Actively Recruiting
A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
Led by Actelion · Updated on 2026-06-05
280
Participants Needed
45
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on participants with pulmonary hypertension (PH) who have completed previous clinical studies involving specific study drugs and currently have no other access to these treatments. The main goal is to evaluate the long-term safety of these study interventions, ensuring participants can continue treatment after their initial study ends. Participants who have finished a parent study and benefit from their study treatment will continue to receive one of three oral study drugs: macitentan, selexipag, or a fixed dose combination of macitentan and tadalafil. Adults and children receive doses tailored to their age and weight. Adult participants typically have study visits every six months, while pediatric participants visit every three months. These visits collect information on the safety and effectiveness of the treatments until the study ends or an approved alternative becomes available. During the study, participants undergo regular visits to monitor safety through assessments of adverse events and other health measures. Researchers track treatment-emergent adverse events, serious adverse events, and deaths from baseline until up to 84 months. The study continues until participants withdraw, the study intervention becomes commercially available, or the sponsor ends the study early. This long-term follow-up aims to gather important safety data while supporting ongoing treatment access.
CONDITIONS
Brief Title
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must sign an informed consent form indicating understanding and willingness to participate
- Participant treated with oral macitentan or selexipag or fixed dose combination of macitentan 10 mg and tadalafil 40 mg at the end of a parent study
- Indication of the parent study must be pulmonary arterial hypertension (PAH)
- Participant has completed the parent study
- No alternative access to study intervention or equivalent approved therapy
- Participant may continue to benefit from the study intervention
- Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag
- Female participants of childbearing potential must have a negative pregnancy test before starting study intervention
- Female participants must agree to monthly pregnancy tests until end of safety follow-up
- If heterosexually active, female participants must agree to use contraception until 30 days after last study intervention intake
- For pediatric females, investigator must ensure appropriate contraception counseling
You will not qualify if you...
- Participants who prematurely discontinued the study intervention in their parent study
- Female participants who are pregnant, breastfeeding, or planning pregnancy during the study
- Planned or current treatment with another investigational treatment
- Known allergies or intolerance to macitentan, selexipag, tadalafil, or their excipients
- Hemoglobin less than 80 g/L (macitentan and macitentan/tadalafil FDC)
- Serum aspartate (AST) or alanine aminotransferases (ALT) greater than 3 times upper limit of normal
- Severe hepatic impairment (Child-Pugh Class C)
- Suspected or known pulmonary veno-occlusive disease (selexipag only)
- Uncontrolled thyroid disease (selexipag only)
- Severe coronary heart disease or unstable angina, recent myocardial infarction, decompensated cardiac failure, severe arrhythmia, recent cerebrovascular events, or significant valvular defects unrelated to pulmonary hypertension (selexipag only)
- Children with current suspicion of intestinal obstruction or low hemoglobin/hematocrit (selexipag only)
- Severe renal impairment (eGFR or creatinine clearance less than 30 mL/min) (macitentan/tadalafil FDC only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 84 months
Participants receive oral study drugs (macitentan, selexipag, or macitentan/tadalafil fixed dose combination) to maintain their pulmonary hypertension therapy as continued from the parent study. The treatment continues until participant discontinuation, study termination, or availability of an approved alternative therapy.
Study visits every 6 months for adults; every 3 months for pediatric participants
Trial Site Locations
Total: 45 locations
1
The Republican Scientific-Practical Center ''Cardiology''
Minsk, Belarus, 220036
Actively Recruiting
2
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk, Belarus
Actively Recruiting
3
UZ Leuven
Leuven, Belgium, 3000
Completed
4
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, Bulgaria, 1750
Actively Recruiting
5
Beijing Anzhen Hospital 1
Beijing, China, 100029
Actively Recruiting
6
Beijing Anzhen Hospital
Beijing, China, 100029
Actively Recruiting
7
The Second Xiangya Hospital of Central South Hospital
Changsha, China, 410011
Actively Recruiting
8
Jiangsu Province Hospital
Nanjing, China
Actively Recruiting
9
Qingdao Women and Children's Hospital
Qingdao, China, 266035
Actively Recruiting
10
Childrens Hospital of Shanghai
Shanghai, China, 200062
Actively Recruiting
11
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China, 710061
Actively Recruiting
12
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary, 1096
Actively Recruiting
13
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
Bialystok, Poland, 15 276
Actively Recruiting
14
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, Poland, 85-168
Completed
15
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, Poland, 40 635
Actively Recruiting
16
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
Lodz, Poland, 91 347
Actively Recruiting
17
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, Poland, 20 718
Completed
18
SPSK2 PUM Klinika Kardiologii
Szczecin, Poland, 70 111
Actively Recruiting
19
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
Wroclaw, Poland, 51 124
Completed
20
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, Poland, 51 124
Actively Recruiting
21
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, Russia, 650002
Completed
22
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, Russia, 630055
Actively Recruiting
23
Federal State Budgetary Institution
Saint Petersburg, Russia, 197341
Completed
24
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk, Russia, 634012
Completed
25
Regional Clinical Hospital No1
Tyumen, Russia, 625000
Actively Recruiting
26
Abdullah, IA
Durban, South Africa, 4001
Completed
27
Dr Kalla
Lenasia, South Africa, 1820
Actively Recruiting
28
Chungnam National University Hospital
Daejeon, South Korea, 35015
Actively Recruiting
29
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
30
Seoul National University Hospital 1
Seoul, South Korea, 03080
Actively Recruiting
31
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
32
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
33
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
34
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Completed
35
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813
Actively Recruiting
36
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
37
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
38
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
39
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
40
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, Thailand, 50200
Actively Recruiting
41
Municipal Inst. Of Dnipropetrovsk Region. Council
Dnipro, Ukraine
Completed
42
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, Ukraine, 03680
Completed
43
Hanoi Heart Hospital
Hanoi, Vietnam
Actively Recruiting
44
Hanoi Medical University Hospital
Hanoi, Vietnam
Actively Recruiting
45
Children's Hospital 1
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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