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A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Sponsor: Actelion
Summary
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.
Official title: A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2022-05-04
Completion Date
2028-02-29
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Macitentan
Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (\>=) 2 year to less than (\<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.
Selexipag
Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of \>=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight \< 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.
Macitentan/Tadalafil FDC
Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.
Locations (43)
The Republican Scientific-Practical Center ''Cardiology''
Minsk, Belarus
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk, Belarus
UZ Leuven
Leuven, Belgium
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, Bulgaria
Beijing Anzhen Hospital
Beijing, China
The Second Xiangya Hospital of Central South Hospital
Changsha, China
Jiangsu Province Hospital
Nanjing, China
Qingdao Women and Children's Hospital
Qingdao, China
Childrens Hospital of Shanghai
Shanghai, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
Bialystok, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, Poland
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, Poland
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
Lodz, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, Poland
SPSK2 PUM Klinika Kardiologii
Szczecin, Poland
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
Wroclaw, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, Poland
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, Russia
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, Russia
Federal State Budgetary Institution
Saint Petersburg, Russia
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk, Russia
Regional Clinical Hospital No1
Tyumen, Russia
Abdullah, IA
Durban, South Africa
Dr Kalla
Lenasia, South Africa
Chungnam National University Hospital
Daejeon, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, Taiwan
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, Thailand
Municipal Inst. Of Dnipropetrovsk Region. Council
Dnipro, Ukraine
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, Ukraine
Hanoi Heart Hospital
Hanoi, Vietnam
Hanoi Medical University Hospital
Hanoi, Vietnam
Children's Hospital 1
Ho Chi Minh City, Vietnam