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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02445521
Other study ID # IRB00079788
Secondary ID
Status Completed
Phase N/A
First received May 13, 2015
Last updated December 9, 2015
Start date May 2015
Est. completion date May 2015

Study information

Verified date December 2015
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of this study is to test four home phenylalanine monitoring prototype devices, selected out of a pool of candidates by the National PKU Alliance Scientific Committee.


Description:

A real time, point-of-care and home phenylalanine monitoring system would provide patients with quick results and feedback. Home monitoring devices' phenylalanine measurements will be compared to the current gold-standard measurement of phenylalanine (plasma concentration) in four subjects with PKU and one control subject. The study will enroll subjects with different baseline phenylalanine concentrations (i.e., patients with poor to good metabolic control, assessed by comparing current phenylalanine concentrations to established treatment ranges).

For each prototype device, three separate measurements of phenylalanine per subject will be performed. Three prototype devices require whole blood, thus 1 teaspoon (approximately 4mL) of whole blood will be collected through venipuncture and blood spots will be used to conduct tests. One prototype requires capillary blood to be collected through a fingerstick, and will require three blood spots from the stick. A single plasma amino acid analysis for each participant will also be performed using leftover whole blood from the 4mL blood draw through quantitative ion exchange chromatography, reported as micromoles/L.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- diagnosis of PKU or hyperphenylalaninemia (PKU group)

- any age

- in good health (PKU and control group)

Exclusion Criteria:

- pregnant

- have any medical comorbidities

- considered unfit for participation by the principal investigator

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Healthcare of Atlanta (CHOA) Atlanta Georgia
United States Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI) Atlanta Georgia
United States Emory University Genetics Clinic Decatur Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University National PKU Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intra-variability of the four devices, assessed by phenylalanine values Phenylalanine values for each of the three runs on each device for the same individual will be compared. Each PKU subject will be assessed separately to assess the reliability of each device since the subjects will have a range of phenylalanine concentrations. Day 1 No
Secondary Inter-variability of the four devices, assessed by average phenylalanine concentrations Average phenylalanine values measured by the four tests of each device in each subject will be calculated. Mean concentrations for each device will be compared to the control (gold standard measure of plasma phenylalanine). Day 1 No
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