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NCT04510142 Clinical Trial

Questionnaire Follow=up Study Sonia 2

Alkaptonuria Clinical Trial

— QSonia  

Official title:
Questionnaire Follow=up Study Sonia 2

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04510142
Other study ID # 5870
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 19, 2019
Est. completion date June 19, 2023

Study information
Verified date May 2022
Source Liverpool University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 3
Est. completion date June 19, 2023
Est. primary completion date June 19, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: - Documented diagnosis of AKU. Age =16 years. Exclusion Criteria: - Not completed SONIA 2 study for the full 4-year duration.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom The Royal Liverpool Hospital Liverpool

Sponsors (1)
Lead Sponsor Collaborator
Liverpool University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Active, not recruiting NCT01916382 - Suitability of Nitisinone in Alkaptonuria 2 Phase 3
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