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AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD

AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD

Recruiting
11 years and younger
Male
Phase N/A
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Overview

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).

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

Eligibility

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

Study details
    Duchenne Muscular Dystrophy

NCT05683379

REGENXBIO Inc.

27 January 2024

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