location_country:
Malaysia
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Spain
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Belarus
Turkey

acronym: AMPLITUDE

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Instituto COI de Pesquisa, Educacao e Gestao

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: Second Affiliated Hospital of Soochow University

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Divisione di Oncologia - Istituto per la ricerca e cura del cancro

location_facility: Western Theater General Hospital of the Chinese People's Liberation Army

location_facility: ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Instituto Joinvilense De Hematologia e Oncologia

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: Specialized Hospital for Active Treatment in Oncology

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)

location_facility: Centro de Investigación Clínica Gramel S.C.

location_facility: McGill University - Jewish General Hospital

location_facility: Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Southwest Hospital, The Third Military Medical University

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Institut Kanser Negara - Clinical Research Center

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Hospital Beneficência Portuguesa de São Paulo

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

location_facility: Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

location_facility: Shengjing Hospital of China Medical University

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Centro de Pesquisa do Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

location_facility: Bobruisk Interregional Oncological Dispensary

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: District Oncology Dispensary with In-Patient Stationary - Plovdiv

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Specjalistyczna przychodnia lekarska POLIMED

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Greater Los Angeles VA Healthcare System

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

location_facility: Sakarya University Training and Research Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: West China Hospital of Sichuan University

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Országos Onkológiai Intézet, C Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Hospital Do Cancer De Barretos - Fundacao Pio Xii

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Marie Curie Research Wing - Mount Vernon Hospital

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

location_facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

location_facility: Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

location_facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Kingston Health Sciences Centre, Kingston General Health Research Institute

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: University of Mississippi Medical Center

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The First Affliated Hospital of Soochow University

location_facility: University College London Hospitals NHSFT

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Private Medical Institution Euromedservice

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Centre Hopitalier Inter-Communal De Cornouaille

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: State Institution National Cancer Institute

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).


intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

lead_sponsor: Bayer

enrollment_type: Anticipated

primary_purpose: Other

location_country:
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Spain
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Belarus
Estonia
Latvia

acronym: Darolutamide roll-over study

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: National hospital Organization Mito Medical Center

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: N.N. Alexandrov National Cancer Centre of Belarus

location_facility: Centre d'Oncologie et de Radiologie du Parc

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Huadong Hospital, Affiliated to Fudan University

location_facility: Associação Hospitalar Beneficente São Vicente de Paulo

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Hospital Central de la Fuerza Aerea del Perú

location_facility: City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA

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

location_facility: Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner

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

location_facility: Instituto de Oncología y Radioterapia de la Clínica Ricardo

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Urologische Gemeinschaftspraxis Dr. Simone Maier

location_facility: Inst. de Assistência Médica ao Sérvidor Público Estadual

location_facility: City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS

location_facility: Clinical Hospital Center Bezanijska kosa

location_facility: Transkarpathian Regional Oncology Center

location_facility: Multi-Field Clinical Medical Center "Medical City"

location_facility: Zuyderland Medisch Centrum Sittard-Geleen

location_facility: Minsk City Clinical Oncological Dispensary

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Medizinische Fakultät der Otto-von-Guericke Universität

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

location_facility: Princess Margaret Hospital-University Health Network

location_facility: CIUSSS de l'Estrie- Centre Haute-Yamaska

location_facility: Turun yliopistollinen keskussairaala, kantasairaala

location_facility: Health Corporation of the Ziv Medical Center (R.A.)

location_facility: Kharkiv Medical Academy of postgraduate education

location_facility: Hospital Universitario "José Eleuterio González"

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer

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

location_facility: Androgeos - private center of urology and andrology

location_facility: Associated Medical Professionals of NY, PLLC

location_facility: National Hospital Organization Shinshu Ueda Medical Center

location_facility: AS "Association of Health Centers" polyclinic "Elite"

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Albert Schweitzer Ziekenhuis, Locatie Dordwijk

location_facility: National Medical Research Radiology Center

location_facility: Hospital Clínico Universitario San Carlos

location_facility: G. Kenneth Jansz Medicine Professional Corporation

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Szpital Grochowski im. dr.med. Rafala Masztaka

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: P. Stradins Clinical University Hospital

location_facility: Pinderfields Hospital The Mid Yorkshire Hospitals NHS Trust

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: Fundación Oftalmológica de Santander Carlos Ardila Lule

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

location_facility: Litavniece Dzintra practice in urology and oncological chem.

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Keimyung University Dongsan Medical Center

location_facility: Krasnoyarsk Regional Clinical Oncology Dispensary

location_facility: Spitalul Clinic Judetean de Urgenta Oradea

location_facility: Dept Radiation and Oncology Tygerberg Academic Hospital

location_facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

location_facility: IRCCS Fondazione del Piemonte per l'Oncologia

location_facility: Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

location_facility: Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

location_facility: Tianjin Medical University Cancer Institiute & Hospital

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: background

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galiè N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

family: Meyer

full_name: Guy Meyer

given: Guy

sequence: first

family: Vicaut

full_name: Eric Vicaut

given: Eric

sequence: additional

family: Danays

full_name: Thierry Danays

given: Thierry

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

family: Becattini

full_name: Cecilia Becattini

given: Cecilia

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

family: Bluhmki

full_name: Erich Bluhmki

given: Erich

family: Bouvaist

full_name: Helene Bouvaist

given: Helene

family: Brenner

full_name: Benjamin Brenner

given: Benjamin

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Dellas

full_name: Claudia Dellas

given: Claudia

family: Empen

full_name: Klaus Empen

given: Klaus

family: Franca

full_name: Ana Franca

given: Ana

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Geibel

full_name: Annette Geibel

given: Annette

family: Goldhaber

full_name: Samuel Z. Goldhaber

given: Samuel Z.

family: Jimenez

full_name: David Jimenez

given: David

family: Kozak

full_name: Matija Kozak

given: Matija

family: Kupatt

full_name: Christian Kupatt

given: Christian

family: Kucher

full_name: Nils Kucher

given: Nils

family: Lang

full_name: Irene M. Lang

given: Irene M.

family: Lankeit

full_name: Mareike Lankeit

given: Mareike

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

family: Pacouret

full_name: Gerard Pacouret

given: Gerard

family: Palazzini

full_name: Massimiliano Palazzini

given: Massimiliano

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

title: Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism

ReferenceCitation: Barco S, Vicaut E, Klok FA, Lankeit M, Meyer G, Konstantinides SV; PEITHO Investigators. Improved identification of thrombolysis candidates amongst intermediate-risk pulmonary embolism patients: implications for future trials. Eur Respir J. 2018 Jan 18;51(1). pii: 1701775. doi: 10.1183/13993003.01775-2017. Print 2018 Jan.

ReferenceCitation: Konstantinides SV, Vicaut E, Danays T, Becattini C, Bertoletti L, Beyer-Westendorf J, Bouvaist H, Couturaud F, Dellas C, Duerschmied D, Empen K, Ferrari E, Galiè N, Jiménez D, Kostrubiec M, Kozak M, Kupatt C, Lang IM, Lankeit M, Meneveau N, Palazzini M, Pruszczyk P, Rugolotto M, Salvi A, Sanchez O, Schellong S, Sobkowicz B, Meyer G. Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism. J Am Coll Cardiol. 2017 Mar 28;69(12):1536-1544. doi: 10.1016/j.jacc.2016.12.039.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Marti C, John G, Konstantinides S, Combescure C, Sanchez O, Lankeit M, Meyer G, Perrier A. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. Eur Heart J. 2015 Mar 7;36(10):605-14. doi: 10.1093/eurheartj/ehu218. Epub 2014 Jun 10. Review.

ReferenceCitation: Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jiménez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2021 Sep 24. doi: 10.1055/a-1653-4699. [Epub ahead of print]

name: Université Paris Descartes, Sorbonne Paris Cité, and INSERM UMR S 1140, Paris, FRANCE, Paris, France

name: Hopital Europeen Georges Pompidou, Paris, France

name: Medicine and Surgery, University of Insubria, Varese, Italy

name: Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland

name: University of Freiburg Faculty of Medicine, Freiburg, Germany

name: Universitätsklinikum Freiburg Medizinische Universitätsklinik, Freiburg im Breisgau, Germany

name: Department of Internal Medicine, Ernst Moritz Arndt University, Greifswald, Germany

name: Hospital Garcia de Orta EPE, Almada, Portugal

name: Département Thoracique, Institut Mutualiste Montsouris, Paris, France

name: Medicine, Leiden University Medical Center, Leiden, Netherlands

name: Respiratory Division, Medicine Department, Ramón y Cajal Hospital, IRYCIS and Alcalá de Henares University, Madrid, Spain

name: Hospital European George Pompidou, Paris, France

name: 15. Department of Vascular Diseases, University Medical Center, Ljubljana, Slovenia

name: Johannes Gutenberg Universität Mainz Klinikum, Mainz, Germany

name: cardiology, CHU Besançon, Besancon, France

name: Department of Internal Medicine & Cardiology, The Medical University of Warsaw, Warszawa, Poland

name: 19. “Grigore T. Popa”University of Medicine and Pharmacy Iasi, Cardiology Clinic, ”St. Spiridon” County Clinical Emergency Hospital, Iasi, Romania

name: Division of Angiology and Haemostasis, Geneva Hospital University, Geneva, Switzerland

name: Universität zu Köln Medizinische Fakultät, Koln, Germany

name: Municipal Hospital of Dresden-Friedrichstadt, Dresden, Germany

name: 21. Coronary Care Unit, Cardiology Clinic,Emergency Center, Clinical Center of Serbia, School of Medicine, University of Belgrade, Belgrade, Serbia

name: Center for Molecular and Vascular Biology, KULeuven, Leuven, Belgium

name: McMaster University Medical Centre, Hamilton, Canada

name: URC Lariboisière – Saint-Louis, AP-HP, Université de Paris, Paris, France

name: Department of Cardiology, Medizinische Universitat Graz, Graz, Austria

name: Centre for Thrombosis and Haemostasis, University Medical Centre, Johannes Gutenberg University Mainz, Mainz, Germany

name: University Medical Centre, Johannes Gutenberg University Mainz, Germany

title: Reduced-dose intravenous thrombolysis for acute intermediate high-risk pulmonary embolism: Rationale and design of the PEITHO-3 trial

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

location_country: Italy Austria Serbia Switzerland Netherlands Spain Germany France Poland Romania Belgium Portugal Canada Slovenia

location_facility: Department of Cardiac and Vascular Diseases

location_facility: Iasi - St Spiridon Emergency Conty Hospital

location_facility: Cardiology Clinic, Clinical Center of Niš

location_facility: Hamilton Health Sciences and St Jospeh's Hospital Hamilton

location_facility: Cardiology Clinic, Emergency Center, Clinical Center of Serbia

location_facility: AP-HP - hôpital européen Georges-Pompidou

location_facility: Institute for Lung Diseases of Vojvodina, Sremska Kamenica

location_facility: Institutul de Boli Cardio-Vasculare Timisoara

location_facility: Hannover, Medizinische Hochschule Hannover

location_facility: CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

location_facility: The Ottawa Hopsital, General and Civic campuses

location_facility: Bucuresti - Spitalul Clinic de Urgenta Sf. Pantelimon

location_facility: University Hospital Ancona / Ospedali Riunit

location_facility: Centro Hospitalar de Lisboa Norte/ Hospitalde Santa Maria

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

title: A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial

summary: In this study, we will assess the efficacy and safety of a reduced dose of thrombolytic therapy given in addition to low-molecular-weight heparin in patients with intermediate-high-risk acute pulmonary embolism. Half of participants will receive thrombolytic treatment, while the other half will receive a placebo.


title: A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

summary:
Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone.

Patients will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Ward J, Berrien-Elliott MM, Gomez F, Luo J, Becker-Hapak M, Cashen AF, Wagner-Johnston ND, Maddocks K, Mosior M, Foster M, Krysiak K, Schmidt A, Skidmore ZL, Desai S, Watkins MP, Fischer A, Griffith M, Griffith OL, Fehniger TA, Bartlett NL. Phase I/Dose Expansion Trial of Brentuximab vedotin/Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma. Blood. 2021 Nov 15. pii: blood.2021011894. doi: 10.1182/blood.2021011894. [Epub ahead of print]

name: Washington University School of Medicine, Saint Louis, Missouri, United States

family: Ward

full_name: Jeffrey Ward

given: Jeffrey

name: Washington University, St. Louis, Missouri, United States

family: Berrien-Elliott

full_name: Melissa M Berrien-Elliott

given: Melissa M

family: Gomez

full_name: Felicia Gomez

given: Felicia

name: Washington University School of Medicine, St. Louis, Missouri, United States

family: Luo

full_name: Jingqin Luo

given: Jingqin

family: Becker-Hapak

full_name: Michelle Becker-Hapak

given: Michelle

name: Washington University School of Medicine, St Louis, Missouri, United States

family: Cashen

full_name: Amanda F Cashen

given: Amanda F

name: Washington University School of Medicine, United States

family: Wagner-Johnston

full_name: Nina D. Wagner-Johnston

given: Nina D.

name: The Ohio State University, Columbus, Ohio, United States

family: Maddocks

full_name: Kami Maddocks

given: Kami

family: Mosior

full_name: Matthew Mosior

given: Matthew

family: Foster

full_name: Mark Foster

given: Mark

family: Krysiak

full_name: Kilannin Krysiak

given: Kilannin

family: Schmidt

full_name: Alina Schmidt

given: Alina

name: Washington University in St Louis, Saint Louis, Missouri, United States

family: Skidmore

full_name: Zachary L. Skidmore

given: Zachary L.

family: Desai

full_name: Sweta Desai

given: Sweta

family: Watkins

full_name: Marcus P. Watkins

given: Marcus P.

family: Fischer

full_name: Anne Fischer

given: Anne

family: Griffith

full_name: Malachi Griffith

given: Malachi

name: Washington University, St Louis, Missouri, United States

full_name: Obi L. Griffith

given: Obi L.

family: Fehniger

full_name: Todd A Fehniger

given: Todd A

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Seagen Inc.

location_country:
Italy
United States
Switzerland
France
Czechia
Poland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies

location_facility: Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Florida Cancer Specialists - North Region

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

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Cancer and Hematology Centers of Western Michigan / Lemmen-Holton Cancer Pavilion

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: CIUSS NIM/Hopital du Sacre-Coeur de Montreal

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Florida Cancer Specialists - East West Palm Beach (SCRI)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Florida Cancer Specialists - South Region

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: H. Bliss Murphy Cancer Centre / Eastern Regional Health Authority

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: The Oncology Institute of Hope & Innovation - California

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Willamette Valley Cancer Institute/Oncology Assc of Oregon

location_facility: Centre Hospitalier Regional Metz-Thionville, Hopital Mercy

location_facility: Illinois Cancer Specialists / Advocate Lutheran General Hospital

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

location_facility: Saint Francis Hospital / Bon Secours - South Carolina

location_facility: Azienda Ospedaliero-Universitaria di Bologna - IRCCS

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: MD Anderson Cancer Center at Cooper Health

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: Centre Hospitalier Metropole Savoie - Chambery

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan

location_facility: University of Cincinnati Cancer Institute

location_facility: Central Coast Local Health District (Gosford and Wyong Hospitals)

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: Keimyung University Dongsan Medical Center

location_facility: Zealand University Hospital (Roskilde Sygehus)

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Carbone Cancer Center / University of Wisconsin

intervention_type: Other


status: Active, not recruiting

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

enrollment_type: Actual

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Spain

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

location_facility: Hospital Regional Universitario de Malaga

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Severance Hospital Yonsei University Health System

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Centro de Tratamento de Tumores Botafogo

location_facility: Centre Hospitalier Intercommunal de CrÃ©teil

location_facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

location_facility: University of California at Davis Medical Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Charite UniversitÃ¤tsmedizin Berlin, CharitÃ© Campus Virchow-Klinikum

location_facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Complexo Hospitalario Universitario A CoruÃ±a Hospital Teresa Herrera

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: Cha Bundang Medical Center, Cha University

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Shiga University of Medical Science Hospital

location_facility: Florida Cancer Specialists Research Panhandle

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center

location_facility: Omsk Regional Clinical Oncology Dispensary

location_facility: Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: Florida Cancer Specialists Research North

location_facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Clinical hospital 2, Group of companies medsi

location_facility: Instituto Catalan de Oncologia Hospital Duran i Reynals

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Instytut Genetyki i Immunologii GENIM Spzoo

location_facility: Washington Cancer Institute at MedStar Washington Hospital

location_facility: Centre Hospitalier Regional Universitaire - Hopital Morvan

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Centre Hospitalier de Nantes - HÃ´pital Nord LaÃ"nnec

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: University of California San Francisco Mission Hall

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: St Marianna University School of Medicine Hospital

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Seoul National University Bundang Hospital

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu

location_facility: National Hospital Organization Himeji Medical Center

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Harbor University of California Los Angeles Medical Center

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: Fundacao Antonio Prudente - Hospital A C Camargo

location_facility: The Center for Cancer and Blood Disorders

location_facility: Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao

location_facility: Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

location_facility: Azienda UnitÃ Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna

location_facility: Kobe City Medical Center General Hospital

location_facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Centre Hospitalier Universitaire RÃ©gional de Lille - HÃ´pital Albert Calmette

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Asklepios - Fachkliniken MÃ¼nchen-Gauting

location_facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: US Oncology Research Investigational Products Center

location_facility: Saint Petersburg scientifical practical center of specialized kinds of medical care oncological

location_facility: Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

location_facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

location_facility: Studiengesellschaft HÃ¤mato Onkologie Hamburg Prof Laack und Partner

ipd_sharing: Yes

title: A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation


title: Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal Study (SANTORINI)

acronym: SANTORINI

summary: High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

study_type: Observational

time_perspective: Other

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 Europe, GmbH, a Daiichi Sankyo Company

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Finland
France
Ireland
Belgium
Portugal
Denmark
Germany
United Kingdom

location_facility: Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli"

location_facility: Ospedale SS Cosma e Damiano di Pescia - Azienda Usl Toscana centro

location_facility: Centro Hospitalar Lisboa Norte - Site 10006

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: MVZ Prof. Detlef Mathey, Prof. Schofer GmbH

location_facility: Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz

location_facility: Liverpool Heart & Chest Hospital NHS Trust

location_facility: Ospedale Civile Santa Maria Incoronata dell'Olmo

location_facility: Presidio Ospedaliero di Mirano - ULSS 3 Serenissima

location_facility: Azienda Ospedaliera Universitaria Mater Domini - Site 8042

location_facility: Complejo Hospitalario Universitario de Ourense (CHOU) Site 11052

location_facility: Zentrum für Diabetes und Gefäßerkrankungen Münster

location_facility: Centro Hospitalar Universitario do Algarve

location_facility: Kardiologische Praxis Papenburg (Site 6098)

location_facility: Zentrum für Prävention und Rehabilitation

location_facility: Hospital de Alta Resolución de Sierra Norte

location_facility: Fondazione Poliambulanza Istituto Ospedaliero - Brescia

location_facility: Krankenhaus Hietzing mit neurologischem Zentrum Rosenhügel

location_facility: Internistische Facharztpraxis Frau Dr. Carmen Gelsinger

location_facility: Kardiologische Gemeinschaftspraxis Dres. Wetzel/Willgeroth

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: Institut Cœur Poumons, Boulevard du Pr Leclercq

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Ordination Dr. Thomas Maca / Evangelische KH Wien

location_facility: Azienda Ospedaliera Universitaria Mater Domini - Site 8053

location_facility: Presidio ospedaliero Cardinal Massaia - A.S.L. AT (SOC Diabetologia e Malattie Metaboliche)

location_facility: Centre de Cardiologie et d'exploration de la Côte Basque

location_facility: Kardiologische Praxis Papenburg (Site 6097)

location_facility: Azienda Ospedaliera-Universitaria S. Anna di Ferrara (Dipartimento medico)

location_facility: Grande Ospedale Metropolitano di Niguarda

location_facility: Kardiologie im Friedrichspalast Bruchsal

location_facility: Gemeinschaftspraxis Drs. Haggenmiller/Jeserich Kardiologie-Angiologie-Innere Medizin

location_facility: Rigshospitalet (Copenhagen University Hospital) - Glostrup (Glostrup Hospital)

location_facility: A.O.U. FEDERICO II (U.O.C. Diabetologia)

location_facility: Azienda Ospedaliera di Rilievo Nazionale(A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta

location_facility: Herzquartier Mühlheim, Kardiologische Gemeinschaftspraxis Dres. med. A. Krapivsky & P. Kekes

location_facility: Praxis für Innere Medizin / Kardiologie - Dr. med. E. Persicke / Dr. med. O. Scheuermann

location_facility: Ospedale S. Andrea - Usl Toscana Sud Est

location_facility: Centro Cardiologico Monzino - IRCCS (Unità Prevenzione dell'Aterosclerosi)

location_facility: Hospital Universitario de la Princesa Site 11075

location_facility: ASL Roma 6 - Ospedali Riuniti Anzio - Nettuno

location_facility: Ijsselland Ziekenhuis, Prins Constanijnweg 2

location_facility: Praxis Dipl. - Med. Petra Herrmann - Fachärztin für Innere Medizin

location_facility: Arcispedale Santa Maria Nuova - Azienda USL/IRCCS Reggio Emilia

location_facility: Östra Sahlgrenska Universitetssjukhuset - Ostra Sjukhuse

location_facility: Gemeinschaftspraxis Dres. J. Hintze und M. Grundner

location_facility: Zentrum für Klinische Studien Dr. Hanusch GmbH

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

location_facility: Praxis für Gefäßerkrankungen und Gerinnungsstörungen Leipzig

location_facility: Konventhospital der Barmherzigen Brüder Linz

location_facility: Centro Hospitalar de Entre Douro e Vouga

location_facility: Ospedale Santo Stefano di Prato - Azienda Usl Toscana Centro

location_facility: Kliniken an der Paar - Krankenhaus Aichach

location_facility: Ordination Dr. med. univ. Evelyn Fließer-Görzer

location_facility: A.O.U di Bologna-Policlinico S.Orsola-Malpighi (U.O. Medicina Interna)

location_facility: Ospedale Civile SS Annunziata (Dipartimento di Medicina Clinica e Sperimentale)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Ospedale di Bolzano (U.O. Cardiologia e Prove Funzionali)

location_facility: Associação Protetora de Diabéticos de Portugal

location_facility: Ospedale di Santo Stefano di Prato - Azienda Usl Toscana centro (UO di Cardiologia)

location_facility: Ropcke Zweers hospital, Jan Weitkamplaan 4-a

location_facility: Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet

location_facility: Ospedale Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria Pisana

location_facility: B. Braun Ambulantes Herzzentrum MVZ GmbH

location_facility: Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut

location_facility: Hospital Universitario de la Princesa Site 11062

location_facility: Praxis für Herzkreislauferkrankungen Greiz

location_facility: Kardiologie Oberschwaben - Bodensee Herz- und Gefäßpraxis

location_facility: Ospedali Riuniti "Umberto I - Lancisi - Salesi

location_facility: Gemeinschaftspraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (U.O Medicina Generale 2)

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH

location_facility: Kardiologische Facharztpraxis Dr. Anne Winkelmann

location_facility: Centro Hospitalar Universitário São João (CHUSJ)

location_facility: Complejo Hospitalario Universitario de Ourense (CHOU) Site 11003

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Centre Hopsitalier Alpes Leman, 552 Route de Findrol

location_facility: A.O.U. Consorziale - Policlinico Bari (Dipartimento di Medicina Interna)

location_facility: Ospedale Civile SS. Annunziata (MEDICINA INTERNA- DIPARTIMENTO DI MEDICINA E SCIENZE DELL'INVECCHIAMENTO)

location_facility: Ordination Dr. Thomas Maca / Evangelisches KH Wien

location_facility: Arcispedale Sant'Anna Ferrara (U.O. Cardiologia)

location_facility: Praxis für Innere Medizin und Angiologie

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Sastamalan seudun sosiaali- ja terveyspalvelut

location_facility: Azienda Ospedaliero-Universitaria Senese Dipartimento Delle Scienze Mediche U.O.C. Medicina Interna e della Complessità

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Ospedale Civile di Baggiovara- AOU di Modena

location_facility: Presidio Ospedaliero "Santa Maria della Misericordia" di Udine

location_facility: MVZ Dres. Ramdohr - Praxis für Cardiovascular und Ultraschalldiagnostik

location_facility: Krankenhaus der Barmherzigen Brüder Trier

location_facility: A.O. San Giuseppe Moscati (U.O.C. Cardiologia/UTIC)

location_facility: A.O.U. Policlinico "G. Martino" (U.O. Cardiologia)

location_facility: Policlinico Sant'Orsola-Malpighi (U.O. Cardiologia)

location_facility: Ordination Universitätsdozent Dr. Alexander Kober

location_facility: Karolinska University Hospital, Huddinge

location_facility: A.O.U. Careggi (S.O.D. Malattie Aterotrombotiche) - Site 8020

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

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Centre Hospitalier de Lisieux, 4 Rue Roger Aini

location_facility: Centro Hospitalar Lisboa Norte - Site 10005

location_facility: Azienda Ospedaliera Universitaria Mater Domini - Site 8059

location_facility: Kobenhavns Universitet - Holbaek Sygehus

location_facility: Hospital Universitario de la Princesa Site 11054


intervention_type: Procedure

ipd_sharing_description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Greece
Australia
Belgium
Russian Federation
France
Poland
Argentina
Canada
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Institut Jean Godinot-Clinical Research Unit

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Klinikum Nuernberg Nord, Urologische Klinik

location_facility: ICANS-Institut de cancerologie Strasbourg Europe

location_facility: Fundacao Antonio Prudente-Hospital Ac Camargo

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier de Cornouaille - Hopital Laennec

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Lakeridge Health Oshawa-Durham Regional Cancer Centre

location_facility: University General Hospital of Athens Attikon

location_facility: University Of Iowa Hospitals And Clinics

type: Other Identifier

title: A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

summary: The purpose of the study is to see if treatment with nivolumab plus bempeg or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.


title: Observational Study on Inappropriate Therapies After Replacement of ICDs

acronym: OSIRIS

summary: The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

time_perspective: Prospective

ipd_sharing_description: A clinical study report will be completed at the end of the study and publication of study results may be performed

lead_sponsor: MicroPort CRM

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

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Hospital General Universitario de Valencia

location_facility: Grande Ospedale Metropolitano Niguarda Ca Granda

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste

location_facility: The University of Chicago Medicine Hospital

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Hospital General Universitario de Alicante

location_facility: Universitätsklinik Innsbruck - Kardiologie und Angiologie

intervention_type: Device


location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Singapore
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

acronym: CheckMate 7DX

location_facility: Real e Benemrita Associao Portuguesa de Beneficencia Portuguesa de Sao Paulo

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Azienda Ospedaliero Universitaria Di Parma

location_facility: Charleston Hematology Oncology Associates CHOA

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino

location_facility: Inonu University Turgut Ozal Medical Center

location_facility: Hospital de Clinicas de Porto Alegre HCPA

location_facility: Centro de Tratamento de Tumores Botafogo - CTTB

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: University of Texas MD Anderson Cancer Clinic

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Prof. Dr. Al.Chiricuta Oncologic Institute Cluj Napoca

location_facility: Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.

location_facility: Toho University - Sakura Hospital Medical Center

location_facility: Desert Hematology Oncology Medical Group Inc. - Main Office

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

location_facility: GU Research Network/Urology Cancer Center

location_facility: Torrance Health Association DBA Cancer Care Associates

location_facility: FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre

location_facility: InVO -Institut fur Versorgungsforschung in der Onkologie GbR

location_facility: Uniklinikum Salzburg Universitatsklinik fur Urologie und Andrologie

location_facility: Kyoto Prefectural University of Medicine

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia Medic-R Sp.k.

location_facility: Otto-von-Guericke-Universitaet Magdeburg - Universitaetsklinikum Magdeburg A.Oe.

location_facility: Universidade Estadual De Campinas Unicamp

location_facility: Szpital Grochowski im. dr med. Rafala Masztaka Sp. z o.o

location_facility: P.A. Herzen Moscow Oncology Research Institute

location_facility: Bradford Hill Centro de Investigacion Clinica

location_facility: Blood Marrow Transplant Group of Georgia at Northside Hospital (Cumming)

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot,

location_facility: Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli

location_facility: IRCCS Istituto Nazionale dei tumori Fondazione G. Pascale

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the

location_facility: SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

location_facility: IDIM-Instituto de Diagnostico e Investigaciones Metabolicas

location_facility: Spitalul Clinic Judetean de Urgenta Constanta

location_facility: SAHI Republican Clinical Oncology Dispensary of MoH of RT

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: ICANS-Institut de cancerologie Strasbourg Europe

location_facility: Centre Hospitalier Universitaire de Nimes Institut de Cancerologie du Gard Oncologie Medicale

location_facility: Niigata University Medical and Dental Hospital

location_facility: Szpital Wojewodzki im. M. Kopernika w Koszalinie

location_facility: Institut Catala D 39 Oncologia Duran I Reynals

location_facility: Hospices Civils de Lyon - Centre hospitalier Lyon Sud

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Fundacion CORI para la Investigacion y Prevencion del Cancer

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Orlando Health Inc., UF Health Cancer Center

location_facility: The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: Institutul Oncologic Prof. Dr. I. Chiricuta

title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

summary: The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.


ReferenceCitation: Francois B, Lambden S, Gibot S, Derive M, Olivier A, Cuvier V, Witte S, Grouin JM, Garaud JJ, Salcedo-Magguilli M, Levy M, Laterre PF. Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial. BMJ Open. 2021 Jul 7;11(7):e042921. doi: 10.1136/bmjopen-2020-042921.

family: Francois

full_name: Bruno Francois

given: Bruno

family: Lambden

full_name: Simon Lambden

given: Simon

family: Gibot

full_name: Sebastien Gibot

given: Sebastien

family: Derive

full_name: Marc Derive

given: Marc

family: Olivier

full_name: Aurelie Olivier

given: Aurelie

family: Cuvier

full_name: Valerie Cuvier

given: Valerie

family: Witte

full_name: Stephan Witte

given: Stephan

family: Grouin

full_name: Jean-Marie Grouin

given: Jean-Marie

family: Garaud

full_name: Jean Jacques Garaud

given: Jean Jacques

family: Salcedo-Magguilli

full_name: Margarita Salcedo-Magguilli

given: Margarita

family: Levy

full_name: Mitchell Levy

given: Mitchell

family: Laterre

full_name: Pierre-François Laterre

given: Pierre-François

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: University of Cambridge - Apollo

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Inotrem

location_country: Finland France Ireland Belgium Spain Denmark

acronym: ASTONISH

location_facility: Helsinki University Hospital Adult ICU PPDS

location_facility: Hospital Universitario Dentral de Asturias

location_facility: Hospital universitario DR. Peset Aleixandre

location_facility: Hospital Universitario y Politecnico la Fe

location_facility: Hôpital d'instruction des Armées Robert Picqué

title: Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study

summary:
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

All patients with a diagnosis of septic shock will be considered for study participation. All potential study patients will receive standard of care for the treatment of septic shock.

After screening for eligibility, patients meeting all inclusion and no exclusion criterion will be randomized. Patients will be randomized to one of three treatment arms.

Treatment with study drug must be initiated as early as possible, but no later than 24 hours after the onset of septic shock, defined by the start of vasopressor therapy.

Patients will be treated for at least 3 days with study drug. After the first 3 days of treatment, patients still requiring vasopressor will be treated until 24 hours after vasopressor withdrawal with a maximum treatment duration of 5 days.

Patients will be assessed at the End of Study (EoS) visit at day 28. After the last patient's day 28 visit, the study will be analyzed. Additional follow up (FU) visits will be conducted after 90 days, 6 and 12 months.

The objective of the study ist to compare the safety, tolerability and efficacy of two doses of nangibotide versus placebo, when given in addition to standard of care.


title: LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

summary:
Primary objectives:

Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

ReferenceCitation: Khanam T, Sandmann S, Seggewiss J, Ruether C, Zimmermann M, Norvil AB, Bartenhagen C, Randau G, Mueller S, Herbrueggen H, Hoffmann P, Herms S, Wei L, Woeste M, Wuensch C, Gowher H, Oschlies I, Klapper W, Woessmann W, Dugas M, Burkhardt B. Integrative genomic analysis of pediatric T-cell lymphoblastic lymphoma reveals candidates of clinical significance. Blood. 2021 Apr 29;137(17):2347-2359. doi: 10.1182/blood.2020005381.

name: Department of Paediatric Hematology and Oncology, University Hospital Muenster, Muenster, Germany;

family: Khanam

full_name: Tasneem Khanam

given: Tasneem

family: Sandmann

full_name: Sarah Sandmann

given: Sarah

name: Institute of Human Genetics, Muenster University, Muenster, Germany;

family: Seggewiss

full_name: Jochen Seggewiss

given: Jochen

family: Ruether

full_name: Charlotte Ruether

given: Charlotte

name: Department of Pediatric Hematology and Oncology, Hannover Medical School, Hannover, Germany;

family: Zimmermann

full_name: Martin Zimmermann

given: Martin

name: Department of Biochemistry, Purdue University, West Lafayette, IN;

family: Norvil

full_name: Allison B. Norvil

given: Allison B.

name: Department of Experimental Pediatric Oncology, University Children’s Hospital, Cologne, Germany;

family: Bartenhagen

full_name: Christoph Bartenhagen

given: Christoph

family: Randau

full_name: Gerrit Randau

given: Gerrit

family: Mueller

full_name: Stephanie Mueller

given: Stephanie

family: Herbrueggen

full_name: Heidi Herbrueggen

given: Heidi

name: Institute of Human Genetics, Department of Genomics, Life and Brain Center, University of Bonn, Bonn, Germany;

family: Hoffmann

full_name: Per Hoffmann

given: Per

family: Herms

full_name: Stefan Herms

given: Stefan

family: Wei

full_name: Lanying Wei

given: Lanying

family: Woeste

full_name: Marius Woeste

given: Marius

family: Wuensch

full_name: Christian Wuensch

given: Christian

family: Gowher

full_name: Humaira Gowher

given: Humaira

name: Hematopathology Section, Department of Pathology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany; and

family: Oschlies

full_name: Ilske Oschlies

given: Ilske

family: Klapper

full_name: Wolfram Klapper

given: Wolfram

name: Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

family: Woessmann

full_name: Wilhelm Woessmann

given: Wilhelm

family: Dugas

full_name: Martin Dugas

family: Burkhardt

full_name: Birgit Burkhardt

given: Birgit

location_country:
Finland
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Norway
Sweden
Switzerland
Netherlands
Hungary
Ireland
China
Portugal
Germany
Italy
Austria
Czechia
Israel
Spain

location_facility: HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie

location_facility: H.C. Andersens Children Hospital, Odense University Hospital

location_facility: Service Immuno-Hématologie Oncologie Pédiatrique

location_facility: Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset

location_facility: Oncoematologia Pediatrica- Ospedale dei Bambini G. di Cristina

location_facility: Vestische Kinderklinik, Universität Witten / Herdecke

location_facility: Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

location_facility: Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie

location_facility: Dipartimento di Scienze Pediatriche Mediche Chirurgiche Ospedale Sant'Orsola Malpighi

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

location_facility: Carl-Thiem-Klinikum, Kinderklinik, Station 5e

location_facility: Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré

location_facility: Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin

location_facility: HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie

location_facility: Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2

location_facility: University Hospitals Leuven, Kinderhemato-oncologie

location_facility: Kuopio University Hospital, Department of Pediatric Hematology and Oncology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Städtisches Klinikum Braunschweig gGmbH, Klinik für Kinder- und Jugendmedizin, Station K5 / Päd. Hämato- und Onkologie

location_facility: Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse, CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

location_facility: Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin

location_facility: Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital

location_facility: Edmond and Lily Safra Children's Hospital, Sheba Medical Center

location_facility: Service Oncologie-Hématologie pédiatrique CHU de Poitiers

location_facility: Kepler Universitätsklinikum, Med Campus IV / Onkologie

location_facility: Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)

location_facility: Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk

location_facility: Ruth Rappaport Children's Hospital, Rambam Medical Center

location_facility: Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping

location_facility: Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University

location_facility: Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie

location_facility: Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

location_facility: U.O. di Pediatria e Oncoematologia Pediatrica. Az. Osp. di Parma

location_facility: Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

location_facility: Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

location_facility: Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie

location_facility: U.O. di Ematologia, Oncologia e Trapianto-Azienda Policlinico di Modena

location_facility: Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie

location_facility: Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics

location_facility: Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University

location_facility: UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni

location_facility: Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant

location_facility: Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers

location_facility: Divisione di Pediatria- Ospedale "Casa Sollievo della Sofferenza"

location_facility: University Hospital Brussels, Pediatrische oncologie

location_facility: Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie

location_facility: Dip. Scienze Pediatriche e dell'Adolescenza Ospedale Infantile Regina Margherita

location_facility: Children's Hospital at Soroka Medical Center

location_facility: Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung

location_facility: Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie

location_facility: Complejo Hospitalario Universitario Insular Materno Infantil

location_facility: Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów

location_facility: Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24

location_facility: Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d

location_facility: Oncoematologia Pediatrica IRCCS, Policlinico San Matteo Piazzale Golgi

location_facility: LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie

location_facility: Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara

location_facility: HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie

location_facility: National Center for Pediatric Hematology, Oncology and Immunology Moscow

location_facility: Unità Autonoma di Oncoematologia Pediatrica, Dipartimento Pediatria - Azienda "A.Meyer"

location_facility: Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: U.O. Emato-Oncologia Pediatrica- Università degli studi di Trieste-Ospedale Infantile Burlo Garofolo

location_facility: Centro Hospitalar e Universitário de Coimbra

location_facility: Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie

location_facility: Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie

location_facility: Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University

location_facility: Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie

location_facility: S.C. Ematologia Oncologica- Ospedale "Pausilipon"

location_facility: Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie

location_facility: Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH

location_facility: Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

location_facility: Dana Children's Hospital, Tel-Aviv Sourasky Medical Center

location_facility: Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie

location_facility: Hospital Universitario Central de Asturias

location_facility: Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice

location_facility: Istituto di Clinica Pediatrica- Ospedale Regionale Microcitemie

location_facility: University Hospital Gent Pediatrische hemato-oncologie

location_facility: University Hospital of Oulu, Paediatric Haematology and Oncology

location_facility: Oncologia Pediatrica,- Ospedale "R. Silvestrini"

location_facility: Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau

location_facility: University Hospital Aalborg, Nord, Department of Pediatrics

location_facility: Department of pediatric oncology and hematology, Children´s Faculty Hospital

location_facility: HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1

location_facility: Dipartimento di Ematologia -Ospedale Civile

location_facility: Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori

location_facility: Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

location_facility: Department of pediatric hematology and oncology, National Institute of Children's Diseases

location_facility: U.O. Oncoematologia Pediatrica- Policlinico "G.B. Rossi"

location_facility: Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw

location_facility: Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac

location_facility: Dipartimento Biomedicina Età Evolutiva- U.O. Pediatrica I Policlinico

location_facility: Oncological center of regional Children's Hospital

location_facility: Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

location_facility: Princess Maxima Centre for Pediatric Oncology

location_facility: Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie

location_facility: Department of Pediatric Oncology and Hematology, Medical University of Bialystok

location_facility: Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie

location_facility: Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Schneider Children's hospital, Rabin Medical Center

location_facility: Département de Pédiatrie et Génétique Médicale CHRU Morvan

location_facility: Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie

location_facility: Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset

location_facility: Instituto Português de Oncologia - Francisco Gentil - Porto

location_facility: Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz

location_facility: Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin

location_facility: Clinica Pediatrica Ospedale S. Gerardo Via Donizetti

location_facility: Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant

location_facility: Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie

location_facility: Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Hospital General Universitario de Alicante

location_facility: Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique

location_facility: Helsinki University Hospital, Department of Pediatric Hematology and Oncology

location_facility: U.O. Pediatria Ospedale Infermi- Azienda USL Rimini

location_facility: Divisione di Ematologia Pediatrica- Ospedale "Bambino Gesù". Istituto di Ricerca Scientifica

location_facility: Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

location_facility: Dipartimento Pediatrico degli OO.RR. di Bergamo

location_facility: Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University

location_facility: Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9

location_facility: Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant

location_facility: Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie

location_facility: Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

location_facility: Divisione Ematologia - Oncologia Pediatrica, Clinica Pediatrica

location_facility: CHR Citadelle Hémato - oncologie pédiatrique

location_facility: Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie

location_facility: Service d'Hémato-Oncologie Pédiatrique- American Hospital

location_facility: Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie

location_facility: Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"

location_facility: Instituto Português de Oncologia - Francisco Gentil - Libosa

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Children's Hospital at Hadassah, Ein Kerem Medical Center

location_facility: Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse

location_facility: service d'oncologie pédiatrique, hopital Félix Guyon

location_facility: Hospital Regional Universitario de Málaga

location_facility: U. O. di Pediatria- Azienda Ospedaliera Annunziata

location_facility: Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Luzerner Kantonspital - Kinderspital Luzern

location_facility: Aarhus University Hospital, Department of Pediatrics

location_facility: Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone

location_facility: Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University

location_facility: Hématologie Oncologie pédiatrique, CHRU Besançon

location_facility: Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie

location_facility: Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22

location_facility: Department of pediatric hematology and oncology, Children´s University Hospital

location_facility: Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie

location_facility: Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie

location_facility: Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT

location_facility: Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie

location_facility: Tampere University Hospital, Paediatric Haematology and Oncology

location_facility: service d'oncologie pédiatrique, institut Curie

location_facility: Service d'Hemato-Oncologie Pediatrique CHU Rouen

location_facility: Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I

location_facility: Turku University Hospital, Paediatric and Adolescent Haematology and Oncology

location_facility: Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie

location_facility: Clinica Pediatrica, Centro Regionale Oncoematologia Pediatrica- Ospedale dei Bambini "G. Salesi"

location_facility: Clinica di Oncoematologia Pediatrica- Azienda Ospedaliera-Università di Padova

location_facility: Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie

location_facility: Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie

location_facility: Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences

location_facility: Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet

location_facility: Department of Pediatric Oncology, Children's Memorial Health Institute

location_facility: Dipartimento di Ematologia e Oncologia Pediatrica Istituto " G. Gaslini"

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie

location_facility: Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD

location_facility: Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie

location_facility: Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre


title: A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

summary: A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

lead_sponsor: Abivax S.A.

location_country:
Italy
Austria
Serbia
United Kingdom
Spain
Germany
France
Czechia
Poland
Slovakia
Hungary
Belgium
Belarus
Canada
Slovenia
Ukraine

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Vitebsk regoinal clinical specialized center

location_facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University Hospitals Leuven - campus Gasthuisberg

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: CNE Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern