Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Insufficient German knowledge
Not able to personally visit to the study pharmacy
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Buccal swab
Diagnostic testPharmacogenetic 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.
EDTA Blood sample (4.9mL)
Diagnostic testGenetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.
Serum sample (7.5mL)
Diagnostic testblood sample to determine the actual levels of the compound in patients on medication assumed to be associated to an observed ADR (phenotype).
communication of test results
Other interventionCertified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician
unstructured interview
Other interventionOne 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
pharmacogenetic profile
genotyping by laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes
Time frame
single time point assessment at Baseline (=Day 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel
Collaborator
Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich
Collaborator
Institut für Spitalpharmazie, Solothurner Spitäler AG, Baslerstrasse 150, 4600 Olten
Collaborator
Source ClinicalTrials.gov