Clinical trial NCT04565990: A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension, Pulmonary
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
measure: Number of Participants With TEAEs Leading to Premature Discontinuation of Selexipag
timeFrame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
measure: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
measure: Number of Participants With Treatment-emergent Deaths
timeFrame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
measure: Number of Pregnant Females With Maternal Exposure to Selexipag
timeFrame: From Day 1 up to 30 days after last dose of drug (up to 29 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: The Republican Scientific-Practical Center ''Cardiology''
city: Minsk
country: Belarus
facility: Minsk Regional Clinical Hospital
city: Ahmedabad
country: India
facility: Sanjivani Hospitals
city: Chennai
country: India
facility: Apollo Hospitals
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Bucuresti
country: Romania
facility: Institutul de pneumoftiziologie Marius Nasta
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Dnipro
country: Ukraine
facility: Municipal Inst. Of Dnipropetrovsk Region. Council
city: Kharkiv
country: Ukraine
facility: Health Care Municipal Institution City Clinical Hospital #13
city: Kyiv
country: Ukraine
facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Study officials:
affiliation: Actelion
name: Actelion Clinical Trial
role: STUDY_DIRECTOR
References: