EXTRACT (EXploratory hisToRicAl Cohort study)

• Research type

  Research Study

• Full title

  Post-authorisation Safety Study (PASS): Retrospective Medical Chart Review of Patients with PAH Newly Treated With Either Uptravi® (selexipag) or any Other PAH-specific Therapy.

• IRAS ID

  321429

• Contact name

  David Kiely

• Contact email

  david.kiely1@nhs.net

• Sponsor organisation

  Actelion Pharmaceuticals Ltd, a Janssen Pharmaceuticals company of Johnson and Johnson

• Clinicaltrials.gov Identifier

  ATC code: B01AC27,

• Duration of Study in the UK

  0 years, 2 months, 1 days

• Research summary

  EXTRACT is a multicentre, international, retrospective chart review study of patients with pulmonary arterial hypertension (PAH) newly treated with Uptravi (generic name: selexipag) or other PAH-specific therapy. The aim of EXTRACT is to complement the EXPOSURE study (AC-065A401; EU PAS 19085) to fulfill the EMA PASS requirement on Uptravi. EXPOSURE is a post-authorisation safety study for Uptravi included in the European Union (EU) Risk Management Plan (RMP) as Additional Pharmacovigilance Activities agreed with the Pharmacovigilance Risk Assessment Committee (PRAC) during the initial Marketing Authorization Application (MAA) in 2016.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  23/NW/0045

• Date of REC Opinion

  22 Jun 2023

• REC opinion

  Further Information Favourable Opinion