Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062825) titled 'A Survey of Reasons for Interruption of Medical Follow-up and Associated Challenges Among Patients with Phenylketonuria (PKU)' on Sept. 7.
Study Type:
Observational
Primary Sponsor:
Institute - Nihon University Hospital
Condition:
Condition - Phenylketonuria; PKU
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To identify unmet needs and challenges associated with the resumption and continuation of treatment among patients aged 15 years and older with phenylketonuria (PKU) who are not regularly attending medical institutions.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 15
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients diagnosed with PKU*
2) Patients who meet either of the following criteria:
a) Patients who have not visited a medical institution for PKU management for approximately one year or longer
b) Patients who have visited a medical institution for PKU management within the past year but had not attended regular follow-up visits (approximately at least once per year) for an extended period prior to that
3) Male or female patients aged 15 years or older
4) Patients who are able to complete the survey independently
5) Patients who are able to provide voluntary informed consent or assent to participate in this study
*Based on a clinical diagnosis according to the standard of care at the time of diagnosis
Key exclusion criteria - 1) Patients who are currently continuing regular outpatient visits for PKU follow-up at a frequency of approximately once per year or more
2) Patients who are currently participating in an interventional clinical trial
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 11 Day
Anticipated trial start date - 2026 Year 08 Month 01 Day
Last follow-up date - 2027 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071918
Disclaimer: Curated by HT Syndication.
