Clinical trial NCT04594707: A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Official title: A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Detailed description: This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.

Eligibility criteria: Inclusion Criteria:

* Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria:

* Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
* History of smoking within 3 months prior to the first visit in the OLE.
* History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
* History of severe allergic reaction or anaphylactic reaction to PRM-151.
* Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
* Prolonged corrected QT interval \> 450 ms (for men) or \> 470 ms (for women) based on the Fridericia correction formula.
* Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: From baseline until 8 weeks after the final dose, an average of 6 months
measure: Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest
timeFrame: From baseline until 8 weeks after the final dose, an average of 6 months
measure: Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs
timeFrame: From baseline until 8 weeks after the final dose, an average of 6 months
Secondary outcomes:
measure: Annual Rate of Change in Forced Vital Capacity (FVC) (mL)
timeFrame: From baseline until study completion (up to approximately 1.5 years)
measure: Annual Rate of Change in 6-Minute Walk Distance (6MWD)
timeFrame: From baseline until study completion (up to approximately 1.5 years)
measure: Annual Rate of Change in FVC% Predicted
timeFrame: From baseline until study completion (up to approximately 1.5 years)
measure: Change in Carbon Monoxide Diffusing Capacity (DLCO)
timeFrame: At Baseline, Week 24 and Week 48
measure: Time to Disease Progression
timeFrame: From baseline until study completion (up to approximately 1.5 years)
measure: Survival
timeFrame: Every 6 Months and at study completion (up to approximately 1.5 years)
measure: IPF-related Mortality
timeFrame: Every 6 Months and at study completion (up to approximately 1.5 years)
measure: Respiratory-related Mortality
timeFrame: Every 6 Months and at study completion (up to approximately 1.5 years)
measure: Plasma Concentrations of PRM-151 at Specified Timepoints
timeFrame: Days 1 and 5, Weeks 4, and 12
measure: Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline
timeFrame: Baseline (Day 1)
measure: Percentage of Participants With ADAs During the Study
timeFrame: Weeks 4, 12 and 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Diego
country: United States
facility: Inst. of Healthcare Assessment, Inc.
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Health Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Celebration
country: United States
facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
state: Florida
city: Daytona Beach
country: United States
facility: Advanced Pulmonary & Sleep Research Institute of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Pulmonology - Jacksonville
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota County Public Hospital
state: Florida
city: Wesley Chapel
country: United States
facility: Renstar Medical Research
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics; Investigational Drug Services
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Health Sciences Center
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Greensboro
country: United States
facility: Pulmonix Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonology & Sleep Center
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah Hosp & Clin; Investigational Pharmacy
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundacion Respirar (Centro Medico Dra. De Salvo)
city: Córdoba
country: Argentina
facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
city: Derqui-Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Florida, Buenos Aires
country: Argentina
facility: Centro Medico de Enfermedades Respiratorias (CEMER)
city: Mar Del Plata
country: Argentina
facility: Centro de estudios respiratorios
city: Mendoza, Mendoza City
country: Argentina
facility: INSARES
city: Mendoza
country: Argentina
facility: Fundacion Scherbovsky
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones en Patologias Respiratorias
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Base Hospital; Cancer Care Centre
state: Queensland
city: Nundah
country: Australia
facility: Lung Research Queensland
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Monash Medical Centre; Medicine
state: Victoria
city: Prahan
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Brussels
country: Belgium
facility: ULB Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc; Pharmacy
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: C. H. U. Sart-Tilman; Laboratory
city: Yvoir
country: Belgium
facility: CHU UCL Namur / site Godinne
city: Sherwood Park
country: Canada
facility: Synergy Respiratory Care
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna Respiratory and Allergy Clinic
state: British Columbia
city: Owen Sound
country: Canada
facility: The Rhema Research Institute
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Profession Corporation
state: Ontario
city: Trois-Rivières
country: Canada
facility: C.I.C. Mauricie
state: Quebec
city: Beijing City
country: China
facility: Peking Union Medical College Hospital; Pharmacy
city: Beijing Shi
country: China
facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changsha
country: China
facility: The Third Xiangya Hospital Of Central South University
city: ShenYang
country: China
facility: Shengjing Hospital of China Medical University
city: Shijiazhuang City
country: China
facility: Hebei Medical University - The Second Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice; Lekarna - pavilon H
city: Zlin
country: Czechia
facility: Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Bobigny
country: France
facility: Hopital Avicenne
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
city: Bron
country: France
facility: Hopital Louis Pradel
city: CHU Hopitaux De Bordeaux
country: France
facility: CHU Hopitaux de Bordeaux
city: Dijon
country: France
facility: CHU Dijon Bourgogne Hôpital François Mitterand
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Marseille
country: France
facility: Servie de Pneumologie et centre de Transplantation Pulmonaire
city: Nice
country: France
facility: CHU Nice - Hôpital Pasteur 2
city: Paris
country: France
facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Berlin
country: Germany
facility: Evang. Lungenklinik Berlin Klinik für Pneumologie
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Marburg
country: Germany
facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
city: Münnerstadt
country: Germany
facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
city: Athens
country: Greece
facility: Evangelismos Hospital; Endocrinology, Diabetes & Metabolism
city: Chaidari
country: Greece
facility: Attikon University General Hospital
city: Heraklio
country: Greece
facility: University General Hospital of Heraklion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina; Pulmonology Department
city: Marousi
country: Greece
facility: Athens Medical Center
city: Mezourlo
country: Greece
facility: University of Thessaly Faculty of Medicine
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Sotiria Athens
country: Greece
facility: General hospital of Chest Diseases "Sotiria", 7th Pulmonary Clinic 
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki G. Papanikolaou
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong; Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz
city: Törökbálint
country: Hungary
facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
city: Ashkelon
country: Israel
facility: Barzilai Medical Center; Neurology Department
city: Be'er Ya'akov
country: Israel
facility: Shamir medical center
city: Beer sheva
country: Israel
facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Petach Tiqwa
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center; Department of Neurology
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
state: Abruzzo
city: Napoli
country: Italy
facility: "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
state: Campania
city: Forlì
country: Italy
facility: Ospedale Morgagni Pierantoni; Patologia clinica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: Emilia-Romagna
city: Rome
country: Italy
facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
state: Lazio
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
state: Lazio
city: Milano
country: Italy
facility: Ospedale San Giuseppe; U.O. di Pneumologia
state: Lombardia
city: Milano
country: Italy
facility: Asst Santi Paolo E Carlo
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
state: Lombardia
city: Foggia
country: Italy
facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
state: Puglia
city: Sassari
country: Italy
facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
state: Sardegna
city: Catania
country: Italy
facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
state: Sicilia
city: Palermo
country: Italy
facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
state: Sicilia
city: Palermo
country: Italy
facility: Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
state: Sicilia
city: Firenze
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
state: Toscana
city: Siena
country: Italy
facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1
state: Veneto
city: Treviso
country: Italy
facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
state: Veneto
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Kamogawa
country: Japan
facility: Kameda Medical Center
city: Kanagawa
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Kawasaki-Shi
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital
city: Kumamoto-Shi
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Sakai-shi
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Seto-shi
country: Japan
facility: Tosei General Hospital
city: Tenri-Shi
country: Japan
facility: Tenri Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital
city: Namdong-gu
country: Korea, Republic of
facility: Gacheon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (SNUH) - Medical Oncology Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
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: Korea University Guro Hospital
city: Ciudad de México
country: Mexico
facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
state: Mexico CITY (federal District)
city: Mexico
country: Mexico
facility: Centro Respiratorio de México
state: Mexico CITY (federal District)
city: San Nicolás de Los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral UMSI
state: Nuevo LEON
city: Chihuahua
country: Mexico
facility: Unidad de Investigacion CIMA SC
city: Morelia
country: Mexico
facility: CICC Morelia
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis, locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: NZ Respiratory & Sleep Institute
city: Christchurch
country: New Zealand
facility: University of Otago, Christchurch
city: Hamilton
country: New Zealand
facility: Waikato Hospital; Gastro Research
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital HF, Rikshospitalet
city: Bia?ystok
country: Poland
facility: Centrum Medycyny Oddechowej Mroz sp. j.
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Braga
country: Portugal
facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
city: Guimarães
country: Portugal
facility: Centro Hospitalar do Alto Ave; EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
city: Vila Nova de Gaia
country: Portugal
facility: CHVNG/E_Unidade 1; Servico de Pneumologia
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital; Oncology
city: Cape Town
country: South Africa
facility: University of Cape Town Lung Institute; Lung Clinical Research
city: Somerset West
country: South Africa
facility: Vergelegen Medi-Clinic
city: Vitoria
country: Spain
facility: HUA - Txagorritxu
state: Alava
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí; Servicio de Neurología
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: CHUS H Clinico U de Santiago
state: LA Coruña
city: Coslada
country: Spain
facility: Hospital Universitario del Henares
state: Madrid
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves; Servicio de Neumologia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa; Servicio de Aparato Digestivo
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra ; Servicio de Farmacia
city: Madrid
country: Spain
facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal;Servicio de Neumología
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz-UTE
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Chia-yi
country: Taiwan
facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology
city: Kaoshiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital; Department of Clinical Pathology
city: Xitun Dist.
country: Taiwan
facility: Veterans General Hospital - Taichung
city: ?stanbul
country: Turkey
facility: Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
city: Adana
country: Turkey
facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine; Chest Diseases
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Maltepe
country: Turkey
facility: Marmara Universitesi Hastanesi Marmara University Hospital
city: Melikgazi/Kayser
country: Turkey
facility: Eriyes universitesi T?p Fakultesi Hastanesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
city: Muratpasa/Antalya
country: Turkey
facility: Akdeniz University Faculty of Medicine Department of Pulmonology
city: Sariyer
country: Turkey
facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: