AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
NCT ID: NCT05683379
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-12-20
2026-09-30
Brief Summary
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Detailed Description
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This study consists of:
* A phone/video interview or at an in-clinic visit to provide e-consent and medical history
* A single home health visit or subsequent in-clinic visit to collect blood sample for antibody testing
* A phone/video call for communication of AAV8 antibody test results
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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AAV8 DetectCDx
An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of DMD
* Provision of signed and dated informed consent form (ICF) and assent as required per local regulations or requirements
Exclusion Criteria
0 Years
25 Years
MALE
No
Sponsors
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REGENXBIO Inc.
INDUSTRY
Responsible Party
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Locations
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Rare Disease Research
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RGX-202-0101
Identifier Type: -
Identifier Source: org_study_id
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