NCT04510142

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

August 10, 2020

Last Update Submit

March 21, 2025

Conditions

AlkaptonuriaHomogentisic AcidHomogentisate DioxygenaseAlkaptonuria Severity Score Index

Keywords

Royal Liverpool University Hospital

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cross-sectional cohort who completed SONIA 2 Study

You may qualify if:

  • \- Documented diagnosis of AKU. Age ≥16 years.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Royal Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Alkaptonuria

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Nurse

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 12, 2020

Study Start

September 19, 2019

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations

GB(1)