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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2023 |
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Main ID: |
NCT03675126 |
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Date of registration:
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06/08/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)
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Scientific title:
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An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 |
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Date of first enrolment:
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December 19, 2018 |
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Target sample size:
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15 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03675126 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sarepta Therapeutics, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
• Has completed a study of SRP-5051 and continues to meet the Eligibility Criteria of Study
5051-102.
Exclusion Criteria:
- Initiation or change of dosing (except for modifications to accommodate changes in
weight or changes in standard of care) since completing a study administering SRP-5051
and while participating in this study for any of the following: angiotensin converting
enzyme (ACE) inhibitors, angiotensin receptor blocking agents (ARBs), beta-blockers,
potassium and steroids*.
- Requires antiarrhythmic and/or diuretic therapy for heart failure.
- Use of any herbal medication/supplement containing aristolochic acid.
- Treatment with any experimental therapy since entering original study or any
experimental gene therapy for the treatment of DMD at any time.
- Participation in an interventional clinical trial since completing original study.
Other inclusion/exclusion criteria apply.
* The dose of steroids must remain constant except for modifications to accommodate changes
in weight.
Age minimum:
4 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Muscular Dystrophy, Duchenne
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Intervention(s)
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Drug: SRP-5051
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Primary Outcome(s)
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Number of Participants Experiencing Adverse Events
[Time Frame: Up to 152 weeks]
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Secondary Outcome(s)
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Plasma Concentration of SRP-5051
[Time Frame: Pre-dose and at multiple time periods after infusion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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