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临床试验/NCT04154553
NCT04154553招募中不适用

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

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
pharmacogenetic profile

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

pharmacogenetic profile

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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