Trials / Completed
CompletedNCT04125927
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients From 6 Months to Less Than 2 Years Old
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- RECORDATI GROUP · Industry
- Sex
- All
- Age
- 6 Months – 2 Years
- Healthy volunteers
- Not accepted
Summary
Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed. However administration of Cystadrops® in patients below 2 years old could be of value for these patients and prevent the crystal deposit. It is the reason why as part of the Cystadrops® pediatric investigational plan (PIP), RECORDATI Rare Diseases committed to conduct a clinical study to assess Cystadrops® safety and efficacy in the pediatric population from 6 months to less than 2 years old.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mercaptamine | Patients will be treated with 1 drop in each eye 4 times a day, at the same dose and regimen than the one indicated in adults and children from 2 years of age. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2022-12-23
- Completion
- 2022-12-23
- First posted
- 2019-10-14
- Last updated
- 2024-02-05
Locations
6 sites across 5 countries: Belgium, France, Germany, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT04125927. Inclusion in this directory is not an endorsement.