Pharmacogenetic testing for patients with drug reactions or therapy failure
Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
University Hospital, Basel, Switzerland · NCT04154553
This study is trying to see if testing patients' genes can help find safer and more effective medications for those who have had bad reactions or who aren't getting better with their current treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT04154553 on ClinicalTrials.gov |
What this trial studies
This study focuses on the impact of genetic factors on drug efficacy and safety by compiling case reports where pharmacogenetic testing has been utilized. It collects health-related data from patients experiencing therapy failure or adverse drug reactions and supplements this with pharmacogenetic testing in a community pharmacy setting. The goal is to develop a reliable standard procedure for pharmacogenetic testing based on the compiled cases and additional literature parameters affecting drug efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates include patients starting new medications or those experiencing adverse drug reactions or therapy failures linked to medications with known pharmacogenetic associations.
Not a fit: Patients who do not have a sufficient understanding of German or cannot visit the study pharmacy in person may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective medication management for patients, reducing adverse drug reactions and therapy failures.
How similar studies have performed: Other studies have shown promising results with pharmacogenetic testing, indicating its potential effectiveness in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel
- Department of Pharmaceutical Sciences, University Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Samuel Allemann, Prof. Dr. — Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
- Study coordinator: Samuel Allemann, Prof. Dr.
- Email: s.allemann@unibas.ch
- Phone: +41 61 207 61 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adverse Drug Reaction, Therapy Failure, pharmacogenetics, single nucleotide polymorphism, absorption, distribution, metabolism and excretion, genotyping, pharmacogenetic testing