CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,950 enrolled
Drug / intervention
Pharmacogenomic testingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093818
NCT03093818N/ACompleted
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PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions

J.J.Swen·interventional·Posted Mar 28, 2017·Updated Apr 19, 2024

In Brief

A clinical study evaluating Pharmacogenomic testing for Adverse Drug Reaction. Completed, enrolled 6,950 participants across 7 sites in 7 countries.

Detailed Summary

PREPARE is an international, prospective, multi-center, open, randomized, cross-over implementation study assessing the impact of pre-emptive pharmacogenomic testing, of a panel of actionable pharmacogenomic variants, on adverse event incidence. Additional outcomes include, healthcare expenditure, process indicators for implementation and provider adoption of pharmacogenomics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Drug Reaction
CountriesAustria, Greece, Italy, Netherlands, Slovenia, Spain, United Kingdom
CollaboratorsUniversity of Liverpool, Medical University of Vienna, Centro di Riferimento Oncologico - Aviano, Andaluz Health Service, University of Patras, University of Ljubljana, Karolinska Institutet, The Golden Helix Foundation, Royal Dutch Pharmacists Association (KNMP), Bio.Logis Genetic Information Management, University Paul Sabatier of Toulouse, Uppsala University, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), Federal Institute for Drugs and Medical Devices, St. Antonius Hospital

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartMar 20, 2017
Primary CompletionSep 30, 2020
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.3 years ago

Interventions

Pharmacogenomic testingother

The pharmacogenomic panel to be used incorporates 48 genetic variants for the following 13 "pharamacogenes": CYP2B6 (cytochrome P450), CYP2C19, CYP2C9, CYP2D6,CYP3A4, DPYD (dihydropyrimidine dehydrogenase), FVL (factor five Leiden), HLA-B (human leukocyte antigen), NUDT15 (Nudix hydrolase), SLCO1B1 (solute carrier organic anion transporter), TPMT (thiopurine methyltransferase), UGT1A1 (UDP-glucuronosyltransferase), and VKORC1 (vitamin K epoxide reductase complex).