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

Adverse Drug Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154553
• Other study ID #: 2019-01452; ex19Hersberger
• Status: Recruiting
• Start date: October 15, 2019
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Samuel Allemann, Prof. Dr.
• Phone: +41 61 207 61 76
• Email: s.allemann[@]unibas.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Drug-Related Side Effects and Adverse Reactions
• Therapy Failure

Intervention

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.
• EDTA Blood sample (4.9mL)
Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.
• 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
• 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

Locations

Country	Name	City	State
Switzerland	Department of Pharmaceutical Sciences, University Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)