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一项为完成家长研究且别无选择的肺动脉高压参与者提供治疗途径的研究 (PLATYPUS)

2026年11月2日 更新者：Actelion

在肺动脉高压父母研究中使用研究干预对参与者进行长期随访的前瞻性、开放标签、平台研究

The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

280

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100029
        • 招聘中
        • Beijing Anzhen Hospital
      • Beijing、中国、100029
        • 招聘中
        • Beijing Anzhen Hospital 1
      • Changsha、中国、410011
        • 招聘中
        • The Second Xiangya Hospital of Central South Hospital
      • Nanjing、中国
        • 招聘中
        • Jiangsu Province Hospital
      • Qingdao、中国、266035
        • 招聘中
        • Qingdao Women and Children's Hospital
      • Shanghai、中国、200062
        • 招聘中
        • Childrens Hospital of Shanghai
      • Xi'an、中国、710061
        • 招聘中
        • The First Affiliated Hospital of Xian Jiaotong University
  • 乌克兰
      • Dnipro、乌克兰
        • 完全的
        • Municipal Inst. Of Dnipropetrovsk Region. Council
      • Kyiv、乌克兰、03680
        • 完全的
        • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
  • 俄罗斯
      • Kemerovo、俄罗斯、650002
        • 完全的
        • Scientific and Research Institution of Cardiovascular Diseases Complex Problems
      • Novosibirsk、俄罗斯、630055
        • 招聘中
        • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
      • Saint Petersburg、俄罗斯、197341
        • 完全的
        • Federal State Budgetary Institution
      • Tomsk、俄罗斯、634012
        • 完全的
        • Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
      • Tyumen、俄罗斯、625000
        • 招聘中
        • Regional Clinical Hospital No1
  • 保加利亚
      • Sofia、保加利亚、1750
        • 招聘中
        • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
  • 匈牙利
      • Budapest、匈牙利、1096
        • 招聘中
        • Gottsegen György Országos Kardiológiai Intézet
  • 南非
      • Durban、南非、4001
        • 完全的
        • Abdullah, IA
      • Lenasia、南非、1820
        • 招聘中
        • Dr Kalla
  • 台湾
      • Kaohsiung City、台湾、813
        • 招聘中
        • Kaohsiung Veterans General Hospital
      • Tainan、台湾、704
        • 招聘中
        • National Cheng Kung University Hospital
      • Taipei、台湾、100
        • 招聘中
        • National Taiwan University Hospital
      • Taipei、台湾、112
        • 招聘中
        • Taipei Veterans General Hospital
      • Taoyuan、台湾、333
        • 招聘中
        • Chang-Gung Memorial Hospital, LinKou Branch
  • 比利时
      • Leuven、比利时、3000
        • 完全的
        • UZ Leuven
  • 波兰
      • Bialystok、波兰、15 276
        • 招聘中
        • Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
      • Bydgoszcz、波兰、85-168
        • 完全的
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
      • Katowice、波兰、40 635
        • 招聘中
        • SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
      • Lodz、波兰、91 347
        • 完全的
        • Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
      • Lublin、波兰、20 718
        • 完全的
        • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
      • Szczecin、波兰、70 111
        • 完全的
        • SPSK2 PUM Klinika Kardiologii
      • Wroclaw、波兰、51 124
        • 完全的
        • Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
      • Wroclaw、波兰、51 124
        • 招聘中
        • Wojewodzki Szpital Specjalistyczny we Wroclawiu
  • 泰国
      • Chiang Mai、泰国、50200
        • 招聘中
        • Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
  • 白俄罗斯
      • Minsk、白俄罗斯、220036
        • 招聘中
        • The Republican Scientific-Practical Center ''Cardiology''
      • Minsk、白俄罗斯
        • 完全的
        • Minsk Regional Clinical Hospital Of The Red Banner Of Labor
  • 越南
      • Hanoi、越南
        • 招聘中
        • Hanoi Medical University Hospital
      • Hanoi、越南
        • 招聘中
        • Hanoi Heart Hospital
      • Ho Chi Minh City、越南
        • 招聘中
        • Children's Hospital 1
  • 韩国
      • Daejeon、韩国、35015
        • 招聘中
        • Chungnam National University Hospital
      • Incheon、韩国、21565
        • 招聘中
        • Gachon University Gil Medical Center
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
      • Seoul、韩国、06591
        • 完全的
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital 1

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension [PAH]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag
  • A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and/or parent(s)/ legally designated representative (LDR)(s) on the acceptable method of contraception

Exclusion Criteria:

General:

  • Participants prematurely discontinued from the study intervention in their parent study
  • Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study
  • Planned or current treatment with another investigational treatment

Macitentan-specific:

  • Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
  • Hemoglobin less than (<) 80 grams per liter (g/L)
  • Serum aspartate (AST) and/or alanine aminotransferases (ALT) greater than (>) 3* upper limit of normal (ULN)
  • Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening

Selexipag-specific:

  • Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
  • Suspected or known pulmonary veno-occlusive disease (PVOD)
  • Uncontrolled thyroid disease
  • Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure (if not under close medical supervision), severe arrhythmia, cerebrovascular events (for example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension (PH)
  • Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening
  • Children only: (a) Current suspicion of intussusception or ileus or gastrointestinal obstruction, per the investigator's judgment; (b) hemoglobin or hematocrit <75 percent (%) of the lower limit of normal range

Macitentan/tadalafil FDC-specific:

  • Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients
  • Hemoglobin <80 g/L
  • Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3* ULN range
  • Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at screening
  • Severe renal impairment (estimated glomerular filtration rate [eGF]/creatinine clearance <30 milliliter per minute [mL/min])

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Macitentan

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug macitentan orally during the course of the study. For adult participants study visits will be scheduled every 6 months and for pediatric participants study visits will be scheduled every 3 months. The study includes on-site visits to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.
药品：Macitentan

Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (>=) 2 year to less than (<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.

其他名称：
  • JNJ-67896062
实验性的：Selexipag

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug selexipag orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.
药品：Selexipag

Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of >=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight < 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.

其他名称：
  • JNJ-67896049
实验性的：Macitentan/Tadalafil FDC

Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive drug Macitentan and Tadalafil fixed dose combination (FDC) orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.
药品：Macitentan/Tadalafil FDC

Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.

其他名称：
  • JNJ-68150420

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Frequency of Treatment Emergent Adverse Events (TEAEs)
大体时间：Baseline until End of Study (EOS) (up to 84 months)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Baseline until End of Study (EOS) (up to 84 months)
Frequency of TEAEs Leading to Discontinuation
大体时间：Baseline until EOS (up to 84 months)

Frequency of TEAEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Baseline until EOS (up to 84 months)
Frequency of Serious Adverse Events (SAEs)
大体时间：Baseline until EOS (up to 84 months)

SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Baseline until EOS (up to 84 months)
Frequency of Deaths
大体时间：Baseline until EOS (up to 84 months)

Frequency of deaths will be reported.
Baseline until EOS (up to 84 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Actelion

调查人员

  • 研究主任：Actelion Pharmaceuticals Ltd Clinical Trial、Actelion

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年5月4日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2033年9月28日

研究注册日期

首次提交

2021年12月17日

首先提交符合 QC 标准的

2021年12月17日

首次发布 (实际的)

2022年1月5日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CR109121
  • 2021-002297-11 (EudraCT编号)
  • NOPRODPAPUH3001 (其他标识符：Janssen Research & Development, LLC)
  • 2023-506791-27-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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