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Recruiting NCT06636383

Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

Trial Parameters

Condition Glycogen Storage Disease Type Ia
Sponsor Ultragenyx Pharmaceutical Inc
Study Type OBSERVATIONAL
Phase N/A
Enrollment 140
Sex ALL
Min Age 2 Years
Max Age N/A
Start Date 2024-11-04
Completion 2036-12
Interventions
No Intervention

Brief Summary

The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration.

Eligibility Criteria

Inclusion Criteria: * Patient who had: * DTX401 (full or partial dose) administered in a parent clinical study (Group 1) or * Prescribed DTX401(full or partial dose) administered in a post-marketing setting (Group 2) * Patient is willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. If a minor or an adult with cognitive limitations, the patient is willing and able (if possible) to provide assent and have a legally authorized representative provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. Exclusion Criteria: * Presence of any condition that would interfere with study participation, interpretation of results or affect patient's safety in the opinion of the Investigator

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