Study Stopped
The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.
A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
STARSCAPE-OLE
A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
2 other identifiers
interventional
117
28 countries
248
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2021
248 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedStudy Start
First participant enrolled
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2023
CompletedResults Posted
Study results publicly available
May 16, 2024
CompletedMay 16, 2024
May 1, 2024
1.4 years
October 15, 2020
February 2, 2024
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0.
From baseline until 8 weeks after the final dose, an average of 6 months
Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest
IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion.
From baseline until 8 weeks after the final dose, an average of 6 months
Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs
From baseline until 8 weeks after the final dose, an average of 6 months
Secondary Outcomes (11)
Annual Rate of Change in Forced Vital Capacity (FVC) (mL)
From baseline until study completion (up to approximately 1.5 years)
Annual Rate of Change in 6-Minute Walk Distance (6MWD)
From baseline until study completion (up to approximately 1.5 years)
Annual Rate of Change in FVC% Predicted
From baseline until study completion (up to approximately 1.5 years)
Change in Carbon Monoxide Diffusing Capacity (DLCO)
At Baseline, Week 24 and Week 48
Time to Disease Progression
From baseline until study completion (up to approximately 1.5 years)
- +6 more secondary outcomes
Study Arms (1)
Zinpentraxin Alfa
EXPERIMENTALCorhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.
Interventions
Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks. Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (248)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California Davis
Sacramento, California, 95817, United States
Inst. of Healthcare Assessment, Inc.
San Diego, California, 92120, United States
UCSF Medical Center
San Francisco, California, 94143-0748, United States
National Jewish Health Medical Center
Denver, Colorado, 80045-2541, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Meris Clinical Research
Brandon, Florida, 33511-5719, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
Celebration, Florida, 34747-1818, United States
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, 32117, United States
University of Florida Health Pulmonology - Jacksonville
Jacksonville, Florida, 32209, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470-9216, United States
Sarasota County Public Hospital
Sarasota, Florida, 34239, United States
Renstar Medical Research
Wesley Chapel, Florida, 33544, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
University of Iowa Hospitals and Clinics; Investigational Drug Services
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 29425-8911, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
The Lung Research Center
Chesterfield, Missouri, 63017-3625, United States
Washington University
St Louis, Missouri, 63128, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-0600, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Pulmonix Research
Greensboro, North Carolina, 27403-1127, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Jefferson University Physicians (JUP) - Jefferson Pulmonary
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201-2953, United States
Lowcountry Lung and Critical Care
North Charleston, South Carolina, 29406, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069, United States
University Of Utah Hosp & Clin; Investigational Pharmacy
Salt Lake City, Utah, 84132, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22031, United States
Virginia Commonwealth University
Richmond, Virginia, 23219-1901, United States
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Fundacion Respirar (Centro Medico Dra. De Salvo)
Ciudad Autonoma Buenos Aires, C1426ABP, Argentina
Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
Córdoba, X5003DCE, Argentina
Hospital Universitario Austral
Derqui-Pilar, B1629ODT, Argentina
Centro Medico de Enfermedades Respiratorias (CEMER)
Florida, Buenos Aires, B1602DQD, Argentina
Centro de estudios respiratorios
Mar del Plata, B7600CLK, Argentina
Fundacion Scherbovsky
Mendoza, M5500AYB, Argentina
INSARES
Mendoza, Mendoza City, M5500CCG, Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, S2000DEJ, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Cairns Base Hospital; Cancer Care Centre
Cairns, Queensland, 4870, Australia
Lung Research Queensland
Nundah, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Monash Medical Centre; Medicine
Melbourne, Victoria, 3186, Australia
The Alfred Hospital
Prahan, Victoria, 3181, Australia
ULB Hôpital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc; Pharmacy
Brussels, 1200, Belgium
UZ Leuven
Leuven, 3000, Belgium
C. H. U. Sart-Tilman; Laboratory
Liège, 4000, Belgium
CHU UCL Namur / site Godinne
Yvoir, B5530, Belgium
Synergy Respiratory Care
Sherwood Park, Alberta, T8H ON2, Canada
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, V1W 1V3, Canada
The Rhema Research Institute
Owen Sound, Ontario, N4K 6M9, Canada
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 1T3, Canada
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, 100050, China
Peking Union Medical College Hospital; Pharmacy
Beijing, 100730, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
The Third Xiangya Hospital Of Central South University
Changsha, 410013, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Hebei Medical University - The Second Hospital
Shijiazhuang, 050004, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030, China
Wuxi People's Hospital
Wuxi, 214023, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Fakultni nemocnice Brno
Brno, 613 00, Czechia
Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie
Hradec Králové, 500 05, Czechia
Thomayerova nemocnice; Lekarna - pavilon H
Prague, 140 00, Czechia
Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni
Zlín, 760 01, Czechia
Gentofte Hospital
Hellerup, 2900, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Hopital Avicenne
Bobigny, 93000, France
Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
Brest, 29200, France
Hopital Louis Pradel
Bron, 69677, France
CHU Hopitaux de Bordeaux
CHU Hopitaux de Bordeaux, 33000, France
CHU Dijon Bourgogne Hôpital François Mitterand
Dijon, 21000, France
CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
La Tronche, 38700, France
Centre Hospitalier Regional Universitaire de Lille
Lille, France
Servie de Pneumologie et centre de Transplantation Pulmonaire
Marseille, 13354, France
CHU Nice - Hôpital Pasteur 2
Nice, 06000, France
Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
Paris, 75018, France
Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
Reims, 51092, France
Centre Hospitalier Universitaire de Rennes
Rennes, 35033, France
CHU Tours - Hôpital Bretonneau
Tours, 37044, France
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, 13125, Germany
Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
Heidelberg, 69126, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
Marburg, 35037, Germany
Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702, Germany
Krankenhaus Bethanien gGmbH
Solingen, 42699, Germany
Evangelismos Hospital; Endocrinology, Diabetes & Metabolism
Athens, 10676, Greece
Attikon University General Hospital
Chaïdári, 124 62, Greece
University General Hospital of Heraklion
Heraklio, 711 10, Greece
University Hospital of Ioannina; Pulmonology Department
Ioannina, 455 00, Greece
Athens Medical Center
Marousi, 151 25, Greece
University of Thessaly Faculty of Medicine
Mezourlo, 41110, Greece
University General Hospital of Patras
Pátrai, 265 00, Greece
"General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "
Sotiria Athens, 115 27, Greece
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki, 57010, Greece
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
Hong Kong, Hong Kong
The University of Hong Kong; Queen Mary Hospital
Hong Kong, Hong Kong
Semmelweis University
Budapest, 1081, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
Szombathely, 9700, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
Törökbálint, 2045, Hungary
Barzilai Medical Center; Neurology Department
Ashkelon, 7830604, Israel
Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
Beersheba, 8410101, Israel
Shamir medical center
Be’er Ya‘aqov, 0070300, Israel
Rambam Health Care Campus
Haifa, 3109600, Israel
Edith Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9112000, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petach Tiqwa, 4941492, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5211401, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, 6423906, Israel
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Abruzzo, 24060, Italy
Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
Foggia, Apulia, 71122, Italy
"AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "
Napoli, Campania, 80131, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
Ospedale Morgagni Pierantoni; Patologia clinica
Forlì, Emilia-Romagna, 47100, Italy
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, 40124, Italy
Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
Rome, Lazio, 00133, Italy
Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
Rome, Lazio, 00168, Italy
Ospedale San Giuseppe; U.O. di Pneumologia
Milan, Lombardy, 20123, Italy
Asst Santi Paolo E Carlo
Milan, Lombardy, 20142, Italy
Ospedale San Gerardo
Monza, Lombardy, 20900, Italy
Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
Pavia, Lombardy, 27100, Italy
A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
Sassari, Sardinia, 07100, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, 95123, Italy
Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
Palermo, Sicily, 90127, Italy
Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
Palermo, Sicily, 90127, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Florence, Tuscany, 50134, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
Siena, Tuscany, 53100, Italy
Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1
Padua, Veneto, 35128, Italy
University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
Treviso, Veneto, 31100, Italy
Nagoya University Hospital
Aichi, 466-8560, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kobe City Medical Center General Hospital
Hyōgo, 650-0047, Japan
National Hospital Organization Himeji Medical Center
Hyōgo, 670-8520, Japan
Kameda Medical Center
Kamogawa, 296-0041, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, 236-0051, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasaki-Shi, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 861-4101, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
Naka-gun, 319-1113, Japan
Kurashiki Central Hospital
Okayama, 710-8602, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555, Japan
Tosei General Hospital
Seto-shi, 489-8642, Japan
Tenri Hospital
Tenri-Shi, 632-8552, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
Tokyo, 113-0034, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-0052, Japan
INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
Mexico City, Mexico CITY (federal District), 14080, Mexico
Centro Respiratorio de México
México, Mexico CITY (federal District), 14050, Mexico
Unidad Médica para la Salud Integral UMSI
San Nicolás de los Garza, Nuevo León, 66465, Mexico
Unidad de Investigacion CIMA SC
Chihuahua City, 31200, Mexico
CICC Morelia
Morelia, Mexico
Sint Antonius Ziekenhuis, locatie Nieuwegein
Nieuwegein, 3430 EM, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3000 CA, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
NZ Respiratory & Sleep Institute
Auckland, 1051, New Zealand
University of Otago, Christchurch
Christchurch, 8011, New Zealand
Waikato Hospital; Gastro Research
Hamilton, 3240, New Zealand
Tauranga Hospital
Tauranga, 3143, New Zealand
Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen
Bergen, 5021, Norway
Akershus universitetssykehus
Lørenskog, 1478, Norway
Oslo University Hospital HF, Rikshospitalet
Oslo, 0424, Norway
Centrum Medycyny Oddechowej Mroz sp. j.
Bia?ystok, 15-044, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-312, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
Braga, 4710-243, Portugal
Centro Hospitalar do Alto Ave; EPE
Guimarães, 4835-044, Portugal
Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
CHVNG/E_Unidade 1; Servico de Pneumologia
Vila Nova de Gaia, 4434-502, Portugal
National University Hospital
Singapore, 117599, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital; Oncology
Singapore, 308433, Singapore
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, 7700, South Africa
Vergelegen Medi-Clinic
Somerset West, 7130, South Africa
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do, 14662, South Korea
Gacheon University Gil Medical Center
Namdong-gu, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
Seoul, (0)7345, South Korea
Seoul National University Hospital (SNUH) - Medical Oncology Center
Seoul, 03080, South Korea
Soonchunhyang University Hospital
Seoul, 04401, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
HUA - Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Corporació Sanitaria Parc Taulí; Servicio de Neurología
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
CHUS H Clinico U de Santiago
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Universitario del Henares
Coslada, Madrid, 28850, Spain
Hospital Univ. Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, 48960, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
Barcelona, 08025, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Virgen de las Nieves; Servicio de Neumologia
Granada, 18014, Spain
Hospital Universitario de la Princesa; Servicio de Aparato Digestivo
Madrid, 28006, Spain
Clinica Universidad de Navarra ; Servicio de Farmacia
Madrid, 28027, Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
Madrid, 28029, Spain
Hospital Ramón y Cajal;Servicio de Neumología
Madrid, 28034, Spain
Fundacion Jimenez Diaz-UTE
Madrid, 28040, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Buddhist Tzu Chi Dalin General Hospital; Rheumatology
Chiayi City, 622, Taiwan
Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
Kaoshiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70457, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Far Eastern Memorial Hospital; Department of Clinical Pathology
Taipei, 220, Taiwan
Veterans General Hospital - Taichung
Xitun Dist., 40705, Taiwan
Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
?stanbul, 34093, Turkey (Türkiye)
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
Adana, 1330, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
Ankara, 06620, Turkey (Türkiye)
Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
Bursa, 16059, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi
Gaziantep, 27310, Turkey (Türkiye)
Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
Istanbul, 34020, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine; Chest Diseases
Izmir, 35340, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Marmara Universitesi Hastanesi Marmara University Hospital
Maltepe, 34854, Turkey (Türkiye)
Eriyes universitesi T?p Fakultesi Hastanesi
Melikgazi/Kayser, 38039, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
Mersin, 33110, Turkey (Türkiye)
Akdeniz University Faculty of Medicine Department of Pulmonology
Muratpasa/Antalya, 07059, Turkey (Türkiye)
Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
Sarıyer, 34450, Turkey (Türkiye)
Related Publications (1)
Mantovani A, Garlanda C. Humoral Innate Immunity and Acute-Phase Proteins. N Engl J Med. 2023 Feb 2;388(5):439-452. doi: 10.1056/NEJMra2206346. No abstract available.
PMID: 36724330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early due to the Sponsor's decision to terminate the parent study early.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 20, 2020
Study Start
August 30, 2021
Primary Completion
February 10, 2023
Study Completion
February 10, 2023
Last Updated
May 16, 2024
Results First Posted
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
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).