AAV8 DetectCDx: An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.
Study 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
MALE
Min age
0 Years
Max age
25 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Prevalence of anti-AAV8 antibodies in patients with DMD — 90 days * To evaluate the prevalence of AAV8 antibodies in patients with DMD
* To identify participants who may be eligible for investigational gene therapy clinical trials in males with DMD
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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