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AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
Actively RecruitingObservationalGene Therapy
Study Overview
- Age
- 0–25 years
- Phase
- Observational
- Sponsor
- REGENXBIO
- Therapeutic Approach
- Gene Therapy
- Variant Requirement
- Has an established clinical diagnosis of DMD based on documentation of clinical findings and prior confirmatory genetic testing using a clinical diagnostic genetic test.
- Eligible Sex
- Male
- Ambulation
- Ambulatory and Non-Ambulatory
- Study Start (Actual)
- 2022-12-20
- Primary Completion (Estimated)
- 2026-09
- Study Completion (Estimated)
- 2026-09
- Enrollment (Estimated)
- 200
- Countries
- United States
Study Requirements and Criteria
Steroid Use
Not yet provided
Inclusion Criteria
- Males at least 0 to <25 years of age
- Diagnosis of DMD
- Provision of signed and dated informed consent form (ICF) and assent as required per local regulations or requirements
Exclusion Criteria
- Prior participation in a gene therapy trial OR recipient of a gene therapy drug
- Other inclusion/exclusion criteria apply
Contacts and Locations
Contacts and Locations
Contact
- Name: Patient Advocacy
- Phone Number: (833) 711-0349
- Email: [email protected]
Locations
This study has 1 locations
United States
Georgia Locations
Atlanta, Georgia, United States, 30329
Rare Disease Research
Clinical Trial Registry
NCT ID
NCT05683379This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.