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NCT01505062 · ClinicalTrials.gov registry record · Phase 1
Study of SAR421869 in Participants With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B
A Phase 1 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01505062: Clinical Trial Phase 1 study, sponsored by Sanofi.
NCT01505062 is a Phase 1 study that was terminated before completion, run by Sanofi. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01505062, a Phase 1 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of ascending doses of subretinal injections of SAR421869 in participants with Usher syndrome type 1B. To evaluate for possible biological activity of SAR421869.
Primary Outcome
An adverse event (AE) was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the IMP. The TEAEs were defined as any event that started or increased in severity after the participant received IMP, including abnormal laboratory results, electrocardiogram, etc.
Interventions
- DRUG SAR421869
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-03-26 |
| Est. Completion | 2019-08-16 |
| Phase | Phase 1 |
Why NCT01505062 stopped before completion
NCT01505062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which SAR421869 is the first listed.
NCT01505062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01505062 about?
NCT01505062 is a clinical study titled "Study of SAR421869 in Participants With Retinitis Pigmentosa Associated With Usher Syndrome Type 1B". To evaluate the safety and tolerability of ascending doses of subretinal injections of SAR421869 in participants with Usher syndrome type 1B. To evaluate for possible biological activity of SAR421869.
What is the current status of trial NCT01505062?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-03-26. Estimated completion is 2019-08-16.
What interventions are being tested in trial NCT01505062?
The interventions under investigation include: SAR421869 (DRUG).
Who is sponsoring clinical trial NCT01505062?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01505062's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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