RECRUITINGOBSERVATIONAL
AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
Anti-AAV8 Antibody Assessment Study of Males With Duchenne Muscular Dystrophy Aged 0 to <25 Years
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- Males at least 0 to \<25 years of age
- Diagnosis of DMD
- Provision of signed and dated willing to sign a consent form form (ICF) and assent as required per local regulations or requirements
Who Should NOT Join This Trial:
- Prior participation in a gene therapy trial OR recipient of a gene therapy drug
- Other inclusion/exclusion criteria apply
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
AAV8 DetectCDx
An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.
Locations (1)
Rare Disease Research
Atlanta, Georgia, United States