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NCT05179876From ClinicalTrials.govRecruiting

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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A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and H | Trialion