Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure

Last updated: May 9, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

EDTA Blood sample (4.9mL)

communication of test results

unstructured interview

Clinical Study ID

NCT04154553
2019-01452; ex19Hersberger
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New medication with known PGx association (preemptive)

  • Current medication with observation of adverse drug reactions probably linked todrugs with known PGx association (reactive)

  • Current medication with observation of therapy failure probably linked to drugs withknown PGx association (reactive)

  • Current and/or new medication and a family history of adverse drug reactions/therapyfailure probably linked to drugs with known PGx association

  • Signed informed consent; for patients < 14 years, the legal representative needs tosign the informed consent

Exclusion

Exclusion Criteria:

  • Insufficient German knowledge

  • Not able to personally visit to the study pharmacy

Study Design

Total Participants: 400
Treatment Group(s): 5
Primary Treatment: EDTA Blood sample (4.9mL)
Phase:
Study Start date:
October 15, 2019
Estimated Completion Date:
August 31, 2026

Study Description

Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. Health-related data of patients experiencing therapy failure (TF) or adverse drug reaction (ADR) is collected and will then be supplemented with pharmacogenetic testing during pharmaceutical care in a study pharmacy. The patient data (diagnoses, medications and results of pharmacogenetic testing) is harmonized in order to generate a compilation of case reports. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.

Connect with a study center

  • Department of Pharmaceutical Sciences, University Basel

    Basel, 4056
    Switzerland

    Active - Recruiting

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