SELECT: SELExipag in inoperable or persistent/recurrent CTEPH

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical treatment Chronic Thromboembolic Pulmonary Hypertension.

• IRAS ID

  253601

• Contact name

  Joanna Pepke-Zaba

• Contact email

  Joanna.pepke-zaba@nhs.net

• Sponsor organisation

  Actelion Pharmaceuticals Ltd.

• Eudract number

  2018-002823-41

• Clinicaltrials.gov Identifier

  NCT03689244

• Duration of Study in the UK

  3 years, 3 months, 1 days

• Research summary

  Summary of Research
  Chronic thromboembolic pulmonary hypertension (CTEPH) is a long-term disease caused by a blockage in the blood vessels that deliver blood from the heart to the lungs. CTEPH is one of the leading causes of Pulmonary hypertension (PH). PH is a rare disorder that causes increased blood pressure within the arteries of the lungs. PH can complicate cardiovascular and respiratory diseases, such as chronic obstructive pulmonary disease (COPD).

  Where possible, pulmonary endarterectomy (PEA) surgery can be undertaken to treat CTEPH, although if left untreated (or the CTEPH is inoperable) CTEPH leads to increasing resistance within the right ventricle of the heart (pulmonary vascular resistance – PVR), and eventually failure in the right ventricle and death.

  This study will explore the efficacy and safety of selexipag (the study medication) in participants with inoperable or persistent/recurrent CTEPH who have been treated with standard of care.

  The study is conducted in four phases, consisting of a screening period of between 14-60 days, a double-blind treatment period of 12 months, an open-label treatment extension period of 24 months and a follow-up period of 30 days.

  Participants will be enrolled into two sequential cohorts. The first 90 participants that are randomised will become the hemodynamic cohort. The remaining participants will become the non-hemodynamic cohort.

  Summary of Results
  No plans for lay summary

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  18/EE/0390

• Date of REC Opinion

  25 Feb 2019

• REC opinion

  Further Information Favourable Opinion