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Cystadrops in pediatric cystinosis (6 months to < 2 years)
NCT04125927Phase 3Completed
- Sponsor
- Recordati Rare Diseases
- Start
- Sep 2020
- Primary completion
- Dec 2022
- Modality
- Small Molecules
- Countries
- 5
01
Overview
Phase 3, open-label, single-arm trial of cysteamine in cystinosis, sponsored by Recordati Rare Diseases. Primary endpoints: Ocular Serious Adverse Events, Serious Adverse Reactions related to Cystadrops, all Adverse Events that required discontinuation/withdrawal of IMP at 90 days, Serious Adverse Reactions related to Cystadrops, all Adverse Events that required discontinuation/withdrawal of IMP at 90 days and 1 more. Started Sep 2020; status: completed.
02
Drugs
cysteamine
03
Conditions
cystinosis
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