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

Recruiting

• Conditions: Adverse Drug Reaction; Therapy Failure

• Registration Number: NCT04154553
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-15
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• New medication with known PGx association (preemptive)
• Current medication with observation of adverse drug reactions probably linked to drugs with known PGx association (reactive)
• Current medication with observation of therapy failure probably linked to drugs with known PGx association (reactive)
• Current and/or new medication and a family history of adverse drug reactions/therapy failure probably linked to drugs with known PGx association
• Signed informed consent; for patients < 14 years, the legal representative needs to sign the informed consent

Exclusion Criteria

• Insufficient German knowledge
• Not able to personally visit to the study pharmacy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacogenetic profile	single time point assessment at Baseline (=Day 0)	genotyping by laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes

Trial Locations

Locations (1)

Department of Pharmaceutical Sciences, University Basel; 🇨🇭 Basel, Switzerland