Back to resultsA Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis (STARSCAPE)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PRM-151 (Zinpentraxin Alfa)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline
- High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
- Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test (6MWT) during screening
- FVC >/= 45% predicted during screening as determined by the over-reader
- Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader
- Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to (</=) 90% of predicted at screening as determined by the over-reader
- If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening
- If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment >/= 4 weeks prior to screening and during screening
- Anticipated life expectancy of at least 12 months at baseline
- Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
- For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
- Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
- For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Exclusion Criteria:
- Evidence of other known causes of Interstitial Lung Disease (ILD)
- FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value
- Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
- Receiving nintedanib in combination with pirfenidone
- Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening
- Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during screening
- Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
- Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])
- Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level) during screening
- Class IV New York Heart Association chronic heart failure
- Historical evidence of left ventricular ejection fraction < 35%
- Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
- Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial
- History of smoking, alcohol or substance abuse disorder, or a malignancy
- Previous treatment with PRM-151
- Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula
- Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant
- Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151
- Women of childbearing potential (Only for participants enrolling in Japan)
Sites / Locations
- University of Alabama at Birmingham
- Banner University Medical Center Phoenix; Main Pharmacy
- Lovelace Scientific Resources, Inc.
- UC Irvine Medical Center
- Stanford Hospital and Clinics
- University of California Davis
- Inst. of Healthcare Assessment, Inc.
- UCSF Medical Center
- Paloma Medical Group
- William Sansum Diabetes Center
- University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
- National Jewish Health Medical Center
- Yale New Haven Hospital
- Georgetown University Medical Center
- Meris Clinical Research
- Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
- Advanced Pulmonary & Sleep Research Institute of Florida
- University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
- Malcom Randall VA Medical Center
- University of Florida Health Pulmonology - Jacksonville
- Advanced Pulmonary Research Institute
- San Marcus Research Clinic Inc.
- Renstar Medical Research
- Central Florida Pulmonary Group, PA
- Sarasota Memorial Health Care System; Cancer Research Program
- University of South Florida
- Integral ? Clinical Trial Solutions
- Clinical Site Partners Orlando
- Emory University
- Piedmont Healthcare Pulmonary and Critical Care Research
- NorthShore University HealthSystem
- Indiana Univ School of Med
- University of Iowa Hospitals and Clinics; Investigational Drug Services
- University of Kansas Medical Center
- University of Louisville Health Sciences Center
- Massachusetts General Hospital
- Brigham & Women'S Hospital
- Covenant Medical Center - Cooper
- University of Minnesota Medical Center
- Mayo Clinic Rochester
- The Lung Research Center
- Washington University
- University of Nebraska Medical Center
- Pulmonary & Allergy Associates
- Lenox Hill Hospital
- American Health Research Inc.
- Duke University Medical Center
- Pulmonix Research
- PMG Research of Wilmington
- University of Cincinnati Cancer Institute
- University Hospitals Cleveland Medical Center
- Mercy St. Vincent Medical Center
- Oregon Health and Science University
- Jefferson University Physicians (JUP) - Jefferson Pulmonary
- Temple University Medical Center
- University of Pittsburgh Medical Center
- Medical University of South Carolina Hospital
- SleepMed of South Carolina
- Lowcountry Lung and Critical Care
- Spartanburg Medical Center
- Vanderbilt University Medical Center
- Horizon Clinical Research Group
- Cardiopulmonary Research Science and Technology Institute
- University of Texas Southwestern Medical Center; Heart and Lung Clinic
- University of Texas Medical Branch; Cardiology Department
- DCOL Center for Clinical Research
- Metroplex Pulmonology & Sleep Center
- Audie L. Murphy VA Hospital, STVHCS
- University Of Utah Hosp & Clin; Investigational Pharmacy
- Inova Fairfax Hospital/IHVI; Cardiology
- Virginia Commonwealth University
- University of Wisconsin-Madison
- Hospital Britanico de Buenos Aires
- Fundacion Respirar (Centro Medico Dra. De Salvo)
- Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
- Centro Medico de Enfermedades Respiratorias (CEMER)
- Centro de estudios respiratorios
- INSARES
- Fundacion Scherbovsky
- Investigaciones en Patologias Respiratorias
- Royal Prince Alfred Hospital
- Cairns Base Hospital; Cancer Care Centre
- Lung Research Queensland
- Princess Alexandra Hospital
- The Queen Elizabeth Hospital
- Austin Hospital; Cancer Clinical Trials Centre
- Monash Medical Centre; Medicine
- The Alfred Hospital
- Fiona Stanley Hospital
- Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
- Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
- ULB Hôpital Erasme
- Cliniques Universitaires Saint-Luc; Pharmacy
- UZ Leuven
- C. H. U. Sart-Tilman; Laboratory
- CHU UCL Namur / site Godinne
- Hospital das Clinicas - UFMG
- Santa Casa de Misericordia de Porto Alegre
- University of Alberta Hospital
- Synergy Respiratory Care
- Kelowna Respiratory and Allergy Clinic
- Vancouver General Hospital; Gordon and Leslie Diamond Health Care
- Eastern Health - General Hospital
- The Rhema Research Institute
- Dr. Syed Anees Medicine Profession Corporation
- Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
- McGill University, Montreal Chest Institute; Viral and other Infectious
- C.I.C. Mauricie
- CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine
- China-Japan Friendship Hospital
- Peking Union Medical College Hospital; Pharmacy
- Beijing Friendship Hospital Affiliated of Capital University of Medical Science
- Peking University Third Hospital
- Xiangya Hospital Central South University
- The Second Xiangya Hospital of Central South University
- The Third Xiangya Hospital Of Central South University
- West China Hospital, Sichuan University
- Southern Medical University Nanfang Hospital
- The First Affilicated Hospital, Sun Yat-sen University
- The First Affiliated Hospital of Guangzhou Medical University
- 1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy
- Inner Mongolia Autonomous Region People's Hospital
- Qilu Hospital of Shandong University
- The 1st Affiliated Hospital of Nanchang Unversity
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
- Ningbo First Hospital
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
- Huadong Hospital Affiliated to Fudan University
- Shanghai Pulmonary Hospital
- China Medical University (CMU) First Affiliated Hospital
- Shengjing Hospital of China Medical University
- Hebei Medical University - The Second Hospital
- Tianjin Medical University General Hospital
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
- Wuxi People's Hospital
- Tangdu Hospital, The Fourth Military Medical University; Neurology Department
- Qinghai Provincial People?s Hospital
- Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital
- The First Affiliated Hospital of Zhengzhou University
- Fakultní Nemocnice Brno
- Fakultni nemocnice Olomouc
- Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie
- Nemocnice Na Bulovce
- Thomayerova nemocnice; Lekarna - pavilon H
- Krajská nemocnice T. Bati, a. s.
- Aarhus Universitetshospital Skejby
- Gentofte Hospital
- Odense Universitetshospital
- Turku University Hospital
- Hopital Avicenne
- Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
- Hopital Louis Pradel
- Hospital d Instructions des Armees Percy
- CHU Dijon Bourgogne Hôpital François Mitterand
- CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
- Centre Hospitalier Regional Universitaire de Lille
- Servie de Pneumologie et centre de Transplantation Pulmonaire
- CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
- CHU Nice - Hôpital Pasteur 2
- Hopital Bichat Claude Bernard; CIC
- European Hospital Georges Pompidou (HEGP)
- Hopital Haut Leveque
- Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
- CHU de Rennes - Hopital de Pontchaillo
- CHU Tours - Hôpital Bretonneau; Pharmacie
- Zentralklinik Bad Berka GmbH; Pneumologie
- Evang. Lungenklinik Berlin Klinik für Pneumologie
- Universitatsklinikum Essen; Innere Klinik
- IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
- Universitatsklinikum Gießen und Marburg GmbH
- Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie
- Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
- Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
- Lungenfachklinik Immenhausen
- Universitatsklinikum Leipzig; Apotheke
- IKF Pneumologie Mainz Helix Medical Excellence Center Mainz
- Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
- Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
- Krankenhaus Bethanien gGmbH
- Evangelismos Hospital; Department of Critical Care and Pulmonary Services
- Attikon University General Hospital
- University General Hospital of Heraklion
- University Hospital of Ioannina; Pulmonology Department
- Hospital is University General Hospital of Larissa
- Athens Medical Center
- University General Hospital of Patras
- "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "
- General Hospital of Thessaloniki G. Papanikolaou
- Prince of Wales Hospital; Dept. of Medicine & Therapeutics
- The University of Hong Kong; Queen Mary Hospital
- Semmelweis University
- Debreceni Egyetem
- Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
- Szent Borbala Korhaz
- Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
- Barzilai Medical Center; Neurology Department
- Shamir medical center
- Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
- Rambam Health Care Campus
- Bnai Zion Medical Center; Internal Medicine
- Carmel Medical Center; Obstetrics and Gynecology
- Edith Wolfson Medical Center
- Shaare Zedek Medical Center; Nrphrology Dept.
- Hadassah Medical Center
- Meir Medical Center
- Rabin Medical Center
- The Chaim Sheba Medical Center
- Kaplan Medical Center
- Tel-Aviv Sourasky Medical Center; Department of Pulmonary
- Azienda Ospedaliera Papa Giovanni XXIII
- AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
- Azienda Ospedaliera Dei Colli
- Azienda Ospedaliera Universitaria Federico II
- Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
- Ospedale Morgagni Pierantoni; Patologia clinica
- A.O.U. Policlinico di Modena
- Azienda Sanitaria Universitaria Integrata di Trieste
- Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
- Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
- "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "
- Ospedale San Giuseppe; U.O. di Pneumologia
- Asst Santi Paolo E Carlo
- Ospedale San Gerardo
- Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
- Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
- Ospedale di Ostuni - Pneumologia
- A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
- Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
- Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
- Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
- AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
- A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
- Azienda Ospedale Università Di Padova; Clinica Pneumologica
- University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
- Nagoya University Hospital
- Chiba University Hospital
- National Hospital Organization Kyushu Medical Center
- Fukuoka University Hospital
- Kobe City Medical Center General Hospital
- National Hospital Organization Himeji Medical Center
- Kameda Medical Center
- Kanagawa Cardiovascular and Respiratory Center
- Nippon Medical School Musashi Kosugi Hospital
- Saiseikai Kumamoto Hospital
- Nagasaki University Hospital
- National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
- Kurashiki Central Hospital
- National Hospital Organization Kinki-Chuo Chest Medical Center
- Tosei General Hospital
- Tenri Hospital
- Jichi Medical University Hospital
- Tokushima University Hospital
- Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
- Center Hospital of the National Center for Global Health and Medicine
- Soon Chun Hyang University Hospital Bucheon
- The Catholic University of Korea Bucheon St. Mary's Hospital
- Gacheon University Gil Medical Center
- Seoul National University Bundang Hospital
- The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
- Seoul National University Hospital (SNUH) - Medical Oncology Center
- Soonchunhyang University Hospital
- Asan Medical Center
- Korea University Guro Hospital
- Samsung Medical Center
- The Catholic University of Korea Seoul St. Mary?s Hospital
- INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
- Centro Respiratorio de México
- Unidad Médica para la Salud Integral UMSI
- Unidad de Investigacion CIMA SC
- CICC Morelia
- VU Medisch Centrum
- Sint Antonius Ziekenhuis, locatie Nieuwegein
- Erasmus Medisch Centrum
- Auckland City Hospital
- NZ Respiratory & Sleep Institute
- University of Otago, Christchurch
- Waikato Hospital; Gastro Research
- Tauranga Hospital
- Helse Bergen HF Haukeland universitetssykehus
- Akershus universitetssykehus
- Oslo University Hospital HF, Rikshospitalet
- Centrum Medycyny Oddechowej Mroz sp. j.
- Nasz Lekarz Osrodek Badan Klinicznych
- Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
- Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
- Centro Hospitalar Algarve
- Hospital Senhora da Oliveira ? Guimarães, E.P.E
- Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
- Centro Hospitalar do Porto - Hospital de Santo António
- Hospital de Sao Joao; Centro de Investigacao
- Hospital de Santa Luzia
- CHVNG/E_Unidade 1; Servico de Pneumologia
- Singapore General Hospital
- Tan Tock Seng Hospital; Oncology
- University of Cape Town Lung Institute; Lung Clinical Research
- Vergelegen Medi-Clinic
- Hospital Txagorritxu
- Hospital Universitario Central de Asturias
- Hospital Universitario de Bellvitge
- Parc Taulí Sabadell Hospital Universitari
- Hospital Universitario Marques de Valdecilla
- Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario
- Hospital Universitario del Henares
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Universitario Quironsalud Madrid
- Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
- Hospital Universitario de Canarias
- Hospital Galdakao-Usansolo
- Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona
- Hospital Clinic de Barcelona
- Hospital Germans Trias i Pujol
- Hospital Virgen de las Nieves; Servicio de Neumologia
- Hospital Universitario de La Princesa
- Hospital Universitario La Paz
- Clínica Universidad de Navarra ? Madrid
- Hospital Ramón y Cajal;Servicio de Neumología
- Hosp. Clinico San Carlos
- Hospital Universitario Fundacion Jimenez Diaz.
- Hospital Universitario 12 de Octubre
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Clinico Universitario de Salamanca
- Hospital Universitario Virgen del Rocio
- Hospital Clinico Universitario de Valencia
- Hospital Arnau de Vilanova (Valencia)
- Hospital Universitari i Politecnic La Fe de Valencia
- Skånes universitetssjukhus Malmö
- Inselspital Bern Universitätsklinik für Pneumologie
- Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)
- Buddhist Tzu Chi Dalin General Hospital; Rheumatology
- Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
- China Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Far Eastern Memorial Hospital; Department of Clinical Pathology
- Veterans General Hospital - Taichung
- Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
- Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
- Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
- Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
- Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi
- Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
- Ege Universitesi Tip Fakultesi Hastanesi
- Dokuz Eylul University Faculty of Medicine; Chest Diseases
- Erciyes Üniversitesi T?p Fakültesi
- Kocaeli Universitesi Tip Fakultesi
- Marmara Universitesi Hastanesi Marmara University Hospital
- Mersin Üniversitesi Tip Fakültesi
- Akdeniz University Faculty of Medicine Department of Pulmonology
- Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
- Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
- National Academy of Medical Science of Ukraine (NAMS); NRCRM
- Yanovskyy Inst of Phth. & Pulm; Clinical-functional
- Edinburgh Royal Infirmary; Respiratory Department
- Royal Brompton Hospital; Respiratory Department
- Manchester University NHS Foundation Trust - Wythenshawe Hospital
- North Manchester General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRM-151
Placebo
Arm Description
Participants will receive intravenous (IV) infusions of PRM-151 over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.
Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Outcomes
Primary Outcome Measures
Absolute Change in Forced Vital Capacity (FVC [mL])
Secondary Outcome Measures
Absolute Change in 6-minute Walk Distance (6MWD)
Absolute Change in FVC% Predicted
Time to Disease Progression
Time to First Respiratory-related Hospitalizations
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
Change in St. George Respiratory Questionnaire (SGRQ) Total Score
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Survival
Survivial is measured by all-cause mortality
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
Percentage of Participants Permanently Discontinuing Study Treatment due to AEs
Change from Baseline in Targeted Clinical Laboratory Test Results
Plasma Concentrations of PRM-151
Prevalence of Anti-drug Antibodies (ADAs) at Baseline
Percentage of Participants with ADAs During the Study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04552899
Brief Title
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Acronym
STARSCAPE
Official Title
A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
665 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRM-151
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) infusions of PRM-151 over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Intervention Type
Drug
Intervention Name(s)
PRM-151 (Zinpentraxin Alfa)
Intervention Description
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Primary Outcome Measure Information:
Title
Absolute Change in Forced Vital Capacity (FVC [mL])
Time Frame
From Baseline up to Week 52
Secondary Outcome Measure Information:
Title
Absolute Change in 6-minute Walk Distance (6MWD)
Time Frame
From Baseline up to Week 52
Title
Absolute Change in FVC% Predicted
Time Frame
From Baseline up to Week 52
Title
Time to Disease Progression
Time Frame
From Baseline up to 2.5 years
Title
Time to First Respiratory-related Hospitalizations
Time Frame
From Baseline up to 2.5 years
Title
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
Time Frame
From Baseline up to Week 52
Title
Change in St. George Respiratory Questionnaire (SGRQ) Total Score
Time Frame
From Baseline up to Week 52
Title
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
Time Frame
From Baseline up to 2.5 years
Title
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Time Frame
From Baseline up to Week 52
Title
Survival
Description
Survivial is measured by all-cause mortality
Time Frame
From Baseline up to 2.5 years
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
From Baseline up to 2.5 years
Title
Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
Time Frame
From Baseline up to 2.5 years
Title
Percentage of Participants Permanently Discontinuing Study Treatment due to AEs
Time Frame
From Baseline up to 2.5 years
Title
Change from Baseline in Targeted Clinical Laboratory Test Results
Time Frame
From Baseline up to 2.5 years
Title
Plasma Concentrations of PRM-151
Time Frame
Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
Title
Prevalence of Anti-drug Antibodies (ADAs) at Baseline
Time Frame
Day 1
Title
Percentage of Participants with ADAs During the Study
Time Frame
Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline
High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test (6MWT) during screening
FVC >/= 45% predicted during screening as determined by the over-reader
Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader
Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to (</=) 90% of predicted at screening as determined by the over-reader
If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening
If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment >/= 4 weeks prior to screening and during screening
Anticipated life expectancy of at least 12 months at baseline
Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Exclusion Criteria:
Evidence of other known causes of Interstitial Lung Disease (ILD)
FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value
Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
Receiving nintedanib in combination with pirfenidone
Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening
Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during screening
Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])
Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level) during screening
Class IV New York Heart Association chronic heart failure
Historical evidence of left ventricular ejection fraction < 35%
Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial
History of smoking, alcohol or substance abuse disorder, or a malignancy
Previous treatment with PRM-151
Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula
Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant
Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151
Women of childbearing potential (Only for participants enrolling in Japan)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Banner University Medical Center Phoenix; Main Pharmacy
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Inst. of Healthcare Assessment, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0748
Country
United States
Facility Name
Paloma Medical Group
City
San Juan Capistrano
State/Province
California
ZIP/Postal Code
92675
Country
United States
Facility Name
William Sansum Diabetes Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045-2541
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Meris Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511-5719
Country
United States
Facility Name
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747-1818
Country
United States
Facility Name
Advanced Pulmonary & Sleep Research Institute of Florida
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-3928
Country
United States
Facility Name
Malcom Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida Health Pulmonology - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Advanced Pulmonary Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470-9216
Country
United States
Facility Name
San Marcus Research Clinic Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sarasota Memorial Health Care System; Cancer Research Program
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Integral ? Clinical Trial Solutions
City
Weston
State/Province
Florida
ZIP/Postal Code
33327
Country
United States
Facility Name
Clinical Site Partners Orlando
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Piedmont Healthcare Pulmonary and Critical Care Research
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Indiana Univ School of Med
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics; Investigational Drug Services
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Louisville Health Sciences Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women'S Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Covenant Medical Center - Cooper
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602-5383
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
29425-8911
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
The Lung Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017-3625
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-0600
Country
United States
Facility Name
Pulmonary & Allergy Associates
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901-4055
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
American Health Research Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pulmonix Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403-1127
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Mercy St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Jefferson University Physicians (JUP) - Jefferson Pulmonary
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140-4105
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
SleepMed of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201-2953
Country
United States
Facility Name
Lowcountry Lung and Critical Care
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Horizon Clinical Research Group
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Cardiopulmonary Research Science and Technology Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Texas Southwestern Medical Center; Heart and Lung Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8575
Country
United States
Facility Name
University of Texas Medical Branch; Cardiology Department
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605-2410
Country
United States
Facility Name
Metroplex Pulmonology & Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Audie L. Murphy VA Hospital, STVHCS
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Of Utah Hosp & Clin; Investigational Pharmacy
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Inova Fairfax Hospital/IHVI; Cardiology
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219-1901
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1284AEB
Country
Argentina
Facility Name
Fundacion Respirar (Centro Medico Dra. De Salvo)
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Centro Medico de Enfermedades Respiratorias (CEMER)
City
Florida, Buenos Aires
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Centro de estudios respiratorios
City
Mar Del Plata
ZIP/Postal Code
B7600CLK
Country
Argentina
Facility Name
INSARES
City
Mendoza, Mendoza City
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Fundacion Scherbovsky
City
Mendoza
ZIP/Postal Code
M5500AYB
Country
Argentina
Facility Name
Investigaciones en Patologias Respiratorias
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Cairns Base Hospital; Cancer Care Centre
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Lung Research Queensland
City
Nundah
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Austin Hospital; Cancer Clinical Trials Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Monash Medical Centre; Medicine
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3186
Country
Australia
Facility Name
The Alfred Hospital
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
ULB Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc; Pharmacy
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
C. H. U. Sart-Tilman; Laboratory
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur / site Godinne
City
Yvoir
ZIP/Postal Code
B5530
Country
Belgium
Facility Name
Hospital das Clinicas - UFMG
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Synergy Respiratory Care
City
Sherwood Park
State/Province
Alberta
ZIP/Postal Code
T8H ON2
Country
Canada
Facility Name
Kelowna Respiratory and Allergy Clinic
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 1V3
Country
Canada
Facility Name
Vancouver General Hospital; Gordon and Leslie Diamond Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
Facility Name
Eastern Health - General Hospital
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
The Rhema Research Institute
City
Owen Sound
State/Province
Ontario
ZIP/Postal Code
N4K 6M9
Country
Canada
Facility Name
Dr. Syed Anees Medicine Profession Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1R9
Country
Canada
Facility Name
McGill University, Montreal Chest Institute; Viral and other Infectious
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X2P4
Country
Canada
Facility Name
C.I.C. Mauricie
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine
City
Beijing City
ZIP/Postal Code
100020
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing City
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital; Pharmacy
City
Beijing City
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
City
Beijing Shi
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha City
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
The Third Xiangya Hospital Of Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Southern Medical University Nanfang Hospital
City
Guangdong Province Guangzhou City
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affilicated Hospital, Sun Yat-sen University
City
Guangzhou City
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy
City
Hangzhou City
ZIP/Postal Code
310003
Country
China
Facility Name
Inner Mongolia Autonomous Region People's Hospital
City
Hohhot City
ZIP/Postal Code
010011
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
The 1st Affiliated Hospital of Nanchang Unversity
City
Nanchang City
ZIP/Postal Code
330006
Country
China
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo City
ZIP/Postal Code
315010
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200025
Country
China
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
China Medical University (CMU) First Affiliated Hospital
City
Shenyang City
ZIP/Postal Code
110001
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
ShenYang
ZIP/Postal Code
110004
Country
China
Facility Name
Hebei Medical University - The Second Hospital
City
Shijiazhuang City
ZIP/Postal Code
050004
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
Tangdu Hospital, The Fourth Military Medical University; Neurology Department
City
Xi'an City
ZIP/Postal Code
710038
Country
China
Facility Name
Qinghai Provincial People?s Hospital
City
Xining City
ZIP/Postal Code
810007
Country
China
Facility Name
Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital
City
Zhengzhou City
ZIP/Postal Code
450000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Fakultní Nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Prague
ZIP/Postal Code
180 01
Country
Czechia
Facility Name
Thomayerova nemocnice; Lekarna - pavilon H
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Krajská nemocnice T. Bati, a. s.
City
Zlín
ZIP/Postal Code
762 75
Country
Czechia
Facility Name
Aarhus Universitetshospital Skejby
City
Aarthus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Hopital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hospital d Instructions des Armees Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CHU Dijon Bourgogne Hôpital François Mitterand
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier Regional Universitaire de Lille
City
Lille
Country
France
Facility Name
Servie de Pneumologie et centre de Transplantation Pulmonaire
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Name
CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nice - Hôpital Pasteur 2
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hopital Bichat Claude Bernard; CIC
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
European Hospital Georges Pompidou (HEGP)
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHU de Rennes - Hopital de Pontchaillo
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Tours - Hôpital Bretonneau; Pharmacie
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Zentralklinik Bad Berka GmbH; Pneumologie
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Evang. Lungenklinik Berlin Klinik für Pneumologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitatsklinikum Essen; Innere Klinik
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitatsklinikum Gießen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitatsklinikum Leipzig; Apotheke
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
IKF Pneumologie Mainz Helix Medical Excellence Center Mainz
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Facility Name
Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
City
Münnerstadt
ZIP/Postal Code
97702
Country
Germany
Facility Name
Krankenhaus Bethanien gGmbH
City
Solingen
ZIP/Postal Code
42699
Country
Germany
Facility Name
Evangelismos Hospital; Department of Critical Care and Pulmonary Services
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Herakleion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University Hospital of Ioannina; Pulmonology Department
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Hospital is University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Athens Medical Center
City
Marousi
ZIP/Postal Code
151 25
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
"General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "
City
Sotiria Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General Hospital of Thessaloniki G. Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
City
Hong Kong
Country
Hong Kong
Facility Name
The University of Hong Kong; Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1081
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Szent Borbala Korhaz
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Barzilai Medical Center; Neurology Department
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Shamir medical center
City
Be'er Ya'akov
ZIP/Postal Code
0070300
Country
Israel
Facility Name
Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
City
Beer sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109600
Country
Israel
Facility Name
Bnai Zion Medical Center; Internal Medicine
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Carmel Medical Center; Obstetrics and Gynecology
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center; Nrphrology Dept.
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar- Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tiqwa
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5211401
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center; Department of Pulmonary
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
State/Province
Abruzzo
ZIP/Postal Code
24060
Country
Italy
Facility Name
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Dei Colli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Morgagni Pierantoni; Patologia clinica
City
Forlì
State/Province
Emilia-Romagna
ZIP/Postal Code
47100
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
40124
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Integrata di Trieste
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34125
Country
Italy
Facility Name
Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
City
Rome
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
"Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "
City
Garbagnate Milanese
State/Province
Lombardia
Country
Italy
Facility Name
Ospedale San Giuseppe; U.O. di Pneumologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20123
Country
Italy
Facility Name
Asst Santi Paolo E Carlo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Torrette Di Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Facility Name
A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
City
Orbassano (to)
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10026
Country
Italy
Facility Name
Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Ospedale di Ostuni - Pneumologia
City
Ostuni
State/Province
Puglia
ZIP/Postal Code
72017
Country
Italy
Facility Name
A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedale Università Di Padova; Clinica Pneumologica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31100
Country
Italy
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kameda Medical Center
City
Kamogawa
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Nippon Medical School Musashi Kosugi Hospital
City
Kawasaki-Shi
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto-Shi
ZIP/Postal Code
861-4101
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
City
Naka-gun
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Tosei General Hospital
City
Seto-shi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Tenri Hospital
City
Tenri-Shi
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
City
Tokyo
ZIP/Postal Code
113-0034
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-0052
Country
Japan
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon-si,
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Bucheon St. Mary's Hospital
City
Gyeonggi-do
ZIP/Postal Code
14662
Country
Korea, Republic of
Facility Name
Gacheon University Gil Medical Center
City
Namdong-gu
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
City
Seoul
ZIP/Postal Code
(0)7345
Country
Korea, Republic of
Facility Name
Seoul National University Hospital (SNUH) - Medical Oncology Center
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary?s Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Centro Respiratorio de México
City
Mexico
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Unidad Médica para la Salud Integral UMSI
City
San Nicolás de Los Garza
State/Province
Nuevo LEON
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Unidad de Investigacion CIMA SC
City
Chihuahua
ZIP/Postal Code
31200
Country
Mexico
Facility Name
CICC Morelia
City
Morelia
Country
Mexico
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Sint Antonius Ziekenhuis, locatie Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
NZ Respiratory & Sleep Institute
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
University of Otago, Christchurch
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital; Gastro Research
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Helse Bergen HF Haukeland universitetssykehus
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Facility Name
Akershus universitetssykehus
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo University Hospital HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Centrum Medycyny Oddechowej Mroz sp. j.
City
Bia?ystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-312
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar Algarve
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Hospital Senhora da Oliveira ? Guimarães, E.P.E
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital de Sao Joao; Centro de Investigacao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Hospital de Santa Luzia
City
Porto
ZIP/Postal Code
4904-858
Country
Portugal
Facility Name
CHVNG/E_Unidade 1; Servico de Pneumologia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Tan Tock Seng Hospital; Oncology
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
University of Cape Town Lung Institute; Lung Clinical Research
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Hospital Txagorritxu
City
Vitoria-Gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Parc Taulí Sabadell Hospital Universitari
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario del Henares
City
Coslada
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
S. Cristobal De La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Virgen de las Nieves; Servicio de Neumologia
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Clínica Universidad de Navarra ? Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Ramón y Cajal;Servicio de Neumología
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz.
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Arnau de Vilanova (Valencia)
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Skånes universitetssjukhus Malmö
City
Malmö
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Inselspital Bern Universitätsklinik für Pneumologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)
City
Neuchâtel
ZIP/Postal Code
2000
Country
Switzerland
Facility Name
Buddhist Tzu Chi Dalin General Hospital; Rheumatology
City
Chia-yi
ZIP/Postal Code
622
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
City
Kaoshiung City
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital; Department of Clinical Pathology
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Veterans General Hospital - Taichung
City
Xitun Dist.
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
City
?stanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
City
Adana
ZIP/Postal Code
1330
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi
City
Gaziantep
Country
Turkey
Facility Name
Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul University Faculty of Medicine; Chest Diseases
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Erciyes Üniversitesi T?p Fakültesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Marmara Universitesi Hastanesi Marmara University Hospital
City
Maltepe
ZIP/Postal Code
34854
Country
Turkey
Facility Name
Mersin Üniversitesi Tip Fakültesi
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Facility Name
Akdeniz University Faculty of Medicine Department of Pulmonology
City
Muratpasa/Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
City
Sariyer
ZIP/Postal Code
34450
Country
Turkey
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
City
Dnipro
State/Province
Katerynoslav Governorate
ZIP/Postal Code
49069
Country
Ukraine
Facility Name
National Academy of Medical Science of Ukraine (NAMS); NRCRM
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Yanovskyy Inst of Phth. & Pulm; Clinical-functional
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Edinburgh Royal Infirmary; Respiratory Department
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Royal Brompton Hospital; Respiratory Department
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust - Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
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