PREemptive Pharmacogenomic testing for Preventing Adverse drug REactions - PREPARE

eiden University Medical Center0 个研究点开始时间: 2017年4月25日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•Subject must be = 18 years old
•Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 5, which is prescribed to them in routine care.
•Subject is able and willing to take part and be followed-up for at least 12 weeks
•Subject is able to donate blood or saliva
•Subject has signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Previous (direct-to-consumer, or clinical) genetic testing for a gene important to the index drug
•Pregnancy or lactating
•Life expectancy estimated to be less than three months by treating clinical team
•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.
•For inpatients: hospital admission is expected to be less than 72 hours (to facilitate acting upon the PGX results)
•Unable to consent to the study
•Unwilling to take part
•Subject has no fixed address
•Subject has no current general practitioner
•Subject is, in the opinion of the Investigator, not suitable to participate in the study
•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.
•Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1,73m2 in a subject with a functioning graft
•Patients with advanced liver failure (stage Child-Pugh C)

发起方

eiden University Medical Center