Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either Uptravi (selexipag) or any other PAH-specific therapy, in clinical practice (EXPOSURE)

Study identification

• EU PAS number:
  EUPAS19085
• Study ID:
  48403
• Official title and acronym:
  Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either Uptravi (selexipag) or any other PAH-specific therapy, in clinical practice (EXPOSURE)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Canada

  Czechia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Lithuania

  Netherlands

  Poland

  Portugal

  Russian Federation

  Slovakia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This prospective observational cohort study is conducted to further characterise the safety profile of Uptravi and to describe clinical characteristics and outcomes of patients newly treated with Uptravi in the post-marketing setting. ; A cohort of patients newly treated with any other PAH-specific therapy than Uptravi and who were never treated with Uptravi is included in this study for the purpose of comparing the incidence of major adverse cardiovascular events (MACE) and all-cause death with patients newly treated with Uptravi.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Actelion Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned:11/04/2017

Actual:11/04/2017

Study start date

Planned:30/09/2017

Actual:13/09/2017

Date of interim report, if expected

Planned:31/03/2024

Actual:21/03/2024

Date of final study report

Planned:30/06/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Actelion Pharmaceuticals Ltd.

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)