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

Hypertension, Pulmonary Clinical Trial

— SOMBRERO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565990
• Other study ID #: CR108892
• Secondary ID: 2020-000475-2167
• Status: Completed
• Phase: Phase 3
• Start date: May 3, 2021
• Est. completion date: November 10, 2023

Study information

• Verified date: March 2024
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary

Intervention

Drug:
• Selexipag
Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.

Locations

Country	Name	City	State
Belarus	Minsk Regional Clinical Hospital	Minsk
Belarus	The Republican Scientific-Practical Center ''Cardiology''	Minsk
India	Sanjivani Hospitals	Ahmedabad
India	Apollo Hospitals	Chennai
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Romania	Institutul de pneumoftiziologie Marius Nasta	Bucuresti
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Ukraine	Municipal Inst. Of Dnipropetrovsk Region. Council	Dnipro
Ukraine	Health Care Municipal Institution City Clinical Hospital #13	Kharkiv
Ukraine	State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

Belarus,  India,  Korea, Republic of,  Romania,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Frequency of Death	Frequency of death will be reported.	From Day 1 up to 7 years (end of study)
Primary	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)