acronym: INBUILD®

lead_sponsor: Boehringer Ingelheim

summary: The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.

ReferenceCitation: Ogura T, Suda T, Inase N, Nishioka Y, Azuma A, Okamoto M, Takizawa A, Ito T, Rohr KB, Inoue Y. Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases: Further subset analysis from the whole INBUILD trial. Respir Investig. 2022 Nov;60(6):787-797. doi: 10.1016/j.resinv.2022.06.009. Epub 2022 Aug 1.

ReferenceCitation: Cottin V, Martinez FJ, Jenkins RG, Belperio JA, Kitamura H, Molina-Molina M, Tschoepe I, Coeck C, Lievens D, Costabel U. Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. Respir Res. 2022 Apr 7;23(1):85. doi: 10.1186/s12931-022-01974-2.

oa_colors: green gold

evidence: oa journal (via doaj)

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Swigris JJ, Bushnell DM, Rohr K, Mueller H, Baldwin M, Inoue Y. Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases. BMJ Open Respir Res. 2022 Mar;9(1):e001167. doi: 10.1136/bmjresp-2021-001167.

ReferenceCitation: Inoue Y, Suda T, Kitamura H, Okamoto M, Azuma A, Inase N, Kuwana M, Makino S, Nishioka Y, Ogura T, Takizawa A, Ugai H, Stowasser S, Schlenker-Herceg R, Takeuchi T. Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial. Respir Med. 2021 Oct;187:106574. doi: 10.1016/j.rmed.2021.106574. Epub 2021 Aug 12.

ReferenceCitation: Flaherty KR, Wells AU, Cottin V, Devaraj A, Inoue Y, Richeldi L, Walsh SLF, Kolb M, Koschel D, Moua T, Stowasser S, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial. Eur Respir J. 2022 Mar 17;59(3):2004538. doi: 10.1183/13993003.04538-2020. Print 2022 Mar.

publisher_dissemination: European Respiratory Society

ReferenceCitation: Maher TM, Brown KK, Kreuter M, Devaraj A, Walsh SLF, Lancaster LH, Belloli EA, Padilla M, Behr J, Goeldner RG, Tetzlaff K, Schlenker-Herceg R, Flaherty KR; INBUILD trial investigators. Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. Eur Respir J. 2022 Feb 3;59(2):2004587. doi: 10.1183/13993003.04587-2020. Print 2022 Feb.

repository_institution: Imperial College London - Spiral

ReferenceCitation: Cottin V, Richeldi L, Rosas I, Otaola M, Song JW, Tomassetti S, Wijsenbeek M, Schmitz M, Coeck C, Stowasser S, Schlenker-Herceg R, Kolb M; INBUILD Trial Investigators. Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Respir Res. 2021 Mar 16;22(1):84. doi: 10.1186/s12931-021-01668-1.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Wells AU, Flaherty KR, Brown KK, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts WA, Stowasser S, Quaresma M, Goeldner RG, Schlenker-Herceg R, Kolb M; INBUILD trial investigators. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020 May;8(5):453-460. doi: 10.1016/S2213-2600(20)30036-9. Epub 2020 Mar 5.

ReferenceCitation: Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.

ReferenceCitation: Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg R. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017.

repository_institution: California Digital Library - eScholarship

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: University of Utah Health Sciences Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA

location_facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

location_facility: University of Texas Southwestern Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The Catholic University of Korea, Bucheon St.Mary's Hospital

location_facility: Scientific Research Institute of Pulmonology

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: Pulmonology Scientific Research Institute

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: University of Florida College of Medicine

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Seoul National University Bundang Hospital

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: University of Maryland School of Medicine

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: The First Hospital of Chinese Medical University

title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Japan
Belgium
United States
China
Korea, Republic of
Spain
Chile
Canada
Russian Federation
France


study_start_date_type: Actual

intervention_type: Drug

acronym: PROfound

lead_sponsor: AstraZeneca

summary: The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

ReferenceType: derived

ReferenceCitation: Roubaud G, Ozguroglu M, Penel N, Matsubara N, Mehra N, Kolinsky MP, Procopio G, Feyerabend S, Joung JY, Gravis G, Nishimura K, Gedye C, Padua C, Shore N, Thiery-Vuillemin A, Saad F, van Alphen R, Carducci MA, Desai C, Brickel N, Poehlein C, Del Rosario P, Fizazi K. Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study. Eur J Cancer. 2022 Jul;170:73-84. doi: 10.1016/j.ejca.2022.04.016. Epub 2022 May 19.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

host_type: repository

repository_institution: Radboud University - Radboud Repository

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Matsubara N, Nishimura K, Kawakami S, Joung JY, Uemura H, Goto T, Kwon TG, Sugimoto M, Kato M, Wang SS, Pang ST, Chen CH, Fujita T, Nii M, Shen L, Dujka M, Hussain M, de Bono J. Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis. Jpn J Clin Oncol. 2022 May 5;52(5):441-448. doi: 10.1093/jjco/hyac015.

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. doi: 10.1016/S1470-2045(22)00017-1. Epub 2022 Feb 11. Erratum In: Lancet Oncol. 2022 Apr;23(4):e161.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Hussain M, Corcoran C, Sibilla C, Fizazi K, Saad F, Shore N, Sandhu S, Mateo J, Olmos D, Mehra N, Kolinsky MP, Roubaud G, Ozguroglu M, Matsubara N, Gedye C, Choi YD, Padua C, Kohlmann A, Huisden R, Elvin JA, Kang J, Adelman CA, Allen A, Poehlein C, de Bono J. Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib). Clin Cancer Res. 2022 Apr 14;28(8):1518-1530. doi: 10.1158/1078-0432.CCR-21-3940.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Ozguroglu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. doi: 10.1056/NEJMoa2022485. Epub 2020 Sep 20.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28.

sponsor_collaborators:
AstraZeneca
Merck Sharp & Dohme LLC
Foundation Medicine, Inc.
Myriad Genetics, Inc.

title: A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Denmark
United States
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel


type: EudraCT Number

title: Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation

summary:
When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.

Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters.

Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Van Mieghem NM, Unverdorben M, Hengstenberg C, Mollmann H, Mehran R, Lopez-Otero D, Nombela-Franco L, Moreno R, Nordbeck P, Thiele H, Lang I, Zamorano JL, Shawl F, Yamamoto M, Watanabe Y, Hayashida K, Hambrecht R, Meincke F, Vranckx P, Jin J, Boersma E, Rodes-Cabau J, Ohlmann P, Capranzano P, Kim HS, Pilgrim T, Anderson R, Baber U, Duggal A, Laeis P, Lanz H, Chen C, Valgimigli M, Veltkamp R, Saito S, Dangas GD; ENVISAGE-TAVI AF Investigators. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med. 2021 Dec 2;385(23):2150-2160. doi: 10.1056/NEJMoa2111016. Epub 2021 Aug 28.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Giacoppo D. Anticoagulation After Transcatheter Aortic Valve Replacement: Evolving Answers and Still Unaddressed Questions. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1714-1716. doi: 10.1016/j.jcin.2021.06.004. Epub 2021 Jul 14. No abstract available. Erratum In: JACC Cardiovasc Interv. 2021 Oct 25;14(20):2311-2313.

ReferenceCitation: Van Mieghem NM, Unverdorben M, Valgimigli M, Mehran R, Boersma E, Baber U, Hengstenberg C, Shi M, Chen C, Saito S, Veltkamp R, Vranckx P, Dangas GD. Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018 Nov;205:63-69. doi: 10.1016/j.ahj.2018.07.006. Epub 2018 Aug 29.

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

sponsor_collaborators:
Daiichi Sankyo, Inc.
Chiltern International Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Canada
France

location_facility: Universitatsmedizin Mainz, Zentrum fur Kardiologie

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica

location_facility: University of California - San Francisco

location_facility: Asklepios St. Georg Abteilung fuer Kardiologie

location_facility: Clinique du Millenaire Service de Cardiologie Interventionelle

location_facility: University Hospitals of Leicester NHS Trust

location_facility: ASST Ovest Milanese - Presidio Ospedallero di Legnana

location_facility: ASST Spedali Civili di Brescia-UO Cardiologia

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: University of Arizona Sarver Heart Center

location_facility: Universitaetsklinik Schleswig-Holstein Campus Kiel

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Complexo Hospitalario Universitario de A Coruna

location_facility: Azienda Socio Sanitaria Territoriale di Lecco

location_facility: ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen

location_facility: Providence Sacred Heart Medical Research Center

location_facility: University Hospital of Wales, Heath Park

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Michigan Heart, St. Joseph Mercy Health System

location_facility: Universitätsklinik für Innere Medizin II

location_facility: NY Presbyterian - Brooklyn Methodist Hospital

location_facility: Complexo hospitalario universitario de Santiago de Compostela

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: Hospital General Universitario de Alicante

location_facility: Newmarket Cardiac Surgery Research Incorporated

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Universitatsklinikum Essen, Klinik fur Kardiologie

location_facility: Penn State Health, Milton S. Hershey Medical Center

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: A.A Dei Colli Monaldi UOC Cardiologia Interventistica

location_facility: Oxford University Hospitals, John Radcliffe Hospital

location_facility: Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Universitaetsklinik fuer Innere Medizin III

location_facility: AOU Careggi, Interventistica Cardiologica Strutturale

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Heart Center Dresden, University Clinic Technical University Dresden

location_facility: University of Iowa Hospitals and Clinics

location_facility: Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

location_facility: University of Texas Health Science Center Houston

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: Doylestown Health Cardiothoracic Surgery

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Shire

summary:
This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir.

Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it.

After treatment, each participant will be followed up for up to 12 weeks.

Participants will visit their study clinic up to 18 times during the study.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: ICO l'Hospitalet Hospital Duran i Reynals

location_facility: Xiangya Hospital Central South University

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: MTZ Clinical Research Sp z o o - PRATIA - PPDS

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Southampton University Hospitals NHS Trust

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Nanfang Hospital Southern Medical University

location_facility: Kirov Research Institute of Haematology and Blood Transfusion

location_facility: VA Puget Sound Health Care System - NAVREF - PPDS

location_facility: First St. Petersburg State Medical University n.a. I.P Pavlov

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Maryland School of Medicine

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Joan and sandford I. Weill Medical College of Cornell University Clinic

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Ospedale Infantile Regina Margherita - INCIPIT - PIN

location_facility: Martin Luther Universitat Halle Wittenberg

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

location_facility: Saint Davids South Austin Medical Center

title: A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

source: euctr

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Poland
New Zealand
Australia
Turkey
Croatia
Czechia
Canada
France
Hungary
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

acronym: EMINENT

summary: The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Goueffic Y, Torsello G, Zeller T, Esposito G, Vermassen F, Hausegger KA, Tepe G, Thieme M, Gschwandtner M, Kahlberg A, Schindewolf M, Sapoval M, Diaz-Cartelle J, Stavroulakis K; EMINENT Investigators. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Circulation. 2022 Nov 22;146(21):1564-1576. doi: 10.1161/CIRCULATIONAHA.122.059606. Epub 2022 Oct 18.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Bern - Bern Open Repository and Information System

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Ireland
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: University Medical Center of Johannes Gutenberg-Mainz

location_facility: Klinikum Nordoberpfalz AG, Klinikum Weiden

location_facility: Manchester University NHS Foundation Trust

location_facility: University Hospital Schleswig-Holstein Campus Kiel

location_facility: Krankenhäuser Landkreis Freudenstadt GmbH

intervention_type: Device

status_simplified: Ongoing


title: A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

summary: The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.

ReferenceCitation: Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O'Connor T, Previtali A, Rose S, Garcia-Manero G. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes. Blood Adv. 2022 Apr 12;6(7):2207-2218. doi: 10.1182/bloodadvances.2021005487.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Hellmann A, Taussig DC, Tormo M, Voso MT, Cavenagh J, O'Connor T, Previtali A, Rose S, Silverman LR. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML. Blood Adv. 2022 Apr 12;6(7):2219-2229. doi: 10.1182/bloodadvances.2021006138.

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Policlinico Agostino Gemelli - Istituto di Ematologia

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Centre Hospitalier Universitaire d' Angers

location_facility: Complejo Hospitalario San Pedro de Alcantara

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Ipo Instituto Portugues De Oncologia Porto

location_facility: Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Medizinische Hochschule HannoverZentrum Innere Medizin

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW

location_facility: Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku

location_facility: Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: I.R.C.C.S. Policlinico San Matteo - Universita di Pavia

location_facility: Cliniques Universitaires UCL de Mont-Godine


title: An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: CheckMate 651

summary: The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

ReferenceCitation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available. Erratum In: Lancet Oncol. 2021 Apr;22(4):e134.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Japan
Austria
Mexico
Switzerland
United States
Korea, Republic of
Spain
Greece
Taiwan
France

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Azienda Ospedaliera Universitaria Di Modena

location_facility: Istituto Nazionale Tumori Fondazione Pascale


title: A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia

acronym: FUSION NHL 001

summary: This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
United States
France

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Southampton University Hospitals NHS Trust

location_facility: Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine

location_facility: Medizinische Klinik III Klinikum der UniversitÃ¤t MÃ¼nchen-GroÃŸhadern

location_facility: Shands Cancer Center University of Florida

location_facility: Washington University School of Medicine

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Nottingham University Hospitals NHS Trust


lead_sponsor: Eisai Inc.

summary: This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

ReferenceCitation: Brose MS, Panaseykin Y, Konda B, de la Fouchardiere C, Hughes BGM, Gianoukakis AG, Joo Park Y, Romanov I, Krzyzanowska MK, Leboulleux S, Binder TA, Dutcus C, Xie R, Taylor MH. A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2022 Feb 17;107(3):776-787. doi: 10.1210/clinem/dgab731.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Oxford - Oxford Academix

repositories_concat: PubMed Central;jdc.jefferson.edu

publisher_dissemination: The Endocrine Society

sponsor_collaborators:
Eisai Inc.
Merck Sharp & Dohme LLC

location_facility:
Facility #1
Royal Brisbane and Women's Hospital
Facility #5
Facility #3
Facility #2
Facility #4
Facility#2
Facility#1
Facility #7
Facility #6

title: A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Romania
Sweden
Belgium
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

ReferenceType: background

ReferenceCitation: Ocran-Appiah J, Boutry C, Herve C, Soni J, Schuind A; ZOSTER-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2021 Jan 3;39(1):6-10. doi: 10.1016/j.vaccine.2020.10.029. Epub 2020 Dec 1.

title: Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

primary_purpose: Prevention

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

location_country:
Finland
Germany
Italy
United Kingdom
Hong Kong
Australia
Brazil
Japan
Mexico
Sweden
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Estonia
France


type: Registry Identifier

title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

acronym: QuANTUM-First

summary:
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

ReferenceCitation: Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

version: acceptedVersion

repositories_concat: PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

unpaywall_oa_status: green

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Croatia
Czechia
Canada
Serbia
France
Portugal
Hungary
Hong Kong
United States
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

location_facility: Franciscan St. Francis Health Indianapolis

location_facility: Complejo Hospitalario Universitario Granada

location_facility: Hospital Universitari Joan XXIII de Tarragona

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: Nizhny Novgorod Regional Clinical Hospital

location_facility: Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: The General Hospital of People's Liberation Army (301 Hospital)

location_facility: University of Florida (UF) Health Shands Hospital

location_facility: ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Kameda Medical Center - Kameda General Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Hospital Clínico Universitario "Lozano Blesa"

location_facility: Tang Du Hospital, Fourth Military Medical University

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Fujian Medical University Union Hospital

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Instituto Português Oncologia do Porto Francisco Gentil, EPE

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Saratov State Medical University named after V.I. Razumovsky

location_facility: Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Centre Henri Becquerel - Centre de Lutte Contre le Cancer

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD

location_facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Instituto do Cancer do Estado de São Paulo

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Daegu Catholic University Medical Center

location_facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: The University of Chicago Medical Center

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

location_facility: Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Centro Hospitalar de São João, EPE - Hospital de São João

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Complejo Hospitalario Universitario de Albacete - Hospital General Universitario

location_facility: Hospital of the University of Pennsylvania

location_facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)

location_facility: University Hospitals Seidman Cancer Center

location_facility: West Virginia University Hospitals, Inc.

location_facility: Almazov Federal North-West Medical Research Centre

location_facility: Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo

location_facility: National University Hospital (S) Pte Ltd

location_facility: NY Medical College - Hudson Valley Hematology Oncology Associates

location_facility: University of Kentucky Chandler Medical Center


type: Other Identifier

title: Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort

acronym: PsaBio

summary: The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Gossec L, Siebert S, Bergmans P, de Vlam K, Gremese E, Joven-Ibanez B, Korotaeva TV, Lavie F, Noel W, Nurmohamed MT, Sfikakis PP, Theander E, Smolen JS. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study. Ann Rheum Dis. 2022 Jun;81(6):823-830. doi: 10.1136/annrheumdis-2021-221640. Epub 2022 Feb 24.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
eprints.gla.ac.uk

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;eprints.gla.ac.uk

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: British Medical Journal

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
United Kingdom
Netherlands
Belgium
Spain
Greece
Russian Federation
France


acronym:
Nintedanib in SSc-ILD

 Nindedanib dans la SSc-ILD

summary: Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

ReferenceCitation: Denton CP, Goh NS, Humphries SM, Maher TM, Spiera R, Devaraj A, Ho L, Stock C, Erhardt E, Alves M, Wells AU. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. Rheumatology (Oxford). 2023 May 2;62(5):1870-1876. doi: 10.1093/rheumatology/keac535.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;spiral.imperial.ac.uk

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Maher TM, Bourdin A, Volkmann ER, Vettori S, Distler JHW, Alves M, Stock C, Distler O. Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects. Respir Res. 2022 Jul 5;23(1):178. doi: 10.1186/s12931-022-02095-6.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

publisher_dissemination: Springer-Nature

ReferenceCitation: Kreuter M, Hoffmann-Vold AM, Matucci-Cerinic M, Saketkoo LA, Highland KB, Wilson H, Alves M, Erhardt E, Schoof N, Maher TM. Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). 2023 Feb 6;62(SI):SI43-SI53. doi: 10.1093/rheumatology/keac325.

repositories_concat: PubMed Central;spiral.imperial.ac.uk

ReferenceCitation: Volkmann ER, Kreuter M, Hoffmann-Vold AM, Wijsenbeek M, Smith V, Khanna D, Denton CP, Wuyts WA, Miede C, Alves M, Sambevski S, Allanore Y. Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091.

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery
pure.eur.nl

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery;pure.eur.nl

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Kreuter M, Del Galdo F, Miede C, Khanna D, Wuyts WA, Hummers LK, Alves M, Schoof N, Stock C, Allanore Y. Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis. Arthritis Res Ther. 2022 Jan 10;24(1):19. doi: 10.1186/s13075-021-02710-9.

repositories:
LIRIAS (KU Leuven)
PubMed Central
Research Square
deepblue.lib.umich.edu

repositories_concat: LIRIAS (KU Leuven);PubMed Central;Research Square;deepblue.lib.umich.edu

repositories_institution:
KU Leuven - Lirias
Research Square - Research Square
University of Michigan - Deep Blue

ReferenceCitation: Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

ReferenceCitation: Roennow A, Sauve M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houyez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473.

ReferenceCitation: Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19.

ReferenceCitation: Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.

ReferenceCitation: Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Kantonspital St. Gallen, Rheumatologie Department

location_facility: University of Utah Health Sciences Center

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: University of Texas Southwestern Medical Center

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: National Hospital Organization Himeji Medical Center

location_facility: University of Minnesota Masonic Cancer Center

location_facility: B.J. Medical College and Sasoon General Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: University of Florida College of Medicine

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: Washington University School of Medicine

location_facility: Azienda Universitaria-Universita' La Sapienza

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: EMED, Center of Medical Services,Private Prac,Rzeszow

location_facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Postgraduate Institute of Medical Education And Research

location_facility: Semmelweis University, Dept. Pulmonology

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: The First Hospital of Chinese Medical University

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
India
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Israel


acronym: NAVIGATE

lead_sponsor: Bayer

summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

ReferenceCitation: Waguespack SG, Drilon A, Lin JJ, Brose MS, McDermott R, Almubarak M, Bauman J, Casanova M, Krishnamurthy A, Kummar S, Leyvraz S, Oh DY, Park K, Sohal D, Sherman E, Norenberg R, Silvertown JD, Brega N, Hong DS, Cabanillas ME. Efficacy and safety of larotrectinib in patients with TRK fusion-positive thyroid carcinoma. Eur J Endocrinol. 2022 Apr 29;186(6):631-643. doi: 10.1530/EJE-21-1259.

ReferenceCitation: Le X, Baik C, Bauman J, Gilbert J, Brose MS, Grilley-Olson JE, Patil T, McDermott R, Raez LE, Johnson JM, Shen L, Tahara M, Ho AL, Norenberg R, Dima L, Brega N, Drilon A, Hong DS. Larotrectinib Treatment for Patients With TRK Fusion-Positive Salivary Gland Cancers. Oncologist. 2022 May 10:oyac080. doi: 10.1093/oncolo/oyac080. Online ahead of print.

ReferenceCitation: Drilon A, Tan DSW, Lassen UN, Leyvraz S, Liu Y, Patel JD, Rosen L, Solomon B, Norenberg R, Dima L, Brega N, Shen L, Moreno V, Kummar S, Lin JJ. Efficacy and Safety of Larotrectinib in Patients With Tropomyosin Receptor Kinase Fusion-Positive Lung Cancers. JCO Precis Oncol. 2022 Jan;6:e2100418. doi: 10.1200/PO.21.00418.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Doz F, van Tilburg CM, Geoerger B, Hojgaard M, Ora I, Boni V, Capra M, Chisholm J, Chung HC, DuBois SG, Gallego-Melcon S, Gerber NU, Goto H, Grilley-Olson JE, Hansford JR, Hong DS, Italiano A, Kang HJ, Nysom K, Thorwarth A, Stefanowicz J, Tahara M, Ziegler DS, Gavrilovic IT, Norenberg R, Dima L, De La Cuesta E, Laetsch TW, Drilon A, Perreault S. Efficacy and safety of larotrectinib in TRK fusion-positive primary central nervous system tumors. Neuro Oncol. 2022 Jun 1;24(6):997-1007. doi: 10.1093/neuonc/noab274.

repositories_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Lee YA, Lee H, Im SW, Song YS, Oh DY, Kang HJ, Won JK, Jung KC, Kwon D, Chung EJ, Hah JH, Paeng JC, Kim JH, Choi J, Kim OH, Oh JM, Ahn BC, Wirth LJ, Shin CH, Kim JI, Park YJ. NTRK and RET fusion-directed therapy in pediatric thyroid cancer yields a tumor response and radioiodine uptake. J Clin Invest. 2021 Sep 15;131(18):e144847. doi: 10.1172/JCI144847.

oa_colors: green other

evidence: open (via free pdf)

publisher_dissemination: American Society for Clinical Investigation

ReferenceCitation: Bebb DG, Banerji S, Blais N, Desmeules P, Gill S, Grin A, Feilotter H, Hansen AR, Hyrcza M, Krzyzanowska M, Melosky B, Noujaim J, Purgina B, Ruether D, Simmons CE, Soulieres D, Torlakovic EE, Tsao MS. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Adults. Curr Oncol. 2021 Jan 15;28(1):523-548. doi: 10.3390/curroncol28010053.

publisher_dissemination: MDPI

ReferenceCitation: Perreault S, Chami R, Deyell RJ, El Demellawy D, Ellezam B, Jabado N, Morgenstern DA, Narendran A, Sorensen PHB, Wasserman JD, Yip S. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Pediatric Patients. Curr Oncol. 2021 Jan 9;28(1):346-366. doi: 10.3390/curroncol28010038.

ReferenceCitation: Hong DS, DuBois SG, Kummar S, Farago AF, Albert CM, Rohrberg KS, van Tilburg CM, Nagasubramanian R, Berlin JD, Federman N, Mascarenhas L, Geoerger B, Dowlati A, Pappo AS, Bielack S, Doz F, McDermott R, Patel JD, Schilder RJ, Tahara M, Pfister SM, Witt O, Ladanyi M, Rudzinski ER, Nanda S, Childs BH, Laetsch TW, Hyman DM, Drilon A. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020 Apr;21(4):531-540. doi: 10.1016/S1470-2045(19)30856-3. Epub 2020 Feb 24.

repository_institution: University of California - eScholarship University of California

ReferenceCitation: O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.

ReferenceCitation: Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.

ReferenceCitation: Shi E, Chmielecki J, Tang CM, Wang K, Heinrich MC, Kang G, Corless CL, Hong D, Fero KE, Murphy JD, Fanta PT, Ali SM, De Siena M, Burgoyne AM, Movva S, Madlensky L, Heestand GM, Trent JC, Kurzrock R, Morosini D, Ross JS, Harismendy O, Sicklick JK. FGFR1 and NTRK3 actionable alterations in "Wild-Type" gastrointestinal stromal tumors. J Transl Med. 2016 Dec 14;14(1):339. doi: 10.1186/s12967-016-1075-6.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: St. Petersburg Clinical Onc. Cent. of Spec. Types of Care

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

location_facility: Institut Jules Bordet/Jules Bordet Instituut

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes

location_facility: Karolinska Universitetssjukhuset i Solna

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Juravinski Cancer Centre-McMaster Medical Unit

location_facility: Clín. de Pesq. e Centro de Estudos em Onco Gineco Mamária

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti

location_facility: Moscow Clinical Scientific Centre n.a.Loginov

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Arkhangelsk Clinical Oncology Dispensary

location_facility: Charité Comprehensive Cancer Center (CCCC)

location_facility: IRCCS Istituti Fisioterapici Ospitalieri - IFO

location_facility: Hosp. Araujo Jorge da Associação de Combate ao Câncer

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Fundación Oftalmológica de Santander Carlos Ardila Lule

location_facility: Instituto Nacional do Câncer - INCA - HC II

location_facility: Hospital de Base | Integrated Research Center

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer

location_facility: Republican Clinical Oncology Dispensary Kazan

location_facility: Jawaharlal Institute Of Postgraduate Medical Education and R

location_facility: Instituto Nacional de Cancerología INC Colombia

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitario "Marqués de Valdecilla"

location_facility: 1st Moscow State Medical University n.a. I.M.Sechenov

location_facility: Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Centro Hospitalar Universitario do Porto

location_facility: A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: London Regional Cancer Program, London Health Sciences Ctr

location_facility: Institute Of Cancer-Barts and The London School of Medicine

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: AGIOS SAVVAS Anticancer Hospital of Athens

location_facility: ICANS - Institut de Cancérologie de Strasbourg Europe

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Hôpital Guillaume et René Laennec - Nantes

location_facility: Fundación Cenit para la Investigación en Neurociencias

location_facility: General Oncology Hospital of Kifissia AGIOI ANARGYROI

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: Cenantron Centro Avançado de Tratamento Oncológico, Ltda.

location_facility: Onkologicky Ustav Svatej Alzbety, s.r.o.

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Governmental Noncommercial Institution "National Cancer Institute

location_facility: Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"

title: A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Ukraine
India
Belgium
China
Italy
Norway
Singapore
United Kingdom
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


acronym: PHOCUS

lead_sponsor: SillaJen, Inc.

summary: This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

location_facility: Hospital of The University of Pennsylvania

location_facility: Tulane University Health Sciences Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Benaroya Research Institute at Virginia Mason Hospital

location_facility: Washington University School of Medicine

title: A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

location_country:
Germany
Italy
Portugal
New Zealand
Israel
Hong Kong
Singapore
Australia
United Kingdom
United States
China
Korea, Republic of
Thailand
Taiwan
Canada
France


lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.

ReferenceType: result

ReferenceCitation: Diene G, Angulo M, Hale PM, Jepsen CH, Hofman PL, Hokken-Koelega A, Ramesh C, Turan S, Tauber M. Liraglutide for Weight Management in Children and Adolescents With Prader-Willi Syndrome and Obesity. J Clin Endocrinol Metab. 2022 Dec 17;108(1):4-12. doi: 10.1210/clinem/dgac549.

repository_institution: Marmara Üniversitesi - Dspace Repository

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

title: Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.

ipd_sharing_description: According to Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Italy
New Zealand
Australia
Netherlands
United States
Turkey
Canada
France


title: ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)

summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

status: Terminated

ReferenceCitation: Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Medknow

lead_sponsor: LTN PHARMACEUTICALS, INC.

location_country:
Italy
United Kingdom
Australia
Belgium
United States
Spain
Canada
France

location_facility: University of Colorado Cancer Center Anschultz Cancer Pavilion

location_facility: Service de Médecine Interne Onco-Hématologie

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: Instituto Catalan de Oncologia (Hospital Durans i Reynals)

location_facility: Ashford Cancer Centre/Adelaide Cancer Centre Research

location_facility: Jules Bordet Institute Clinique d'Oncologie Medicale

location_facility: Urology Cancer Center and GU Research Network

location_facility: University of Surrey Post Graduate Medical Hospital

location_facility: Unità Operativa di Oncologia Ospedale Civile degli Infe

location_facility: St. George Private Hospital, Oncology Day Care Centre

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Walter Reed National Military Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Unidad Cnio Ibima de Investigacion en Prostata

location_facility: University of Florida Health Cancer Center

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: University of Maryland Greenenbaum Cancer Center

location_facility: Texas Oncology/Baylor University Medical Center

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Centre Hospitalier De I'Universite de Montreal

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Hospital Clínic i Provincial de Barcelona-Oncology

location_facility: Guy's and St. Thomas' NHS Foundation Trust

location_facility: Hospital Clinico Universitario de Navarra

status_simplified: Unknown


lead_sponsor: Genentech, Inc.

summary: This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

ReferenceCitation: Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7):e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23.

publisher_dissemination: American Society for Microbiology

location_facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD

location_facility: Centre Hospitalier de la Universite Laval

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD

location_facility: Anesthesia and Intensive Care Dept., Regional Hospital Liberec

location_facility: Royal Jubilee Hospital Victoria general Hospital

location_facility: Service de Réanimation médicale - Bocage Central

location_facility: Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace

location_facility: Uppsala University Hospital, Department of Infectious Diseases

location_facility: Municipal Institution Central City Hospital #1 City of Zhytomyr

location_facility: Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

location_facility: St. Paul's Hospital, Providence Health Care

location_facility: Hospital de la Amistad Peru Corea II-2 Santa Rosa

location_facility: Erasmus Medical Centre; Department of Virology L-359

location_facility: Southampton University Hospitals NHS Trust

location_facility: Municipal Institution City Clinical Infectious Diseases Hospital

location_facility: A.O.U. S. Giovanni di Dio e Ruggi d'Aragona

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: University Hospital Modena, Intensive Care Unit

location_facility: Servicio de Medicina Intensiva Hospital Universitario la Fe

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Gelre Ziekenhuizen Apeldoorn; Hospitals Pharmacy

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Leeds General Infirmary, Anaesthetic Department, D Floor

location_facility: National Institute for Infectious Diseases "L. Spallanzani"

location_facility: LHSC - University Hospital; Research Pharmacy

location_facility: Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk

location_facility: Municipal Healthcare Institution "City Hospital №2"

location_facility: Oddział Anestezjologii i Intensywnej Terapii;Wojewódzki Szpital Zespolony im. L. Rydygiera

location_facility: University Multiprofile Hospital for Active Treatment "St. George"

location_facility: University hospital Ostrava, Clinic of infectious medicine

location_facility: Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran

location_facility: Poltava Regional Clinical Infectious Hospital

location_facility: 5th Multifunctional Hospital for Active treatment

location_facility: Hadasit Medical Research Services and Development Ltd

location_facility: Universitätsklinikum Frankfurt Goethe Universität

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: University Division of Infective and Tropical Diseases, University of Brescia, Italy

location_facility: Centro de Especialidades Medicas Del Estado de Veracruz Dr Rafael Lucio

location_facility: Clinica Divino Nino Jesus; Orden de Malta

location_facility: Centre de santé et de services sociaux de Trois-Rivières

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Kaohsiung Medical University Hospital, Cancer Center

location_facility: King College Hospital NHS Foundation Trust

location_facility: MHAT Lyulin EAD, Department of internal diseases

location_facility: Hospital Univ. de Getafe.Servicio de Neurologia

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

location_facility: Taunton and Somerset NHS Foundation Trust Musgrove Park Hospital

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Service de réanimation médicale, Hôpital Bretonneau

location_facility: MHAT TOKUDA SOFIA/ICU-Intensive Care Unit

location_facility: Hallym university Kangnam Sacred Heart Hospital; Infectious devision

title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR TREATMENT OF SEVERE INFLUENZA A INFECTION

location_country:
Germany
Poland
New Zealand
Brazil
Chile
Czechia
Canada
France
Hungary
Hong Kong
Ukraine
Belgium
Peru
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: BORA

summary: The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

ReferenceCitation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.

ReferenceCitation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8. Erratum In: Lancet Respir Med. 2019 Jan;7(1):e1.

title: A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

primary_purpose: Other

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Vietnam
Turkey
Chile
Czechia
Canada
France
United States
Ukraine
Romania
Peru
Philippines
United Kingdom
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Sweden


title: Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

ReferenceCitation: Del Brutto VJ, Diener HC, Easton JD, Granger CB, Cronin L, Kleine E, Grauer C, Brueckmann M, Toyoda K, Schellinger PD, Lyrer P, Molina CA, Chutinet A, Bladin CF, Estol CJ, Sacco RL. Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE-SPECT ESUS Trial. J Am Heart Assoc. 2022 Jun 7;11(11):e023545. doi: 10.1161/JAHA.121.023545. Epub 2022 Jun 3.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.

ReferenceCitation: Bahit MC, Sacco RL, Easton JD, Meyerhoff J, Cronin L, Kleine E, Grauer C, Brueckmann M, Diener HC, Lopes RD, Brainin M, Lyrer P, Wachter R, Segura T, Granger CB; RE-SPECT ESUS Steering Committee and Investigators. Predictors of Atrial Fibrillation Development in Patients With Embolic Stroke of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial. Circulation. 2021 Nov 30;144(22):1738-1746. doi: 10.1161/CIRCULATIONAHA.121.055176. Epub 2021 Oct 15.

ReferenceCitation: Uchiyama S, Toyoda K, Lee BC, Liou CW, Wong LKS, Grauer C, Brueckmann M, Taniguchi A, Urano Y, Easton JD; RE-SPECT ESUS Investigators. Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis. Stroke. 2021 Mar;52(3):1069-1073. doi: 10.1161/STROKEAHA.120.031891. Epub 2021 Feb 16.

ReferenceCitation: Diener HC, Chutinet A, Easton JD, Granger CB, Kleine E, Marquardt L, Meyerhoff J, Zini A, Sacco RL. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke. 2021 Mar;52(3):1065-1068. doi: 10.1161/STROKEAHA.120.031237. Epub 2021 Jan 28.

ReferenceCitation: Diener HC, Sacco RL, Easton JD, Granger CB, Bar M, Bernstein RA, Brainin M, Brueckmann M, Cronin L, Donnan G, Gdovinova Z, Grauer C, Kleine E, Kleinig TJ, Lyrer P, Martins S, Meyerhoff J, Milling T, Pfeilschifter W, Poli S, Reif M, Rose DZ, Sanak D, Schabitz WR. Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups. Stroke. 2020 Jun;51(6):1758-1765. doi: 10.1161/STROKEAHA.119.028643. Epub 2020 May 14.

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmunzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
Ukraine
India
Belgium
China
Malaysia
Peru
Estonia
Italy
Singapore
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility: UHS Wilson Medical Center,Office of Clin Trials

location_facility: General Hospital of Shenyang Military Region

location_facility: Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: CHUV - Centre hospitalier universitaire vaudois

location_facility: Univ. Debrecen Medical Health Science Center, Neurology Dept

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: East Estonia Central Hospital, Neurology Dept, Ahtme

location_facility: Military Institute of Medicine Neurology Clinic, Warsaw

location_facility: Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi

location_facility: Hospital General de Culiacán "Dr. Bernardo J. Gastellum"

location_facility: Instituto Nacional de Ciencias Neurológicas

location_facility: Clinica Neurologica e Neurocirurgica de Joinvile

location_facility: The First Affiliated Hospital of Jinan University

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Universitätsklinikum Tulln, Abteilung für Neurologie

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: St. Mary's Hospital and Regional Medical Center

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

location_facility: Instit.f.applicative Research in med.rehab.Dobrna

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan

location_facility: North Estonia Medical Centre Foundation, Tallin

location_facility: Regional Hospital Lugano,Neurocenter of Southern Switzerland

location_facility: Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese

location_facility: Hospital General Universitario de Albacete

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep

location_facility: Osp. Guglielmo da Saliceto AUSL di Piacenza

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology

location_facility: Southern Illinois University School of Medicine

location_facility: The Ohio State University Wexner Medical Center

location_facility: Bruce W. Carter, Miami VA Healthcare System

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Tokyo Women's Medical University Hospital

location_facility: Public Central Clinical Hosp,Neurology Clinic,Warsaw

location_facility: Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.

location_facility: Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz

location_facility: Affiliated Hospital, Xuzhou Medical college

location_facility: Mangala Hospital and Mangala Kidney Foundation

location_facility: New York Presbyterian Hudson Valley Hospital

location_facility: Reserch Institute for Brain and Blood Vessels Akita

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Center of Clinical Neurology, private prac, Krakow

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien

location_facility: City Clin.Emergency Hosp of Kursk, Neurology Department No.2

location_facility: Quincy Physicians and Surgeons Clinic, S.C.

location_facility: Military Medical Academy n.a. C. M. Kirov, St. Petersburg

location_facility: Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona

location_facility: Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.

location_facility: Beijing Tiantan Hospital affiliated to Cap Med University

location_facility: RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH

location_facility: Veterans Affairs Portland Health Care System

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

location_facility: Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

location_facility: The Catholic University of Korea, Seoul St.Mary's Hospital

location_facility: Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow

location_facility: KH d. Barmherzigen Brüder Linz, Neurologie

location_facility: Università degli Studi Campus Bio-Medico

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: Sacred Heart Medical Center at RiverBend

location_facility: Shree Krishna Hospital and Research Centre

location_facility: Abbott Northwestern Hospital, Radiology Department

location_facility: City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow

location_facility: Cardial d.o.o., Specialist out-patient unit, Ljubljana

location_facility: Saitama Medical University International Medical Center

location_facility: Cerebrovascular site, private prac., Brno

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep

location_facility: The Duluth Clinic dba Essentia Health Duluth Clinic

location_facility: Medical corporation Suiseikai Suiseikai Kajikawa Hospital

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Gesundheit Nord gGmbH | Klinikverbund Bremen

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: University Hosp. Zürich, Dept. of Neurology, Stroke Center

location_facility: First Affiliated Hospital of Guangzhou University of TCM

location_facility: Westside Medical Associates of Los Angeles

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Vero Beach Neurology and Research Institute

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Kortrijk - HOSP AZ Groeninge Kennedylaan

location_facility: Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3

location_facility: Sociedad de Cirugia de Bogota Hospital de San José

location_facility: Saint Alphonsus Medical Center-Neurology

location_facility: Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg

location_facility: Canton Hospital Aarau, Neurology Dept., Stroke Center

location_facility: The affiliated hospital of medicalcollege qingdao university

location_facility: National Instit.of Neurosciences,Neurology Dept,Budapest

location_facility: Krankenhaus der Barmherzigen Brüder Trier

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: West Tallinn Central Hospital, Neurology Dept.

location_facility: Kobe City Medical Center General Hospital

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow

location_facility: Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin

location_facility: Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin

location_facility: Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

location_facility: Hospital de Braga - Centro Clínico Académico (2CA)

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ruan Neurology Clinic and Research Center

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz

location_facility: The Affiliated Hospital of Hangzhou Normal University

location_facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: National Hospital Organization Toyohashi Medical Center

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Univ. Hospital Bern, Neurology Dept, Stroke Center

location_facility: Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice

location_facility: Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care


title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia

summary: The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.

ReferenceCitation: Owen RG, McCarthy H, Rule S, D'Sa S, Thomas SK, Tournilhac O, Forconi F, Kersten MJ, Zinzani PL, Iyengar S, Kothari J, Minnema MC, Kastritis E, Aurran-Schleinitz T, Cheson BD, Walter H, Greenwald D, Chen DY, Frigault MM, Hamdy A, Izumi R, Patel P, Wei H, Lee SK, Mittag D, Furman RR. Acalabrutinib monotherapy in patients with Waldenstrom macroglobulinemia: a single-arm, multicentre, phase 2 study. Lancet Haematol. 2020 Feb;7(2):e112-e121. doi: 10.1016/S2352-3026(19)30210-8. Epub 2019 Dec 19. Erratum In: Lancet Haematol. 2021 Apr;8(4):e249.

repository_institution: University of Illinois at Chicago - INDIGO

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
Greece
France