SCOB2
Research type
Research Study
Full title
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 [SCOB2 Study]
IRAS ID
267010
Contact name
Helene Picot
Contact email
Sponsor organisation
RECORDATI Rare Diseases SARL
Eudract number
2018-002984-24
Duration of Study in the UK
1 years, 10 months, 30 days
Research 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), Orphan Europe 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.REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0259
Date of REC Opinion
25 Oct 2019
REC opinion
Further Information Favourable Opinion