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A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option (PLATYPUS)

Last Updated   April 23, 2025

Want to learn how to participate in this trial?

CR109121

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    2+ years
  • Phase
    phase 3
    3
  • Sites
    33 Sites
  • Status
    Recruiting

SUMMARY

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 and NCT04565990]), 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.

CONDITIONS

  • Hypertension, Pulmonary

ELIGIBILITY


Inclusion Criteria:

* Participant must sign an informed consent form (ICF) (or their legally acceptable 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] or chronic thromboembolic pulmonary hypertension [CTEPH] for adults, PAH for pediatric participants); 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 selexipag or macitentan/tadalafil FDC, and at least 2 years old for macitentan
* 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) agree to follow contraceptive methods until 30 days after the last intake of the study intervention


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

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])


Inclusion Criteria:

* Participant must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Participan

More...

DETAILS

LOCATIONS

Locations in:
Belarus, Belgium, Bulgaria, South Korea, Poland, Russia, South Africa, Taiwan, Ukraine, China
Country (10) City or Province (33) Status
Belarus Minsk The Republican Scientific-Practical Center ''Cardiology''
RECRUITING
Belarus Minsk Minsk Regional Clinical Hospital Of The Red Banner Of Labor
RECRUITING
Belgium Leuven UZ Leuven
COMPLETED
Bulgaria Sofia University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
RECRUITING
South Korea Daejeon Chungnam National University Hospital
RECRUITING
South Korea Incheon Gachon University Gil Medical Center
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Asan Medical Center
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Poland Bydgoszcz Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
RECRUITING
Russia Kemerovo Scientific and Research Institution of Cardiovascular Diseases Complex Problems
RECRUITING
Russia St Petersburg Federal State Budgetary Institution
RECRUITING
Russia Tomsk Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
RECRUITING
South Africa Durban Abdullah, IA
RECRUITING
South Africa Lenasia Dr Kalla
RECRUITING
Taiwan Kaohsiung Kaohsiung Veterans General Hospital
RECRUITING
Taiwan Tainan National Cheng Kung University Hospital
RECRUITING
Taiwan Taipei National Taiwan University Hospital
RECRUITING
Taiwan Taipei Taipei Veterans General Hospital
RECRUITING
Taiwan Taoyuan Chang-Gung Memorial Hospital, LinKou Branch
RECRUITING
Ukraine Dnipro Municipal Inst. Of Dnipropetrovsk Region. Council
RECRUITING
Ukraine Kyiv State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
RECRUITING
China Xi'An The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
China Beijing Beijing Anzhen Hospital
RECRUITING
China Changsha The Second Xiangya Hospital of Central South Hospital
RECRUITING
China Nanjing Jiangsu Province Hospital
RECRUITING
Poland Bialystok Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
RECRUITING
Poland Katowice SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
RECRUITING
Poland Lodz Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
RECRUITING
Poland Lublin Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
RECRUITING
Poland Szczecin SPSK2 PUM Klinika Kardiologii
RECRUITING
Poland Wroclaw Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
RECRUITING
Show More
Geo Locations

53.9, 27.56667

53.9, 27.56667

50.87959, 4.70093

42.69751, 23.32415

36.32139, 127.41972

37.45646, 126.70515

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

53.1235, 18.00762

55.33333, 86.08333

59.93863, 30.31413

56.49771, 84.97437

-29.8579, 31.0292

-26.32052, 27.83564

22.61626, 120.31333

22.99083, 120.21333

25.04776, 121.53185

25.04776, 121.53185

24.95233, 121.20193

48.4593, 35.03864

50.45466, 30.5238

34.25833, 108.92861

39.9075, 116.39723

28.19874, 112.97087

32.06167, 118.77778

53.13333, 23.16433

50.25841, 19.02754

51.75, 19.46667

51.25, 22.56667

53.42894, 14.55302

51.1, 17.03333

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10

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5

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Corresponds to individual site.

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