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

NCT ID: NCT04154553

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2026-08-31

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.

Conditions

Adverse Drug Reaction; Therapy Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

EDTA Blood sample (4.9mL)

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

Intervention Type: 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).

Intervention Type: DIAGNOSTIC_TEST

communication of test results

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel

UNKNOWN

Sponsor Role: collaborator

Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt Hersberger, Prof. Dr.

Role: STUDY_CHAIR

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

Samuel Allemann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Pharmaceutical Sciences, University Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Samuel Allemann, Prof. Dr.

Role: CONTACT

s.allemann@unibas.ch

+41 61 207 61 76

Kurt Hersberger, Prof. Dr.

Role: CONTACT

kurt.hersberger@unibas.ch

+41 61 207 1971

Facility Contacts

Kurt Hersberger, Prof. Dr.

Role: primary

kurt.hersberger@unibas.ch

+41 61 207 1971

Other Identifiers

2019-01452; ex19Hersberger

Identifier Type: -

Identifier Source: org_study_id