A Post-Authorisation Disease Registry Safety Study to Generate Data on the Long-Term Safety and Clinical Effectiveness of SCENESSE® (Afamelanotide 16mg) in Patients with Erythropoietic Protoporphyria (EPP) (SCENESSE® PASS-001)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46824
• EU PAS number:
  EUPAS13001
• Study ID:
  46824
• Official title and acronym:
  A Post-Authorisation Disease Registry Safety Study to Generate Data on the Long-Term Safety and Clinical Effectiveness of SCENESSE® (Afamelanotide 16mg) in Patients with Erythropoietic Protoporphyria (EPP) (SCENESSE® PASS-001)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Finland

  Italy

  Netherlands

  Slovenia

  United Kingdom
• Study description:
  This non-interventional study has been designed to gather long-term safety data and outcome endpoints. The objectives are to assess whether SCENESSE® can be used safely within designated treatment centres and to generate data to support the clinical effectiveness derived from the use of SCENESSE®
• Study status:
  Ongoing

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

Networks

Porphryia treatment centres

Study timelines

Date when funding contract was signed

Planned: 30/04/2016

Actual: 19/06/2016

Study start date

Planned: 31/05/2016

Actual: 22/06/2016

Date of final study report

Planned: 01/04/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Clinuvel

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)