Open-label, longitudinal, post-authorisation safety study to assess the safety of Cystadrops in pediatric and adult cystinosis patients in long term use (CYT-DS-001)

Study identification

• EU PAS number:
  EUPAS25688
• Study ID:
  29320
• Official title and acronym:
  Open-label, longitudinal, post-authorisation safety study to assess the safety of Cystadrops in pediatric and adult cystinosis patients in long term use (CYT-DS-001)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands
• Study description:
  This is an European prospective, observational, non-interventional, longitudinal, multi-center, single-arm study designed mainly to collect safety data in long term use on patients treated with Cystadrops
• Study status:
  Planned

Research institutions and networks

Institutions

Recordati

Rare Diseases

Study timelines

Date when funding contract was signed

Planned:31/10/2018

Study start date

Planned:20/05/2019

Date of final study report

Planned:15/07/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Recordati Rare Diseases

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)