A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
- Hypertension, Pulmonary
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Actelion
- Enrolment target
- 280
- Started
- 4 May 2022
- Main results due
- 31 January 2027
- Study sites
- 45
- Registry updated
- 25 September 2026
Can you take part?
- Aged 2 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension \[PAH\]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag * A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and/or parent(s)/ legally designated representative (LDR)(s) on the acceptable method of contraception Exclusion Criteria: General: * Participants prematurely discontinued from the study intervention in their parent study * Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study * Planned or current treatment with another investigational treatment Macitentan-specific: * Known allergies, hypersensitivity, or intolerance to macitentan or its excipients * Hemoglobin less than (\<) 80 grams per liter (g/L) * Serum aspartate (AST) and/or alanine aminotransferases (ALT) greater than (\>) 3\* upper limit of normal (ULN) * Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening Selexipag-specific: * Known allergies, hypersensitivity, or intolerance to selexipag or its excipients * Suspected or known pulmonary veno-occlusive disease (PVOD) * Uncontrolled thyroid disease * 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 (for 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 pulmonary hypertension (PH) * Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening * Children only: (a) Current suspicion of intussusception or ileus or gastrointestinal obstruction, per the investigator's judgment; (b) hemoglobin or hematocrit \<75 percent (%) of the lower limit of normal range Macitentan/tadalafil FDC-specific: * Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients * Hemoglobin \<80 g/L * Serum aspartate (AST) and/or alanine aminotransferases (ALT) \>3\* ULN range * Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at screening * Severe renal impairment (estimated glomerular filtration rate \[eGF\]/creatinine clearance \<30 milliliter per minute \[mL/min\])
What this study is about
In the sponsor’s own words, from the registry.
The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.
Study sites(45)
The Republican Scientific-Practical Center ''Cardiology''
Minsk, Belarus
Recruiting
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk, Belarus
Completed
UZ Leuven
Leuven, Belgium
Completed
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, Bulgaria
Recruiting
Beijing Anzhen Hospital 1
Beijing, China
Recruiting
Beijing Anzhen Hospital
Beijing, China
Recruiting
The Second Xiangya Hospital of Central South Hospital
Changsha, China
Recruiting
Jiangsu Province Hospital
Nanjing, China
Recruiting
Qingdao Women and Children's Hospital
Qingdao, China
Recruiting
Childrens Hospital of Shanghai
Shanghai, China
Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Recruiting
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
Recruiting
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
Bialystok, Poland
Recruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, Poland
Completed
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, Poland
Recruiting
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
Lodz, Poland
Completed
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, Poland
Completed
SPSK2 PUM Klinika Kardiologii
Szczecin, Poland
Completed
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
Wroclaw, Poland
Completed
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, Poland
Recruiting
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, Russia
Completed
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, Russia
Recruiting
Federal State Budgetary Institution
Saint Petersburg, Russia
Completed
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk, Russia
Completed
Regional Clinical Hospital No1
Tyumen, Russia
Recruiting
Abdullah, IA
Durban, South Africa
Completed
Dr Kalla
Lenasia, South Africa
Recruiting
Chungnam National University Hospital
Daejeon, South Korea
Recruiting
Gachon University Gil Medical Center
Incheon, South Korea
Recruiting
Seoul National University Hospital 1
Seoul, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
Completed
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan
Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan
Recruiting
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, Taiwan
Recruiting
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, Thailand
Recruiting
Municipal Inst. Of Dnipropetrovsk Region. Council
Dnipro, Ukraine
Completed
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, Ukraine
Completed
Hanoi Heart Hospital
Hanoi, Vietnam
Recruiting
Hanoi Medical University Hospital
Hanoi, Vietnam
Recruiting
Children's Hospital 1
Ho Chi Minh City, Vietnam
Recruiting
Showing 45 of 45 sites. 31 of the 45 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05179876. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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