PREemptive Pharmacogenomic testing for Preventing Adverse drug REactions (PREPARE)

Phase 1

• Conditions: Adverse drug reactions; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-003325-41-AT
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified