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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Actelion Industry-sponsored |
| Locations | 45 sites (Minsk and 44 other locations) |
| Status | Recruiting |
| Started | May 4, 2022 |
| Main results expected | January 31, 2027 |
| Study ends | September 28, 2033 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT05179876 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
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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
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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
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Vasoactive Agents in Pulmonary Hypertension Crisis
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-
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.
-
Digital stethoscope and 3-lead ECG detection of pulmonary hypertension and low ejection fraction
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-
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.
-
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.
-
Levosimendan to see if it helps the heart after PEA in CTEPH
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.