Adverse Drug ReactionNCT04154553
Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
An observational study of Adverse Drug Reaction and Therapy Failure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Reaction, Therapy Failure
- What is being tested?
- Buccal swab, EDTA Blood sample (4.9mL) and Serum sample (7.5mL)
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Oct 2019to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Insufficient German knowledge
- Not able to personally visit to the study pharmacy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Pharmaceutical Sciences, University Basel
Basel, 4056
Kurt Hersberger, Prof. Dr., +41 61 207 1971, kurt.hersberger@unibas.ch
About this study
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.
Read the 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
- Being tested
- Buccal swab, EDTA Blood sample (4.9mL), Serum sample (7.5mL), communication of test results, unstructured interview
- Keywords
- pharmacogenetics, single nucleotide polymorphism, absorption, distribution, metabolism and excretion (ADME), genotyping, pharmacogenetic testing
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal swabDiagnostic 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 resultsOther
Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician
unstructured interviewOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacogenetic profile
genotyping by laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes
Measured: single time point assessment at Baseline (=Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start15 Oct 2019
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel, Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich, Institut für Spitalpharmazie, Solothurner Spitäler AG, Baslerstrasse 150, 4600 Olten
- Responsible party
- Sponsor
- Investigators
- Kurt Hersberger, Prof. Dr., Study chair, Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University BaselSamuel Allemann, Prof. Dr., Principal investigator, Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154553
- Sponsor's protocol ID
- 2019-01452; ex19Hersberger
- Other IDs
- 2019
- Status last verified
- May 2025
- First submitted
- 31 Oct 2019
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bollinger A, Jeiziner C, Meyer Zu Schwabedissen HE, Hersberger KE, Allemann SS, Stauble CK. Severe systemic adverse reactions to ophthalmic timolol in a CYP2D6 homozygous *4 allele carrier: a case report. Pharmacogenomics. 2023 Sep;24(14):739-746. doi: 10.2217/pgs-2023-0122. Epub 2023 Sep 15.
PubMed 37712172
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
- ClinicalTrials.gov ID
- NCT04154553
- Acronym / sponsor ID
- 2019-01452; ex19Hersberger
- Conditions
- Adverse Drug Reaction, Therapy Failure
- Keywords
- pharmacogenetics, single nucleotide polymorphism, absorption, distribution, metabolism and excretion (ADME), genotyping, pharmacogenetic testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel, Universitätskinderspital Zürich, Lenggstrasse 30, 8008 Zürich, Institut für Spitalpharmazie, Solothurner Spitäler AG, Baslerstrasse 150, 4600 Olten
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Insufficient German knowledge
- Not able to personally visit to the study pharmacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal swabPharmacogenetic 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. | Diagnostic test | – |
| EDTA Blood sample (4.9mL)Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample. | 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). | Diagnostic test | – |
| communication of test resultsCertified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician | Other | – |
| unstructured interviewOne 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 | Other | – |
Primary outcome
pharmacogenetic profile
Time frame: single time point assessment at Baseline (=Day 0)
genotyping by laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 37712172Bollinger A, Jeiziner C, Meyer Zu Schwabedissen HE, Hersberger KE, Allemann SS, Stauble CK. Severe systemic adverse reactions to ophthalmic timolol in a CYP2D6 homozygous *4 allele carrier: a case report. Pharmacogenomics. 2023 Sep;24(14):739-746. doi: 10.2217/pgs-2023-0122. Epub 2023 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kurt Hersberger, Prof. Dr. study chair
Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
Samuel Allemann, Prof. Dr. principal investigator
Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reaction and Therapy Failure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Allemann, Prof. Dr. (+41 61 207 61 76, s.allemann@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacogenetic profile (time frame: single time point assessment at Baseline (=Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.