- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00872079
Personalized Warfarin Dosing by Genomics and Computational Intelligence
Personalized Warfarin Dosing Using Genomics and Computational Intelligence
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The objective of this project is to develop new techniques to incorporate genomic data into pharmacodynamic models to improve the dosing of chronically administered drugs. Specifically, the investigators look to improve warfarin therapy by decreasing the variability in the effect of this drug using information about the subjects genotype and computational intelligence. The investigators propose to achieve our objectives using a prospective, randomized, controlled clinical trial of a computer program that they will develop from both historical and prospective data. This computer program will be tested against a control group using standard warfarin dosing, and a group using standard dosing plus subject genotype. Warfarin dose and response data will be obtained from patients seen in the Louisville VA anticoagulation clinic. Following informed consent, subject genotype for cytochrome P450 allele 2C9 (2C9) and vitamin K epoxide reductase complex subunit 1 (VKORC1) will be determined. Other data routinely obtained to aid in warfarin dosing will also be recorded. Using this information, the investigators will develop many different models for warfarin dosing using incrementally more information. Each of these models will be tested using computer simulation until they have obtained the best model. This model will be used in a pilot study to test performance in real time. The results of the pilot study will then be used to power a final clinical trial of standard dosing, standard dosing and genetic information, computer dosing, and computer dosing plus genetic information.
The specific aims of this research are:
- Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model)
- Prospectively develop an individualized neural network and nonlinear mixed effect modelling (NONMEM) model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques.
- Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model)
- Determine the utility of the computer programs prospectively in the clinical setting.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Kentucky
-
Louisville, Kentucky, Förenta staterna, 40206
- VA Medical Center, Louisville
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Warfarin therapy
- Attend anticoagulation clinic
- Warfarin therapy for 6 months
Exclusion Criteria:
- History of non-compliance
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Genomics
Aim 1: Collect historical data on warfarin dosing in subjects at the VA. Aim 2: Collect genotype information on up to 300 subjects receiving warfarin anticoagulation. Aim 3: Develop a computer model incorporating the information from Aim 1 and 2. Aim 4: Conduct randomized clinical trial. |
Model predictive control is a computer based algorithm that can be applied to drug dosing.
This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response.
A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy.
In the case of warfarin, we will calculate an international normalized ratio (INR) value within a specific target range.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient Genomics
Tidsram: Baseline
|
During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.
|
Baseline
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Michael E. Brier, PhD, VA Medical Center, Louisville
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CAMM-04-07S
Läkemedels- och apparatinformation, studiedokument
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