폐동맥고혈압이 있는 일본 소아 참가자의 Macitentan 연구
2026년 4월 16일 업데이트: Janssen Pharmaceutical K.K.
일본 소아 환자를 대상으로 마시텐탄의 효능, 안전성 및 약동학을 평가하기 위한 다기관 공개 라벨 III상 연구(>= 3개월 ~
이 연구의 목적은 소아 인구에서 24주차에 혈류역학적 측정에 대한 마시텐탄의 효과를 평가하는 것입니다.
연구 개요
연구 유형
중재적
등록 (실제)
7
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Azumino-shi, 일본, 399-8288
- Nagano Children's Hospital
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Bunkyō City, 일본, 113 8519
- Institute of Science Tokyo Hospital
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Fukuoka, 일본, 813-0017
- Fukuoka Children's Hospital
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Okayama, 일본, 700 8558
- Okayama University Hospital
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Sapporo, 일본, 060-8648
- Hokkaido University Hospital
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Setagaya Ku, 일본, 157 8535
- National Center for Child Health and Development
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Shinjuku-ku, 일본, 162-8666
- Tokyo Women's Medical University Hospital
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Suita-Shi, 일본, 564-8565
- National Cerebral and Cardiovascular Center
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Suita-shi, 일본, 565-0871
- Osaka University Hospital
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Tokyo, 일본, 113-8655
- The University of Tokyo Hospital
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Ōta-ku, 일본, 143-8541
- Toho University Medical Center Omori Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3개월 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 나이스 2013 업데이트 분류군 1에 속하는 폐동맥고혈압(PAH)
- 폐정맥 폐쇄 및/또는 심각한 폐 질환이 없는 경우 폐동맥 쐐기압(PAWP)을 좌심방압(LAP) 또는 좌심실 이완기말압(LVEDP)으로 대체할 수 있는 과거 우심장 카테터 삽입으로 PAH 진단이 확인되었습니다(in 승모판 협착증 없음) 심장 카테터 삽입으로 평가
- 세계보건기구(WHO) 기능 등급(FC) I~IV
- PAH 특정 치료 경험이 없는 참여자 또는 PAH 특정 치료 참여자
- 가임 여성은 스크리닝 시 고감도 혈청 베타-인간 융모성 성선 자극 호르몬(베타-hCG) 검사에서 음성이어야 하고 연구 개입의 첫 번째 투여 시 소변 임신 검사에서 음성이어야 합니다.
- 여성 참가자는 임신을 해서는 안 되며 연구 기간 동안 및 연구 종료 후 최대 4주 동안 난자를 기증하지 않는다는 데 동의해야 합니다.
제외 기준:
- 문맥압항진증, 주혈흡충증, 폐정맥 폐쇄성 질환 및/또는 폐모세혈관종증 및 신생아의 지속성 폐고혈압으로 인한 PAH 참가자
- 다음 질환이 있는 참가자: 폐정맥 협착증; 기관지폐 이형성증
- 스크리닝 시 중증 간 장애, 예를 들어 Child-Pugh Class C
- 본 연구에 등록하는 동안 또는 연구 개입의 마지막 투여 후 4주 이내에 임신, 모유 수유 또는 임신 계획
- 마시텐탄 또는 그 부형제에 대한 알려진 알레르기, 과민성 또는 불내성
- 단심실 심장과 같은 선천성 심장 이상, 폐 질환으로 인한 폐고혈압 및 신장 기능 장애가 있는 개방 션트와 관련된 PAH 환자
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 마시텐탄
참가자는 52주차까지 나이와 체중에 따라 마시텐탄을 경구 투여받게 됩니다.
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Macitentan은 정제로 경구 투여됩니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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폐혈관 저항 지수(PVRI)의 24주차 기준선 대비 변화 배수
기간: 기준선(1일차), 24주차
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24주차의 PVRI 배수 변화는 100*(24주차의 PVRI를 기준선의 PVRI로 나눈 값)으로 계산되었습니다.
PVR은 우심장 카테터 삽입으로 결정되었습니다.
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기준선(1일차), 24주차
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Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
기간: Baseline (Day 1), Weeks 8, 16, 20, 40, 52
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Change from baseline in hematology parameters: NBF was reported.
Data for each parameters was planned to be reported at specified timepoints only.
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Baseline (Day 1), Weeks 8, 16, 20, 40, 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
기간: Baseline (Day 1), Week 24
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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].
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Mean Right Atrial Pressure (mRAP)
기간: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: mRAP was reported.
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Mean Pulmonary Arterial Pressure (mPAP)
기간: Baseline (Day 1), Week 24
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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.
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Index (CI)
기간: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: CI was reported.
CI was calculated as: CO/Body surface area (BSA).
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Cardiac Output (CO)
기간: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: CO was reported.
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Baseline (Day 1), Week 24
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Change From Baseline to Week 24 in Hemodynamic Variable: Total Pulmonary Resistance (TPR)
기간: Baseline (Day 1), Week 24
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Change from baseline to Week 24 in hemodynamic variable: TPR was reported.
TPR was calculated as: (mPAP/CO)*80.
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Baseline (Day 1), Week 24
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Percent Change From Baseline to Week 24 in Hemodynamic Variable: Mixed Venous Oxygen Saturation (SvO[2])
기간: Baseline (Day 1), Week 24
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Percent change from baseline to Week 24 in hemodynamic variable: SvO(2) was reported.
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Baseline (Day 1), Week 24
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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)
기간: Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
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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.
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Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52
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Number of Participants With Change From Baseline at Weeks 4, 8, 12, 16, 20, 24, 28, 40, and 52 in Panama Functional Class (FC)
기간: Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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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.
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Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline to Weeks 24 and 52 in 6-minute Walk Distance (6MWD) as Measured by the 6-minute Walk Test (6MWT)
기간: Baseline (Day 1), Weeks 24 and 52
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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.
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Baseline (Day 1), Weeks 24 and 52
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Change From Baseline to Weeks 12, 24, 28, 40, and 52 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
기간: Baseline (Day 1), Week 12, 24, 28, 40, and 52
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Change from baseline to Weeks 12, 24, 28, 40, and 52 in NT-proBNP was reported.
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Baseline (Day 1), Week 12, 24, 28, 40, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Tricuspid Annular Plane Systolic Excursion (TAPSE)
기간: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Week 12, 24, and 52 in Left Ventricular Eccentricity Index (LVEI)
기간: Baseline (Day 1), Weeks 12, 24 and 52
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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.
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Baseline (Day 1), Weeks 12, 24 and 52
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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)
기간: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Number of Hours of Daytime Activity
기간: Baseline (Day 1), Weeks 12, 24, and 52
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Change from baseline to Weeks 12, 24, and 52 in physical activity as measured by accelerometry: number of hours of daytime activity was reported.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Count Per Minute of Daily Activity
기간: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Weeks 12, 24, and 52 in Physical Activity as Measured by Accelerometry: Mean Daily Time Spent in Light Physical Activity
기간: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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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
기간: Baseline (Day 1), Weeks 12, 24, and 52
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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.
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Baseline (Day 1), Weeks 12, 24, and 52
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Change From Baseline to Week 24 and Week 52 in Borg Dyspnea Index (BDI)
기간: Baseline (Day 1), Weeks 24 and 52
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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.
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Baseline (Day 1), Weeks 24 and 52
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
기간: From Baseline (Day 1) up to Week 56
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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.
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From Baseline (Day 1) up to Week 56
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Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
기간: From Baseline (Day 1) up to Week 56
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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.
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From Baseline (Day 1) up to Week 56
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Number of Participants With AEs Leading to Premature Discontinuation of Study Drug
기간: From Baseline (Day 1) up to Week 52
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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.
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From Baseline (Day 1) up to Week 52
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Number of Participants With TEAEs of Special Interest
기간: From Baseline (Day 1) up to Week 56
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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.
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From Baseline (Day 1) up to Week 56
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Number of Participants With Postbaseline Markedly Abnormal Hematology Laboratory Values
기간: Weeks 20, 40, 52
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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.
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Weeks 20, 40, 52
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Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Potassium and Calcium
기간: Week 4
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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.
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Week 4
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Number of Participants With Postbaseline Markedly Abnormal Clinical Chemistry Laboratory Values: Alkaline Phosphatase (ALP)
기간: Week 28
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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.
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Week 28
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Change From Baseline in Hematology Parameters: Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, and Basophils
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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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.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Hematology Parameter: Hematocrit
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in hematology parameter: hematocrit was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Hematology Parameters: Hemoglobin
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in hematology parameter: hemoglobin was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Hematology Parameter: Erythrocytes
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in hematology parameter: erythrocytes was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Sodium, Potassium, Urea Nitrogen, Glucose, and Calcium
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameters: sodium, potassium, urea nitrogen, glucose, and calcium was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Creatinine (Jaffe Reaction), Bilirubin, and Direct Bilirubin
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameters: Creatinine, bilirubin, and direct bilirubin was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameter: Creatinine Clearance
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameter: creatinine clearance was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Glomerular Filtration Rate (GFR) From Cystatin C Adjusted for Body Surface Area (BSA)
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameter: GFR from Cystatin C Adjusted for BSA was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP)
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in chemistry parameters: AST, ALT, and ALP was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Vital Signs: Blood Pressure
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in vital signs: blood pressure was reported.
It included systolic blood pressure (SBP) and diastolic blood pressure (DBP).
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Vital Signs: Pulse Rate
기간: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change from baseline in vital signs: pulse rate was reported.
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Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 40, 52
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Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 11월 14일
기본 완료 (실제)
2024년 8월 23일
연구 완료 (실제)
2025년 3월 5일
연구 등록 날짜
최초 제출
2021년 11월 24일
QC 기준을 충족하는 최초 제출
2021년 12월 21일
처음 게시됨 (실제)
2021년 12월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 16일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR109128
- 67896062PAH3001 (기타 식별자: Janssen Research & Development, LLC)
- 2023-000984-30 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Johnson & Johnson의 Janssen 제약 회사의 데이터 공유 정책은 www.janssen.com/clinical-trials/transparency에서 확인할 수 있습니다.
이 사이트에 명시된 바와 같이 연구 데이터에 대한 액세스 요청은 Yale Open Data Access(YODA) 프로젝트 사이트(yoda.yale.edu)를 통해 제출할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .