肺動脈性肺高血圧症の日本人小児参加者におけるマシテンタンの研究
2026年4月16日 更新者：Janssen Pharmaceutical K.K.
日本人小児患者（3 か月以上から
この研究の目的は、小児集団における 24 週目の血行動態測定に対するマシテンタンの効果を評価することです。
調査の概要
研究の種類
介入
入学 (実際)
7
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Azumino-shi、日本、399-8288
- Nagano Children's Hospital
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Bunkyō City、日本、113 8519
- Institute of Science Tokyo Hospital
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Fukuoka、日本、813-0017
- Fukuoka Children's Hospital
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Okayama、日本、700 8558
- Okayama University Hospital
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Sapporo、日本、060-8648
- Hokkaido University Hospital
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Setagaya Ku、日本、157 8535
- National Center for Child Health and Development
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Shinjuku-ku、日本、162-8666
- Tokyo Women's Medical University Hospital
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Suita-Shi、日本、564-8565
- National Cerebral and Cardiovascular Center
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Suita-shi、日本、565-0871
- Osaka University Hospital
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Tokyo、日本、113-8655
- The University of Tokyo Hospital
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Ōta-ku、日本、143-8541
- Toho University Medical Center Omori Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
3ヶ月～15年 (子)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 2013 年に更新されたナイス分類グループ 1 に属する肺動脈性肺高血圧症 (PAH)
- 肺静脈閉塞および/または重大な肺疾患がない場合、肺動脈楔入圧（PAWP）を左心房圧（LAP）または左心室拡張終期圧（LVEDP）（僧帽弁狭窄の欠如) 心臓カテーテル検査によって評価
- 世界保健機関 (WHO) の機能分類 (FC) I から IV
- PAH特異的治療未経験の参加者またはPAH特異的治療の参加者
- -出産の可能性のある女性は、スクリーニング時に高感度血清ベータ-ヒト絨毛性ゴナドトロピン（ベータ-hCG）検査が陰性であり、研究介入の最初の投与時に尿妊娠検査が陰性でなければなりません
- -女性の参加者は妊娠してはならず、研究中および研究終了後最大4週間、卵子を提供しないことに同意する必要があります
除外基準:
- -門脈圧亢進症、住血吸虫症、肺静脈閉塞性疾患、および/または肺毛細血管腫症、および新生児の持続性肺高血圧症によるPAHの参加者
- 次の疾患のある参加者：肺静脈狭窄。気管支肺異形成
- -スクリーニング時の重度の肝障害、例、チャイルドピュークラスC
- -妊娠中、授乳中、または妊娠を計画している この研究に登録されている間、または研究介入の最後の投与後4週間以内
- マシテンタンまたはその賦形剤に対する既知のアレルギー、過敏症、または不耐性
- -オープンシャントに関連するPAHの参加者、単心室などの先天性心臓異常、肺疾患による肺高血圧症、および腎機能障害
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：マシテンタン
参加者は、52 週目まで、年齢と体重に基づいてマシテンタンの経口投与を受けます。
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マシテンタンは錠剤として経口投与されます。
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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肺血管抵抗指数 (PVRI) の 24 週目のベースラインからの変化倍数
時間枠：ベースライン (1 日目)、24 週目
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24週目でのPVRI倍率変化は100*(24週目でのPVRIをベースラインでのPVRIで割ったもの)として計算した。
PVR は右心カテーテル検査によって測定されました。
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ベースライン (1 日目)、24 週目
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Change From Baseline in Hematology Parameter: Neutrophils Band Form (NBF)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline to Week 24 in Hemodynamic Variable: Pulmonary Vascular Resistance (PVR)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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])
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline (Day 1), Weeks 12, 24, and 52
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Change from baseline in ECG: heart rate was reported.
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Baseline (Day 1), Weeks 12, 24, and 52
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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)
時間枠：Baseline (Day 1), Weeks 12, 24, and 52
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Change from baseline in ECG: PR, QRS, QT, QTcB, and QTcF intervals was reported.
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Baseline (Day 1), Weeks 12, 24, and 52
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Plasma Concentration of Macitentan: Participants >=2 Years Old
時間枠：Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma concentration of macitentan was reported.
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Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma Concentration of Aprocitentan (Active Metabolite): Participants >=2 Years Old
時間枠：Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma concentration of aprocitentan was reported.
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Day 11 (0, 1, 2, 4, 8, 12, 24 hours post-dose), Week 12
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Plasma Concentration of Macitentan: Participants <2 Years Old
時間枠：Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Plasma concentration of macitentan was reported.
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Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Plasma Concentration of Aprocitentan (Active Metabolite): Participants <2 Years Old
時間枠：Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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Plasma concentration of aprocitentan was reported.
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Day 1 (2, 5, 24 hours post-dose), Weeks 4 and 8
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Janssen Pharmaceutical K.K. Clinical Trial、Janssen Pharmaceutical K.K.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年11月14日
一次修了 (実際)
2024年8月23日
研究の完了 (実際)
2025年3月5日
試験登録日
最初に提出
2021年11月24日
QC基準を満たした最初の提出物
2021年12月21日
最初の投稿 (実際)
2021年12月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月7日
QC基準を満たした最後の更新が送信されました
2026年4月16日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CR109128
- 67896062PAH3001 (その他の識別子：Janssen Research & Development, LLC)
- 2023-000984-30 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Johnson & Johnson の Janssen Pharmaceutical Companies のデータ共有ポリシーは、www.janssen.com/clinical-trials/transparency で入手できます。
このサイトに記載されているように、研究データへのアクセスのリクエストは、Yale Open Data Access (YODA) Project サイト (yoda.yale.edu) から送信できます。
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。