Clinical trial NCT04154553: Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
Official title: Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adverse Drug Reaction
Therapy Failure
Keywords: pharmacogenetics
single nucleotide polymorphism
absorption, distribution, metabolism and excretion (ADME)
genotyping
pharmacogenetic testing
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel
name: Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich
name: Institut für Spitalpharmazie, Solothurner Spitäler AG, Baslerstrasse 150, 4600 Olten
First posted: 2019-11-06
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient population are patients experiencing TF and/or ADRs with substances known to be affected by genetic variants that influence their drug metabolism (pharmacokinetics) and/or the activity of the drug target (pharmacodynamics).

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.

Eligibility criteria: 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

Primary outcomes:
measure: pharmacogenetic profile
timeFrame: single time point assessment at Baseline (=Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Pharmaceutical Sciences, University Basel
Study officials:
affiliation: Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
name: Kurt Hersberger, Prof. Dr.
role: STUDY_CHAIR
affiliation: Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
name: Samuel Allemann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: