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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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])

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05179876
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Actelion Clinical Trial
Principal Investigator Affiliation Actelion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belarus, Belgium, Bulgaria, Korea, Republic of, Poland, Russian Federation, South Africa, Taiwan, Ukraine
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary
Arms & Interventions

Arms

Experimental: Macitentan

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug macitentan orally during the course of the study. For adult participants study visits will be scheduled every 6 months and for pediatric participants study visits will be scheduled every 3 months. The study includes on-site visits to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.

Experimental: Selexipag

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug selexipag orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.

Experimental: Macitentan/Tadalafil FDC

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive drug Macitentan and Tadalafil fixed dose combination (FDC) orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.

Interventions

Drug: - Macitentan

Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (>=) 2 year to less than (<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.

Drug: - Selexipag

Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms.

Drug: - Macitentan/Tadalafil FDC

Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Minsk, Belarus

Status

Recruiting

Address

The Republican Scientific-Practical Center ''Cardiology''

Minsk, , 220036

Minsk, Belarus

Status

Recruiting

Address

Minsk Regional Clinical Hospital Of The Red Banner Of Labor

Minsk, ,

UZ Leuven, Leuven, Belgium

Status

Completed

Address

UZ Leuven

Leuven, , 3000

Sofia, Bulgaria

Status

Recruiting

Address

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

Sofia, , 1750

Chungnam National University Hospital, Daejeon, Korea, Republic of

Status

Recruiting

Address

Chungnam National University Hospital

Daejeon, , 35015

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center

Incheon, , 21565

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , 06591

Białystok, Poland

Status

Recruiting

Address

Klinika Kardiologii z Oddzialem Intensywnego Nadzoru Kardiologicznego, UM w Białymstoku

Białystok, , 15-276

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

Bydgoszcz, , 85-168

Lodz, Poland

Status

Recruiting

Address

Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im. W.Bieganskiego

Lodz, , 91-347

Lublin, Poland

Status

Recruiting

Address

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

Lublin, , 20-718

SPSK2 PUM, Klinika Kardiologii, Szczecin, Poland

Status

Recruiting

Address

SPSK2 PUM, Klinika Kardiologii

Szczecin, , 70-111

Wroclaw, Poland

Status

Recruiting

Address

Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

Wroclaw, , 51-124

Kemerovo, Russian Federation

Status

Recruiting

Address

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

Kemerovo, , 650002

Federal State Budgetary Institution, St Petersburg, Russian Federation

Status

Recruiting

Address

Federal State Budgetary Institution

St Petersburg, , 197341

Tomsk, Russian Federation

Status

Recruiting

Address

Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences

Tomsk, , 634012

Abdullah, IA, Durban, South Africa

Status

Recruiting

Address

Abdullah, IA

Durban, , 4001

Dr Kalla, Lenasia, South Africa

Status

Recruiting

Address

Dr Kalla

Lenasia, , 1820

Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Status

Recruiting

Address

Kaohsiung Veterans General Hospital

Kaohsiung, , 813

National Cheng Kung University Hospital, Tainan, Taiwan

Status

Recruiting

Address

National Cheng Kung University Hospital

Tainan, , 704

National Taiwan University Hospital, Taipei, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei, , 100

Taipei Veterans General Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Veterans General Hospital

Taipei, , 112

Dnipro, Ukraine

Status

Suspended

Address

Municipal Inst. Of Dnipropetrovsk Region. Council

Dnipro, ,

Kyiv, Ukraine

Status

Suspended

Address

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Kyiv, , 03680

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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