A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Sarepta Therapeutics, Inc.
Study ID
NCT05967351
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • delandistrogene moxeparvovec — GENETIC
    No study drug will be administered as part of this study. Eligible participants who received treatment with delandistrogene moxeparvovec during a previous clinical study will be included.

Study Details

The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study. No study drug will be administered as part of this study.

Key Dates

Start date
Sep 27, 2023
Status verified
Feb 2026
Primary completion
Oct 31, 2033
Completion
Oct 31, 2033

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Delandistrogene Moxeparvovec
    Participants received delandistrogene moxeparvovec in a previous clinical study.

Primary Outcome Measure

Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) [ Time Frame: Up to 10 years ]

Locations (22)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202-
UCLA Medical CenterLos AngelesCalifornia90095-
Lucile Packard Children's Hospital Stanford (LPCH)Palo AltoCalifornia94304-
University of California, DavisSacramentoCalifornia95817-
Rady Children's HospitalSan DiegoCalifornia92123-
Children's Hospital of ColoradoAuroraColorado80045-7106-
University of Florida Clinical Research CenterGainesvilleFlorida32610-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of Iowa ICTS Clinical Research UnitIowa CityIowa52242-
The Johns Hopkins Hospital, Rubenstein Child Health BldgBaltimoreMaryland21287-
Boston Children's HospitalBostonMassachusetts02115-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Pediatric Neuromuscular CenterNew YorkNew York10032-
University of Rochester Medical CenterRochesterNew York14642-
Lenox Baker Children's Hospital (Duke University)DurhamNorth Carolina27705-
Nationwide Children's HospitalColumbusOhio43205-
Oregon Health and Science UniversityPortlandOregon97239-
Chiildren's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Health Specialty CenterDallasTexas75207-
University of Utah HealthSalt Lake CityUtah84132-
Children's Hospital of The King's DaughtersNorfolkVirginia23510-
Children's Hospital WisconsinMilwaukeeWisconsin53226-

Find similar trials in Little Rock, AR

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
Arkansas Children's Hospital· Little Rock, ARUCLA Medical Center· Los Angeles, CALucile Packard Children's Hospital Stanford (LPCH)· Palo Alto, CAUniversity of California, Davis· Sacramento, CARady Children's Hospital· San Diego, CAChildren's Hospital of Colorado· Aurora, CO

Related Studies