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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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20 November 2023 |
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Main ID: |
NCT03863119 |
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Date of registration:
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21/02/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy
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Scientific title:
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An Open-Label, Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy Who Have Completed the Long-Term Extension (VBP15-LTE) or VBP15-004 or VBP15-006 Studies |
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Date of first enrolment:
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August 1, 2018 |
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Target sample size:
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Recruitment status: |
Available |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03863119 |
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Study type:
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Expanded Access |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Israel
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United States
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Contacts
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Name:
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Ana de Vera, MD |
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Address:
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Telephone:
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+41619068 |
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Email:
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ana.devera@santhera.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject's parent or legal guardian has provided written informed consent/HIPAA
authorization
- Subject has previously completed at a participating US or Canada study site VBP15-LTE
up to and including the Month 24 assessments, OR VBP15-004 up to and including the
Week 48 assessments, VBP15-006 up to and including the Week 12 assessment
- Subject and parent/guardian are willing and able to comply with recommended study drug
administration plan, and standard of care follow-up and monitoring as recommended by
their Treating Physician
Exclusion Criteria:
- Subject had a serious or severe adverse event in study VBP15-LTE or VBP15-004 or
VBP15-006 that, in the opinion of the Treating Physician and Sponsor, was probably or
definitely related to vamorolone use and precludes safe use of vamorolone for the
subject in this expanded access program
- Subject and/or parent/guardian are unable and/or unwilling to comply with regular
medical care and follow-up as recommended by their Treating Physician throughout
participation in the VBP15-EAP
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy
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Intervention(s)
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Drug: Vamorolone
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Secondary ID(s)
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VBP15-EAP
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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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