Status: Ongoing First registered on: 01/04/2016
Last updated on: 20/04/2022
1. Study identification
EU PAS Register NumberEUPAS13004
Official titleProtocol 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).
Study title acronymSCENESSE® PASS-002
Study typeOther: Non-interventional trial
Brief description of the studyThis 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®
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 2 (specific obligation of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre namePorphyria Center Düsseldorf
Centre locationGermany
Details of (Primary) lead investigator
Title Dr
Last name Bilbao
First name Pilar
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4
Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/06/201626/09/2016
Start date of data collection31/07/201614/11/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report01/06/2027
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesClinuvel100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bilbao
First name Pilar
Address line 1Wesley House
Address line 2Bull Hill 
Address line 3 
CityLeatherhead 
PostcodeKT22 7AH 
CountryUnited Kingdom
Phone number (incl. country code)441372860765 
Alternative phone number 
Fax number (incl. country code) 
Email address mail@clinuvel.com
Public Enquiries
Title Dr 
Last name Bilbao 
First name Pilar 
Address line 1Wesley House 
Address line 2Bull Hill 
Address line 3 
CityLeatherhead 
PostcodeKT22 7AH 
CountryUnited Kingdom 
Phone number (incl. country code)441372860765 
Alternative phone number 
Fax number (incl. country code) 
Email address mail@clinuvel.com 
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