AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
ConditionDuchenne Muscular Dystrophy
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
This trial does not accept healthy volunteersQualifiers
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 population
Primary care clinic, Musculoskeletal care, Neuromusculoskeletal care
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AAV8 DetectCDx
Diagnostic testAn in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Prevalence of anti-AAV8 antibodies in patients with DMD
* 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
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov