Clinical trial Recruiting at 31 sites Phase 3 Interventional Ages 2 and up

Access to treatment for patients with pulmonary hypertension after completing a parent study

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

Run by Actelion · NCT05179876 · Data updated 2026-11-12

This study is testing whether patients with pulmonary hypertension can keep receiving effective treatments after finishing a previous study to see if it remains safe for them.

More Pulmonary Hypertension trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages2 Years and up
SexAll
Enrollment280 (estimated)
SponsorActelion
Industry-sponsored
Locations45 sites (Minsk and 44 other locations)
StatusRecruiting
StartedMay 4, 2022
Main results expectedJanuary 31, 2027
Study endsSeptember 28, 2033
Registry record updatedNovember 3, 2026
Trial IDNCT05179876 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults and children aged 2 years and older who have completed a parent study and are currently receiving macitentan or selexipag.

Probably not a fit

Patients who have alternative treatment options available or who have not participated in a parent study may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to provide continued access to treatment for participants with pulmonary hypertension who have completed a parent study and have no other options for receiving the intervention. Participants will be treated with macitentan, selexipag, or a fixed-dose combination of macitentan and tadalafil. The study will assess the long-term safety of these interventions while allowing patients to maintain their treatment regimen. It is designed for individuals who have previously benefited from these treatments in parent studies.

Why it matters

Potential benefit: If successful, this study could ensure ongoing treatment for patients with pulmonary hypertension who have limited options.

How similar studies have gone: Other studies involving long-term access to treatments for chronic conditions have shown success, indicating a potential for positive outcomes in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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 \[mL/min\])

Where it's running

  • The Republican Scientific-Practical Center ''Cardiology''
    Minsk, Belarus
    Recruiting
  • 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
Show 39 more locations
  • 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
  • SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
    Katowice, Poland
    Recruiting
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu
    Wroclaw, Poland
    Recruiting
  • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
    Novosibirsk, Russia
    Recruiting
  • Regional Clinical Hospital No1
    Tyumen, Russia
    Recruiting
  • 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
  • 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
  • Hanoi Heart Hospital
    Hanoi, Vietnam
    Recruiting
  • Hanoi Medical University Hospital
    Hanoi, Vietnam
    Recruiting
  • Children's Hospital 1
    Ho Chi Minh City, Vietnam
    Recruiting
  • Minsk Regional Clinical Hospital Of The Red Banner Of Labor
    Minsk, Belarus
    Completed
  • UZ Leuven
    Leuven, Belgium
    Completed
  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
    Bydgoszcz, Poland
    Completed
  • 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
  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems
    Kemerovo, Russia
    Completed
  • 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
  • Abdullah, IA
    Durban, South Africa
    Completed
  • The Catholic University of Korea Seoul St Marys Hospital
    Seoul, South Korea
    Completed
  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Vasoactive Agents in Pulmonary Hypertension Crisis

    This trial tests whether dopamine, norepinephrine, or epinephrine can safely and effectively help people with a pulmonary hypertension crisis who are in the hospital.

    Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality and 2 other locations · NCT07667829

  • TX000045 for pulmonary hypertension from interstitial lung disease

    This study tests TX000045 to see if it can reduce pulmonary vascular resistance in people with PH caused by interstitial lung disease and to check its safety.

    Recruiting at 12 sites Phase 2 Tectonic Operating Company, Inc. · Phoenix, Arizona and 15 other locations · NCT07473700

  • Digital stethoscope and 3-lead ECG detection of pulmonary hypertension and low ejection fraction

    This project will test whether heart sounds and a three-lead ECG recorded with a digital stethoscope can find pulmonary hypertension or low left ventricular ejection fraction in adults having an echocardiogram.

    Recruiting at 4 sites Eko Devices, Inc. · O'Fallon, Illinois and 3 other locations · NCT07087613

  • Deep-learning ECG to detect pulmonary hypertension

    This trial tests whether an AI-powered ECG can spot high blood pressure in the lungs (pulmonary hypertension) in adults aged 50–85 who have had a recent ECG.

    Recruiting National Defense Medical Center, Taiwan · Taipei · NCT07079592

  • How lung capillary surface area changes after balloon pulmonary angioplasty for CTEPH

    This will test whether balloon pulmonary angioplasty restores downstream functional pulmonary capillary surface area in people with chronic thromboembolic pulmonary hypertension.

    Recruiting Jewish General Hospital · Montreal, Quebec · NCT05719415

  • Levosimendan to see if it helps the heart after PEA in CTEPH

    This small randomized trial tests whether giving levosimendan around surgery helps reduce pulmonary artery pressure and support right heart function after pulmonary endarterectomy for CTEPH.

    Recruiting Meshalkin Research Institute of Pathology of Circulation · Novosibirsk · NCT07914933

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.