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Completed

NCT Number: NCT04510142

Questionnaire Follow=up Study Sonia 2

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

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Key information

Conditions

Alkaptonuria Alkaptonuria Severity Score Index Amino Acid Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Homogentisate Dioxygenase Homogentisic Acid Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool Royal Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of AKU. Age ≥16 years.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Registry information

Acronym: QSonia

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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