- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154553
Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
November 24, 2021 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kurt Hersberger, Prof. Dr.
- Phone Number: +41 61 207 1971
- Email: kurt.hersberger@unibas.ch
Study Locations
-
-
-
Basel, Switzerland, 4056
- Recruiting
- Department of Pharmaceutical Sciences, University Basel
-
Contact:
- Kurt Hersberger, Prof. Dr.
- Phone Number: +41 61 207 1971
- Email: kurt.hersberger@unibas.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
single time point assessment at Baseline (=Day 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kurt Hersberger, Prof. Dr., Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 15, 2019
Primary Completion (ANTICIPATED)
October 1, 2022
Study Completion (ANTICIPATED)
October 1, 2022
Study Registration Dates
First Submitted
October 31, 2019
First Submitted That Met QC Criteria
November 5, 2019
First Posted (ACTUAL)
November 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01452; ex19Hersberger
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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