Clinical trial NCT04905693: Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Official title: An Open-label Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Keywords: Treprostinil
IPF
ILD
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 792
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label Extension
Primary purpose: TREATMENT

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

Detailed description: Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). 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 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, 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 may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Eligibility criteria: Inclusion Criteria:

1. Subject gives voluntary informed consent to participate in the study.
2. The subject participated in Study RIN-PF-301 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study RIN-PF-303 at the time that the study or study subject was discontinued by the Sponsor.
3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will 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.
4. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
5. 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:

1. Subject is pregnant or lactating.
2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.

Primary outcomes:
measure: Long-term safety and tolerability of inhaled treprostinil in subjects with IPF
timeFrame: Baseline to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center-Phoenix
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Sacramento
country: United States
facility: UC Davis Health Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: University of Florida Health at Shands
state: Florida
city: Jacksonville
country: United States
facility: Ascension St. Vincent's
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists, PA d/b/a PDS Research
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Pulmonary & Critical Care PLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Pulmonary Specialists
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Healthcare Outpatient Center
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Science Center Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
city: Silver Spring
country: United States
facility: Adventist Healthcare White Oak Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Int Med Pulmonary and critical care
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Division of Pulmonary and Critical Care Medicine
state: Minnesota
city: Jackson
country: United States
facility: University Mississippi Medical Center
state: Mississippi
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Creighton University Clinical Research Office
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Greensboro
country: United States
facility: PulmonIx, LLC
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S.Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson,Hospital University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health Midlands
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Knoxville
country: United States
facility: StatCare Pulmonary Consultants, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: McAllen
country: United States
facility: A & A Research Consultants, LLC
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center PA
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Madison
country: United States
facility: University Hospital and UW Health Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CINME S.A. - Centro de Investigaciones Metabólicas
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto Ave Pulmo - Fundación enfisema
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Sanatorio Allende Cerro
state: Provincia De Córdoba
city: Rio Cuarto
country: Argentina
facility: Instituto Medico Río Cuarto
state: Provincia De Córdoba
city: Mendoza
country: Argentina
facility: Centro Médico INSARES
state: Provincia De Mendoza
city: San Miguel de Tucumán
country: Argentina
facility: Centro Integral de Medicina Respiratoria (CIMER)
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: Investigaciones en Patologías Respiratorias
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Médico Dra. De Salvo
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Lung Research Qld
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Anderlecht
country: Belgium
facility: Hôpital Erasme
state: Brussels
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
state: Namur
city: Aalst
country: Belgium
facility: vzw AZORG - Aalst - Moorselbaan
city: Antwerpen
country: Belgium
facility: Ziekenhuis Aan de Stroom
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Liège
country: Belgium
facility: CHU de Liège
city: Ajax
country: Canada
facility: Dynamic Drug Advancement Limited
state: Ontario
city: Ajax
country: Canada
facility: Dynamic Drug Advancement Limited
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Trois-Rivières
country: Canada
facility: Centre d'investigation Clinique Mauricie
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
city: Talca
country: Chile
facility: Centro de Investigación del Maule SpA
state: Maule
city: Santiago
country: Chile
facility: CEC Centro de Estudios Clínicos
state: Metropolitana
city: Santiago
country: Chile
facility: Instituto Nacional del tórax
state: Región Metropolitana
city: Santiago
country: Chile
facility: Fundación Médica San Cristobal
state: Región Metropolitana
city: Quillota
country: Chile
facility: Centro Respiratorio Integral Limitada
state: Valparaiso
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit
city: Hellerup
country: Denmark
facility: Gentofte Hospital - Lungemedicinsk forskningsafdeling
city: Odense C
country: Denmark
facility: Odense University Hospital - Department of Respiratory Medicine
city: Marseille
country: France
facility: Hopital Nord AP-HM (Assistance Publique Hôpitaux De Marseille - Centre Hospitalier Régional de Marseille
state: Bouches-du-Rhône
city: Caen
country: France
facility: CHU Caen Normandie
state: Calvados
city: Toulouse
country: France
facility: Hopital Larrey
state: Haute-Garonne
city: Tours
country: France
facility: Hôpital Bretonneau
state: Indre-et-Loire
city: Rouen
country: France
facility: CHU Rouen Hopital Charles Nicolle
state: Seine-Maritime
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Bobigny
country: France
facility: AP-HP - Hopital Avicenne
city: Bron
country: France
facility: Hospices Civils De Lyon - Université Hospital of Lyon
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôptial Bichat
city: Reims
country: France
facility: Centre Hospitalier Universitaire De Reims - Hôpital Maison Blanche
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Löwenstein
country: Germany
facility: SLK Kliniken Heilbronn GmbH Standort Fachklink Löwenstein Med. Klinik I Pneumologie Beatmungsmedizin Intensivmedizin
state: Baden-Württemberg
city: München
country: Germany
facility: LMU Klinikum der Universität München
state: Bayern
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
state: Bayern
city: Essen
country: Germany
facility: Universitätsmedizin Essen Ruhrlandklinik Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
state: Nordrhein-Westfalen
city: Coswig
country: Germany
facility: Prüfstelle der GWT am Fachkrankenhaus Coswig
state: Sachsen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH Klinik für Pneumologie
state: Thüringen
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
state: HaDarom
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
state: Haifa
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center - PPDS
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
state: Yerushalayim
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center - PPDS
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center - PPDS
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli-Rome
state: Lazio
city: Milan
country: Italy
facility: Gruppo MultiMedica SpA - Ospedale San Giuseppe
state: Lombardia
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele presidio "G.Rodolico"
state: Sicilia
city: Siena
country: Italy
facility: Azienda ospedaliero-universitaria Senese
state: Toscana
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche
city: Forlì
country: Italy
facility: Presidio Ospedaliero GB Morgagni L Pierantoni
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon Gwang'yeogsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea - Eunpyeong St. Mary's Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Monterrey
country: Mexico
facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas (CEPREP)
state: Nuevo León
city: Monterrey
country: Mexico
facility: Unidad de Investigación Clínica en Medicina, S.C.
state: Nuevo León
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum - Heerlen
state: Limburg
city: Rotterdam
country: Netherlands
facility: Erasmus MC -Dr. Molewaterplein 40
state: Zuid-Holland
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Christchurch
country: New Zealand
facility: Canterbury Respiratory Research Group
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco - Red Asistencial Cusco
city: Lima
country: Peru
facility: Clinica Ricardo Palma
city: Lima
country: Peru
facility: Hospital Central de la Fuerza Aérea del Perú
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Baleares
city: L´Hospitalet de LLobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Málaga
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen de La Arrixaca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: