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

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.

Conditions

• Adverse Drug Reaction
• Therapy Failure

Interventions

DIAGNOSTIC_TEST

Buccal swab

Pharmacogenetic panel testing is conducted by Stratipharm with the DNA of the buccal swab. TaqMan® polymerase chain reaction is proceeded to express the genetic information. Stratipharm is a product offered by Humatrix Aktiengesellschaft (AG). It consists of a laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes, which code for transport proteins, metabolizing enzymes, or drug targets.

DIAGNOSTIC_TEST

EDTA Blood sample (4.9mL)

Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.

DIAGNOSTIC_TEST

Serum sample (7.5mL)

blood sample to determine the actual levels of the compound in patients on medication assumed to be associated to an observed ADR (phenotype).

OTHER

communication of test results

Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician

OTHER

unstructured interview

One and six months after the communication of test results, the study center will make a phone call to the patient for an unstructured interview in order to gather information about potential outcomes

Sponsors & Collaborators

• Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel

  collaborator UNKNOWN

• Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich

  collaborator UNKNOWN

• Institut für Spitalpharmazie, Solothurner Spitäler AG, Baslerstrasse 150, 4600 Olten

  collaborator UNKNOWN

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Kurt Hersberger, Prof. Dr. · Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel

• Samuel Allemann, Prof. Dr. · Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-15

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• Switzerland

Study Locations