NCT05179876RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 17 Dec 2021
- Start date
- 4 May 2022
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Actelion
- NCT number
- NCT05179876
- EU CT number
- 2023-506791-27-00
- EudraCT number
- 2021-002297-11
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 280
- From 4 May 2022 to the primary completion date, 31 Jan 2027
- 47 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned or current treatment with another investigational treatment
- Macitentan-specific:
Other illness
- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
- 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
- Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients
- 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
Lab values
- 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)
- 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:
- Hemoglobin \<80 g/L
- Serum aspartate (AST) and/or alanine aminotransferases (ALT) \>3\* ULN range
- Severe renal impairment (estimated glomerular filtration rate \[eGF\]/creatinine clearance \<30 milliliter per minute \[mL/min\])
Other
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| University Hospital St. Anna Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| The Republican Scientific-Practical Center ''Cardiology'' Coordinator of this site? Confirm its status | Minsk | Belarus | Recruiting |
| Minsk Regional Clinical Hospital Of The Red Banner Of Labor Coordinator of this site? Confirm its status | Minsk | Belarus | Completed |
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Anzhen Hospital 1 Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Xiangya Hospital of Central South Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Qingdao Women and Children's Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Childrens Hospital of Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Not yet recruiting |
| Gottsegen National Cardiovascular Center Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Seoul National University Hospital 1 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Scientific and Research Institution of Cardiovascular Diseases Complex Problems Coordinator of this site? Confirm its status | Kemerovo | Russia | Completed |
| E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
| Federal State Budgetary Institution Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Completed |
| Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences Coordinator of this site? Confirm its status | Tomsk | Russia | Completed |
| Regional Clinical Hospital No1 Coordinator of this site? Confirm its status | Tyumen | Russia | Recruiting |
| Maharaj Nakorn Chiang Mai hospital Faculty of Medicine Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Recruiting |
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Municipal Inst. Of Dnipropetrovsk Region. Council Coordinator of this site? Confirm its status | Dnipro | Ukraine | Completed |
| State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Completed |
| Hanoi Medical University Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Recruiting |
| Hanoi Heart Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Recruiting |
| Children's Hospital 1 Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| Abdullah, IA Coordinator of this site? Confirm its status | Durban | South Africa | Completed |
| Dr Kalla Coordinator of this site? Confirm its status | Lenasia | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.