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

NCT04154553 RECRUITING

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.

Details

Lead sponsor	University Hospital, Basel, Switzerland
Status	RECRUITING
Enrolment	400
Start date	2019-10-15
Completion	2026-08

Conditions

• Adverse Drug Reaction
• Therapy Failure

Interventions

• Buccal swab
• EDTA Blood sample (4.9mL)
• Serum sample (7.5mL)
• communication of test results
• unstructured interview

Primary outcomes

• 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

Countries

Switzerland