A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety of selexipag while providing continued selexipag treatment for participants who were previously enrolled in an Actelion-sponsored study with selexipag and who derived benefit from selexipag in indications for which a positive benefit-risk has been established.

Official Title
-----------------
A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Selexipag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with selexipag at the end of a parent study and: a) the parent study has established efficacy with a favorable benefit/risk profile for the indication under investigation; b) participant may continue to benefit from treatment with selexipag; c) has completed the end of treatment (EOT) visit of the parent study; d) no alternative means of access to selexipag have been identified Women of childbearing potential must use an acceptable method of contraception throughout the study and until at least 1 month following the last dose of study intervention Women of childbearing potential must have a negative urine (or serum if applicable) pregnancy test at screening on Day 1 or at the last visit of the parent study Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study Exclusion Criteria: Suspected or known pulmonary veno-occlusive disease Known allergies, hypersensitivity, or intolerance to selexipag or its excipients Interruption of study intervention for more than 14 days since the last dose of study intervention taken in the parent study Female participant being pregnant, or breastfeeding, or planning to become pregnant at the time of screening and while enrolled in this study Uncontrolled thyroid disease Known and documented severe hepatic impairment, example, Child-Pugh Class C Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention: a) treatment with a strong CYP 2C8 inhibitor (example, gemfibrozil); b) treatment with oral prostacyclin analogs (example, beraprost, treprostinil) since the last dose of study intervention taken in the parent study; c) any investigational treatment other than selexipag Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure if not under close medical supervision, severe arrhythmia, cerebrovascular events (example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selexipag<br>Participants will receive selexipag tablets twice daily with the dose strength corresponding to their individual maximum tolerated dose (iMTD) from the parent study. | Drug: Selexipag<br>* Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.<br>* Other names: ACT-293987;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. | From Day 1 up to 7 years (end of study) | 
| Frequency of AEs Leading to Premature Discontinuation of Selexipag | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. | From Day 1 up to 7 years (end of study) | 
| Frequency of Serious Adverse Events (SAEs) | An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product or medically important. | From Day 1 up to 7 years (end of study) | 
| Frequency of Death | Frequency of death will be reported. | From Day 1 up to 7 years (end of study) | 
| Number of Pregnancies with Maternal Exposure to Selexipag | Number of pregnancies with maternal exposure to selexipag will be reported. | From Day 1 up to 7 years (end of study) |