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
- Countries
- United States
Study Requirements and Criteria
Steroid Use
N/A
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
Contact Information
This section provides contact details for people who can answer questions about joining this study
- Name: Patient Advocacy
- Phone Number: (833) 711-0349
- Email: Duchenne@regenxbio.com
Clinical Trial Registry
NCT ID
NCT05683379This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.