PREemptive pharmacogenomic testing for Preventing Adverse drug REactions - PREPARE

eids Universitair Medisch Centrum0 个研究点目标入组 1,450 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1. Subject must be >= 18 years old
•2. Subject must receive a 1st prescription (meaning no known prescription for
•this drug in the preceding 12 months) for a drug of interest (Flecainide,
•Propafenon, Codeine, Tramadol, Capecitabine, Fluorouracil, Irinotecan,
•Tamoxifen, Tegafur, Acenocoumarol, Clopidrogel , Phenprocoumon, Warfarin,
•Citalopram , Escitalopram, Paroxetine, Sertraline, Venlafaxine, Amitriptyline,
•Clomipramine, Doxepine, Imipramine, Nortryptiline, Phenytoin, Metoprolol,
•Efavirenz, Flucloxacillin, Voriconazole, Aripiprazole, Haloperidol, Pimozide,
•Zuclopenthixol, Atorvastatin, Simvastatin, Azathioprine, Mercaptopurine,
•Tacrolimus, Thioguanine or Atomoxetine), which is prescribed to them in routine
•3. Subject is able and willing to take part and be followed-up for at least 12
•4. Subject is able to donate blood or saliva
•5. Subject has signed informed consent

•1. Previous (direct-to-consumer, or clinical) genetic testing for a gene
•important to the index drug
•2. Pregnancy or lactating
•3. Life expectancy estimated to be less than three months by treating clinical
•4. Duration of index drug total treatment length is planned to be less than
•seven consecutive days. A drug whose route of administration changes during the
•first seven days (e.g. intravenous to oral flucloxacillin) but whose total
•treatment duration is seven days or longer, is still eligible.
•5. For inpatients: hospital admission is expected to be less than 72 hours (to
•facilitate acting upon the PGX results)
•6. Unable to consent to the study
•7. Unwilling to take part
•8. Subject has no fixed address
•9. Subject has no current general practitioner
•10. Subject is, in the opinion of the Investigator, not suitable to participate
•in the study
•11. Patient has existing impaired hepatic or renal function for which a lower
•dose or alternate drug selection are already part of current routine care.
•This would not apply to any drugs specifically given to manage liver/renal
•impairment/transplantation.
•12. Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per
•1,73m2 in a subject with a functioning graft
•13. Patients with advanced liver failure (stage Child-Pugh C)

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