RecruitingNCT05683379
AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
Anti-AAV8 Antibody Assessment Study of Males With Duchenne Muscular Dystrophy Aged 0 to <25 Years
Sponsor
REGENXBIO Inc.
Enrollment
200 participants
Start Date
Dec 20, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Sex: MALEMin Age: 0 YearsMax Age: 25 Years
Inclusion Criteria3
- 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 Criteria1
- Prior participation in a gene therapy trial OR recipient of a gene therapy drug
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Interventions
DIAGNOSTIC_TESTAAV8 DetectCDx
An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05683379
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