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Исследование мацитентана у японских педиатров с легочной артериальной гипертензией

16 апреля 2026 г. обновлено: Janssen Pharmaceutical K.K.

Многоцентровое открытое исследование III фазы по оценке эффективности, безопасности и фармакокинетики мацитентана у педиатрических пациентов в Японии (>=3 месяцев до

Целью данного исследования является оценка влияния мацитентана на показатели гемодинамики на 24-й неделе в педиатрической популяции.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

7

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Япония
      • Azumino-shi, Япония, 399-8288
        • Nagano Children's Hospital
      • Bunkyō City, Япония, 113 8519
        • Institute of Science Tokyo Hospital
      • Fukuoka, Япония, 813-0017
        • Fukuoka Children's Hospital
      • Okayama, Япония, 700 8558
        • Okayama University Hospital
      • Sapporo, Япония, 060-8648
        • Hokkaido University Hospital
      • Setagaya Ku, Япония, 157 8535
        • National Center for Child Health and Development
      • Shinjuku-ku, Япония, 162-8666
        • Tokyo Women's Medical University Hospital
      • Suita-Shi, Япония, 564-8565
        • National Cerebral and Cardiovascular Center
      • Suita-shi, Япония, 565-0871
        • Osaka University Hospital
      • Tokyo, Япония, 113-8655
        • The University of Tokyo Hospital
      • Ōta-ku, Япония, 143-8541
        • Toho University Medical Center Omori Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 3 месяца до 15 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • Легочная артериальная гипертензия (ЛАГ), относящаяся к группе 1 обновленной классификации Nice 2013 г.
  • Диагноз ЛАГ подтверждается катетеризацией правых отделов сердца в анамнезе, при этом при отсутствии обструкции легочных вен и/или значительного заболевания легких давление заклинивания легочной артерии (ДЗЛА) может быть заменено давлением в левом предсердии (КЛП) или конечно-диастолическим давлением в левом желудочке (КДЛЖ) (в отсутствие митрального стеноза) оценивается катетеризацией сердца
  • Функциональный класс Всемирной организации здравоохранения (ВОЗ) (FC) с I по IV
  • Участники, ранее не получавшие лечения по поводу ЛАГ, или участники, получавшие лечение по поводу ЛАГ
  • Женщина детородного возраста должна иметь отрицательный высокочувствительный тест на бета-хорионический гонадотропин человека (бета-ХГЧ) в сыворотке при скрининге и отрицательный тест мочи на беременность при первом введении исследуемого вмешательства.
  • Участник женского пола не должен забеременеть и должен дать согласие не сдавать яйцеклетки во время исследования и в течение периода до 4 недель после окончания исследования.

Критерий исключения:

  • Участники с ЛАГ из-за портальной гипертензии, шистосомоза, легочной веноокклюзионной болезни и/или легочного капиллярного гемангиоматоза и персистирующей легочной гипертензии новорожденных
  • Участники со следующими заболеваниями: стеноз легочных вен; бронхолегочная дисплазия
  • Тяжелая печеночная недостаточность, например, класс С по Чайлд-Пью, при скрининге
  • Беременные, или кормящие грудью, или планирующие забеременеть во время участия в этом исследовании или в течение 4 недель после последней дозы исследуемого вмешательства.
  • Известные аллергии, гиперчувствительность или непереносимость мацитентана или его вспомогательных веществ.
  • Участник с ЛАГ, связанной с открытыми шунтами, с врожденными сердечными аномалиями, такими как одножелудочковое сердце, с легочной гипертензией из-за заболевания легких и почечной дисфункцией.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Маситентан
Участники будут получать пероральную дозу мацитентана в зависимости от возраста и веса до 52-й недели.
Лекарство: Маситентан
Мацитентан будет вводиться перорально в виде таблеток.
Другие имена:
  • ОПСУМИТ
  • ЗЕПЕНДО

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Кратное изменение индекса легочного сосудистого сопротивления (PVRI) по сравнению с исходным уровнем на 24 неделе
Временное ограничение: Исходный уровень (день 1), неделя 24
Кратное изменение PVRI на 24 неделе рассчитывали как 100*(PVRI на 24 неделе деленное на PVRI на исходном уровне). ЛСС определяли путем катетеризации правых отделов сердца.
Исходный уровень (день 1), неделя 24
Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
Временное ограничение: Baseline (Day 1), Weeks 8, 16, 20, 40, 52
Change from baseline in hematology parameters: NBF was reported. Data for each parameters was planned to be reported at specified timepoints only.
Baseline (Day 1), Weeks 8, 16, 20, 40, 52

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
Временное ограничение: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: PVR was reported. PVR is calculated as: PVR= (Mean pulmonary artery pressure [mPAP]-Pulmonary artery wedge pressure [PAWP)/ Cardiac output [CO].
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Mean Right Atrial Pressure (mRAP)
Временное ограничение: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: mRAP was reported.
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Mean Pulmonary Arterial Pressure (mPAP)
Временное ограничение: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: mPAP was reported. mPAP is calculated as: 2*diastolic pulmonary arterial pressure (dPAP) + systolic pulmonary arterial pressure (sPAP)/3.
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Index (CI)
Временное ограничение: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: CI was reported. CI was calculated as: CO/Body surface area (BSA).
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Output (CO)
Временное ограничение: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: CO was reported.
Baseline (Day 1), Week 24
Change From Baseline to Week 24 in Hemodynamic Variable: Total Pulmonary Resistance (TPR)
Временное ограничение: Baseline (Day 1), Week 24
Change from baseline to Week 24 in hemodynamic variable: TPR was reported. TPR was calculated as: (mPAP/CO)*80.
Baseline (Day 1), Week 24
Percent Change From Baseline to Week 24 in Hemodynamic Variable: Mixed Venous Oxygen Saturation (SvO[2])
Временное ограничение: Baseline (Day 1), Week 24
Percent change from baseline to Week 24 in hemodynamic variable: SvO(2) was reported.
Baseline (Day 1), Week 24
Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in World Health Organization (WHO) Functional Class (FC)
Временное ограничение: Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
WHO-FC for participants with pulmonary arterial hypertension (PAH) ranges: Class I (no limitation in physical activity, ordinary physical activity did not cause undue dyspnea or fatigue, chest pain or near syncope), Class II (slight limitation of physical activity, comfortable at rest, ordinary physical activity caused undue dyspnea or fatigue, chest pain, or near syncope), Class III (marked limitation of physical activity, comfortable at rest, less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope) and Class IV (cannot perform a physical activity without any symptoms, signs of right heart failure, dyspnea and/or fatigue may be present even at rest, discomfort is increased by any physical activity). Participants who improve in WHO FC are reported below. Improvement was defined as reduction in FC.
Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama Functional Class (FC)
Временное ограничение: Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Panama FC for PAH ranges: Class I (asymptomatic, growing normally, attending nursery/school regularly, no limitation of physical activity, playing sports with his/her classmates), Class II (slight limitation of physical activity, unduly dyspnoeic and fatigued when playing with his/her classmates, comfortable at rest, grow along own centiles, nursery/school attendance 75% normal, no chest pain), Class IIIa (marked limitation of physical activity, no attempt at sports, comfortable at rest, less than ordinary activity (example: dressing) causes undue dyspnea, fatigue, syncope and/or presyncope or chest pain, nursery/schooling compromised <50% normal attendance), Class IIIb (growth compromised, poor appetite, supplemental feeding, same as class IIIa) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in Panama FC are reported below. Improvement was defined as reduction in Panama FC.
Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline to Weeks 24 and 52 in 6-minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT)
Временное ограничение: Baseline (Day 1), Weeks 24 and 52
Change from baseline to Weeks 24 and 52 in 6MWD as measured by 6MWT was reported. 6MWD was the distance that a participant could walk in 6 minutes. Rest periods were allowed if the participant could no longer continue. If the participant need to rest, he/she may pause, lean against the wall and continue walking whenever he/she feels able. The timer continued to run even if the participant stopped to rest.
Baseline (Day 1), Weeks 24 and 52
Change From Baseline to Weeks 12, 24, 28, 40, and 52 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Временное ограничение: Baseline (Day 1), Week 12, 24, 28, 40, and 52
Change from baseline to Weeks 12, 24, 28, 40, and 52 in NT-proBNP was reported.
Baseline (Day 1), Week 12, 24, 28, 40, and 52
Change From Baseline to Weeks 12, 24, and 52 in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in TAPSE was reported. It was calculated as: original TAPSE value/body surface area (BSA). TAPSE was a dimension used to evaluate Right Ventricle (RV) longitudinal systolic function; it measured the extent of systolic motion of the lateral portion of the tricuspid ring towards the apex.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Week 12, 24, and 52 in Left Ventricular Eccentricity Index (LVEI)
Временное ограничение: Baseline (Day 1), Weeks 12, 24 and 52
Change from baseline to Weeks 12, 24, and 52 in LVEI was reported. It included diastolic (D) LVEI and systolic (S) LVEI. Left ventricular (LV) internal diameters were measured using the parasternal short axis view at the level of the papillary muscles: D1: LV internal diameter perpendicular to interventricular septum at end-diastole; D2: LV internal diameter parallel to interventricular septum, and at right angle from D1, at end-diastole; S1: LV internal diameter perpendicular to interventricular septum at end-systole; S2: LV internal diameter parallel to interventricular septum, and at a right angle from S1, at end-systole. The LVEI was a ratio that was calculated by sponsor as: LVEI diastole = D2/D1; LVEI systole = S2/S1.
Baseline (Day 1), Weeks 12, 24 and 52
Change From Baseline to Week 12, 24, and 52 in Quality of Life (QoL) as Assessed by Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales Short Form (SF-15)
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in QoL as assessed by PedsQL 4.0 generic core scales SF-15 was reported. The PedsQL 4.0 questionnaire generic core scales score SF-15 assessed general physical, emotional, social and school functioning on a 5-point Likert scale from 0 to 4 with 0= if it is never a problem, 1= if it is almost never a problem, 2= if it is sometime a problem, 3= if it is often a problem, 4 if it is almost always a problem. Scores were transformed on a scale from 0 to 100. Higher scores indicated better health related QoL. The QoL questionnaire was completed by parent(s)/caregiver(s) and by participants.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Number of Hours of Daytime Activity
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: number of hours of daytime activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Count Per Minute of Daily Activity
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean count per minute of daily activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Light Physical Activity
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean daily time spent in light physical activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Moderate to Vigorous Physical Activity
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: mean daily time spent in moderate to vigorous physical activity was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline to Week 24 and Week 52 in Borg Dyspnea Index (BDI)
Временное ограничение: Baseline (Day 1), Weeks 24 and 52
Change from baseline to Weeks 24 and 52 in BDI was reported. BDI was a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores ranged from 0 (no shortness of breath) to 10 (worst shortness of breath you have ever had). Higher score indicated worse outcome.
Baseline (Day 1), Weeks 24 and 52
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Временное ограничение: From Baseline (Day 1) up to Week 56
Number of participants with TEAEs was reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days.
From Baseline (Day 1) up to Week 56
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: From Baseline (Day 1) up to Week 56
Number of participants with TESAEs was reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TESAEs are defined as any SAE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days.
From Baseline (Day 1) up to Week 56
Number of Participants With AEs Leading to Premature Discontinuation of Study Drug
Временное ограничение: From Baseline (Day 1) up to Week 52
Number of participants with AEs leading to premature discontinuation of study drug was reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
From Baseline (Day 1) up to Week 52
Number of Participants With TEAEs of Special Interest
Временное ограничение: From Baseline (Day 1) up to Week 56
Number of participants with TEAEs of special interest was reported. It included anemia/decreased hemoglobin level, oedema/fluid retention, hepatic impairment and hypotension. TEAEs are defined as any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days.
From Baseline (Day 1) up to Week 56
Number of Participants With Postbaseline Markedly Abnormal Hematology Laboratory Values
Временное ограничение: Weeks 20, 40, 52
Number of participants with postbaseline markedly abnormal hematology laboratory values was reported. It included Hematocrit:<0.28% of blood cells (<0.32M[%]), Hemoglobin: < 100 grams per liter (g/L), Leukocytes: <3.0 10^9 cells per Liter (L), and Leukocytes: <3.0 10^9 cells/L. Abnormality was judged at the discretion of investigator. Data is reported for categories where at least one participant had abnormality.
Weeks 20, 40, 52
Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Potassium and Calcium
Временное ограничение: Week 4
Number of participants with postbaseline markedly abnormal clinical chemistry laboratory values was reported. It included Potassium: >6.0 millimoles per liter (mmol/L) and Calcium: <1.75 mmol/L. Abnormality was judged at the discretion of investigator. Data is reported for categories where at least one participant had abnormality.
Week 4
Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Alkaline Phosphatase (ALP)
Временное ограничение: Week 28
Number of participants with postbaseline markedly abnormal clinical chemistry laboratory values (ALP) was reported. It included Alkaline Phosphatase (ALP): > 2.5 * Upper Limit of Normal (ULN). Abnormality was judged at the discretion of investigator. Participants were assessed at Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52. Data is reported for categories where at least one participant had abnormality at any time point: Weeks 20, 40, and 52 reported.
Week 28
Change From Baseline in Hematology Parameters: Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, and Basophils
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameters: platelets, leukocytes, lymphocytes, monocytes, eosinophils, and basophils was reported. Data for each parameters was planned to be reported at specified timepoints only.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Hematology Parameter: Hematocrit
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameter: hematocrit was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Hematology Parameters: Hemoglobin
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameter: hemoglobin was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Hematology Parameter: Erythrocytes
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in hematology parameter: erythrocytes was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Sodium, Potassium, Urea Nitrogen, Glucose, and Calcium
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameters: sodium, potassium, urea nitrogen, glucose, and calcium was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Creatinine (Jaffe Reaction), Bilirubin, and Direct Bilirubin
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameters: Creatinine, bilirubin, and direct bilirubin was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameter: Creatinine Clearance
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameter: creatinine clearance was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Glomerular Filtration Rate (GFR) From Cystatin C Adjusted for Body Surface Area (BSA)
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameter: GFR from Cystatin C Adjusted for BSA was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP)
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in chemistry parameters: AST, ALT, and ALP was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Vital Signs: Blood Pressure
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in vital signs: blood pressure was reported. It included systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Vital Signs: Pulse Rate
Временное ограничение: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change from baseline in vital signs: pulse rate was reported.
Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline in ECG: heart rate was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Change From Baseline in Electrocardiogram (ECG) Parameter: PR, QRS, QT, Corrected QT Interval-Bazett's Formula (QTcB), and Corrected QT Interval-Fridericia's Formula (QTcF)
Временное ограничение: Baseline (Day 1), Weeks 12, 24, and 52
Change from baseline in ECG: PR, QRS, QT, QTcB, and QTcF intervals was reported.
Baseline (Day 1), Weeks 12, 24, and 52
Plasma Concentration of Macitentan: Participants >=2 Years Old
Временное ограничение: Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma concentration of macitentan was reported.
Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma Concentration of Aprocitentan (Active Metabolite): Participants >=2 Years Old
Временное ограничение: Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma concentration of aprocitentan was reported.
Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
Plasma Concentration of Macitentan: Participants <2 Years Old
Временное ограничение: Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
Plasma concentration of macitentan was reported.
Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
Plasma Concentration of Aprocitentan (Active Metabolite): Participants <2 Years Old
Временное ограничение: Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
Plasma concentration of aprocitentan was reported.
Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Janssen Pharmaceutical K.K.

Следователи

  • Директор по исследованиям: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

14 ноября 2022 г.

Первичное завершение (Действительный)

23 августа 2024 г.

Завершение исследования (Действительный)

5 марта 2025 г.

Даты регистрации исследования

Первый отправленный

24 ноября 2021 г.

Впервые представлено, что соответствует критериям контроля качества

21 декабря 2021 г.

Первый опубликованный (Действительный)

22 декабря 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

7 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CR109128
  • 67896062PAH3001 (Другой идентификатор: Janssen Research & Development, LLC)
  • 2023-000984-30 (Номер EudraCT)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Политика обмена данными фармацевтических компаний Janssen компании Johnson & Johnson доступна на сайте www.janssen.com/clinical-trials/transparency. Как указано на этом сайте, запросы на доступ к данным исследования можно отправить через сайт проекта Yale Open Data Access (YODA) по адресу yoda.yale.edu.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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