lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Peru
Finland
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Colombia
Chile
Switzerland
Netherlands
Ireland
China
United States
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0236)

location_facility: Toho University Sakura Medical Center ( Site 0732)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708)

location_facility: Yokohama City University Medical Center ( Site 0735)

location_facility: Assaf Harofeh Medical Center ( Site 1405)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 2002)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 2403)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0834)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 1212)

location_facility: Weill Cornell Medical College ( Site 0263)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0901)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 2104)

location_facility: Carolina Urologic Research Center ( Site 0259)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 2101)

location_facility: Urology Associates [Nashville, TN] ( Site 0233)

location_facility: Hospital San Lucas Cardiologica del Sureste ( Site 2606)

location_facility: Providence Alaska Medical Center ( Site 0276)

location_facility: Azienda Ospedaliera Santa Maria ( Site 1502)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1404)

location_facility: Herlev og Gentofte Hospital. ( Site 1004)

location_facility: Institut Jean Godinot-Clinical Research Unit ( Site 1118)

location_facility: Hamamatsu University Hospital ( Site 0748)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509)

location_facility: Peter MacCallum Cancer Centre ( Site 0306)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0250)

location_facility: Centre Georges Francois Leclerc ( Site 1112)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 1317)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1320)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2506)

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204)

location_facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900)

location_facility: Radboud University Medical Center ( Site 1606)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 0602)

location_facility: Niagara Health System - St. Catharines ( Site 0107)

location_facility: Riverina Cancer Care Center ( Site 0302)

location_facility: CISSS de la Monteregie-Centre ( Site 0105)

location_facility: Tallaght University Hospital ( Site 1301)

location_facility: Hospital Clinico San Carlos ( Site 1906)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508)

location_facility: Hospital Universitario Lucus Augusti ( Site 1905)

location_facility: The Sidney Kimmel Comprehensive Cancer Center ( Site 0204)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 1501)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1603)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700)

location_facility: Clinica de Oncologia Reichow ( Site 2308)

location_facility: St Vincents University Hospital ( Site 1300)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0241)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1902)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1318)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109)

location_facility: Hospital Sao Vicente de Paulo ( Site 2303)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 1103)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305)

location_facility: Nippon Medical School Hospital ( Site 0738)

location_facility: Taipei Veterans General Hospital ( Site 0501)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2105)

location_facility: Sapporo Medical University Hospital ( Site 0730)

location_facility: Aalborg Universitetshospital ( Site 1000)

location_facility: University Hospital Waterford ( Site 1303)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0502)

location_facility: University Hospital Limerick ( Site 1305)

location_facility: Winship Cancer Institute of Emory University ( Site 0209)

location_facility: Cotton-O'Neil Cancer Center ( Site 0228)

location_facility: John Flynn Hospital & Medical Centre ( Site 0308)

location_facility: Hospital 12 de Octubre de Madrid ( Site 1903)

location_facility: Istituto Nazionale dei Tumori ( Site 1510)

location_facility: Centro Investigación del Cáncer James Lind ( Site 2401)

location_facility: Franciscus Gasthuis en Vlietland ( Site 1605)

location_facility: Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600)

location_facility: Seattle Cancer Care Alliance ( Site 0258)

location_facility: Odense Universitetshospital ( Site 1003)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 2608)

location_facility: Centro Oncologico Internacional. SEDNA ( Site 2609)

location_facility: Medizinische Universitaet Wien ( Site 0903)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 2706)

location_facility: Institucion Prestadora de Servicios de Salud Clinica de la Costa LTDA ( Site 2504)

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

location_facility: Fundacao Dr Amaral Carvalho ( Site 2302)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0736)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 0253)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 1805)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 1707)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709)

location_facility: Keski-Suomen keskussairaala ( Site 1017)

location_facility: Velindre Cancer Centre Hospital ( Site 1322)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1901)

location_facility: Gallipoli Medical Research Foundation ( Site 0309)

location_facility: Severance Hospital Yonsei University Health System ( Site 0402)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1201)

location_facility: Isala Klinieken, Locatie Sophia ( Site 1604)

location_facility: Centre D Oncologie de Gentilly ( Site 1107)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1813)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1512)

location_facility: Universitaetsspital Zuerich ( Site 2001)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306)

location_facility: Osaka City University Hospital ( Site 0741)

location_facility: Hospital Militar Central [Lima, Peru] ( Site 2704)

location_facility: Administradora Country SA - Clinica del Country ( Site 2507)

location_facility: Tampereen yliopistollinen sairaala ( Site 1022)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0404)

location_facility: Zhejiang Provincial People's Hospital ( Site 0809)

location_facility: Universitaetsklinikum Freiburg ( Site 1200)

location_facility: Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721)

location_facility: Vrije Universiteit Medisch Centrum ( Site 1601)

location_facility: Centro Di Riferimento Oncologico ( Site 1511)

location_facility: Seoul National University Bundang Hospital ( Site 0401)

location_facility: Springfield Clinic [Springfield, IL] ( Site 0240)

location_facility: Pontificia Universidad Catolica de Chile ( Site 2402)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1500)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0101)

location_facility: Hospital Virgen de la Macarena ( Site 1904)

location_facility: Clinica Peruano Americana S.A. ( Site 2702)

location_facility: Tokyo Women's Medical University Hospital ( Site 0739)

location_facility: Nara Medical University Hospital ( Site 0744)

location_facility: Port Macquarie Base Hospital ( Site 0301)

location_facility: A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504)

location_facility: TYKS T-sairaala Syopatautien pkl ( Site 1019)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 1211)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100)

location_facility: Seoul National University Hospital ( Site 0405)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: Chonnam National University Hwasun Hospital ( Site 0406)

location_facility: Boca Raton Clinical Research QTO ( Site 2611)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117)

location_facility: Hartford HealthCare Medical Group ( Site 0212)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0504)

location_facility: Saitama Medical University International Medical Center ( Site 0737)

location_facility: Krankenhaus der Barmherzigen Brüder Wien ( Site 0904)

location_facility: Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106)

location_facility: Associated Medical Professionals of NY ( Site 0251)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717)

location_facility: Staedtisches Klinikum Braunschweig gGmbH ( Site 1217)

location_facility: Radomskie Centrum Onkologii ( Site 1701)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1800)

location_facility: National Cheng Kung University Hospital ( Site 0503)

location_facility: Alaska Clinical Research Center ( Site 0274)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1809)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 2304)

location_facility: Kitasato University Hospital ( Site 0734)

location_facility: Clinica Universidad Catolica del Maule ( Site 2407)

location_facility: City of Hope Medical Center ( Site 0217)

location_facility: Peking University First Hospital ( Site 0800)

location_facility: Yamaguchi University Hospital ( Site 0746)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 1718)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0269)

location_facility: St. Vincent Frontier Cancer Center-Research ( Site 0213)

title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).


title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

acronym: O'HAND

summary: This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Romania
Australia
Belgium
Russian Federation
Ukraine
Spain
Croatia
France
Poland
Canada
Colombia
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Georgia
Egypt
New Zealand

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Republican Clinical Hospital For Rehabilitation Treatment

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: City Out Patient Clinic For Rehabilitation Treatment #7

location_facility: Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Municipal Institution Vinnytsia Regional Psychoneurological Hospital n.a. O.I. Yushchenko

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: State University of New York at Buffalo; Department of Neurology

location_facility: Siberian State Medical University of Roszdrav

location_facility: Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX

location_facility: Unidad de Investigacion en Salud de Chihuahua

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: City Clinical Hospital #15 n.a. N.F. Filatov

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

location_facility: Walton Centre For Neurology and Neurosurgery

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Peninsula College of Medicine and Dentistry

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: Moscow Regional Research Clinical Institute Na Mfvladimirskiy

location_facility: Sociedad de Cirugia de Bogota Hospital San Jose

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak

location_facility: SPSK Nr 1 Im Prof S Szyszko Slaskiego Uniwersytetu Medcznego

location_facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

location_facility: State Healthcare Institution Territorial Clinical Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Dalhousie Multiple Sclerosis Research Unit

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

location_facility: Targu Mures Clinical Emergency County Hospital

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Kliniki Neurologii

location_facility: Medical Centre of PE First Private Clinic

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Zaporizhia City Multispecialty Clinical Hospital #9

location_facility: Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

location_facility: Alexandria University Hospital; New University Hospitlal Building;Clinical Research Center CRC

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Multiprofile Hospital For Active Treatment Avis Medica

location_facility: M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

location_facility: Centre Hospitalier de Colmar - Hopital Louis Pasteur; Service de Neurologie

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Centro de Diagnostico Neurofisiologico S.C

location_facility: Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa

location_facility: Sayed Galal University Hospital; Neurology Department

location_facility: Medical Center of LLC Medical Clinic Blagomed

location_facility: Spitalul Municipal Dr.Alexandru Simionescu Hunedoara

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Hopital Saint Vincent de Paul - GHICL Lille - Parent

location_facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: ASST degli Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari

location_facility: Wellington Hospital; Department of Neurology

location_facility: Samara Regional Clinical Hospital named after V.D. Seredavina

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socié G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.

name: From the Department of Medicine I, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg (R.Z.), the Department of Hematology and Oncology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck (N.B.), the Department of Hematology and Oncology, University of Leipzig, Leipzig (D.N.), and the Department of Hematology, Oncology, and Pneumology, University Medical Center Mainz, Mainz (E.M.W.) — all in Germany; the Department of Bone Marrow Transplantation, Royal Brisbane and Women’s...

family: Zeiser

full_name: Robert Zeiser

given: Robert

sequence: first

family: von Bubnoff

full_name: Nikolas von Bubnoff

given: Nikolas

sequence: additional

family: Butler

full_name: Jason Butler

given: Jason

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

family: Niederwieser

full_name: Dietger Niederwieser

given: Dietger

family: Or

full_name: Reuven Or

given: Reuven

family: Szer

full_name: Jeff Szer

given: Jeff

family: Wagner

full_name: Eva M. Wagner

given: Eva M.

family: Zuckerman

full_name: Tsila Zuckerman

given: Tsila

family: Mahuzier

full_name: Bruyère Mahuzier

given: Bruyère

family: Xu

full_name: Judith Xu

given: Judith

family: Wilke

full_name: Celine Wilke

given: Celine

family: Gandhi

full_name: Kunal K. Gandhi

given: Kunal K.

family: Socié

full_name: Gérard Socié

given: Gérard

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

name: Vanderbilt-Ingram Cancer Center, 1301 Medical Center Dr #1710, Nashville, TN, USA 37232

family: Jagasia

full_name: Madan Jagasia

given: Madan

name: Department of Hematology, Oncology & Stem Cell Transplantation, University Hospital Freiburg, Hugstetter Str. 55, 79106 Freiburg im Breisgau, Germany

name: Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE, USA 19803

family: Arbushites

full_name: Michael Arbushites

given: Michael

family: Delaite

full_name: Patricia Delaite

given: Patricia

name: Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA 07936

family: Gadbaw

full_name: Brian Gadbaw

given: Brian

family: Bubnoff

given: Nikolas von

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Greece
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Norway
Canada
Korea, Republic of
Saudi Arabia
Hong Kong
Netherlands
Bulgaria
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Turkey

title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

summary: To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation


title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

summary: Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

ipd_sharing: No

lead_sponsor: Galderma R&D

location_country:
Australia
Belgium
France
Poland
Lithuania
Canada
Korea, Republic of
Netherlands
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Georgia
New Zealand
Spain
Estonia
Latvia

location_facility:
Galderma Investigational Site 6185
Galderma Investigational Site 8728
Galderma Investigational Site 6164
Galderma Investigational Site 5407
Galderma Investigational Site 6031
Galderma Investigational Site 6065
Galderma Investigational Site 6028
Galderma Investigational Site 6058
Galderma Investigational Site 8901
Galderma Investigational Site 8904
Galderma Investigational Site 6068
Galderma Investigational Site 6186
Galderma Investigational Site 8536
Galderma Investigational Site 6214
Galderma Investigational Site 8610
Galderma Investigational Site 8896
Galderma Investigational Site 8206
Galderma Investigational Site 5005
Galderma Investigational Site 8434
Galderma Investigational Site 5382
Galderma Investigational Site 6071
Galderma Investigational Site 8804
Galderma Investigational Site 6154
Galderma Investigational Site 8745
Galderma Investigational Site 8637
Galderma Investigational Site 8672
Galderma Investigational Site 8155
Galderma Investigational Site 6116
Galderma Investigational Site 8893
Galderma Investigational Site 6061
Galderma Investigational Site 6223
Galderma Investigational Site 6216
Galderma Investigational Site 5448
Galderma Investigational Site 6040
Galderma Investigational Site 8329
Galderma Investigational Site 6053
Galderma Investigational Site 6166
Galderma Investigational Site 5469
Galderma Investigational Site 6056
Galderma Investigational Site 8142
Galderma Investigational Site 8670
Galderma Investigational Site 6122
Galderma Investigational Site 6078
Galderma Investigational Site 8857
Galderma Investigational Site 8866
Galderma Investigational Site 8743
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Galderma Investigational Site 6095


title: A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE

acronym: SAPPHIRE

summary: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

lead_sponsor: Mirati Therapeutics Inc.

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Israel
Hungary
Belgium
Spain
Canada
United Kingdom

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: Klinikum rechts der Isar der Technischen Universität München

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

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Summit Medical Group - Florham Park Campus

location_facility: The Oncology Institute of Hope and Innovation - Tucson

location_facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"

location_facility: SCRI - Florida Cancer Specialists - West Palm Beach

location_facility: University Cancer and Blood Center - LLC - Athens

location_facility: Texas Oncology - Beaumont Mamie Mcfaddin Ward Cancer Center

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz - III. Medizinischen Klinik und Poliklinik

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Pontchartrain Cancer Center - Covington Office

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center

location_facility: Florida Cancer Affiliates - Ocala - Main

location_facility: Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

location_facility: California Cancer Associates for Research and Excellence - San Marcos

location_facility: Palo Verde Cancer Specialists - Glendale

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: The Richard and Annette Bloch Cancer Care Pavilion and Westwood Medical Pavilion

location_facility: Maryland Oncology Hematology - Rockville Aquilino Cancer Center

location_facility: The Oncology Institute of Hope and Innovation - Thousand Oaks

location_facility: Horizon Health Network - The Moncton Hospital

location_facility: Torrance Memorial Physician Network - Cancer Care and Infusion Center

location_facility: Klinikverbund Kempten-Oberallgäu - Klinik Immenstadt - Klinikverbund Allgäu gGmbH

location_facility: Semmelweis Egyetem - Pulmonológiai Klinika

location_facility: Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office

location_facility: Oregon Health and Science University Knight Cancer Institute

location_facility: The Oncology Institute of Hope and Innovation - Whittier

location_facility: The Oncology Institute of Hope and Innovation - Corona

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Hospital Universitario Central de Asturias

location_facility: The Center for Cancer & Blood Disorders - Fort Worth

location_facility: Tricounty Hematology and Oncology- Massillon

location_facility: USOR - Consultants in Medical Oncology and Hematology PC - Abington Hematology/Oncology Associates

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec-Universite Laval

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Indiana University Health Arnett Cancer Care

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: SCRI - Florida Cancer Specialists - North Region Research Office

location_facility: NEA Baptist Fowler Family Center for Cancer Care

location_facility: S.C Oncologia Medica, ASST Monza - Ospedale San Gerardo

location_facility: Mercy Clinic Oncology and Hematology - Coletta

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Park Nicollet - Frauenshuh Cancer Center

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

location_facility: Institut Català d'Oncologia Badalona, Hospital Universitari Germans Trias i Puj

location_facility: Kansas City Care Health Center - Research Medical Campus

location_facility: Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Azienda Ospedaliero - Universitaria Pisana

location_facility: IRCCS Istituto Tumori "Giovanni Paolo II"

location_facility: Providence Cancer Institute Franz Clinic

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Froedtert Hospital - Medical College of Wisconsin

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Comprehensive Blood and Cancer Center - Bakersfield

location_facility: Rouen University Hôpital Charles-Nicolle

location_facility: Hospital Regional Universitario de Málaga - Hospital Civil

location_facility: Országos Korányi Tbc És Pulmonológiai Intézet

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: MultiCare Institute for Research & Innovation

location_facility: Martha-Maria Krankenhaus Halle-Dölau gGmbH, Studiensekretariat

location_facility: Northwest Georgia Oncology Centers - Marietta

location_facility: Virginia Cancer Institute - Reynolds Crossing

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: SCRI - Florida Cancer Specialists - Panhandle Research Office

location_facility: SCRI - Tennessee Oncology - Nashville - Centennial

location_facility: Sisters of Charity of Leavenworth Health St. Mary's

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum

location_facility: Regional Cancer Care Associates - Little Silver

location_facility: University Wisconsin Carbone Cancer Center

location_facility: The Ohio State University College of Medicine


status: Active, not recruiting

lead_sponsor: Gilead Sciences

enrollment_type: Actual

location_country:
Italy
Austria
United States
Switzerland
Germany
Finland
France
Japan
Israel
Australia
Belgium
New Zealand
Spain
Denmark
Canada
United Kingdom

acronym: PRIMIS

location_facility: University of Colorado Denver and Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie

location_facility: Baylor Scott & White Medical Center at Fort Worth

location_facility: Center for Liver Disease and Transplantation, Columbia University Medical Center

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Sutter Pacific Medical Foundation - California Pacific Medical Center

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia

location_facility: Istituto Clinico Humanitas - Unita Operativa di Epatologia

location_facility: Hospital Universitari Politecnic La Fe de Valencia

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: Southern Therapy and Advanced Research LLC

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: Walter Reed National Military Medical Center

location_facility: Copenhagen University Hospital - Hvidovre

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Chronic Viral Illness Service/McGill University Health Centre (MUHC)

location_facility: University of California, San Francisco Liver Clinic

location_facility: University of Manitoba/Health Sciences Centre

location_facility: Rutgers New Jersey Medical School - Doctors Office Center

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

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

location_facility: Altman Clinical and Translational Research Institute (Clinic)

location_facility: The University of Vermont Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: San Antonio Military Medical Center, Gastro/Hepatology

location_facility: Dipartimento Gastroenterologico e dei Trapianti

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: University of Chicago Medical Center (outpatient clinic)

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Turku University Hospital, Gastroenterology Outpatient Clinic

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Coral Sea Clinical Research Institute - Mackay

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

location_facility: Virginia Commonwealth University Clinical Research Services Unit

location_facility: Hospital General Universitario de Valencia

location_facility: Universitätsmedizin Mannheim, II. Medizinische Klinik

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone

location_facility: Hopital Robert Debré - Centre Hospitalier Universitaire de Reims

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital General Universitario de Alicante

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

location_facility: Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara

location_facility: Northwell Health Center for Liver Diseases and Transplantation

location_facility: University of California, Davis Medical Center (study visits)

location_facility: Saint Louis University, Gastroenterology & Hepatology

location_facility: Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: IRCCS Ospedale Sollievo della Sofferenza

location_facility: Intermountain Medical Center - Transplant Services

location_facility: Michigan Medicine - University of Michigan

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Carolinas Medical Center - Center for Liver Disease

location_facility: Nottingham University Hospitals NHS Trust

location_facility: William Osler Health System - Brampton Civic Hospital

type: EudraCT Number

type: Registry Identifier

source: euctr

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis

summary: The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).


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

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
Brazil
Peru
Spain
Germany
Finland
France
Bulgaria
Japan
Korea, Republic of
Poland
Romania
Hungary
Belgium
China
Turkey
Denmark
United States
Canada

acronym: DUO-O

title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

summary: This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.


title: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

summary: Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual standard of care in patients with intracranial hemorrhage anticoagulated with a direct oral anticoagulant

lead_sponsor: Alexion Pharmaceuticals

location_country:
Finland
Greece
Belgium
Denmark
France
Poland
Lithuania
Norway
Canada
Switzerland
Netherlands
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Estonia
Latvia

location_facility: Vitkovicka nemocnice a.s.-Neurologicke oddeleni

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4

location_facility: Hopital Sainte Anne, GHU Paris Psychiatrie et Neurosciences

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: University of Calgary, Foothills Medical Center

location_facility: Azienda Unità Sanitaria Locale (AUSL) Bologna Ospedale Maggiore

location_facility: CHU de Quebec-Universite Laval, Hôpital de l'Enfant Jésus

location_facility: Medizinische Hochschule Hannover Klinik für Neurologie OE 7210

location_facility: Azienda Ospedaliera di Perugia Ospedale "Santa Maria della Misericordia" Medicina Interna Cardiovascolare e d'Urgenza Stroke Unit

location_facility: U.O. Neurologia - Stroke Unit Ospedale San Raffaele Milan

location_facility: Fondation Ophtalmologique Rothschild - Hôpital, Neurovascular unit

location_facility: Universitätsklinik Heidelberg , Neurologische Klinik

location_facility: CHU Purpan-Pierre Paul de Riquet, Toulouse, Intensive care-resuscitation

location_facility: Hôpital d'Instruction des Armées Sainte Anne

location_facility: CHU Bordeaux, Groupe Hospitalier Pellegrin

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Neurologie Kopf- und Neurozentrum

location_facility: University General Hospital of Alexandroupolis

location_facility: "UKSH - Klinik für Neurologie des Universitätsklinikums Schleswig-Holstein Campus Lübeck

location_facility: Krankenhaus Dresden Friedrichstadt, II. Medizinische Klinik, Innere Medizin, Angiologie und Hämostaseologie

location_facility: Universitätsklinikum Frankfurt -Zentrum der Neurologie und Neurochirurgie

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Dignity Health/Barrow Neurological Institute

location_facility: Christian-Doppler Klinik, Landeskliniken Salzburg, Universitätsklinik für Neurologie

location_facility: Charité Universitätsmedizin Berlin und Centrum für Schlaganfallforschung Berlin Neurologie

location_facility: University General Hospital of Athens "Attikon"

location_facility: Klinikum Frankfurt - Klinik für Neurologie

location_facility: Azienda Socio-Sanitaria Territoriale (ASST) Grande Ospedale Metropolitano "Niguarda" Dipartimento di Neuroscienze Struttura Complessa di Neurologia e Stroke Unit

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Holy Spirit Specialist Hospital in Sandomierz

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Universitätsklinik für Neurologie und Stroke Zentrum Inselspital

location_facility: Washington University School of Medicine

location_facility: Klinikum Klagenfurt, Abteilung für Neurologie

location_facility: CHU Edouard Herriot, Anaesthesia-resuscitation

location_facility: Montreal Neurological Institute and Hospital

location_facility: CHU Gabriel Montpied, CHU de Clermont-Ferrand

location_facility: Medizinische Universität Wien, Neurologie

location_facility: Ospedale Policlinico "San Martino" Clinica Neurologica Centro Ictus

location_facility: Alfried-Krupp Krankenhaus Essen, Neuologie

location_facility: Ziekenhuis Oost-Limburg campus St-Jan, Neurologie

location_facility: Universitätsklinikum Mannheim, Neuroligische Klinik

location_facility: Ascension St. John Clinical Research Institute

location_facility: Kepler Universitätsklinikum, Med. Campus II.

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

location_facility: University General Hospital of Thessaloniki "AHEPA"

location_facility: Universitätsmedizin Greifswald, Abteilung Transfusionsmedizin am Institut für Immunologie

location_facility: Kepler Universitätsklinikum, Neuromed Campus

location_facility: Centre Hospitalier Fleyriat Service de Neurologie

location_facility: Krankenhaus der Barmherzige Brüder KH Wien, Neurologie

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: Universitätsklinikum St. Pölten, Neurologie

location_facility: Azienda Ospedaliera "San Camillo-Forlanini" Padiglione "Lancisi"

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni

location_facility: Fondazione Policlinico "Tor Vergata" Dipartimento di Neurologia

location_facility: Policlinico "Umberto I" Università degli Studi di Roma "La Sapienza" Dipartimento di Neurologia e Psichiatria

location_facility: Universitätsklinik Erlangen, Neurologische Klinik

location_facility: Complejo Asistencial Universitario de León

location_facility: Nordwest-Krankenhaus Sanderbusch gGmbH, Neurologie

location_facility: Policlinico "Gemelli" Area Neuroscienze Neurologia

location_facility: RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH, Abteilung für Neurologie

location_facility: Asklepios Klinik Barmbek, Abteilung Neurologie

location_facility: Universitatsklinikum Munster, Klinik Fur Neurologie


title: A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer

acronym: Appalaches

summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Jordan
Spain
France
Poland
Belgium
Portugal
Germany
United Kingdom

location_facility: Rimini Hospital Unit - Ospedale Sacra Famiglia

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena

location_facility: AUSL Romagna - Rimini Hospital Unit - Infermi Hospital

location_facility: Barts Health NHS Trust - St. Bartholomew'S Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska - Curie's National Institute of Oncology - National Research Institute

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: Onkologie Haematologie Gemeinschaftspraxis - Studienzentrum Onkologie Ravensburg

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Faenza Hospital Unit - Ospedale degli Infermi

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

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Fundacion Instituto Valenciano De Oncologia

location_facility: ORTENAU KLINIKUM Offenburg-Gengenbach - Klinikum Offenburg Ebertplatz

location_facility: Hospital prive du Confluent - Centre Catherine de Sienne

location_facility: Riccione Hospital Unit - Ospedale Cervesi di Cattolica

location_facility: CHU de Lyon - Hopital De La Croix Rousse

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool Victoria Hospital-NHS Fundation Trust

location_facility: Instituto Portugues De Oncologia - Instituto Portugues de Oncologia do Porto

location_facility: Institut Jules Bordet-Hopital Universitaire ULB

location_facility: AULSS 9 - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

location_facility: NHS Borders - Borders General Hospital Melrose By-pass


type: Other Identifier

title: Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

acronym: PIONEER 3

summary: This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.

status: Completed

study_completion_date_type: Actual

ReferenceType: result

ReferenceCitation: Rosenstock J, Allison D, Birkenfeld AL, Blicher TM, Deenadayalan S, Jacobsen JB, Serusclat P, Violante R, Watada H, Davies M; PIONEER 3 Investigators. Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1466-1480. doi: 10.1001/jama.2019.2942.

name: Dallas Diabetes Research Center at Medical City, Dallas, Texas

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

name: Hillcrest Family Health Center, Waco, Texas

family: Allison

full_name: Dale Allison

given: Dale

name: Department of Medicine III, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany

name: Paul Langerhans Institute Dresden, Helmholtz Center Munich at Technische Universität Dresden, Dresden, Germany

family: Birkenfeld

full_name: Andreas L. Birkenfeld

given: Andreas L.

family: Blicher

full_name: Thalia Marie Blicher

given: Thalia Marie

family: Deenadayalan

full_name: Srikanth Deenadayalan

given: Srikanth

family: Jacobsen

full_name: Jacob Bonde Jacobsen

given: Jacob Bonde

name: Endocrinology, Diabetology and Nutrition, Clinique Portes du Sud, Venissieux, France

family: Serusclat

full_name: Pierre Serusclat

given: Pierre

name: Departamento Endocrinología, Instituto Mexicano del Seguro Social, Ciudad Madero, Mexico

family: Violante

full_name: Rafael Violante

given: Rafael

name: Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan

family: Watada

full_name: Hirotaka Watada

given: Hirotaka

name: Diabetes Research Centre, University of Leicester, Leicester, England

family: Davies

full_name: Melanie Davies

given: Melanie

journal_name: JAMA

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: University of Leicester - Leicester Research Archive

version: submittedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

family: Pratley

full_name: Richard E. Pratley

given: Richard E.

family: Crowley

full_name: Matthew J. Crowley

given: Matthew J.

family: Gislum

full_name: Mette Gislum

given: Mette

family: Hertz

full_name: Christin L. Hertz

given: Christin L.

title: Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13. Review.

name: AdventHealth Translational Research Institute Orlando Florida USA

name: Diabetes Centre Bochum‐Hattingen, St Josef‐HospitalRuhr‐University Bochum Bochum Germany

title: Efficacy, safety and cardiovascular outcomes of once‐daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

name: Ted Rogers Centre for Heart ResearchToronto General Hospital Research Institute Toronto Canada

name: Swansea University Medical School, Diabetes Research Unit Cymru Swansea UK

name: UT Southwestern Medical Center, Internal Medicine and Population and Data Sciences Dallas Texas

name: Steno Diabetes Center CopenhagenGentofte Hospital, University of Copenhagen Copenhagen Denmark

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

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

location_country:
Brazil
South Africa
India
Mexico
Germany
France
Japan
Israel
Romania
Argentina
Russian Federation
Turkey
United States
United Kingdom
Ukraine


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus

acronym: STEP

summary: The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
Sweden
Netherlands
France
Bulgaria
Japan
Malaysia
Poland
Argentina
Australia
Russian Federation
Spain
United States
Korea, Republic of
Taiwan
Ukraine

location_facility: Barwon Health - University Hospital Geelong

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: National Hospital Organization Ibarakihigashi

location_facility: Saint-Petersburg State Health Care Institution 'Vvedenskaya Hospital'

location_facility: Japanese Red Cross Society Nagano Hospital

location_facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: Northwestern University - Northwestern Memorial Hospital - Infectious Disease Center

location_facility: Hospital Privado-Universitario de Cordoba

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika

location_facility: Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

location_facility: Wojewódzki Szpital Specjalistyczny im. św. Rafała w Czerwonej Górze

location_facility: Seoul National University Bundang Hospital

location_facility: Tohoku Medical And Pharmaceutical University Hospital

location_facility: Japanese Red Cross Nagasaki Genbaku Isahaya Hospital

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Kharkiv National Medical University, Regional Clinical Infectious Hospital

location_facility: State Health Care Institution of Voronezh region 'Voronezh regional clinical infectious hospital'

location_facility: Saint-Petersburg State Public Health Organization City Clinical Hospital #26

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: National Hospital Organization Tenryu Hospital

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

location_facility: Kobe City Medical Center General Hospital

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: Bukovian State Medical University, Dept. of Infectious Disease and Epidemiology

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Proszowicach

location_facility: Regional State Health Care Institution 'Clinical Hospital #1'

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: State Health Care Institution 'Engels city hospital #2'

location_facility: National Hospital Organization Higashinagoya National Hospital

status_simplified: Unknown


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

acronym: REVERSE

summary: The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

lead_sponsor: Intercept Pharmaceuticals

location_country:
United States
Germany
France
Poland
Hungary
Australia
Puerto Rico
New Zealand
Spain
Canada
United Kingdom
Ukraine

location_facility: University of Colorado Denver and Hospital

location_facility: University of California, San Francisco-Fresno

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

location_facility: Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department

location_facility: University of Mississippi Medical Center

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University of Louisville, Clinical Trials Unit

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute

location_facility: University of Iowa Hospitals and Clinics

location_facility: The Ohio State University Wexner Medical Center

location_facility: Diabetes & Endocrinology Consultants, PC

location_facility: Baylor College of Medicine - Ben Taub Hospital

location_facility: Carolinas Center for Liver Disease/Carolinas HealthCare System

location_facility: Synexus Polska Sp. z o.o., Oddział w Łodzi

location_facility: Walter Reed National Military Medical Center

location_facility: Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department

location_facility: Carolinas Health Care System Center for Liver Disease

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Hospital Universitari i Politécnic La Fe

location_facility: Hospital Clinico Universitario de Valencia

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

location_facility: Objective GI d/b/a North Alabama GI Research Center

location_facility: Gastroenterology Consultants of Southwest Virginia

location_facility: The University of Vermont Medical Center

location_facility: Center Hospitalier Universitaire Grenoble Alpes

location_facility: Gordon and Leslie Diamond Helath Care Centre

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Digestive Health Specialists of the Southeast

location_facility: Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours

location_facility: The University of Texas Medical School at Houston

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Clinique de medecine Urbaine du Quartier Latin

location_facility: Ichan School of Medicine at Mount Sinai Beth Israel

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Hospital General Universitario de Valencia

location_facility: Methodist Healthcare University Hospital

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

location_facility: Washington University School of Medicine

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Nepean Blue Mountains Local Health District, Nepean Hospital

location_facility: Royal Free Hospital NHS Foundation Trust

location_facility: Synexus Polska Sp. z.o.o., Oddział w Gdańsku

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Synexus Polska Sp. z o.o., Oddział w Poznaniu

location_facility: University of Alabama at Birmingham Hospital

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: London Health Sciences Centre-University Hospital

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: Synexus Polska Sp. z o.o., Oddział w Warszawie

location_facility: Abertawe Bro Morganinwg University Local Health Board

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Synexus Polska Sp. z o.o., Oddział w Katowicach

location_facility: Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: CHU de Rouen-Centre Hospitalier Universitaire

location_facility: Synexus Polska Sp. z o.o., Oddział w Wrocławiu

location_facility: Synexus Polska Sp. Z.o.o., Oddział w Gdyni

location_facility: University of California, Davis Medical Center

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Synexus Polska Sp. z o.o., Oddział w Częstochowie

location_facility: Derby Teaching Hospitals NHS Foundation Trust

location_facility: Chronic Viral Illness/McGill University Health Centre (MUHC)

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

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Baylor Scott and White All Saints Medical Center

location_facility: Tulane University Health Sciences Center


title: A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

lead_sponsor: Incyte Corporation

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Israel
Hungary
Australia
Ireland
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: National Medical Research Radiological Centre

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

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

location_facility: Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

location_facility: Severance Hospital Yonsei University Health System

location_facility: Klinikum rechts der Isar der Technischen Universitat

location_facility: Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Clinic of Bashkortostan State Medical University

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Dokuz Eylul University Faculty of Medicine

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Tennessee Medical Center Knoxville

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH

location_facility: Medical University of South Carolina-Hollings Cancer Center

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin

location_facility: Medical Hospital, Tokyo Medical And Dental University

location_facility: University of California Irvine Medical Center

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Oklahoma Cancer Specialists & Research Institute

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet

status_simplified: Completed


lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Italy
Austria
Sweden
Netherlands
Spain
Finland
France
Czechia
Greece
Lithuania
Poland
Norway
Hungary
Belgium
Slovakia
Portugal
Denmark
United Kingdom

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Instituto Nazionale Neurologico "Carlo Besta"

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: Azienda Ospedaliera Sant'Andrea Università La Sapienza

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Vseobecna fakultni nemocnice v Praze (11163)

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

location_facility: GM LCRN - Great Manchester Local Clinical Research Network

location_facility: Centro Hospitalar do Porto E.P.E. Hospital de Santo António

location_facility: Hospital Universitario Nuestra Senora de la Candelaria (4776)

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert

location_facility: Centre hospitalier de la Côte Basque - Saint Léon

location_facility: Azienda Ospedaliera S. Camillo Forlanini (8025)

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

location_facility: Hospital General Universitario Gregorio Marañón (5030)

location_facility: Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Seconda Univesità degli Studi di Napoli, AOU

location_facility: Hospital de Sant Joan Despí Moisès Broggi

title: A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)

summary: The main purpose of the study is to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) subjects treated with Mavenclad® for 2 years (24 months).


title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Poland
Israel
Ireland
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: National Medical Research Radiological Centre

location_facility: Grand Hopital de Charleroi - Site Notre Dame - Oncology

location_facility: GLOBE Badania Kliniczne Oddzial we Wroclawiu

location_facility: GU Research Network-Urology Cancer Center

location_facility: Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

location_facility: Chang Gung Medical Foundation - Kaohsiung

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital General Universitari Vall d Hebron

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

location_facility: Klinikum rechts der Isar der Technischen Universitat

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Clinic of Bashkortostan State Medical University

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST

location_facility: University of Tennessee Medical Center Knoxville

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne

location_facility: Consorci Hospitalari Parc Tauli de Sabadell

location_facility: Moncton Hospital - Horizon Health Network

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Medical University of South Carolina-Hollings Cancer Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin

location_facility: Medical Hospital, Tokyo Medical And Dental University

location_facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego

location_facility: University of California Irvine Medical Center

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Xarxa Assistencial Universitaria Manresa

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute

location_facility: RMI Sumy Regional Clinical Oncology Dispensary

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II

location_facility: Krankenhaus der Barmherzigen Brueder Trier


location_country:
Peru
Belgium
Australia
Russian Federation
Taiwan
Costa Rica
France
Japan
Panama
Poland
Thailand
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
Singapore
Germany
United States
Italy
Brazil
Serbia
Mexico
Israel
New Zealand
Spain
Turkey

acronym: B-FAST

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

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

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: CancerCare Manitoba; Department of Medical Oncology

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

location_facility: Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Hemato Oncología de Panamá Especializada

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Clinical Oncology Dispensary; Chemotherapy

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Henry Ford Health System; Hematology/Oncology

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Medipol University MF; Oncology Department

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: National Cancer Centre; Medical Oncology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: University of Michigan Comprehensive Cancer Center

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

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: University of Kentucky; Markey Cancer Center

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Niigata University Medical & Dental Hospital

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: London Health Sciences Centre · Victoria Hospital; Department of Medicine

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Krakowski Szpital Specjalistyczny im.Jana Pawla II

location_facility: Hopital Bretonneau; Pneumologie Oncologie

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Pendik Training and Research Hospital; Medical Oncology

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: University of Washington Seattle Cancer Care Alliance

ipd_sharing: Undecided

title: A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

summary: This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.


title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

summary: This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).

ReferenceCitation: Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20.

family: Katsiki

full_name: Niki Katsiki

given: Niki

family: Athyros

full_name: Vasilios G. Athyros

given: Vasilios G.

family: Mikhailidis

full_name: Dimitri P. Mikhailidis

given: Dimitri P.

family: Mantzoros

full_name: Christos Mantzoros

given: Christos

journal_name: Metabolism

oa_host_type: publisher

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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

location_country: Italy Sweden France Belgium Portugal Denmark Germany

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centres Hospitaliers Jolimont - Hopital de Jolimont

location_facility: Otto von Guericke UniversitÃ¤t Magdeburg

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

location_facility: Cliniques universitaires de Bruxelles Hopital Erasme

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Deutsches Rotes Kreuz Kliniken Berlin KÃ¶penick

location_facility: Herz-GefÃ¤ÃŸ-Zentrum Nymphenburg am Klinikum Dritter Orden

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Centre Hospitalier Intercommunal Haute Saone

location_facility: Deutsches Herzzentrum MÃ¼nchen des Freistaates Bayern

location_facility: Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Center for Clinical and Basic Research Aalborg

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Centre Hospitalier de Pau - Hopital Francois Mitterrand

location_facility: Centre for Clinical and Basic Research Ballerup

location_facility: Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa

location_facility: Centre Hospitalier RÃ©gional Universitaire de Tours - HÃ´pital Trousseau

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen

location_facility: Center for Clinical and Basic Research Vejle