Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

ID#: NCT06636383

Age: 2 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: November 04, 2024

End Date: December 01, 2036

Contact Information:
Patients Contact
1-888-756-8657
HCPs Contact
1-888-756-8657
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:

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