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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

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumCompleted
University Hospital St. Anna
Coordinator of this site? Confirm its status
SofiyaBulgariaRecruiting
The Republican Scientific-Practical Center ''Cardiology''
Coordinator of this site? Confirm its status
MinskBelarusRecruiting
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Coordinator of this site? Confirm its status
MinskBelarusCompleted
Beijing Anzhen Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Beijing Anzhen Hospital 1
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The Second Xiangya Hospital of Central South Hospital
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Qingdao Women and Children's Hospital
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
Childrens Hospital of Shanghai
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
The First Affiliated Hospital of Xian Jiaotong University
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainNot yet recruiting
Centre Hospitalier Universitaire De Toulouse
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceNot yet recruiting
Gottsegen National Cardiovascular Center
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
Chungnam National University Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaRecruiting
Gachon University Gil Medical Center
Coordinator of this site? Confirm its status
IncheonSouth KoreaRecruiting
Seoul National University Hospital 1
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
The Catholic University of Korea Seoul St Marys Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaCompleted
Uniwersytecki Szpital Kliniczny w Bialymstoku
Coordinator of this site? Confirm its status
BialystokPolandRecruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Coordinator of this site? Confirm its status
KatowicePolandRecruiting
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Coordinator of this site? Confirm its status
LodzPolandRecruiting
Wojewodzki Szpital Specjalistyczny Im. Stefana Kardynala Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lublinie
Coordinator of this site? Confirm its status
LublinPolandRecruiting
Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
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PoznanPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandRecruiting
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Coordinator of this site? Confirm its status
WroclawPolandRecruiting
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Coordinator of this site? Confirm its status
KemerovoRussiaCompleted
E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation
Coordinator of this site? Confirm its status
NovosibirskRussiaRecruiting
Federal State Budgetary Institution
Coordinator of this site? Confirm its status
Saint PetersburgRussiaCompleted
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Coordinator of this site? Confirm its status
TomskRussiaCompleted
Regional Clinical Hospital No1
Coordinator of this site? Confirm its status
TyumenRussiaRecruiting
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Coordinator of this site? Confirm its status
Chiang MaiThailandRecruiting
Kaohsiung Veterans General Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Veterans General Hospital
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TaipeiTaiwanRecruiting
Chang Gung Memorial Hospital, Linkou Branch
Coordinator of this site? Confirm its status
TaoyuanTaiwanRecruiting
Municipal Inst. Of Dnipropetrovsk Region. Council
Coordinator of this site? Confirm its status
DniproUkraineCompleted
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Coordinator of this site? Confirm its status
KyivUkraineCompleted
Hanoi Medical University Hospital
Coordinator of this site? Confirm its status
HanoiVietnamRecruiting
Hanoi Heart Hospital
Coordinator of this site? Confirm its status
HanoiVietnamRecruiting
Children's Hospital 1
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamRecruiting
Abdullah, IA
Coordinator of this site? Confirm its status
DurbanSouth AfricaCompleted
Dr Kalla
Coordinator of this site? Confirm its status
LenasiaSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.