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ENROLLING BY INVITATION
NCT05967351
PHASE3

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

Sponsor: Sarepta Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical Study

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2023-09-27

Completion Date

2033-10-31

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

GENETIC

delandistrogene moxeparvovec

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.

Locations (38)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

UCLA Medical Center

Los Angeles, California, United States

Lucile Packard Children's Hospital Stanford (LPCH)

Palo Alto, California, United States

University of California, Davis

Sacramento, California, United States

Rady Children's Hospital

San Diego, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

University of Florida Clinical Research Center

Gainesville, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Iowa ICTS Clinical Research Unit

Iowa City, Iowa, United States

The Johns Hopkins Hospital, Rubenstein Child Health Bldg

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Columbia University Pediatric Neuromuscular Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Lenox Baker Children's Hospital (Duke University)

Durham, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Chiildren's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Health Specialty Center

Dallas, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Children's Hospital Wisconsin

Milwaukee, Wisconsin, United States

Universitair Ziekenhuis Gent, Neuromuscular Reference Centre (NMRC)

Ghent, East Flanders, Belgium

Universitätsklinikum Essen - Klinik für Kinderheilkunde I

Essen, North Rhine-Westphalia, Germany

Hong Kong Children's Hospital

Hong Kong, Hong Kong

UOC Neurologia Pediatrica e Malattie Muscolari, Istituto G. Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico

Genova, Italy

UOC Neurologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

UOC Neuropsichiatria Infantile, Area Salute del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattoclica del Sacro Cuore

Roma, Italy

Kobe University Hospital

Kobe, Hyōgo, Japan

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Tokyo Women's Medical University Hospital

Tokyo, Japan

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitario y Politecnico La fe. Neurology Department

Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Great Ormond Street Hospital For Children NHS Foundation Trust

London, Greater London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Institute of Translational and Clinical Research

Newcastle upon Tyne, United Kingdom