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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2022 |
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Main ID: |
NCT03093818 |
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Date of registration:
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06/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions
PREPARE |
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Scientific title:
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PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions |
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Date of first enrolment:
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March 20, 2017 |
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Target sample size:
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6950 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03093818 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Greece
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Italy
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Netherlands
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Slovenia
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Spain
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United Kingdom
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Contacts
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Name:
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George P. Patrinos, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Patras |
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Name:
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Gere Sunder-Plassmann, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Name:
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Munir Pirmohamed, MB ChB(Hons) PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Liverpool |
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Name:
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Jesse J. Swen, PharmD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Leiden University Medical Center |
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Name:
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Vita Dolzan, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Ljubljana |
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Name:
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Cristina Lucía Dávila Fajardo, PharmD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Andaluz Health Service |
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Name:
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Giuseppe Toffoli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro di Riferimento Oncologico |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject must be = 18 years old
- Subject must receive a first prescription (meaning no known prescription for this drug
in the preceding 12 months) for one or more of 42 drugs, for which a Dutch
Pharmacogenomic Working Group guideline is available, 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
- The study limit of enrolment (200 per arm, per 18-month block) for that drug has not
been reached
Exclusion Criteria:
- Subject has previous (direct-to-consumer, or clinical) genetic testing for a gene
important to the drug of inclusion
- Subject is pregnant or lactating
- Subject has a life expectancy estimated to be less than three months by treating
clinical team
- Duration of the drug of inclusion 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
- Subject is unable to consent to the study
- Subject is 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
- Subject 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.
- Subject has an estimated glomerular filtration rate (MDRD) of less than 15 ml/min per
1,73m2 in a subject with a functioning graft
- Subject has advanced liver failure (stage Child-Pugh C)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adverse Drug Reaction
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Intervention(s)
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Other: Pharmacogenomic testing
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Primary Outcome(s)
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Occurrence of a clinically relevant adverse drug reaction which is caused by the drug of inclusion. For oncology patients only hematological toxicities (grade 4-5) and non-hematological toxicities (grade 3-5) will be considered clinically relevant.
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Healthcare expenditure related to adverse events
[Time Frame: 18 months]
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Physician and pharmacist adherence to Dutch Pharmacogenomics Working Group guidelines
[Time Frame: 18 months]
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Attitudes towards and knowledge of pharmacogenomics
[Time Frame: 18 months]
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Incidence of dose adjustments
[Time Frame: 18 months]
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Incidence of discontinuation due to lack of efficacy
[Time Frame: 18 months]
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Incidence of drug discontinuation due to an adverse event
[Time Frame: 18 months]
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Quality of life
[Time Frame: 18 months]
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Secondary ID(s)
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668353 (U-PGx)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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