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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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4 December 2023 |
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Main ID: |
NCT02065011 |
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Date of registration:
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14/02/2014 |
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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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A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B
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Scientific title:
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An Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B |
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Date of first enrolment:
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September 12, 2013 |
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Target sample size:
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9 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02065011 |
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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: Other. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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United States
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Contacts
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Name:
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Clinical Sciences & Operations, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion criteria :
Provide signed and dated written informed consent (and if appropriate assent) and any
locally required authorization eg, Health Insurance Portability and Accountability Act
(HIPAA).
Must have been enrolled in protocol TDU13600. Must have received a subretinal injection of
SAR421869
Exclusion criteria:
Did not receive SAR421869 as part of the TDU13600 protocol.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Usher's Syndrome
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Intervention(s)
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Drug: Blood draw for the laboratory assessment
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Primary Outcome(s)
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The incidence of adverse events
[Time Frame: 15 years]
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Secondary Outcome(s)
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Clinically important changes in ocular safety assessments
[Time Frame: baseline to 15 years]
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Delay in retinal degeneration
[Time Frame: baseline to 15 years]
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Secondary ID(s)
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2013-000597-29
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LTS13619
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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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