Clinical trial NCT05934526: Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: seralutinib
GB002
PROSERA
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.


Eligibility criteria: Inclusion Criteria:

1. Adult subjects aged 18 to 75 years.
2. Body mass index (BMI) ≥ 15 kg/m\^2 and ≤ 40 kg/m\^2.
3. Diagnosis of PAH classified by one of the following:

   1. Idiopathic PAH (IPAH) or heritable PAH (HPAH).
   2. PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.
   3. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
4. 6MWDs ≥ 150 meters and ≤ 475 meters during Screening prior to randomization.
5. WHO FC II or III.
6. US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 5 OR NT-proBNP ≥ 300 ng/L OR PVR ≥ 800 dyne s/cm\^5.
7. Cardiac catheterization within the screening period, or a standard of care right heart catheterization (RHC) (with pressure wave forms available for review) up to 48 weeks prior to Screening.

   1. Mean pulmonary arterial pressure (mPAP) \> 20 mmHg (at rest), AND
   2. Pulmonary vascular resistance (PVR) ≥ 400 dyne·s/cm\^5, AND
   3. Pulmonary capillary wedge pressure (PCWP) or left ventricle end-diastolic pressure (LVEDP) ≤ 15 mmHg.
8. Treatment with at least one allowed background PAH disease-specific medication prior to Screening.

   1. Subjects receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, guanylate cyclase stimulators, and/or prostacyclin analogues or prostacyclin receptor agonists are eligible only if on a stable dose for at least 12 weeks prior to and throughout Screening.
   2. Subjects receiving treatment with sotatercept are eligible only if on a stable dose of sotatercept for at least 24 weeks prior to and throughout Screening, with a RHC performed during Screening (or within 2 weeks prior to Screening).
9. Pulmonary function tests (PFTs) at Screening or completed no more than 12 weeks prior to Screening.
10. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).
11. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
12. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

Exclusion Criteria:

1. Evidence of chronic thromboembolic disease or acute pulmonary embolism.
2. Uncontrolled systemic hypertension as evidenced by systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg.
3. Systolic blood pressure \< 90 mm Hg during Screening.
4. WHO Pulmonary Hypertension Group 2 - 5.
5. Human immunodeficiency virus (HIV)-associated PAH, schistosomiasis associated PAH, PAH associated with portal hypertension, or pulmonary veno-occlusive disease (PVOD).
6. Recent history of left-sided heart disease and/or clinically significant cardiac disease within 48 weeks of Screening.
7. Left ventricular ejection fraction (LVEF) ≤ 50% within 24 weeks of Screening.
8. Hemodynamically significant valvular heart disease or uncontrolled symptomatic coronary disease.
9. History of atrial septostomy.
10. Uncontrolled atrial fibrillation or paroxysmal atrial fibrillation.
11. Untreated severe obstructive sleep apnea.
12. Hepatic dysfunction defined as Child-Pugh Class A or higher, or as evidenced by one of the following at Screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN.
13. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg, history of intracranial hemorrhage, recurrent syncope).
14. Any musculoskeletal disease, injury, or any other disease that limits evaluation of 6MWT.
15. Initiation of an exercise program for cardiopulmonary rehabilitation within 12 weeks prior to Screening or planned during the study.
16. Pregnant or nursing or intends to become pregnant during the duration of the study.
17. Body weight \< 37 kg at Screening.
18. Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m\^2 Hemoglobin (Hgb) concentration \< 8.5 g/dL at Screening.
19. Evidence of active or latent Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, or tuberculosis (TB) infection at Screening.
20. Prior/concurrent treatment with tyrosine kinase inhibitors or activin signaling inhibitors:

    1. Tyrosine kinase inhibitors, other than Janus kinase inhibitors approved for systemic autoimmune rheumatic diseases, within 12 weeks prior to Screening.
    2. Activin signaling inhibitors within 5 half-lives prior to Screening.
21. Requirement of IV inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) or IV diuretics for more than 24 hours within 4 weeks prior to Screening.
22. Subjects currently receiving oral anticoagulants (ie, warfarin/other vitamin K antagonists or direct-acting oral anticoagulants \[DOACs\]) if any of the following criteria are met:

    a. History within 24 weeks of Screening of: i. Syncope, or ii. Symptomatic bleeding in a critical area or organ iii. Intramuscular with compartment syndrome, or iv. Bleeding causing a fall in hemoglobin levels of 1.24 mmol/L (20 g/L or greater) or more, or v. Bleeding leading to a transfusion of 2 U or more of whole blood or red blood cells.

    b. History of central nervous system pathology.

    c. History of clinically significant (massive) hemoptysis.

    d. If on warfarin/other vitamin K antagonist, uncontrolled International normalized ratio (eg, INR \> 3) as assessed.

    e. Platelet count \< 150 x 10\^9/L at Screening.

    f. Concomitant use of antiplatelet agents.

    g. CTD-APAH

    h. Concomitant use of sotatercept.
23. Prior participation in seralutinib studies and/or prior treatment with seralutinib.
24. Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PAH within 12 weeks or 5 half-lives of the investigational agent, whichever is longer, prior to Screening.
25. Current use of inhaled tobacco- or nicotine-containing products (including e-vapor products) and/or inhaled marijuana.
26. Current alcohol use disorder based on the opinion of the Investigator, and/or a positive test for drugs of abuse.
27. Subjects with a history of severe milk protein allergy or known intolerance to lactose.
28. QT interval corrected for heart rate using Fridericia's formula (QTcF) of \> 500 msec.
29. Have any other condition or reason that, in the opinion of the Investigator or in the opinion of the Sponsor's Medical Monitor (MM) (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study.

Primary outcomes:
measure: Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study
timeFrame: Baseline to 48 weeks
measure: Proportion of subjects who achieve all of the following components of clinical improvement at Week 24, in the absence of clinical worsening:
timeFrame: Baseline to 24 weeks
measure: Change in NT-proBNP from baseline to Week 24
timeFrame: Baseline to 24 weeks
measure: Proportion of subjects with ≥ 1 point decrease from baseline in US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score at Week 24
timeFrame: Baseline to 24 weeks
measure: Proportion of subjects with each of the Clinical Worsening Outcomes:
timeFrame: Baseline to 52 weeks
measure: Proportion of subjects who improve from baseline in WHO FC or maintain WHO FC II
timeFrame: Baseline to 24 weeks
measure: Change in PAH-SYMPACT™ from baseline to Week 24
timeFrame: Baseline to 24 weeks
measure: Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to Week 24
timeFrame: Baseline to 24 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs (SAEs), and treatment-emergent adverse events of special interest (AESIs)
timeFrame: Baseline to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fresno
country: United States
facility: Valley Advanced Lung Diseases Institute
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center (La Jolla)
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: Dept of Veterans Affairs Greater Los Angeles Healthcare System
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Santa Barbara
country: United States
facility: Medical Corporation
state: California
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Farmington
country: United States
facility: UConn Health/Clinical Research Center
state: Connecticut
city: New Haven
country: United States
facility: Winchester Center for Lung Disease
state: Connecticut
city: Washington
country: United States
facility: The George Washington University Medical Faculty Associates
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital Laboratory - Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital, Clinical Research Unit
state: Illinois
city: Chicago
country: United States
facility: UI Health Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
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
state: Michigan
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center - Duke South
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Cardiovascular Physicians, LLC
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Heart and Vascular Institute (Outpatient Clinic)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina - Nexus Research Center
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Outpatient Center
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Medical Center - The Heart Hospital
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Milwaukee
country: United States
facility: Advocate Aurora Health-Aurora St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital/Medical College of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Cardiologia Palermo
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes Juana Francisca Cabral
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordóba S.A.
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
city: Rosario
country: Argentina
facility: Sanatorio Parque S.A.
city: Río Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto
city: Santa Fe
country: Argentina
facility: Hospital Provincial Dr. José María Cullen
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Auchenflower
country: Australia
facility: Wesley Research Institute
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Kingswood
country: Australia
facility: Nepean Hospital
city: Linz
country: Austria
facility: Religious Hospital Linz GmbH
city: Vienna
country: Austria
facility: AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology
city: Anderlecht
country: Belgium
facility: Hôpital Erasme
city: Leuven
country: Belgium
facility: University Hospitals of Leuven (Campus Gasthuisberg)
city: Belo Horizonte
country: Brazil
facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
city: Blumenau
country: Brazil
facility: Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP
city: London
country: Canada
facility: London Health Science Centre - Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Calgary
country: Canada
facility: Peter Lougheed Center
city: Toronto
country: Canada
facility: University Health Network
city: Santiago
country: Chile
facility: Enroll SpA
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica UC-CICUC
city: Bogotá
country: Colombia
facility: Fundación Abood Shaio
city: Bogotá
country: Colombia
facility: Fundación Neumologica Colombiana
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
city: Praha
country: Czechia
facility: Institut Klinicke a Experimentalni Mediciny
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Department of Cardiology
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Department of Cardiology
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Lille
country: France
facility: Institut Coeur Poumon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nice
country: France
facility: Hôpital Pasteur
city: Poitiers
country: France
facility: CHU de Poitiers
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Dresden
country: Germany
facility: Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat
city: Gießen
country: Germany
facility: Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Zentrum für Onkologie Studienzentrum Pneumologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover Klinik für Pneumologie und Infektiologie
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Innere Medizin V - Pneumologie, Allergologie, Beatmungs- und Umweltmedizin
city: Koln
country: Germany
facility: Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln
city: Munich
country: Germany
facility: Krankenhaus Neuwittelsbach
city: München
country: Germany
facility: Klinikum der LMU Medizinische Klinik und Poliklinik V
city: Würzburg
country: Germany
facility: Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
city: Athens
country: Greece
facility: "Evangelismos" General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic
city: Athens
country: Greece
facility: ATTIKON University Hospital, 2nd Critical Care Department
city: Kallithéa
country: Greece
facility: Onassis Cardiac Surgery Center
city: Thessaloníki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital, Respiratory Department
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino - Cardiovascular Diseases Unit - Cardiac, Thoracic and Vascular Department
city: Napoli
country: Italy
facility: Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia
city: Rome
country: Italy
facility: Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Nagoya-Shi
country: Japan
facility: Nagoya University Hospital
city: Okayama
country: Japan
facility: NHO Okayama Medical Center
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tokyo
country: Japan
facility: University of Tokyo Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System Seoul
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary´s Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Mexico City
country: Mexico
facility: Instituto nacional de Cardiologia Ignacio Chavez
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina, S.C.
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de Santo António
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova De Gaia
city: Guaynabo
country: Puerto Rico
facility: CardioPulmonary Research Center
city: Bucharest
country: Romania
facility: Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2
city: Cluj-Napoca
country: Romania
facility: "Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases
city: Cluj-Napoca
country: Romania
facility: Mediprax Centrum S.R.L
city: Târgu-Mureş
country: Romania
facility: Targu-Mures Emergency Clinical County Hospital, Internal Medicine II
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia, Cardiology Clinic
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: National University Heart Centre Singapore
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro Majadahonda
city: Marbella
country: Spain
facility: Hospital Costa del Sol
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca (Complejo Asistencial Universitario De Salamanca)
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Valencia
country: Spain
facility: Hospital universitario Y Politecnico La Fe
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital, Agamemnon Street
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Clinical Research Facility, Royal Hallamshire Hospital
Study officials:
affiliation: Gossamer Bio Inc.
name: Richard Aranda, MD
role: STUDY_DIRECTOR
References: