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.

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

Hypertension, Pulmonary

Pulmonary Hypertension

Lung Conditions

Heart and lung conditions

Macitentan

Selexipag

Macitentan/Tadalafil FDC

A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.

Frequency of TEAEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.

SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug macitentan orally during the course of the study. For adult participants study visits will be scheduled every 6 months and for pediatric participants study visits will be scheduled every 3 months. The study includes on-site visits to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug selexipag orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive drug Macitentan and Tadalafil fixed dose combination (FDC) orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.

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 and NCT04565990]), 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.

The Republican Scientific-Practical Center ''Cardiology''

UZ Leuven

Chungnam National University Hospital

Gachon University Gil Medical Center

Seoul National University Hospital

Asan Medical Center

Samsung Medical Center

The Catholic University of Korea Seoul St. Mary's Hospital

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im. W.Bieganskiego

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

SPSK2 PUM, Klinika Kardiologii

Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

Abdullah, IA

Kaohsiung Veterans General Hospital

National Cheng Kung University Hospital

National Taiwan University Hospital

Taipei Veterans General Hospital

Municipal Inst. Of Dnipropetrovsk Region. Council

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Frequency of TEAEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

The Second Xiangya Hospital of Central South Hospital

Qingdao Women and Children's Hospital

The First Affiliated Hospital of Xian Jiaotong University

Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku

SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca

Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ

SPSK2 PUM Klinika Kardiologii

Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy

E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

Dr Kalla

Seoul National University Hospital 1

The Catholic University of Korea Seoul St Marys Hospital

Chang-Gung Memorial Hospital, LinKou Branch

Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

Hanoi Heart Hospital

Minsk Regional Clinical Hospital Of The Red Banner Of Labor

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

Beijing Anzhen Hospital 1

Beijing Anzhen Hospital

Childrens Hospital of Shanghai

Wojewodzki Szpital Specjalistyczny we Wroclawiu

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

Federal State Budgetary Institution

Regional Clinical Hospital No1

Hanoi Medical University Hospital

Children's Hospital 1

Jiangsu Province Hospital

Gottsegen György Országos Kardiológiai Intézet

Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

Trials at a glance

Trials at a glance

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

Outcome measures

Primary outcome measures