- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510142
Questionnaire Follow=up Study Sonia 2 (QSonia)
May 27, 2022 updated by: Emily Luangrath, Liverpool University Hospitals NHS Foundation Trust
Survey of health of patients completing SONIA 2 study: A cross-sectional analysis by questionnaire
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Anticipated)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Liverpool, United Kingdom, L7 8XP
- Recruiting
- The Royal Liverpool Hospital
-
Contact:
- Prof L Ranganath
- Phone Number: 01517064256
- Email: lrang@liv.ac.uk
-
Contact:
- Helen Bygott
- Phone Number: 01517064289
- Email: helen.bygott@rlbuht.nhs.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
cross-sectional cohort who completed SONIA 2 Study
Description
Inclusion Criteria:
- Documented diagnosis of AKU. Age ≥16 years.
Exclusion Criteria:
- Not completed SONIA 2 study for the full 4-year duration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2019
Primary Completion (Anticipated)
June 19, 2023
Study Completion (Anticipated)
June 19, 2023
Study Registration Dates
First Submitted
August 10, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 12, 2020
Study Record Updates
Last Update Posted (Actual)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5870
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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