A Study to Evaluate Whether or Not Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 19-000875
    NCT ID: NCT03689244
    Sponsor Protocol Number: AC-065B302

About this study

The purpose of this study is to assess the effectiveness and safety of selexipag in subjects with inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Charles Burger, M.D.

Open for enrollment

Contact information:

Inna Abrea

127or7833855

Abrea.Inna@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available