An extension study of selexipag in subjects with pulmonary hypertension who benefit from selexipag at the end of a previous study.
- Conditions
- Pulmonary Hypertension.MedDRA version: 21.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-000475-21-RO
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
1. 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 EOT visit of the parent study
d) no alternative means of access to selexipag have been identified.
2. 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.
3. 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.
4. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1. Suspected or known pulmonary veno-occlusive disease.
2. Known allergies, hypersensitivity, or intolerance to selexipag or its excipients (Selexipag IB).
3. Interruption of study intervention for more than 14 days since the last dose of study intervention taken in the parent study.
4. Female participant being pregnant, or breastfeeding, or planning to become pregnant at the time of screening and while enrolled in this study.
5. Uncontrolled thyroid disease.
6. 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 (eg, 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.
7. Known and documented severe hepatic impairment, eg, Child-Pugh Class C.
8. Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention:
• treatment with a strong CYP 2C8 inhibitor (eg, gemfibrozil)
• treatment with oral prostacyclin analogs (eg, beraprost, treprostinil) since the last dose of study intervention taken in the parent study
• any investigational treatment other than selexipag.
9. Criterion modified per Amendment 1
9.1 plan to receive an investigational intervention (including investigational vaccines) other than selexipag.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety of selexipag while providing continued 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.;Secondary Objective: NA;Primary end point(s): • Frequency of AEs<br>• Frequency of AEs leading to premature discontinuation of selexipag<br>• Frequency of SAEs<br>• Frequency of deaths<br>• Number of pregnancies with maternal exposure to selexipag.;Timepoint(s) of evaluation of this end point: These safety endpoints will be assessed continuously from enrollment on Day 1 up to End-of-Study (EOS) visit.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA