
- hypothesisThe 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
- Healt Condition(s) or Problem(s) studiedThiopurines, Hepatotoxicity
- 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)
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2015
- planned closingdate1-apr-2017
- Target number of participants200
- Interventionsno interventions. prospective observational study
- Primary outcomehepatotoxicity
- Secondary outcomeleukopenia
GI-complaints
- Timepointsfollow up is 12 weeks
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. S.A.W. van Moorsel
- CONTACT for SCIENTIFIC QUERIESdrs. S.A.W. van Moorsel
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Zuyderland Medical Center, Heerlen
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD8-okt-2015 - 4-feb-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl