Questionnaire Follow=up Study Sonia 2 | NCT04510142

Studies
Questionnaire Follow=up Study Sonia 2

NCT04510142

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Mar 26, 2025Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Alkaptonuria
Homogentisic Acid
Homogentisate Dioxygenase
Alkaptonuria Severity Score Index

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2019Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

Aug 10, 2020

First Submission Date that Met QC Criteria

Aug 10, 2020

First Posted Date

Aug 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2025

Last Update Posted Date

Mar 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emily Luangrath, Research Nurse, Liverpool University Hospitals NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Liverpool University Hospitals NHS Foundation TrustOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Documented diagnosis of AKU. Age ≥16 years.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

cross-sectional cohort who completed SONIA 2 Study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liverpool Royal Hospitals NHS Foundation Trust		Liverpool		L7 8XP	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000474	Alkaptonuria

Ancestor Terms

ID	Term
D000592	Amino Acid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided