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

    picot.h@recordati.com

  • 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