title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

acronym: REGENERATE

summary: The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

ReferenceCitation: Younossi ZM, Stepanova M, Nader F, Loomba R, Anstee QM, Ratziu V, Harrison S, Sanyal AJ, Schattenberg JM, Barritt AS, Noureddin M, Bonacci M, Cawkwell G, Wong B, Rinella M; RandomizEd Global Phase 3 Study to Evaluate the Impact on NASH with FibRosis of Obeticholic Acid TreatmEnt Study Investigators. Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis. Clin Gastroenterol Hepatol. 2021 Jul 15. pii: S1542-3565(21)00751-5. doi: 10.1016/j.cgh.2021.07.020. [Epub ahead of print]

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

family: Stepanova

full_name: Maria Stepanova

given: Maria

family: Nader

full_name: Fatema Nader

given: Fatema

family: Loomba

full_name: Rohit Loomba

given: Rohit

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Harrison

full_name: Stephen Harrison

given: Stephen

family: Sanyal

full_name: Arun J. Sanyal

given: Arun J.

family: Schattenberg

full_name: Jörn M. Schattenberg

given: Jörn M.

family: Barritt

full_name: A. Sidney Barritt

given: A. Sidney

family: Noureddin

full_name: Mazen Noureddin

given: Mazen

family: Bonacci

full_name: Martin Bonacci

given: Martin

family: Cawkwell

full_name: Gail Cawkwell

given: Gail

family: Wong

full_name: Bruce Wong

given: Bruce

family: Rinella

full_name: Mary Rinella

given: Mary

journal_name: Clinical Gastroenterology and Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5. Erratum in: Lancet. 2020 Aug 1;396(10247):312. Erratum in: Lancet. 2021 Jun 19;397(10292):2336.

full_name: Zobair M Younossi

given: Zobair M

full_name: Quentin M Anstee

given: Quentin M

family: Goodman

full_name: Zachary Goodman

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Ratziu V, Sanyal AJ, Loomba R, Rinella M, Harrison S, Anstee QM, Goodman Z, Bedossa P, MacConell L, Shringarpure R, Shah A, Younossi Z. REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis. Contemp Clin Trials. 2019 Sep;84:105803. doi: 10.1016/j.cct.2019.06.017. Epub 2019 Jun 29.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

location_country:
Finland
Australia
Belgium
Denmark
France
Poland
Canada
Sweden
Switzerland
Hungary
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Austria
Serbia
Israel
New Zealand
Spain

location_facility: The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition

location_facility: The Research Institute of the McGill University Health Centre

location_facility: The University of Chicago Medical Center

location_facility: Universitätsklinik für Innere Medizin I Innsbruck

location_facility: University Hospitals Coventry & Warwickshire

location_facility: Hospital Clinico Universitario de Valencia

location_facility: St. Josef-Hospital, Ruhr University Bochum

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr WI. Bieganskiego

location_facility: Indiana University Health University Hospital

location_facility: Soroka Medical Center Division of Internal Medicine

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: The Queen's Medical Center - Liver Center

location_facility: California Pacific Medical Center (CPMC)

location_facility: Hospital (Universitario) Virgen de la Victoria

location_facility: University of Wisconsin Hospital & Clinics

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Hôpital Henri Mondor - Service d'hépatologie

location_facility: Prisma Health- Upstate Gastroenterology and Liver Center

location_facility: University Hospitals Case Medical Center

location_facility: Norfolk and Norwich University Hospitals

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: AW Morrow Gastroenterology and Liver Centre Royal Prince Alfred Hospital

location_facility: Hospital Universitario Fundación Alcorcon

location_facility: Aarhus University Hospital Medicinsk Hepatogastroenterologisk Afdeling

location_facility: Washington University School of Medicine - Gastroenterology

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: Veteran Affairs Great Los Angeles Healthcare System

location_facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Royal Adelaide Hospital Gastroenterology and Hepatology Dept.

location_facility: Banner Advanced Liver Disease and Transplant Institute

location_facility: Universitätsklinikum Leipzig Klinik für Gastroenterologie und Rheumatologie-Sektion Hepatologie

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: University of Louisville Medical, Clinical Trials Unit

location_facility: Hospital (Universitario) Marqués de Valdecilla

location_facility: Charite Universitätsmedizin Campus Virchow

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Florida Digestive Health Specialist Research Institute

location_facility: University Hospital Bristol NHS Foundation Trust

location_facility: University di Bologna - Dipartimento di Scienze Mediche e Chirurgiche - DIMEC

location_facility: University of North Carolina at Chapel Hill, School of Medicine

location_facility: Baylor Scott & White All Saints Medical Center

location_facility: Krankenhaus Barmherzige Bruder Innere Medizin I - Gastroenterologie

location_facility: Azienda Socio-Sanitaria Territoriale (ASST) Santi Paolo e Carlo

location_facility: New York University (NYU) Langone Medical Center

location_facility: Nottingham Digestive Diseases and Biomedical Research Unit

location_facility: Rambam Medical Center Center for Liver diseases

location_facility: University of Colorado Denver and Hospital

location_facility: Indianapolis Gastroenterology & Hepatology

location_facility: Gastroenterology Department Hull Royal Infirmary

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Methodist Healthcare, University Hospital

location_facility: UZ Leuven Campus Gathuisberg Hepatology Department

location_facility: Walter Reed National Military Medical Center

location_facility: Hospital Saint Antoine Department of Hepatology

location_facility: London Health Sciences Centre University Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Azienda Ospedaliera Universitaria Policlinico

location_facility: Baylor College of Medicine Ben Taub General Hospital

location_facility: Carolinas Center for Liver Disease/Carolinas HeatlhCare System

location_facility: Friedrich-Alexander-Universität Erlangen Medizinische Klinik 1

location_facility: CHLC, EPE - Hospital de Santo Antonio dos Capuchos

location_facility: Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Institute for Liver and Digestive Health

location_facility: Southern Therapy and Advanced Research, LLC

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: University of California Davis Medical Center

location_facility: Universitätsklinikum Heidelberg Medizinischen Klinik IV Gastroenterologie und Hepatologie

location_facility: Hospital del Mar Gastroenterology Department

location_facility: Hospital General y Universitario de Alicante

location_facility: University Clinic of Gastroenterology & Hepatology

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hosp. de Santa Maria

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Service d'Hepato-Gastroenterologie CHR Orleans - La Source

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: Rutgers University New Jersey Medical School

location_facility: Asheville Gastroenterology Associates, PA

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

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: CHI Health Alegent Creighton Clinic Gastroenterology

location_facility: Gastroenterology Consultants of San Antonio

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Hospital of the University of Pennsylvania

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz

location_facility: CHU de Nancy - Hôpital de Brabois adultes

location_facility: Institute for Liver Health DBA Arizona Liver Health

location_facility: Digestive Health Specialists of the Southeast

location_facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

location_facility: Universitatsklinikum Aachen, RWTH Aachen, Medizinische Klinik III

location_facility: Hospital Clinico Universitario de Santiago

location_facility: The University of Vermont Medical Center - Smith 2

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: The Alfred Hospital, Department of Gastroenterology

location_facility: Central Manchester University Hospital NHS Foundation Trust Manchester Royal Infirmary

location_facility: University of Massachusetts Medical School

location_facility: Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Consorcio Hospital General Universitario

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

location_facility: Huron Gastroenterology Associates/Center for Digestive Care

location_facility: University Hosptial Cologne Clinics for Gastroenterology and Hepatology


ReferenceType: background

ReferenceCitation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Nowack C, Kolkhof P, Ferreira AC, Schloemer P, Filippatos G; on behalf of the FIDELIO-DKD study investigators; FIDELIO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):333-344. doi: 10.1159/000503713. Epub 2019 Oct 25.

ReferenceType: result

ReferenceCitation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

name: From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.),...

family: Bakris

full_name: George L. Bakris

given: George L.

sequence: first

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

sequence: additional

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Pitt

full_name: Bertram Pitt

given: Bertram

family: Ruilope

full_name: Luis M. Ruilope

given: Luis M.

family: Rossing

full_name: Peter Rossing

given: Peter

family: Kolkhof

full_name: Peter Kolkhof

family: Nowack

full_name: Christina Nowack

given: Christina

family: Schloemer

full_name: Patrick Schloemer

given: Patrick

family: Joseph

full_name: Amer Joseph

given: Amer

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16.

name: National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Greece (G.F.).

name: Department of Cardiology, and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.).

name: Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis (R.A.).

name: Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.).

name: Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain (L.M.R.).

name: Biomedical Research Networking Center on Cardiovascular Diseases, Hospital Universitario 12 de Octubre, Madrid, Spain (L.M.R.).

name: Faculty of Sport Sciences, European University of Madrid, Spain (L.M.R.).

name: Steno Diabetes Center Copenhagen, Gentofte, Denmark (P.R.).

name: Department of Clinical Medicine, University of Copenhagen, Denmark (P.R.).

name: Research and Development, Preclinical Research Cardiovascular (P.K.), Bayer AG, Wuppertal, Germany.

name: Research and Development, Statistics and Data Insights (P.S.), Bayer AG, Wuppertal, Germany.

name: Cardiology and Nephrology Clinical Development (I.T., A.J.), Bayer AG, Wuppertal, Germany.

family: Tornus

full_name: Ingo Tornus

given: Ingo

name: Department of Medicine, University of Chicago Medicine, IL (G.L.B.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Ruilope LM, Boletis J, Toto R, Umpierrez GE, Wanner C, Wada T, Scott C, Joseph A, Ogbaa I, Roberts L, Scheerer MF, Bakris GL. Effects of canagliflozin versus finerenone on cardiorenal outcomes: exploratory post-hoc analyses from FIDELIO-DKD compared to reported CREDENCE results. Nephrol Dial Transplant. 2021 Nov 25. pii: gfab336. doi: 10.1093/ndt/gfab336. [Epub ahead of print]

title: OUP accepted manuscript

ReferenceCitation: Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Erraez S, López-Mesa M, Gómez-Fernández P. [Mineralcorticoid receptor blockers in chronic kidney disease]. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. Review. English, Spanish.

title: Bloqueantes del receptor mineralcorticoide en la enfermedad renal crónica

ReferenceCitation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2020 Dec 6. pii: gfaa294. doi: 10.1093/ndt/gfaa294. [Epub ahead of print]

name: Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN, USA

name: Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany

name: Department of Medicine, University of Chicago Medicine, Chicago, IL, USA

name: National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece

name: Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA

name: Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark

name: IBER-CV, Hospital Universitario, 12 de Octubre, Madrid, Spain

name: Faculty of Sport Sciences, European University of Madrid, Madrid, Spain

name: Research and Development, Statistics and Data Insights, Bayer AG, Berlin, Germany

name: Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany

name: Research and Development, Clinical Development Operations, Bayer AG, Wuppertal, Germany

name: Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany

name: on behalf of the FIDELIO-DKD and FIGARO-DKD Investigators

repository_institution: Universidad Europea - ABACUS. Repositorio de Producción Científica

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

name: Department of Medicine; Royal North Shore Hospital; Sydney Australia

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Emergency and Organ Transplantation; University of Bari; Bari Italy

name: Institute of Clinical Physiology; CNR - Italian National Council of Research; Reggio Calabria Italy

name: Baylor College of Medicine; Houston Texas USA

name: Department of Medicine; University of Otago Christchurch; Christchurch New Zealand

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Vietnam
Bulgaria
Singapore
Hungary
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

summary: The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.


type: Other Identifier

title: POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)

acronym: CONNECT-IBD

summary:
This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:

To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
Netherlands
Spain
Finland
France
Czechia
Greece
Slovakia
Hungary
Belgium
Portugal
Germany
United Kingdom

location_facility: ASUR Area Vasta n. 4 - Ospedale A. Murri

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Ospedale Generale Provinciale di Macerata

location_facility: Azienda Ospedaliera Universitaria di PISA

location_facility: Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello

location_facility: Azienda Ospedaliera - Universitaria di Modena Policlinico

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Medizinisches Versorgungszentrum Portal 10

location_facility: V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Centrum péce o zažívací trakt, Vítkovická nemocnice

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen

location_facility: Szte szent-gyorgyi albert klinikai kozpont

location_facility: Centro Hospitalar entre Douro e Vouga E.P.E.

location_facility: Azienda Ospedaliera per l'Emergenza Cannizzaro

location_facility: Hamburgisches Forschungsinstitut fur chronisch entzuendliche

location_facility: Zentrum für Gastroenterologie Saarbrücken MVZ GmbH

location_facility: Hospital Universitario de Gran Canaria DR NEGRIN

location_facility: Fondazione Poliambulanza - Istituto Ospedaliero

location_facility: IKEM (Institut Klinické a Experimentální Medicíny)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Prof. Doutor Fernando Fonseca E.P.E

location_facility: Gloucestershire Hospitals - NHS Foundation Trust

location_facility: Internisten am Markt Dres. Schwerdtfeger & Lehmann

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"

location_facility: Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner

location_facility: Onco Studies an der Onkologie Dreiländereck

location_facility: Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main

location_facility: Gastroenterologische Gemeinschaftspraxis am Germania-Campus

location_facility: Gastroenterologische Praxis Dr. med. B. Adami

location_facility: Università degli Studi "G. d'Annunzio" Chieti - Pescara

location_facility: A.O.U. "S. Maria della Misericordia di Udine"

location_facility: Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Magen-Darm Praxis Prof. Dr. Krammer & Kollegen

location_facility: Centro Hospitalar Barreiro Montijo, E.P.E

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Groupe hospitalier mutualiste les portes du Sud

location_facility: Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Micra Transcatheter Pacing System Post-Approval Registry

summary:
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.

name: Division of Cardiology, Section of Electrophysiology Emory University Atlanta Georgia USA

family: El‐Chami

full_name: Mikhael F. El‐Chami

given: Mikhael F.

family: Shinn

full_name: Timothy Shinn

given: Timothy

name: Lancaster General Health  Lancaster Pennsylvania USA

family: Bansal

full_name: Sundeep Bansal

given: Sundeep

name: Unidad de Arritmias, Servicio de Cardiología, University Clinical Hospital of Santiago de Compostela Santiago de Compostela Spain

family: Martinez‐Sande

full_name: Jose L. Martinez‐Sande

given: Jose L.

name: Department of Cardiologic Medicine Centre Hospitalier Régional Universitaire de Tours ‐ Hôpital Trousseau Tours France

family: Clementy

full_name: Nicolas Clementy

given: Nicolas

name: Division of Cardiovascular Medicine, Department of Internal Medicine, Electrophysiology Section The Ohio State University Wexner Medical Center  Columbus Ohio USA

family: Augostini

full_name: Ralph Augostini

given: Ralph

family: Ravindran

full_name: Bipin Ravindran

given: Bipin

name: Baptist Heart Specialists, Baptist Medical Center  Jacksonville Florida USA

family: Sagi

full_name: Venkata Sagi

given: Venkata

name: Department of Cardiology Haga Teaching Hospital  The Hauge The Netherlands

family: Ramanna

full_name: Hemanth Ramanna

given: Hemanth

name: Department of Cardiovascular Sciences, Department of Cardiology University Hospitals Leuven Leuven Belgium

family: Garweg

full_name: Christophe Garweg

given: Christophe

name: University Hospital Southampton NHS Foundation Trust  Southampton UK

family: Roberts

full_name: Paul R. Roberts

given: Paul R.

name: Department of Cardiovascular Medicine Kyorin University School of Medicine  Tokyo Japan

family: Soejima

full_name: Kyoko Soejima

given: Kyoko

name: Medtronic, Inc.  Mounds View Minnesota USA

family: Stromberg

full_name: Kurt Stromberg

given: Kurt

family: Fagan

full_name: Dedra H. Fagan

given: Dedra H.

family: Zuniga

full_name: Nicky Zuniga

given: Nicky

name: Duke University Medical Center and Duke Clinical Research Institute  Durham North Carolina USA

family: Piccini

full_name: Jonathan P. Piccini

given: Jonathan P.

journal_name: Journal of Cardiovascular Electrophysiology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

family: Garg

full_name: Aatish Garg

given: Aatish

family: Koneru

full_name: Jayanthi N. Koneru

given: Jayanthi N.

ReferenceCitation: El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Viñolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

location_country:
Greece
Belgium
Denmark
Iceland
France
Japan
Poland
Kuwait
Norway
Canada
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Czechia
Israel
New Zealand
Spain


design_allocation: Randomized

intervention_type: Radiation

study_type: Interventional

lead_sponsor: Aragon Pharmaceuticals, Inc.

primary_purpose: Treatment

location_country:
Malaysia
Romania
Belgium
Russian Federation
Taiwan
Ukraine
France
Poland
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
China
United States
Germany
United Kingdom
Brazil
Mexico
Czechia
Israel
Spain
Turkey

type: EudraCT Number

source: euctr

title: ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy

summary: The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

status_simplified: Ongoing


ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country: Austria Switzerland Germany Finland France Czechia Greece Poland Slovakia Romania Hungary Belgium Spain Denmark Canada Slovenia

acronym: APPRISE

location_facility:
Investigational Site Number 642-002
Investigational Site Number 756004
Investigational Site Number 124015
Investigational Site Number 124007
Investigational Site Number 056015
Investigational Site Number 616002
Investigational Site Number 724015
Investigational Site Number 056008
Investigational Site Number 250015
Investigational Site Number 703001
Investigational Site Number 250021
Investigational Site Number 056011
Investigational Site Number 040006
Investigational Site Number 724011
Investigational Site Number 724001
Investigational Site Number 724010
Investigational Site Number 040007
Investigational Site Number 250017
Investigational Site Number 250041
Investigational Site Number 250037
Investigational Site Number 040002
Investigational Site Number 056002
Investigational Site Number 124031
Investigational Site Number 250010
Investigational Site Number 124012
Investigational Site Number 124020
Investigational Site Number 208002
Investigational Site Number 124003
Investigational Site Number 040004
Investigational Site Number 124018
Investigational Site Number 056001
Investigational Site Number 724007
Investigational Site Number 276003
Investigational Site Number 208003
Investigational Site Number 724002
Investigational Site Number 124023
Investigational Site Number 124013
Investigational Site Number 250044
Investigational Site Number 124014
Investigational Site Number 724017
Investigational Site Number 124008
Investigational Site Number 250002
Investigational Site Number 250016
Investigational Site Number 250050
Investigational Site Number 124009
Investigational Site Number 250024
Investigational Site Number 250001
Investigational Site Number 724009
Investigational Site Number 250051
Investigational Site Number 056019
Investigational Site Number 300001
Investigational Site Number 056007
Investigational Site Number 250054
Investigational Site Number 040005
Investigational Site Number 250013
Investigational Site Number 642-003
Investigational Site Number 250046
Investigational Site Number 250039
Investigational Site Number 040003
Investigational Site Number 756003
Investigational Site Number 124001
Investigational Site Number 124002
Investigational Site Number 203001
Investigational Site Number 250038
Investigational Site Number 056009
Investigational Site Number 724003
Investigational Site Number 056018
Investigational Site Number 703003
Investigational Site Number 250023
Investigational Site Number 724005
Investigational Site Number 124026
Investigational Site Number 348003
Investigational Site Number 250026
Investigational Site Number 705001
Investigational Site Number 124027
Investigational Site Number 250032
Investigational Site Number 724012
Investigational Site Number 724008
Investigational Site Number 703002
Investigational Site Number 250045
Investigational Site Number 756001
Investigational Site Number 124025
Investigational Site Number 056005
Investigational Site Number 250030
Investigational Site Number 203005
Investigational Site Number 300002
Investigational Site Number 250047
Investigational Site Number 724019
Investigational Site Number 250019
Investigational Site Number 124024
Investigational Site Number 124005
Investigational Site Number 250018
Investigational Site Number 724006
Investigational Site Number 040008
Investigational Site Number 124030
Investigational Site Number 250011
Investigational Site Number 250008
Investigational Site Number 056006
Investigational Site Number 124022
Investigational Site Number 300003
Investigational Site Number 756005
Investigational Site Number 250036
Investigational Site Number 056013
Investigational Site Number 724014
Investigational Site Number 203004
Investigational Site Number 250022
Investigational Site Number 724020
Investigational Site Number 348004
Investigational Site Number 203002
Investigational Site Number 246003
Investigational Site Number 250035
Investigational Site Number 276001
Investigational Site Number 250004
Investigational Site Number 250057
Investigational Site Number 250040
Investigational Site Number 124011
Investigational Site Number 250014
Investigational Site Number 724016
Investigational Site Number 250048
Investigational Site Number 040010
Investigational Site Number 124017
Investigational Site Number 124019
Investigational Site Number 250027
Investigational Site Number 250049
Investigational Site Number 616005
Investigational Site Number 250031
Investigational Site Number 246001
Investigational Site Number 616003
Investigational Site Number 250006
Investigational Site Number 056004
Investigational Site Number 250012
Investigational Site Number 056017
Investigational Site Number 348001
Investigational Site Number 124032
Investigational Site Number 250028
Investigational Site Number 250025
Investigational Site Number 056016
Investigational Site Number 616001
Investigational Site Number 724004
Investigational Site Number 124028
Investigational Site Number 250034
Investigational Site Number 040001
Investigational Site Number 250042
Investigational Site Number 056010
Investigational Site Number 208001
Investigational Site Number 250033
Investigational Site Number 348002
Investigational Site Number 056003
Investigational Site Number 056014
Investigational Site Number 642-001
Investigational Site Number 756002
Investigational Site Number 250007
Investigational Site Number 616004

ipd_sharing: Yes

title: A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies

summary:
Primary Objective:

To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population.

Secondary Objectives:

To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment.

To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).


title: Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF

summary: The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

time_perspective: Cross-Sectional

lead_sponsor: Boehringer Ingelheim

location_country:
United Kingdom
France
Bulgaria
Slovakia
Spain
Denmark
Germany
Czech Republic

location_facility: Boehringer Ingelheim Investigational Site 153

location_facility: Boehringer Ingelheim Investigational Site 67

location_facility: Boehringer Ingelheim Investigational Site 4

location_facility: Boehringer Ingelheim Investigational Site 28

location_facility: Boehringer Ingelheim Investigational Site 64

location_facility: Boehringer Ingelheim Investigational Site 144

location_facility: Boehringer Ingelheim Investigational Site 136

location_facility: Boehringer Ingelheim Investigational Site 160

location_facility: Boehringer Ingelheim Investigational Site 33

location_facility: Boehringer Ingelheim Investigational Site 70

location_facility: Boehringer Ingelheim Investigational Site 105

location_facility: Boehringer Ingelheim Investigational Site 91

location_facility: Boehringer Ingelheim Investigational Site 39

location_facility: Boehringer Ingelheim Investigational Site 79

location_facility: Boehringer Ingelheim Investigational Site 92

location_facility: Boehringer Ingelheim Investigational Site 97

location_facility: Boehringer Ingelheim Investigational Site 154

location_facility: Boehringer Ingelheim Investigational Site 26

location_facility: Boehringer Ingelheim Investigational Site 24

location_facility: Boehringer Ingelheim Investigational Site 49

location_facility: Boehringer Ingelheim Investigational Site 89

location_facility: Boehringer Ingelheim Investigational Site 131

location_facility: Boehringer Ingelheim Investigational Site 102

location_facility: Boehringer Ingelheim Investigational Site 15

location_facility: Boehringer Ingelheim Investigational Site 108

location_facility: Boehringer Ingelheim Investigational Site 62

location_facility: Boehringer Ingelheim Investigational Site 41

location_facility: Boehringer Ingelheim Investigational Site 9

location_facility: Boehringer Ingelheim Investigational Site 23

location_facility: Boehringer Ingelheim Investigational Site 74

location_facility: Boehringer Ingelheim Investigational Site 86

location_facility: Boehringer Ingelheim Investigational Site 100

location_facility: Boehringer Ingelheim Investigational Site 94

location_facility: Boehringer Ingelheim Investigational Site 73

location_facility: Boehringer Ingelheim Investigational Site 130

location_facility: Boehringer Ingelheim Investigational Site 125

location_facility: Boehringer Ingelheim Investigational Site 6

location_facility: Boehringer Ingelheim Investigational Site 18

location_facility: Boehringer Ingelheim Investigational Site 159

location_facility: Boehringer Ingelheim Investigational Site 65

location_facility: Boehringer Ingelheim Investigational Site 68

location_facility: Boehringer Ingelheim Investigational Site 117

location_facility: Boehringer Ingelheim Investigational Site 155

location_facility: Boehringer Ingelheim Investigational Site 148

location_facility: Boehringer Ingelheim Investigational Site 82

location_facility: Boehringer Ingelheim Investigational Site 83

location_facility: Boehringer Ingelheim Investigational Site 69

location_facility: Boehringer Ingelheim Investigational Site 140

location_facility: Boehringer Ingelheim Investigational Site 87

location_facility: Boehringer Ingelheim Investigational Site 56

location_facility: Boehringer Ingelheim Investigational Site 139

location_facility: Boehringer Ingelheim Investigational Site 119

location_facility: Boehringer Ingelheim Investigational Site 16

location_facility: Boehringer Ingelheim Investigational Site 77

location_facility: Boehringer Ingelheim Investigational Site 8

location_facility: Boehringer Ingelheim Investigational Site 111

location_facility: Boehringer Ingelheim Investigational Site 10

location_facility: Boehringer Ingelheim Investigational Site 58

location_facility: Boehringer Ingelheim Investigational Site 80

location_facility: Boehringer Ingelheim Investigational Site 141

location_facility: Boehringer Ingelheim Investigational Site 43

location_facility: Boehringer Ingelheim Investigational Site 151

location_facility: Boehringer Ingelheim Investigational Site 14

location_facility: Boehringer Ingelheim Investigational Site 35

location_facility: Boehringer Ingelheim Investigational Site 124

location_facility: Boehringer Ingelheim Investigational Site 47

location_facility: Boehringer Ingelheim Investigational Site 55

location_facility: Boehringer Ingelheim Investigational Site 66

location_facility: Boehringer Ingelheim Investigational Site 75

location_facility: Boehringer Ingelheim Investigational Site 7

location_facility: Boehringer Ingelheim Investigational Site 110

location_facility: Boehringer Ingelheim Investigational Site 109

location_facility: Boehringer Ingelheim Investigational Site 84

location_facility: Boehringer Ingelheim Investigational Site 13

location_facility: Boehringer Ingelheim Investigational Site 145

location_facility: Boehringer Ingelheim Investigational Site 150

location_facility: Boehringer Ingelheim Investigational Site 120

location_facility: Boehringer Ingelheim Investigational Site 71

location_facility: Boehringer Ingelheim Investigational Site 88

location_facility: Boehringer Ingelheim Investigational Site 135

location_facility: Boehringer Ingelheim Investigational Site 37

location_facility: Boehringer Ingelheim Investigational Site 149

location_facility: Boehringer Ingelheim Investigational Site 17

location_facility: Boehringer Ingelheim Investigational Site 5

location_facility: Boehringer Ingelheim Investigational Site 12

location_facility: Boehringer Ingelheim Investigational Site 54

location_facility: Boehringer Ingelheim Investigational Site 121

location_facility: Boehringer Ingelheim Investigational Site 142

location_facility: Boehringer Ingelheim Investigational Site 61

location_facility: Boehringer Ingelheim Investigational Site 122

location_facility: Boehringer Ingelheim Investigational Site 146

location_facility: Boehringer Ingelheim Investigational Site 107

location_facility: Boehringer Ingelheim Investigational Site 93

location_facility: Boehringer Ingelheim Investigational Site 147

location_facility: Boehringer Ingelheim Investigational Site 127

location_facility: Boehringer Ingelheim Investigational Site 36

location_facility: Boehringer Ingelheim Investigational Site 38

location_facility: Boehringer Ingelheim Investigational Site 29

location_facility: Boehringer Ingelheim Investigational Site 60

location_facility: Boehringer Ingelheim Investigational Site 123

location_facility: Boehringer Ingelheim Investigational Site 22

location_facility: Boehringer Ingelheim Investigational Site 32

location_facility: Boehringer Ingelheim Investigational Site 53

location_facility: Boehringer Ingelheim Investigational Site 52

location_facility: Boehringer Ingelheim Investigational Site 40

location_facility: Boehringer Ingelheim Investigational Site 76

location_facility: Boehringer Ingelheim Investigational Site 78

location_facility: Boehringer Ingelheim Investigational Site 106

location_facility: Boehringer Ingelheim Investigational Site 158

location_facility: Boehringer Ingelheim Investigational Site 129

location_facility: Boehringer Ingelheim Investigational Site 72

location_facility: Boehringer Ingelheim Investigational Site 1

location_facility: Boehringer Ingelheim Investigational Site 113

location_facility: Boehringer Ingelheim Investigational Site 30

location_facility: Boehringer Ingelheim Investigational Site 118

location_facility: Boehringer Ingelheim Investigational Site 152

location_facility: Boehringer Ingelheim Investigational Site 46

location_facility: Boehringer Ingelheim Investigational Site 50

location_facility: Boehringer Ingelheim Investigational Site 27

location_facility: Boehringer Ingelheim Investigational Site 44

location_facility: Boehringer Ingelheim Investigational Site 85

location_facility: Boehringer Ingelheim Investigational Site 3

location_facility: Boehringer Ingelheim Investigational Site 31

location_facility: Boehringer Ingelheim Investigational Site 157

location_facility: Boehringer Ingelheim Investigational Site 2

location_facility: Boehringer Ingelheim Investigational Site 112

location_facility: Boehringer Ingelheim Investigational Site 19

location_facility: Boehringer Ingelheim Investigational Site 20

location_facility: Boehringer Ingelheim Investigational Site 25

location_facility: Boehringer Ingelheim Investigational Site 63

location_facility: Boehringer Ingelheim Investigational Site 99

location_facility: Boehringer Ingelheim Investigational Site 81

location_facility: Boehringer Ingelheim Investigational Site 48

location_facility: Boehringer Ingelheim Investigational Site 42

location_facility: Boehringer Ingelheim Investigational Site 143

location_facility: Boehringer Ingelheim Investigational Site 156

location_facility: Boehringer Ingelheim Investigational Site 138

location_facility: Boehringer Ingelheim Investigational Site 11

location_facility: Boehringer Ingelheim Investigational Site 96

location_facility: Boehringer Ingelheim Investigational Site 104

location_facility: Boehringer Ingelheim Investigational Site 101

location_facility: Boehringer Ingelheim Investigational Site 45

location_facility: Boehringer Ingelheim Investigational Site 132

location_facility: Boehringer Ingelheim Investigational Site 137

location_facility: Boehringer Ingelheim Investigational Site 59

location_facility: Boehringer Ingelheim Investigational Site 161

location_facility: Boehringer Ingelheim Investigational Site 103

location_facility: Boehringer Ingelheim Investigational Site 114

location_facility: Boehringer Ingelheim Investigational Site 57

location_facility: Boehringer Ingelheim Investigational Site 115

location_facility: Boehringer Ingelheim Investigational Site 128

location_facility: Boehringer Ingelheim Investigational Site 90

location_facility: Boehringer Ingelheim Investigational Site 116

location_facility: Boehringer Ingelheim Investigational Site 21

location_facility: Boehringer Ingelheim Investigational Site 51

location_facility: Boehringer Ingelheim Investigational Site 95

location_facility: Boehringer Ingelheim Investigational Site 98

location_facility: Boehringer Ingelheim Investigational Site 34

location_facility: Boehringer Ingelheim Investigational Site 134

location_facility: Boehringer Ingelheim Investigational Site 133

location_facility: Boehringer Ingelheim Investigational Site 126


title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE (SA4AG) IN ADULTS UNDERGOING ELECTIVE OPEN POSTERIOR SPINAL FUSION PROCEDURES WITH MULTILEVEL INSTRUMENTATION

acronym: STRIVE

summary: The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

status: Terminated

primary_purpose: Prevention

location_country:
Austria
Sweden
Germany
France
Bulgaria
Japan
Hungary
Spain
United States
United Kingdom
Canada

location_facility: University of Colorado Denver, School of Medicine

location_facility: University of Miami Hospital and Clinics and Research Pharmacy

location_facility: St. David's Neuroscience and Spine Institute

location_facility: Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)

location_facility: Service de Chirurgie Orthopedique et Traumatologie

location_facility: St, Michael's Hospital - St. Michael's Pharmacy

location_facility: University Medical Center of Southern Nevada

location_facility: University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: VCU Medical Center Investigational Drug Service

location_facility: Santa Monica UCLA Medical Center & Orthopaedic Hospital

location_facility: Barnes Jewish Center for Advanced Medicine

location_facility: Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck

location_facility: University of Iowa Hospitals and Clinics

location_facility: Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center

location_facility: Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital

location_facility: Meridian Hospitals Corp c/o Jersey Shore University Medical Center

location_facility: Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital

location_facility: Dell Seton Medical Center at The University of Texas

location_facility: Carilion Clinic - Department of Pharmacy

location_facility: Rush University Medical Center Professional Office Building Infusion Pharmacy

location_facility: University of Michigan Investigational Pharmacy

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Baylor College of Medicine - McNair Campus

location_facility: Cleveland Clinic Foundation - Investigation Pharmacy

location_facility: Thomas Jefferson University Hospital, Cardiovascular Associates

location_facility: Carilion Clinic Institute for Orthopaedics and Neurosciences

location_facility: University of Colorado Clinical & Translational Research Center Clinic

location_facility: Thomas Jefferson University Hospital - Pre-Admission Testing Center

location_facility: UMass Memorial Medical Center- Clinical Research Center

location_facility: The Clinical Research Unit at Mount Sinai

location_facility: Brigham and Women's Hospital Investigational Drug Services (IDS)

location_facility: Cleveland Clinic Foundation Center for Spine Health

location_facility: National Hospital Organization Murayama Medical Center

location_facility: University of Maryland Medical Systems, Investigational Drug Services

location_facility: The Rothman Institute Washington Township, NJ Office

location_facility: Anne Arundel Health System Research Institute (AAHSRI)

location_facility: The Johns Hopkins Hospital Investigational Drug Service

location_facility: VCU Heatlh Neuroscience Orthopedic and Wellness Center

location_facility: HonorHealth Scottsdale Osborn Medical Center

location_facility: Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S)

location_facility: The Feinstein Institute for Medical Research

location_facility: IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital

location_facility: Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy

location_facility: Sentara Medical Group DBA Sentara Neurosurgery Specialists

location_facility: Pharmacy Service of Hospital Clinico de Valladolid

location_facility: Twin Cities Spine Surgeons dba Twin Cities Spine Center

location_facility: Massachusetts General Hospital, Clinical Research Pharmacy

location_facility: Abington Jefferson Health-Pharmacy Department

location_facility: The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center

location_facility: Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute)

location_facility: WVU Medicine Physician Office Center Orthopaedic Surgery

location_facility: Montreal Neurological Institute and Hospital

location_facility: The Rothman Institute Marlton, NJ Office

location_facility: Orthopaedic Associates of Michigan - Research

location_facility: University of California Irvine Medical Center

location_facility: Bingham Memorial Family Medicine & Specialty Clinic

location_facility: CHI St. Luke's Health Baylor College of Medicine Medical Center

location_facility: The Lindner Center for Research and Education at The Christ Hospital

location_facility: Allina Health - Abbott Northwestern Hospital /

location_facility: Mermorial Hermann - Memorial City Medical Center

location_facility: Cedars-Sinai Medical Center - Investigational Drug

location_facility: Montreal Neurological Hospital Research Pharmacy

location_facility: Yale New Haven Hospital - St. Raphael campus

location_facility: Klinikum rechts der Isar, Technische Universitat Munchen

location_facility: University of Massachusetts Medical Center Memorial Campus

location_facility: Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School

location_facility: University of Maryland, Medical Systems, Oriole Park

location_facility: Mayo Clinic Rochester, Methodist Hospital Campus

location_facility: University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage

location_facility: Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Hospital Clínico Universitario Santiago de Compostela

location_facility: Seton Brain and Spine Institute Williamson

location_facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Detroit Receiving Hospital, Heart Hospital, Harper Hospital at

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center

location_facility: Foothills Medical Centre, University of Calgary

location_facility: Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research

location_facility: Milton S. Hershey Medical Center Pharmacy

location_facility: Ronald Reagan Med Center - University of California, Los Angeles (UCLA)

location_facility: University of Maryland Medical Systems, Department of Neurosurgery

location_facility: Boulder Community Health - Foothills Hospital

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Scott & White Memorial Hospital and Clinic

location_facility: WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy

location_facility: University of Colorado Hospital, Lone Tree Health Center

location_facility: Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Brent H. Greenwald, M.D. Neurological Surgery

location_facility: Carolina Neurosurgery and Spine Associates, P.A.

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

location_facility: Yale New Haven Hospital - Investigational Drug Services

location_facility: Hospital Universitario Politecnico La Fe

location_facility: Anne Arundel Medical Center Infusion Center

intervention_type: Other

status_simplified: Unknown


title: Clinical and Device Functional Assessment of Real World ICD Patients

acronym: CARAT

summary:
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition.

It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).

lead_sponsor: MicroPort CRM

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
France
Czechia
Slovakia
Portugal
Canada
United Kingdom

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Hospital Universitario Virgen de la Victoria

intervention_type: Device


ReferenceCitation: van der Heijden MS, Loriot Y, Durán I, Ravaud A, Retz M, Vogelzang NJ, Nelson B, Wang J, Shen X, Powles T. Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial. Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.

family: van der Heijden

full_name: Michiel S. van der Heijden

given: Michiel S.

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Durán

full_name: Ignacio Durán

given: Ignacio

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Retz

full_name: Margitta Retz

given: Margitta

family: Vogelzang

full_name: Nicholas J. Vogelzang

given: Nicholas J.

family: Nelson

full_name: Betty Nelson

given: Betty

family: Wang

full_name: Jingjing Wang

given: Jingjing

family: Shen

full_name: Xiaodong Shen

given: Xiaodong

family: Powles

full_name: Thomas Powles

given: Thomas

journal_name: European Urology

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

name: Biometrics Genentech Inc. South San Francisco CA USA

family: He

full_name: Xian He

given: Xian

family: Zhang

full_name: Wei Zhang

given: Wei

name: Clinical Pharmacology Genentech‐Roche Marseille France

family: Bruno

full_name: René Bruno

given: René

currency_apc_doaj: USD

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.

name: Department of Medical Oncology, Hotel Dieu de France University Hospital, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon

name: Department of Urology, Hotel Dieu de France University Hospital, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon

name: Department of Biostatistics, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon

ReferenceCitation: Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, Fléchon A, Gravis G, Hussain S, Takano T, Leng N, Kadel EE 3rd, Banchereau R, Hegde PS, Mariathasan S, Cui N, Shen X, Derleth CL, Green MC, Ravaud A. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748-757. doi: 10.1016/S0140-6736(17)33297-X. Epub 2017 Dec 18. Erratum in: Lancet. 2018 Oct 20;392(10156):1402.

ReferenceCitation: Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Durán I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thåström A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8. Erratum in: Lancet. 2017 Aug 26;390(10097):848.

ReferenceCitation: Kim YS, Lee SI, Park SH, Park S, Hwang IG, Lee SC, Sun JM, Lee J, Lim HY. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):76-81. doi: 10.1016/j.clgc.2015.09.008. Epub 2015 Sep 25.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Canada
Slovenia
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Spain
Turkey

location_facility: Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: National Cancer Center Hospital; Urology

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Scunthorpe General Hospital; Dept of Oncology

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: University Hospital of Patras Medical Oncology

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Northern Centre for Cancer Care; Northern Centre for Cancer Care

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Turku University Central Hospital; Urology clinic

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Osaka International Cancer Institute; Urology

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Medical University of Bialystok; Oncology clinic

location_facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

location_facility: National Cancer Center Hospital East; Breast and Medical Oncology

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology

location_facility: Sapporo Medical University Hospital; Urology

location_facility: Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

location_facility: Yokohama City University Hospital; Urology

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Uniklinik RWTH Aachen; Klinik für Urologie

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

location_facility: National Hospital Organization Shikoku Cancer Center; Urology

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Spitalul Judetean de Urgenta Dr Constantin Opris

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Uni Hospital of Tromso; Dept. of Oncology

location_facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Emory University; Winship Cancer Institute

location_facility: Iwate Medical University Hospital; Urology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: China Medical University Hospital; Urology

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Maastricht University Medical Centre; Medical Oncology

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Royal Brisbane and Women's Hospital; Medical Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Institute Of Oncology Bucharest; Medical Oncology

location_facility: Hiroshima City Hiroshima Citizens Hospital; Urology

location_facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

location_facility: University Hospital coventry; Oncology Department

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Hirosaki University School of Medicine & Hospital; Urology

location_facility: Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Istanbul VKV American Hospital; Medical Oncology

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Centre D'Oncologie de Gentilly; Oncology

title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy

summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.