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.
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Incidence and Severity of Serious Adverse Events (SAEs) Assessed as Related to DTX401 by the Investigator
Timeframe: 10 Years
Incidence, Relationship, Severity and Seriousness of Adverse Events of Special Interest (AESIs) for Adeno-Associated Virus (AAV) Therapies
Timeframe: 10 Years
Incidence of Pregnancy in Patients Treated with DTX401 or Patient's Partner
Timeframe: 10 Years
Outcomes of Pregnancy in Patients Treated with DTX401 or Patient's Partner
Timeframe: 10 Years
Incidence and Severity of SAEs of Infusion-Related Reactions Including Hypersensitivity (Group 2 only)
Timeframe: 1 Year
Incidence and Severity of SAEs Assessed by the Investigator as Related to Concomitant Immunomodulatory Therapies (Group 2 only)
Timeframe: 1 Year
Patients Contact: Trial Recruitment