Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 49 of 1110 for:    pharmacogenomics OR pharmacogenetics

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154553
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Adverse Drug Reaction Therapy Failure Diagnostic Test: Buccal swab Diagnostic Test: EDTA Blood sample (4.9mL) Diagnostic Test: Serum sample (7.5mL) Other: communication of test results Other: unstructured interview

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions


Intervention Details:
  • 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.
  • 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).
  • Other: communication of test results
    Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician
  • 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


Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
The buccal swab and the extracted DNA are destroyed after two to three weeks after the accomplished labor analysis. The coded ethylenediaminetetraacetic acid (EDTA) blood samples will be stored at -80°C in the Biobank of Biopharmacy Laboratory until further use.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154553


Contacts
Layout table for location contacts
Contact: Kurt Hersberger, Prof. Dr. +41 61 207 1971 kurt.hersberger@unibas.ch

Locations
Layout table for location information
Switzerland
Department of Pharmaceutical Sciences, University Basel Recruiting
Basel, Switzerland, 4056
Contact: Kurt Hersberger, Prof. Dr.    +41 61 207 1971    kurt.hersberger@unibas.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Toppharm Apotheke Hersberger, Spalenberg 41, CH-4051 Basel
Investigators
Layout table for investigator information
Principal Investigator: Kurt Hersberger, Prof. Dr. Pharmaceutical Care Research Group; Department of Pharmaceutical Sciences, University Basel

Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04154553     History of Changes
Other Study ID Numbers: 2019-01452; ex19Hersberger
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
pharmacogenetics
single nucleotide polymorphism
absorption, distribution, metabolism and excretion (ADME)
genotyping
pharmacogenetic testing
Additional relevant MeSH terms:
Layout table for MeSH terms
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders