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

NCT04154553 | Recruiting

• 1 other identifier: 2019-01452; ex19Hersberger
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Reaction; Therapy Failure

Keywords

pharmacogenetics; single nucleotide polymorphism; absorption, distribution, metabolism and excretion (ADME); genotyping; pharmacogenetic testing

Outcome Measures

Primary Outcomes (1)

• pharmacogenetic profile

  genotyping by laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes

  single time point assessment at Baseline (=Day 0)

Interventions

Buccal swab DIAGNOSTIC_TEST

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.

EDTA Blood sample (4.9mL) DIAGNOSTIC_TEST

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

Serum sample (7.5mL) DIAGNOSTIC_TEST

blood 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

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

unstructured interview OTHER

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• 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

Study Sites (1)

Department of Pharmaceutical Sciences, University Basel

Basel, 4056, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The buccal swab and the extracted DNA are destroyed after two to three weeks after the accomplished labor analysis. The coded ethylenediaminetetraacetic acid (EDTA) blood samples will be stored at -80°C in the Biobank of Biopharmacy Laboratory until further use.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Kurt Hersberger, Prof. Dr.

  Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel

  STUDY CHAIR

• Samuel Allemann, Prof. Dr.

  Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Allemann, Prof. Dr.

CONTACT

+41 61 207 61 76; s.allemann@unibas.ch

Kurt Hersberger, Prof. Dr.

CONTACT

+41 61 207 1971; kurt.hersberger@unibas.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 6, 2019
• Study Start: October 15, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CH (1)