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Children's Hospital of the King's Daughters | Novel Therapeutics and Gene Therapy

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

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Sarepta Therapeutics

Status and phase

Invitation-only
Phase 3

Conditions

Duchenne Muscular Dystrophy

Treatments

Genetic: delandistrogene moxeparvovec

Study type

Interventional

Funder types

Industry

Identifiers

NCT05967351
SRP-9001-305
2023-505043-39-00 (Other Identifier)

Details and patient eligibility

About

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. Pre-infusion baseline will be defined as the timepoint just prior to infusion of delandistrogene moxeparvovec from a previous clinical study. Each participant will be followed for a minimum of 5 years post-infusion of delandistrogene moxeparvovec from a previous clinical study. The duration of participation in this study is dependent on the length of follow-up the participant completed post-infusion of delandistrogene moxeparvovec from a previous clinical study.

Enrollment

400 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a previous clinical study.
  • Has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements.

Exclusion criteria

  • Participant or family does not want to disclose participation with general practitioner/primary care physician and other medical providers.

Other inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

400 participants in 1 patient group

Delandistrogene Moxeparvovec
Experimental group
Description:
Participant received delandistrogene moxeparvovec in a previous clinical study.
Treatment:
Genetic: delandistrogene moxeparvovec

Trial contacts and locations

34

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Central trial contact

Sarepta Therapeutics Inc. For Clinical Trial Information, Select Option 4

Data sourced from clinicaltrials.gov

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