A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent S

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

Last Updated September 4, 2024

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CR109121

OVERVIEW

Sexes Eligible for Study
all
Age
2+ years
Phase
phase 3

3
Sites
30 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:

More...

DETAILS

LOCATIONS

Locations in:

Belarus, Belgium, Bulgaria, South Korea, Poland, Russia, South Africa, Taiwan, Ukraine, China

Country (10)	City or Province (30)	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	Białystok Klinika Kardiologii z Oddzialem Intensywnego Nadzoru Kardiologicznego, UM w Białymstoku	RECRUITING
Poland	Bydgoszcz Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii	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
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

Geo Locations

53.9, 27.56667

50.87959, 4.70093

42.69751, 23.32415

36.32139, 127.41972

37.45646, 126.70515

37.566, 126.9784

53.13333, 23.16433

53.1235, 18.00762

50.25841, 19.02754

51.75, 19.46667

51.25, 22.56667

53.42894, 14.55302

51.1, 17.03333

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

24.95233, 121.20193

48.4593, 35.03864

50.45466, 30.5238

34.25833, 108.92861

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

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

53.13333, 23.16433

53.1235, 18.00762

50.25841, 19.02754

51.75, 19.46667

51.25, 22.56667

53.42894, 14.55302

51.1, 17.03333

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

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