A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

Study Purpose

The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.

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	3 Months - 15 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Pulmonary arterial hypertension (PAH) belonging to the nice 2013 updated classification group 1.

- PAH diagnosis confirmed by historical right heart catheterization where in the absence of pulmonary vein obstruction and/or significant lung disease pulmonary artery wedge pressure (PAWP) can be replaced by left atrium pressure (LAP) or left ventricular end diastolic pressure (LVEDP) (in absence of mitral stenosis) assessed by heart catheterization.

- World Health Organization (WHO) functional class (FC) I to IV.

- PAH-specific treatment-naïve participants or participants on PAH-specific treatment.

- A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) test at screening and a negative urine pregnancy test at the first administration of study intervention.

- A female participant must not get pregnant and must agree not to donate eggs during the study and for a period of up to 4 weeks following the end of study.

Exclusion Criteria:

- Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn.

- Participants with the following diseases: pulmonary vein stenosis; bronchopulmonary dysplasia.

- Severe hepatic impairment, example, Child-Pugh Class C, at screening.

- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 weeks after the last dose of study intervention.

- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients.

- Participant with PAH associated with open shunts, with congenital cardiac abnormalities such as univentricular heart, with pulmonary hypertension due to lung disease, and renal dysfunction

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.	NCT05167825
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.	Janssen Pharmaceutical K.K.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Pharmaceutical K.K. Clinical Trial
Principal Investigator Affiliation	Janssen Pharmaceutical K.K.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Arms & Interventions

Arms

Experimental: Macitentan

Participants will receive oral dose of macitentan based on age and weight through Week 52.

Interventions

Drug: - Macitentan

Macitentan will be administered orally as a tablet.

Contact a Trial Team

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