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特发性肺纤维化患者吸入曲前列环素的扩展研究 (TETON-OLE)

2026年10月15日更新者：United Therapeutics

特发性肺纤维化患者吸入曲前列素的开放标签扩展研究

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (AE)/serious adverse event (SAE) or other reason, inhaled treprostinil becomes commercially available for IPF or PPF, or the study is discontinued by the Sponsor (whichever is sooner).

Efficacy assessments will include spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]), time to clinical worsening, time to first acute exacerbation of IPF or interstitial lung disease (ILD), overall survival, King's Brief Interstitial Lung Disease (K-BILD) Questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and diffusion capacity of lungs for carbon monoxide (DLCO). Safety assessments will include monitoring for the development of AEs/SAEs, vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. In addition, up to 24 eligible subjects with IPF rolling over from Study RIN-PF-301 and up to 24 eligible subjects with PPF rolling over from Study RIN-PF-305 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

研究类型

介入性

注册 (估计的)

1850

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。

学习地点

丹麦
- - Aarhus N、丹麦、8200
    - Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit
  - Hellerup、丹麦、2900
    - Gentofte Hospital - Lungemedicinsk forskningsafdeling
  - Odense C、丹麦、5000
    - Odense University Hospital - Department of Respiratory Medicine
以色列
- - Haifa、以色列、34362
    - Lady Davis Carmel Medical Center
  - Kfar Saba、以色列、4428100
    - Meir Medical Center
  - Petah Tikva、以色列、49100
    - Rabin Medical Center - PPDS
  - Tel Aviv、以色列、64239
    - Tel Aviv Sourasky Medical Center - PPDS
- Central District
  - Rehovot、Central District、以色列、76100
    - Kaplan Medical Center
- Haifa District
  - Hadera、Haifa District、以色列、38100
    - Hillel Yaffe Medical Center
- Jerusalem
  - Jerusalem、Jerusalem、以色列、91031
    - Shaare Zedek Medical Center
  - Jerusalem、Jerusalem、以色列、91120
    - Hadassah Medical Center - PPDS
- Southern District
  - Ashkelon、Southern District、以色列、78278
    - Barzilai Medical Center
- Tel Aviv
  - Ramat Gan、Tel Aviv、以色列、52621
    - Sheba Medical Center - PPDS
加拿大
- - Québec、加拿大、G1V 4G5
    - Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- British Columbia
  - Vancouver、British Columbia、加拿大、V6Z 1Y6
    - St.Paul's Hospital
- Ontario
  - Ajax、Ontario、加拿大、L1S2J5
    - Dynamic Drug Advancement Limited
  - Hamilton、Ontario、加拿大、L8N 4A6
    - St. Joseph's Healthcare Hamilton
  - Toronto、Ontario、加拿大、M5G 2N2
    - Toronto General Hospital
- Quebec
  - Trois-Rivières、Quebec、加拿大、G8T7A1
    - Centre d'investigation Clinique Mauricie
台湾
- - Kaohsiung City、台湾、83301
    - Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  - Kaohsiung City、台湾、80756
    - Kaohsiung Medical University - Chung-Ho Memorial Hospital
  - Kaohsiung City、台湾、82445
    - E-DA hospital
  - New Taipei City、台湾、22060
    - Far Eastern Memorial Hospital
  - Taipei、台湾、11217
    - Taipei Veterans General Hospital
墨西哥
- - Mexico City、墨西哥、14080
    - Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
- Nuevo León
  - Monterrey、Nuevo León、墨西哥、64718
    - Unidad de Investigación Clínica en Medicina, S.C.
  - Monterrey、Nuevo León、墨西哥、64460
    - Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)
德国
- Baden-Wurttemberg
  - Löwenstein、Baden-Wurttemberg、德国、74245
    - SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin
- Bavaria
  - München、Bavaria、德国、81377
    - LMU Klinikum der Universität München
  - Rosenheim、Bavaria、德国、83022
    - RoMed Klinikum Rosenheim
- North Rhine-Westphalia
  - Essen、North Rhine-Westphalia、德国、45239
    - Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
- Saxony
  - Coswig、Saxony、德国、1640
    - Prüfstelle der GWT am Fachkrankenhaus Coswig
- Thuringia
  - Bad Berka、Thuringia、德国、99437
    - Zentralklinik Bad Berka GmbH Klinik für Pneumologie
意大利
- - Ancona、意大利、60126
    - Azienda Ospedaliero Universitaria delle Marche
  - Forlì、意大利、47121
    - Presidio Ospedaliero GB Morgagni L Pierantoni
  - Roma、意大利、00133
    - Fondazione PTV Policlinico Tor Vergata
- Emilia-Romagna
  - Modena、Emilia-Romagna、意大利、41124
    - Azienda Ospedaliero Universitaria Di Modena Policlinico
- Lazio
  - Rome、Lazio、意大利、00168
    - Fondazione Policlinico Universitario A Gemelli-Rome
- Lombardy
  - Milan、Lombardy、意大利、20123
    - Gruppo MultiMedica SpA - Ospedale San Giuseppe
- Sicily
  - Catania、Sicily、意大利、95123
    - A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"
- Tuscany
  - Siena、Tuscany、意大利、53100
    - Azienda ospedaliero-universitaria Senese
新西兰
- - Christchurch、新西兰、8013
    - Canterbury Respiratory Research Group
- Waikato Region
  - Hamilton、Waikato Region、新西兰、3204
    - Waikato Hospital
智利
- Maule Region
  - Talca、Maule Region、智利、3481349
    - Centro de Investigación del Maule SpA
- Santiago Metropolitan
  - Santiago、Santiago Metropolitan、智利、76302266
    - Fundación Médica San Cristobal
  - Santiago、Santiago Metropolitan、智利、7750495
    - CEC Centro de Estudios Clínicos
  - Santiago、Santiago Metropolitan、智利、7500691
    - Instituto Nacional del tórax
- Valparaiso
  - Quillota、Valparaiso、智利、2260000
    - Centro Respiratorio Integral Limitada
比利时
- - Aalst、比利时、9300
    - vzw AZORG - Aalst - Moorselbaan
  - Antwerp、比利时、2020
    - Ziekenhuis Aan de Stroom
  - Brussels、比利时、1200
    - Cliniques Universitaires Saint-Luc
  - Leuven、比利时、3000
    - UZ Leuven
  - Liège、比利时、4000
    - CHR de la Citadelle
  - Liège、比利时、4000
    - CHU de Liège
- Brussels Capital
  - Anderlecht、Brussels Capital、比利时、1070
    - Hôpital Erasme
- Namur
  - Yvoir、Namur、比利时、5530
    - CHU UCL Namur - Site Godinne
法国
- - Amiens、法国、80054
    - CHU Amiens-Picardie
  - Bobigny、法国、93000
    - AP-HP - Hopital Avicenne
  - Bron、法国、69500
    - Hospices Civils De Lyon - Université Hospital of Lyon
  - Paris、法国、75018
    - Hôptial Bichat
  - Paris、法国、75015
    - AP-HP - Hôpital Européen Georges Pompidou
  - Reims、法国、51092
    - Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche
  - Rennes、法国、35000
    - Hôpital Pontchaillou
- Bouches-du-Rhône
  - Marseille、Bouches-du-Rhône、法国、13015
    - Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille
- Calvados
  - Caen、Calvados、法国、14000
    - CHU Caen Normandie
- Haute-Garonne
  - Toulouse、Haute-Garonne、法国、31059
    - Hopital Larrey
- Indre-et-Loire
  - Tours、Indre-et-Loire、法国、37044
    - Hôpital Bretonneau
- Seine-Maritime
  - Rouen、Seine-Maritime、法国、76000
    - CHU Rouen Hopital Charles Nicolle
澳大利亚
- New South Wales
  - Camperdown、New South Wales、澳大利亚、2050
    - Royal Prince Alfred Hospital
  - Kogarah、New South Wales、澳大利亚、2217
    - St. George Hospital
  - Macquarie Park、New South Wales、澳大利亚、2109
    - Macquarie University
  - Westmead、New South Wales、澳大利亚、2145
    - Westmead Hospital
- Queensland
  - Cairns、Queensland、澳大利亚、5870
    - Cairns Hospital
  - Chermside、Queensland、澳大利亚、4032
    - The Prince Charles Hospital
  - Chermside、Queensland、澳大利亚、4032
    - Lung Research Qld
  - South Brisbane、Queensland、澳大利亚、4101
    - Mater Misericordiae Ltd
- Victoria
  - Melbourne、Victoria、澳大利亚、3004
    - Alfred Health
秘鲁
- - Cusco、秘鲁、08002
    - Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco
  - Lima、秘鲁、15036
    - Clinica Ricardo Palma
  - Lima、秘鲁、15046
    - Hospital Central de la Fuerza Aérea del Perú
美国
- Alabama
  - Birmingham、Alabama、美国、35233
    - The University of Alabama at Birmingham
- Arizona
  - Franklin、Arizona、美国、37067
    - Clinical Trials Center of Middle Tennessee
  - Phoenix、Arizona、美国、85006
    - Banner University Medical Center-Phoenix
  - Phoenix、Arizona、美国、85013
    - St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
  - Tucson、Arizona、美国、85724
    - University of Arizona
- California
  - La Jolla、California、美国、92037
    - UC San Diego Health
  - Los Angeles、California、美国、90095
    - David Geffen School of Medicine at UCLA
  - Newport Beach、California、美国、92663
    - NewportNativeMD, Inc
  - Sacramento、California、美国、95817
    - UC Davis Health Medical Center
  - San Francisco、California、美国、94143
    - University of California San Francisco
  - Stanford、California、美国、94305
    - Stanford University School of Medicine
- Colorado
  - Denver、Colorado、美国、80206
    - National Jewish Health
- Florida
  - Gainesville、Florida、美国、32610
    - University of Florida Health at Shands
  - Jacksonville、Florida、美国、32224
    - Mayo Clinic Florida
  - Jacksonville、Florida、美国、32204
    - Ascension St. Vincent's
  - Kissimmee、Florida、美国、34741
    - Pulmonary Disease Specialists, PA d/b/a PDS Research
  - Orlando、Florida、美国、32803
    - Central Florida Pulmonary Group, PA
  - Tampa、Florida、美国、33606
    - University of South Florida Health
  - Weston、Florida、美国、33331
    - Cleveland Clinic Florida
- Georgia
  - Atlanta、Georgia、美国、30322
    - Emory University
  - Atlanta、Georgia、美国、30309
    - Piedmont Healthcare Atlanta
- Illinois
  - Chicago、Illinois、美国、60611
    - Northwestern Memorial Hospital
  - Maywood、Illinois、美国、60153
    - Loyola University Medical Center
- Kansas
  - Kansas City、Kansas、美国、66160
    - University of Kansas Medical Center
- Kentucky
  - Louisville、Kentucky、美国、40202
    - Norton Pulmonary Specialists
  - Louisville、Kentucky、美国、40202
    - University of Louisville Healthcare Outpatient Center
- Louisiana
  - New Orleans、Louisiana、美国、70112
    - Tulane University Medical Center
  - Shreveport、Louisiana、美国、71103
    - LSU Health Science Center Shreveport
- Maryland
  - Baltimore、Maryland、美国、21224
    - Johns Hopkins Asthma and Allergy Center
  - Silver Spring、Maryland、美国、98374
    - Adventist Healthcare White Oak Medical Center
- Massachusetts
  - Boston、Massachusetts、美国、02115
    - Brigham and Women's Hospital
  - Boston、Massachusetts、美国、02114
    - Massachusetts General Hospital
  - Boston、Massachusetts、美国、02111
    - Tufts Medical Center
- Michigan
  - Ann Arbor、Michigan、美国、48109
    - University of Michigan Int Med Pulmonary and critical care
  - Royal Oak、Michigan、美国、48073
    - Corewell Health William Beaumont Hospital
- Minnesota
  - Minneapolis、Minnesota、美国、55455
    - University of Minnesota
  - Rochester、Minnesota、美国、55905
    - Mayo Clinic, Division of Pulmonary and Critical Care Medicine
- Mississippi
  - Jackson、Mississippi、美国、39216
    - University Mississippi Medical Center
- Missouri
  - Chesterfield、Missouri、美国、63017
    - The Lung Research Center, LLC
  - St Louis、Missouri、美国、63110
    - Washington University School of Medicine
- Nebraska
  - Omaha、Nebraska、美国、68124
    - Creighton University Clinical Research Office
- New Mexico
  - Albuquerque、New Mexico、美国、87106
    - University of New Mexico Health Sciences Center
- New York
  - Commack、New York、美国、11725
    - Stony Brook Advanced Specialty Care
  - New Hyde Park、New York、美国、11042
    - Northwell Health
  - New York、New York、美国、10021
    - Weill Cornell Medical Center
  - Rochester、New York、美国、14642
    - University of Rochester Medical Center
  - The Bronx、New York、美国、10467
    - Montefiore Medical Center
- North Carolina
  - Durham、North Carolina、美国、27710
    - Duke University Medical Center
  - Greensboro、North Carolina、美国、27403
    - PulmonIx, LLC
  - Greenville、North Carolina、美国、27834
    - East Carolina University
  - Winston-Salem、North Carolina、美国、27103
    - Southeastern Research Center
- Ohio
  - Cincinnati、Ohio、美国、45227
    - University of Cincinnati Medical Center
  - Cleveland、Ohio、美国、44195
    - Cleveland Clinic
  - Columbus、Ohio、美国、43201
    - The Ohio State University Wexner Medical Center
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Portland、Oregon、美国、97220
    - The Oregon Clinic
- Pennsylvania
  - Hershey、Pennsylvania、美国、17033
    - Penn State Milton S.Hershey Medical Center
  - Philadelphia、Pennsylvania、美国、19104
    - Hospital of the University of Pennsylvania
  - Philadelphia、Pennsylvania、美国、19140
    - Temple University Hospital
  - Philadelphia、Pennsylvania、美国、19107
    - Thomas Jefferson,Hospital University
- South Carolina
  - Charleston、South Carolina、美国、29425
    - Medical University of South Carolina
  - Columbia、South Carolina、美国、29203
    - Prisma Health Midlands
  - Rock Hill、South Carolina、美国、29732
    - Clinical Research of Rock Hill
- Tennessee
  - Knoxville、Tennessee、美国、37919
    - StatCare Pulmonary Consultants, PLLC
  - Nashville、Tennessee、美国、37204
    - Vanderbilt University Medical Center
- Texas
  - Dallas、Texas、美国、75246
    - Baylor University Medical Center
  - Dallas、Texas、美国、75390-8550
    - University of Texas Southwestern Medical Center
  - Houston、Texas、美国、77030
    - Baylor College of Medicine
  - Houston、Texas、美国、77030
    - Houston Methodist
  - Houston、Texas、美国、77030
    - The University of Texas Health Science Center at Houston
  - Houston、Texas、美国、77030
    - The University of Texas Health Science Center at Houston, McGovern Medical School
  - McAllen、Texas、美国、78503
    - A & A Research Consultants, LLC
  - McKinney、Texas、美国、75069
    - Metroplex Pulmonary and Sleep Center PA
  - The Woodlands、Texas、美国、77380
    - Renovatio Clinical
- Utah
  - Murray、Utah、美国、84107
    - Intermountain Healthcare
  - Salt Lake City、Utah、美国、84108
    - University of Utah Health
- Virginia
  - Charlottesville、Virginia、美国、22903
    - University of Virginia Health Systems
  - Falls Church、Virginia、美国、22042
    - Inova Fairfax Hospital
  - Richmond、Virginia、美国、23230
    - Pulmonary Associates of Richmond, Inc.
- Wisconsin
  - Madison、Wisconsin、美国、53792
    - University Hospital and UW Health Clinics
  - Milwaukee、Wisconsin、美国、53226
    - Medical College of Wisconsin
荷兰
- Limburg
  - Heerlen、Limburg、荷兰、6419 PC
    - Zuyderland Medisch Centrum - Heerlen
- South Holland
  - Rotterdam、South Holland、荷兰、3015 GD
    - Erasmus MC -Dr. Molewaterplein 40
西班牙
- - Barcelona、西班牙、08036
    - Hospital Clinic de Barcelona
  - Barcelona、西班牙、08035
    - Hospital Universitario Vall d'Hebron
  - Granada、西班牙、18014
    - Hospital Universitario Virgen de Las Nieves
  - Madrid、西班牙、28040
    - Hospital Clinico San Carlos
  - Madrid、西班牙、28006
    - Hospital Universitario de La Princesa
  - Madrid、西班牙、28007
    - Hospital General Universitario Gregorio Marañon
  - Murcia、西班牙、30120
    - Hospital Clinico Universitario Virgen de La Arrixaca
  - Santander、西班牙、39008
    - Hospital Universitario Marques de Valdecilla
- A Coruña
  - Santiago de Compostela、A Coruña、西班牙、15706
    - Hospital Clinico Universitario de Santiago de Compostela
- Balearic Islands
  - Palma de Mallorca、Balearic Islands、西班牙、07120
    - Hospital Universitario Son Espases
- Barcelona
  - L'Hospitalet de Llobregat、Barcelona、西班牙、08907
    - Hospital Universitario de Bellvitge
- Málaga
  - Málaga、Málaga、西班牙、29010
    - Hospital Universitario Virgen de la Victoria
- Principality of Asturias
  - Oviedo、Principality of Asturias、西班牙、33011
    - Hospital Universitario Central de Asturias
阿根廷
- - Buenos Aires、阿根廷、C1426ABP
    - Centro Médico Dra. De Salvo
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1027AAP
    - CINME S.A. - Centro de Investigaciones Metabólicas
  - Mar del Plata、Buenos Aires、阿根廷、7600
    - Instituto Ave Pulmo - Fundación enfisema
- Córdoba Province
  - Córdoba、Córdoba Province、阿根廷、5021
    - Sanatorio Allende Cerro
  - Río Cuarto、Córdoba Province、阿根廷、5800
    - Instituto Medico Río Cuarto
- Mendoza Province
  - Mendoza、Mendoza Province、阿根廷、5500
    - Centro Médico INSARES
- Santa Fe Province
  - Rosario、Santa Fe Province、阿根廷、2000
    - Sanatorio Parque de Rosario - Consultorios Externos
- Tucumán Province
  - San Miguel de Tucumán、Tucumán Province、阿根廷、4000
    - Centro Integral de Medicina Respiratoria (CIMER)
  - San Miguel de Tucumán、Tucumán Province、阿根廷、4000
    - Investigaciones en Patologías Respiratorias
韩国
- - Seoul、韩国、06351
    - Samsung Medical Center
  - Seoul、韩国、02841
    - Korea University Anam Hospital
- Gyeonggido
  - Seongnam-si、Gyeonggido、韩国、13620
    - Seoul National University Bundang Hospital
  - Seongnam-si、Gyeonggido、韩国、13496
    - CHA Bundang Medical Center, CHA University
- Incheon Gwang'yeogsi
  - Incheon、Incheon Gwang'yeogsi、韩国、21565
    - Gachon University Gil Medical Center
- Seoul Teugbyeolsi
  - Seoul、Seoul Teugbyeolsi、韩国、03312
    - The Catholic University of Korea - Eunpyeong St. Mary's Hospital
  - Seoul、Seoul Teugbyeolsi、韩国、07061
    - SMG - SNU Boramae Medical Center

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

40年及以上 (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:

Subject gives voluntary informed consent to participate in the study.
The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Exclusion Criteria:

Subject is pregnant or lactating.
In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement). Subjects participating in non-interventional, observational, or registry studies are eligible.

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：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Inhaled Treprostinil Treprostinil inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated to a target of 15 breaths QID or until the subject reaches their maximum clinically tolerated dose.	药品：Inhaled Treprostinil Inhaled Treprostinil (6 mcg/breath) administered QID 其他名称：泰瓦索设备：Treprostinil Ultrasonic Nebulizer Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

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
Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF 大体时间：Baseline to 6 years	Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs	Baseline to 6 years

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

United Therapeutics

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9月6日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2021年5月20日

首先提交符合 QC 标准的

2021年5月25日

首次发布 (实际的)

2021年5月28日

研究记录更新

最后更新发布 (实际的)

2026年10月19日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2026年10月1日

特发性肺纤维化患者吸入曲前列环素的扩展研究 (TETON-OLE)

特发性肺纤维化患者吸入曲前列素的开放标签扩展研究

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (估计的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

合作者和调查者

赞助

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品