Trial Outcomes & Findings for Personalized Warfarin Dosing by Genomics and Computational Intelligence (NCT NCT00872079)

Last Updated: 2014-02-24

Results Overview

During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.

Recruitment status

TERMINATED

Study phase

Target enrollment

175 participants

Primary outcome timeframe

Baseline

Results posted on

2014-02-24

Participants were not enrolled into the randomized clinical trial for Aim 4 due to lack of funding.

Participant milestones
Measure	Genomics Model Predictive Control: 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 INR value within a specific target range.
Overall Study STARTED	175
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Personalized Warfarin Dosing by Genomics and Computational Intelligence

Baseline characteristics by cohort
Measure	Genomics n=175 Participants The specific aims of this research are: 1. Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model) 2. Prospectively develop an individualized neural network and NONMEM model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques. 3. Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model) 4. Determine the utility of the computer programs prospectively in the clinical setting.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	125 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	165 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	157 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: Baseline

During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.

Outcome measures
Measure	Genomics n=175 Participants Model Predictive Control: 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 INR value within a specific target range. There are 4 Aims in this study. 1. To collect historical data on warfarin dosing in subjects. 2. To collect genotype information on up to 300 subjects receiving warfarin anticoagulation. 3. to develop a computer model incorporating the information from aim 1 and aim 2. 4. To conduct a randomized clinical trial.
Patient Genomics CYP2C9: 1/1	112 participants
Patient Genomics CYP2C9: 1/2	23 participants
Patient Genomics CYP2C9: 1/3	19 participants
Patient Genomics CYP2C9: 2/2	3 participants
Patient Genomics CYP2C9: 2/3	3 participants
Patient Genomics CYP2C9: 3/3	2 participants
Patient Genomics CYP2C9: Not Determined	13 participants
Patient Genomics VKORC1: AA	23 participants
Patient Genomics VKORCI:GA	72 participants
Patient Genomics VKORCI:GG	67 participants
Patient Genomics VKORCI: Not Determined	13 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Louisville

Phone: 502-852-0246