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Clinical Trials/NCT04510142
NCT04510142CompletedNot Applicable

Questionnaire Follow=up Study Sonia 2

Liverpool University Hospitals NHS Foundation Trust1 site in 1 country24 target enrollmentStarted: September 19, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
to collect information on their health status since completing participation in SONIA 2

Study Overview

Brief Summary

Survey of health of patients completing SONIA 2 study: A cross-sectional analysis by questionnaire

Detailed Description

The Liverpool site will post the once only, short questionnaire (in the correct language using translated documents as appropriate) to the address of those patients who completed SONIA 2. Hospital approved translation services will be used. A return-addressed stamped envelope for ease of return will also be provided. Those who received nitisinone will be sent the nitisinone-administration questionnaire and those who did not receive nitisinone will be sent a no-nitisinone questionnaire

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented diagnosis of AKU. Age ≥16 years.

Exclusion Criteria

  • Not completed SONIA 2 study for the full 4-year duration.

Outcomes

Primary Outcomes

to collect information on their health status since completing participation in SONIA 2

Time Frame: 12 months

All of the SONIA 2 completed questionnaire data collection is completed by 2 Sept 2020

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Emily Luangrath

Research Nurse

Liverpool University Hospitals NHS Foundation Trust

Study Sites (1)

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