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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age0-25
SponsorREGENXBIO Inc.

About this trial

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

Qualifiers

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

Disqualifiers

Prior participation in a gene therapy trial OR recipient of a gene therapy drug

Other inclusion/exclusion criteria apply

Trial design

Treatments tested in this trial

  • AAV8 DetectCDx

Treatment groups

No treatment groups listed

Sponsors and collaborators