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

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

Nagano Children's Hospital, Azumino-shi, Nagano, Japan

Status

Completed

Address

Nagano Children's Hospital

Azumino-shi, Nagano, , 399-8288

Bunkyo-Ku, Japan

Status

Recruiting

Address

Tokyo Medical and Dental University Hospital

Bunkyo-Ku, , 113-8519

Fukuoka Children's Hospital, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka Children's Hospital

Fukuoka, , 813-0017

Okayama University Hospital, Okayama, Japan

Status

Completed

Address

Okayama University Hospital

Okayama, , 700-8558

Ota, Japan

Status

Completed

Address

Toho University Medical Center Omori Hospital

Ota, , 143-8541

Hokkaido University Hospital, Sapporo-shi, Japan

Status

Completed

Address

Hokkaido University Hospital

Sapporo-shi, , 060-8648

Setagaya Ku, Japan

Status

Completed

Address

National Center for Child Health and Development

Setagaya Ku, , 157 8535

Shinjuku-ku, Japan

Status

Completed

Address

Tokyo Women's Medical University Hospital

Shinjuku-ku, , 162-8666

Suita-Shi, Japan

Status

Recruiting

Address

National Cerebral and Cardiovascular Center

Suita-Shi, , 564-8565

Osaka University Hospital, Suita-shi, Japan

Status

Recruiting

Address

Osaka University Hospital

Suita-shi, , 565-0871

The University of Tokyo Hospital, Tokyo, Japan

Status

Active, not recruiting

Address

The University of Tokyo Hospital

Tokyo, , 113-8655

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

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