Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pharmacogenetic Testing for Medication Management.

30. juli 2019 opdateret af: First Vitals LLC

Medication Interactions to Detect Adverse Situations

The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.

Undersøgelsestype

Observationel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.

Beskrivelse

Inclusion Criteria:

  1. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
  2. Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
  3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;

5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.

Exclusion Criteria:

  1. Patient is currently hospitalized;
  2. Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
  3. Patient is unable to provide an accurate history due to mental incapacity;
  4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Andet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
No treatment.
Data collection only trial design.
Andet: Observational study, data collection only trial.
Data collection only trial design.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen.
Tidsramme: 90-day period following receipt of PGx test results
90-day period following receipt of PGx test results

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Vitals LLC

Efterforskere

  • Studieleder: Ernie Lee, CHRS, First Vitals LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

1. maj 2018

Studieafslutning (Faktiske)

1. maj 2018

Datoer for studieregistrering

Først indsendt

22. september 2015

Først indsendt, der opfyldte QC-kriterier

22. september 2015

Først opslået (Skøn)

24. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • MIDAS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Medicinhåndtering

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner