A Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients (Besremi-PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42880
• EU PAS number:
  EUPAS29462
• Study ID:
  42880
• Official title and acronym:
  A Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients (Besremi-PASS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Romania
• Study description:
  The objective of the study is to provide further data to characterize the safety and tolerability of ropeginterferon alfa-2b by monitoring the hepatic and cardiovascular safety in patients with polycythaemia vera treated with ropeginterferon alfa-2b in routine post-authorisation use.
• Study status:
  Ongoing

Research institutions and networks

Institutions

AOP Orphan Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 30/04/2019

Study start date

Planned: 31/12/2019

Actual: 17/12/2019

Data analysis start date

Planned: 30/06/2025

Date of interim report, if expected

Planned: 31/12/2024

Actual: 17/12/2024

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AOP Orphan Pharmaceuticals GmbH

Study protocol

Initial protocol

190913_Ropeg PASS_Protocol_2.0_Redacted

Updated protocol

Ropeg PASS_Protocol_2.3_26Apr2022_clean_Redacted

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)