Clinical Trials Logo
  1. Home
  2. Duchenne Muscular Dystrophy
  3. NCT05683379
  4. Details
NCT05683379 Clinical Trial

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

Duchenne Muscular Dystrophy Clinical Trial

Official title:
Anti-AAV8 Antibody Assessment Study of Boys With Duchenne Muscular Dystrophy Aged 0 to <12 Years

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05683379
Other study ID # RGX-202-0101
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2022
Est. completion date December 2024

Study information
Verified date January 2023
Source REGENXBIO Inc.
Contact Patient Advocacy
Phone 866-860-0117
Email Duchenne@regenxbio.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Description:

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). Information collected in this study may be used to identify potential participants for DMD investigational gene therapy clinical trials. This study consists of: - A phone/video interview to provide e-consent and medical history - A single home health visit to collect blood sample for antibody testing - A phone/video call for communication of AAV8 antibody test results

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Male
Age group 0 Years to 11 Years
Eligibility Inclusion Criteria: - Males at least 0 to <12 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• AAV8 DetectCDx
An in vitro diagnostic assay to detect antibodies to AAV8 in human serum specimens.

Locations
Country Name City State
United States Rare Disease Research Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
REGENXBIO Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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		 90 days
Secondary Prevalence of anti-AAV9 antibodies in patients with DMD • To evaluate the prevalence of AAV9 antibodies in patients with DMD 90 days
See also
  Status Clinical Trial Phase
Completed NCT05575648 - Dual Task in Duchenne Muscular Dystrophy N/A
Terminated NCT03907072 - Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy Phase 2/Phase 3
Not yet recruiting NCT06450639 - An Open-label Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy Phase 2
Completed NCT04335942 - Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor N/A
Active, not recruiting NCT04906460 - Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53) Phase 1/Phase 2
Active, not recruiting NCT02500381 - Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD) Phase 3
Enrolling by invitation NCT05967351 - A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study Phase 3
Recruiting NCT03067831 - Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy Phase 1/Phase 2
Recruiting NCT01834040 - Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy Phase 1/Phase 2
Completed NCT02246478 - A Study of TAS-205 for Duchenne Muscular Dystrophy Phase 1
Active, not recruiting NCT01772043 - Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping N/A
Terminated NCT01168908 - Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy Phase 2
Completed NCT00758225 - Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Phase 2
Completed NCT03680365 - Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
Recruiting NCT03513367 - The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM.
Recruiting NCT05712447 - Duchenne Muscular Dystrophy Video Assessment Registry
Recruiting NCT01484678 - Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
Completed NCT03319030 - Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)
Terminated NCT01753804 - A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy. N/A
Completed NCT02530905 - Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients Phase 1