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Recruiting NCT05683379
NCT05683379 AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
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Plain-language summary for patients
| NCT ID | NCT05683379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | REGENXBIO Inc. |
| Condition | Duchenne Muscular Dystrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2026-09 |
Trial Parameters
Condition Duchenne Muscular Dystrophy
Sponsor REGENXBIO Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex MALE
Min Age 0 Years
Max Age 25 Years
Start Date 2022-12-20
Completion 2026-09
Interventions
AAV8 DetectCDx
Eligibility Fast-Check
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Brief 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 Criteria
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
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