PREemptive Pharmacogenomic Testing for Preventing Adverse Drug REactions

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.

Conditions

• Adverse Drug Reaction

Interventions

OTHER

Pharmacogenomic testing

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).

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Centro di Riferimento Oncologico - Aviano

  collaborator OTHER

• Andaluz Health Service

  collaborator OTHER_GOV

• University of Patras

  collaborator OTHER

• University of Ljubljana

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• The Golden Helix Foundation

  collaborator UNKNOWN

• Royal Dutch Pharmacists Association (KNMP)

  collaborator UNKNOWN

• Bio.Logis Genetic Information Management

  collaborator UNKNOWN

• University Paul Sabatier of Toulouse

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

  collaborator OTHER

• Federal Institute for Drugs and Medical Devices

  collaborator UNKNOWN

• St. Antonius Hospital

  collaborator OTHER

• J.J.Swen

  lead OTHER

Principal Investigators

• Jesse J. Swen, PharmD PhD · Leiden University Medical Center

• Munir Pirmohamed, MB ChB(Hons) PhD · University of Liverpool

• Gere Sunder-Plassmann, MD · Medical University of Vienna

• Giuseppe Toffoli, MD · Centro di Riferimento Oncologico

• Cristina Lucía Dávila Fajardo, PharmD PhD · Andaluz Health Service

• George P. Patrinos, PhD · University of Patras

• Vita Dolzan, MD PhD · University of Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-20

Primary Completion

2020-09-30

Completion

2021-05-01

Countries

• Austria
• Greece
• Italy
• Netherlands
• Slovenia
• Spain
• United Kingdom

Study Locations