AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD
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About
This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD).
Full description
This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD). Information collected in this study may be used to identify potential participants for DMD investigational gene therapy clinical trials.
This study consists of:
- A phone/video interview to provide e-consent and medical history
- A single home health visit to collect blood sample for antibody testing
- A phone/video call for communication of AAV8 antibody test results
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Males at least 0 to <12 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
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Data sourced from clinicaltrials.gov
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