AlkaptonuriaQSoniaNCT04510142
Questionnaire Follow=up Study Sonia 2
An observational study of Alkaptonuria and Homogentisic Acid, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Survey of health of patients completing SONIA 2 study: A cross-sectional analysis by questionnaire Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Alkaptonuria, Homogentisic Acid, Homogentisate Dioxygenase
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2019to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cross-sectional cohort who completed SONIA 2 Study
Who may be able to join
- Documented diagnosis of AKU. Age ≥16 years.
Who cannot join
- Not completed SONIA 2 study for the full 4-year duration.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Royal Hospitals NHS Foundation Trust
Liverpool, L7 8XP
About this study
Survey of health of patients completing SONIA 2 study: A cross-sectional analysis by questionnaire
Read the 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
- Conditions
- Alkaptonuria, Homogentisic Acid, Homogentisate Dioxygenase, Alkaptonuria Severity Score Index
- Keywords
- Royal Liverpool University Hospital
- Medical subject headings
- Alkaptonuria
What is being measured
The primary outcome is the main question the study is designed to answer.
to collect information on their health status since completing participation in SONIA 2
All of the SONIA 2 completed questionnaire data collection is completed by 2 Sept 2020
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start19 Sep 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlkaptonuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emily Luangrath, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510142
- Sponsor's protocol ID
- 5870
- Acronym
- QSonia
- Status last verified
- Mar 2025
- First submitted
- 10 Aug 2020
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire Follow=up Study Sonia 2
- ClinicalTrials.gov ID
- NCT04510142
- Acronym / sponsor ID
- QSonia / 5870
- Conditions
- Alkaptonuria, Homogentisic Acid, Homogentisate Dioxygenase, Alkaptonuria Severity Score Index
- Keywords
- Royal Liverpool University Hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cross-sectional cohort who completed SONIA 2 Study
Key inclusion criteria (1 listed)
- Documented diagnosis of AKU. Age ≥16 years.
Key exclusion criteria (1 listed)
- Not completed SONIA 2 study for the full 4-year duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Related trials for Alkaptonuria
RecruitingObservational study
Study of Alkaptonuria
Alkaptonuria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alkaptonuria and Homogentisic Acid, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to collect information on their health status since completing participation in SONIA 2 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.