A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery

  • Interventional
  • Not Recruiting
  • NCT03689244
Eligibility Details Visit Clinicaltrials.gov

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 and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension

Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in subjects with inoperable or persistent/recurrent CTEPH.

Subjects will be recruited in two sequential cohorts: the first 90 randomized subjects will undergo a right heart catheterization (RHC) with measurement of pulmonary vascular resistance (PVR) at Week 20 and will constitute the hemodynamic cohort; the remaining participants will constitute the non-hemodynamic cohort; they will undergo the same overall study assessments as the hemodynamic cohort excepted for RHC at Week 20.

Gender
All

Age Group
18 Years to 85 Years

Accepting Healthy Volunteers?
No

Main Inclusion Criteria:

         - Signed and dated informed consent form

         - Male and female subjects from 18 to 85 years old (inclusive).

         - With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee

         - With pulmonary hypertension (PH) in WHO FC I-IV.

         - Subject able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.

         - Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization.

        Main Exclusion Criteria:

         - Planned or current treatment with another investigational treatment up to 3 months prior to randomization.

         - Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

         - Known concomitant life-threatening disease with a life expectancy < 12 months.

         - Planned balloon pulmonary angioplasty within 26 weeks after randomization.

         - Change in dose or initiation of new PH-specific therapy within 90 days prior to randomization.

         - Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization.

         - Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC.

         - Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc).

         - Any other criteria as per selexipag Summary of Product Characteristics (SmPC).

At a Glance

National Government IDNCT03689244

IRB#IRB19-0653

Lead SponsorActelion

Lead PhysicianRemzi Bag

Collaborator(s)N/A

EligibilityAll
18 Years to 85 Years
Not Recruiting