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Clinical Trials in France / NCT02065011
Active, not recruiting Phase 2

A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

NCT02065011 · tracked via the Priya Life Science France tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2013-09-12
Last updated
2026-01-13

Condition(s) studied

Usher's Syndrome

Investigational drug(s) / intervention(s)

Blood draw for the laboratory assessment

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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 TDU13600. Must have received a subretinal injection of SAR421869 Exclusion criteria: Did not receive SAR421869 as part of the TDU13600 protocol.

Primary outcome measure(s)

  • The incidence of adverse events — 15 years
    The number and percentage of patients with treatment emergent adverse events

Trial sites (2)

FacilityCityRegionStatus
Oregon Health and Science University Site Number : 840001 Portland Oregon
Investigational Site Number : 250001 Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02065011 on ClinicalTrials.gov ↗ ← All trials in France