Actively Recruiting
Anti-AAV8 Antibody Assessment Study of Males with Duchenne Muscular Dystrophy Aged 0 to <25 Years
Led by REGENXBIO Inc. · Updated on 2025-11-25
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational screening study to find out how common anti-adeno-associated serotype 8 (AAV8) antibodies are in males with Duchenne muscular dystrophy (DMD). The goal is to gather information that may help identify candidates for future DMD gene therapy clinical trials. This study is sponsored by REGENXBIO Inc. and focuses on males aged from birth up to 25 years. Participants will take part in interviews either by phone, video, or during a clinic visit to provide consent and share their medical history. They will then have a single blood sample collected either at home by a health professional or during a later clinic visit to test for AAV8 antibodies. After testing, participants will receive their antibody test results through a phone or video call. During the study, researchers will review the antibody test results to determine the presence of anti-AAV8 antibodies within 90 days. The study involves minimal visits and procedures, focusing mainly on blood sample collection and communication of results. Participants are involved for the period needed to complete these steps, with no ongoing treatment provided as part of the study.
CONDITIONS
Brief Title
AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 0 to less than 25 years
- Diagnosis of Duchenne muscular dystrophy
- Signed and dated informed consent and assent as required by local regulations
You will not qualify if you...
- Prior participation in a gene therapy trial or recipient of a gene therapy drug
- Other inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 90 days
Participants are screened for eligibility to participate in the trial.
1 to 2 visits including a phone/video interview or in-clinic visit for consent and medical history, and a home health or in-clinic visit for blood sample collection
Trial Site Locations
Total: 1 location
1
Rare Disease Research
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
P
Patient Advocacy
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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