NCT02065011Active, not recruitingPhase 2
An Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Sanofi
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- The incidence of adverse events
Study Overview
Brief Summary
Primary Objective:
To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B
Secondary Objective:
To assess long-term safety and biological activity of SAR421869
Detailed Description
The total duration of study period is up to 15 years.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 TDU
- •Must have received a subretinal injection of SAR421869
Exclusion Criteria
- •Did not receive SAR421869 as part of the TDU13600 protocol.
Arms & Interventions
Long-term follow up
Other
Long-term follow up of patients who received SAR421869 in a previous study TDU13600
Intervention: Blood draw for the laboratory assessment (Drug)
Outcomes
Primary Outcomes
The incidence of adverse events
Time Frame: 15 years
The number and percentage of patients with treatment emergent adverse events
Secondary Outcomes
- Delay in retinal degeneration(baseline to 15 years)
- Clinically important changes in ocular safety assessments(baseline to 15 years)
Investigators
Study Sites (2)
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