Protocol version for countries where patients treated off-label cannot be included in the disease registry: 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-002)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46827
• EU PAS number:
  EUPAS13004
• Study ID:
  46827
• Official title and acronym:
  Protocol version for countries where patients treated off-label cannot be included in the disease registry: 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-002)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• 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

Porphyria Center Düsseldorf

Study timelines

Date when funding contract was signed

Planned: 30/06/2016

Actual: 26/09/2016

Study start date

Planned: 31/07/2016

Actual: 14/11/2016

Date of final study report

Planned: 01/06/2027

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)