title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

acronym: GRAVITI

summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Israel
Turkey
Mexico
Norway
Malaysia
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Jordan
New Zealand
Korea, Republic of
France
Chile
Netherlands

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: National Hospital Organization Fukuoka Hospital

location_facility: Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum

location_facility: Oklahoma University Health Science Center

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: The First Affiliated Hospital of NanChang University

location_facility: USF Asthma, Allergy, Immunology Clinical Research Unit

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: SER - Serviços Especializados em Reumatologia da Bahia

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: The First People's Hospital Of Changzhou

location_facility: Texas Gastroenterology Associates - Research

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: Policlinio, AOU Consoziale Policlinico di Bari

location_facility: Special hospital for Internal diseases, Oncomed system

location_facility: Universidade Federal Do Piaui - Campos Universitario

location_facility: Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.

location_facility: Hospital das Clinicas - Universidade Federal de Pernambuco

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

location_facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi

location_facility: Complejo Asistencial Hospital Dr. Sótero del Río

location_facility: Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: National Hospital Organization Mito Medical Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University hospital Clinical centre Banja Luka

location_facility: University of Southern California, Keck School of Medicine

location_facility: The first affiliated hospital of suzhou University

location_facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Digestive Research Alliance of Michiana, LLC

location_facility: South Eastern Health and Social Care Trust

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Harmony Medical Research Institute, Inc.

location_facility: Digestive Health Research of Southern California, LLC

location_facility: Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

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

location_facility: Institute for Digestive Health and Liver Disease

location_facility: Middlemore Hospital Clinical Research Centre

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: The Speciality Hospital (TSH) / Advanced Clinical Center

location_facility: Osceola Mental Health D/B/A Park Place Behavioral Health Care

location_facility: Gruppo Ospedaliero San Donato - Istituto di Ricovero e Cura

location_facility: Gastroenterology Associates of SW Florida

location_facility: Baylor College Of Medicine - Dept Of Dermatology

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE - Unidade de Vila Real

location_facility: The Affiliated Hospital of Bengbu Medical College

location_facility: The second Xiangya Hospital of Central South University

location_facility: Gastroentreology and Nutrition Specialists, P.A.

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú

location_facility: Egyesített Szent István és Szent László Kórház

location_facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

location_facility: AGA Clinical Research Associates, L.L.C.

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Shiga University of Medical Science Hospital

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

location_facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

location_facility: Digestive Health Research of North Texas, LLC

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: National Hospital Organization Osaka National Hospital

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

location_facility: Xiangya Hospital Central South University

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Curiositas ad Sanum Studien und Beratungs GmBH

location_facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: Gastroenterolgy Associates of Central GA

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Digestive Health Specialists of the Southeast

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Universidade Federal da Bahia (UFBA) - Complexo Hospitalar U

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Shenzhen Hospital of Southern Medical University

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

location_facility: Niigata University Medical & Dental Hospital

location_facility: DiGiovanna Institute for Medical Education & Research

location_facility: Private Practice - Dr. Krzysztof Cymerman

location_facility: Azienda Ospedaliera San Paolo-Polo Universitario

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: National Taiwan University Hospital, Division of Infectious Diseases

location_facility: Western Connecticut Health Network/Danbury Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: University of Mississippi Medical Center

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica

location_facility: Marmara University Pendik Training Hospital

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

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

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie

location_facility: Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi


ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

acronym: GALACTIC-HF

intervention_type: Drug

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

study_completion_date_type: Actual

lead_sponsor: Cytokinetics

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: background

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.

ReferenceType: derived

ReferenceCitation: Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144. Erratum in: Eur Heart J. 2022 Jun 18;:.

ReferenceCitation: Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlström U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsányi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sørensen T, Böhm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlström U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.

ReferenceCitation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Büchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6. Review.

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

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Greece
New Zealand
France
Chile
Colombia
Netherlands

summary: The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: Registry Identifier

title: A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction

acronym: VICTOR

summary: The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
South Africa
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
Canada
Guatemala
Hungary
China
Germany
Denmark
Taiwan
Greece
Ireland
New Zealand
Korea, Republic of
France
Chile
Colombia

location_facility: Centrum Zdrowia Tuchów-Poradnia Chorób Metabolicznych ( Site 3063)

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2454)

location_facility: Polsko-Amerykańskie Kliniki Serca ( Site 3077)

location_facility: The Second Affiliated Hospital of Nanchang University-Cardiology ( Site 0912)

location_facility: Hospital Universiti Sains Malaysia-Medical Department ( Site 2357)

location_facility: CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 3666)

location_facility: Afyon Kocatepe Üniversitesi Tıp Fakültesi-Cardiology Department ( Site 4058)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María ( Site 0951)

location_facility: L.T. Mala National Institute of Therapy of NAMS of Ukraine-Clinical Pharmacology and Pharmacogeneti

location_facility: William Harvey Heart Centre ( Site 4169)

location_facility: Instituto de investigaciones Centro Medico Imbanaco ( Site 0963)

location_facility: Universitaetsklinikum Wuerzburg ( Site 1458)

location_facility: Universitätsmedizin Greifswald ( Site 1470)

location_facility: Netcare Sunninghill Hospital ( Site 3457)

location_facility: Wuxi No.2 People's Hospital-Cardiology Department ( Site 0877)

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital-Cardiology Department ( Site 0855)

location_facility: St. Vinzenz-Hospital-Cardiology ( Site 1455)

location_facility: People's Hospital of Lishui City-department of cardiovascular ( Site 0862)

location_facility: Slagelse Sygehus-Ambulatorium for Hjertesygdomme ( Site 1153)

location_facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitau-Centre Investigation Clinique Plurithé

location_facility: The First People's Hospital of Foshan ( Site 0898)

location_facility: Sydvestjysk Sygehus Esbjerg-Hjertemedicinsk Projekt ( Site 1154)

location_facility: Heritage Medical Research Clinic ( Site 0679)

location_facility: Centro De Estudios Cardiologicos Y De Medicina Interna ( Site 0752)

location_facility: Communal non-profit enterprise "Cherkasy Regional Hospital of Сherkasy Regional Council" ( Site 4292

location_facility: Clínica El Golf-Cardiologia ( Site 2857)

location_facility: Hospital General de Acapulco ( Site 2469)

location_facility: Louisiana Heart Center - Hammond ( Site 0004)

location_facility: Flinders Medical Centre-Cardiology Research ( Site 0455)

location_facility: Semmelweis University-Városmajori Szív- és Érgyógyászati Klinika ( Site 1855)

location_facility: Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 1059)

location_facility: Hadassah Medical Center-Heart Institute ( Site 2062)

location_facility: The Prince Charles Hospital-Cardiology Research Centre ( Site 0451)

location_facility: Clemenstorgets Hjartmottagning ( Site 3755)

location_facility: Istanbul University Cerrahpasa Medical School Internal Diseases Institute-CARDIOLOGY INSTITUTE ( Sit

location_facility: Peace River Cardiovascular Center ( Site 0088)

location_facility: Diex Recherche Trois-Rivieres ( Site 0677)

location_facility: Unidad Médica para la Salud Integral ( Site 2472)

location_facility: Emory University School of Medicine ( Site 0123)

location_facility: State budgetary Healthcare Institution of the city of Moscow "V. V. Vinogradov City Clinical Hospita

location_facility: Parc de Salut Mar - Hospital del Mar ( Site 3663)

location_facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente ( Site 2466)

location_facility: Hôpital de la Cité-de-la-Santé ( Site 0673)

location_facility: Wuxi People's Hospital-Cardiovascular Department ( Site 0870)

location_facility: Tyler Cardiovascular Consultants ( Site 0039)

location_facility: Hunan Provincial People's Hospital ( Site 0857)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-Cardiologia 1 ( Site 2151)

location_facility: Institute for Medical Research ( Site 3316)

location_facility: Queen Mary Hospital-Medicine - Cardiology ( Site 1752)

location_facility: Nordsjællands Hospital - Hillerød ( Site 1159)

location_facility: Clinical Hospital S.R.Mirotvortseva name SSMU ( Site 3254)

location_facility: Pécsi Tudományegyetem Klinikai Központ ( Site 1865)

location_facility: King's College Hospital-Cardiac Research Department ( Site 4154)

location_facility: Communal non-profit enterprise "City Clinical Hospital # 27" of Kharkiv City Council ( Site 4262)

location_facility: Washington University-Department of Medicine ( Site 0044)

location_facility: Nemocnice Slany-Interna - kardiologicka ambulance ( Site 1063)

location_facility: Herzzentrum Dresden GmbH Universitätsklinik ( Site 1469)

location_facility: Hospital Queen Elizabeth II ( Site 2359)

location_facility: South Texas Cardiovascular Consultants, PLLC-Research ( Site 0024)

location_facility: Skellefteå Lasarett-Research unit, floor 5 ( Site 3760)

location_facility: The Second Affiliated Hospital of Nanjing Medical University-Cardiology ( Site 0900)

location_facility: MNE " Kyiv City Clinical Emergency Hospital" of Kyiv Regional Council (KCSA) ( Site 4256)

location_facility: Taichung Veterans General Hospital ( Site 3855)

location_facility: Tolna Megyei Balassa János Kórház ( Site 1868)

location_facility: Incor - Instituto do Coracao ( Site 0557)

location_facility: Blackpool Victoria Hospital ( Site 4161)

location_facility: Flor Ferenc Hospital of Pest County-5th Department of Internal Medicine ( Site 1852)

location_facility: AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 1558)

location_facility: OSF Healthcare Cardiovascular Institute ( Site 0122)

location_facility: PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR ( Site 0555)

location_facility: MUDr. Libor Nechvatal s.r.o. , Kardiologie ( Site 1057)

location_facility: National Heart Centre Singapore ( Site 3351)

location_facility: State Institution National Scientific Center M.D. Strazhesko-Department of clinical arrhythmology a

location_facility: Fondazione IRCCS Policlinico San Matteo-Cardiology ( Site 2157)

location_facility: Sentara Norfolk General Hospital ( Site 0114)

location_facility: Hospital de Clínicas de Ribeirão Preto ( Site 0559)

location_facility: Shanghai Xuhui Central Hospital-Cardiovascular Department ( Site 0872)

location_facility: University of Pretoria - Faculty of Health Sciences-CRU ( Site 3462)

location_facility: The First Affiliated Hospital of Jinan University ( Site 0897)

location_facility: Institut Klinicke a Experimentalni Mediciny-Klinika kardiologie ( Site 1052)

location_facility: Centre Hospitalier Louis Pasteur ( Site 1360)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0161)

location_facility: The People's Hospital of Liaoning Province ( Site 0859)

location_facility: Ukrayins'kyy Derzhavnyy Naukovo-Doslidnyy Instytut Rebilitatsiyi Invalidiv ( Site 4274)

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman

location_facility: Hospital Universitari Vall d'Hebron ( Site 3659)

location_facility: Xiangya Hospital Central South University-Cardiological Department ( Site 0899)

location_facility: Västmanlands Sjukhus Västerås ( Site 3757)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2468)

location_facility: Norton Healthcare-Norton Heart Specialist ( Site 0062)

location_facility: Cardiovascular Institute of the South ( Site 0072)

location_facility: The University of Hong Kong - Shenzhen Hospital-Cardiovascular department ( Site 0895)

location_facility: Municipal Non-Profit Enterprise -City clinical hospital No8 of Kharkiv city council ( Site 4278)

location_facility: Hospital Clinico San Carlos-Cardiology ( Site 3661)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 2159)

location_facility: Excellentis Clinical Trial Consultants ( Site 3464)

location_facility: Volgograd State Medical University ( Site 3258)

location_facility: West Houston Area Clinical Trial Consultants ( Site 0014)

location_facility: Royal Brisbane and Women's Hospital-Cardiology Research ( Site 0453)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Cardiology ( Site 0868)

location_facility: Communal Non-profit Enterprise "City Hospital #6" Zaporizhzhia City Counci-Therapy department ( Site

location_facility: Shanghai Tongji Hospital-Cardiovascular Department ( Site 0905)

location_facility: NZOZ Centrum Medyczne KERmed ( Site 3066)

location_facility: Victoria Heart Institute Foundation ( Site 0680)

location_facility: CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 3651)

location_facility: Staedtisches Klinikum Dresden-2. Medizinische Klinik ( Site 1468)

location_facility: Chris Hani Baragwanath Academic Hospital ( Site 3455)

location_facility: Siping Central People's Hospital-Cardiovascular Department ( Site 0915)

location_facility: University Hospital of Alexandroupolis-First Department of Internal Medicine ( Site 1551)

location_facility: Cardiovascular Center of Sarasota ( Site 0154)

location_facility: Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 1058)

location_facility: Private Practice - Dr. Lakatos Ferenc ( Site 1854)

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 1356)

location_facility: Zhejiang Provincial People's Hospital ( Site 0914)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 3854)

location_facility: Başkent Üniversitesi Istanbul Hastanesi ( Site 4057)

location_facility: Instituto de Pesquisa clinica de Campinas ( Site 0551)

location_facility: Marienhaus Klinikum St. Elisabeth Neuwied ( Site 1452)

location_facility: Private Practice - Dr. James Cha ( Site 0655)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Vasculocardiology Department ( Site 0874

location_facility: Zhongshan Hospital,Fudan University-Cardiology ( Site 0851)

location_facility: Óbudai Egészségügyi Centrum ( Site 1861)

location_facility: Klinik Floridsdorf-Karl Landsteiner Institute for Cardiovascular and Critical Care Research c/o Dep

location_facility: Valley Clinical Trials, Inc. ( Site 0085)

location_facility: Advanced Cardiovascular - Alexander City ( Site 0038)

location_facility: Uniklinikum Salzburg-Universitätsklinik für Innere Medizin II, Kardiologie, Internistische Intensiv

location_facility: Ankara City Hospital-cardiology ( Site 4053)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1874)

location_facility: Research and Cardiovascular Corp. ( Site 3152)

location_facility: Hallym University Sacred Heart Hospital-Cardiovascular center ( Site 3556)

location_facility: Chungbuk National University Hospital-Internal medicine ( Site 3551)

location_facility: Communal Enterprise "Hospital #1" of Zhytomyr City Council-Advisory and Treatment department of Sci

location_facility: Medical Park zmir Hastanesi-cardiology ( Site 4059)

location_facility: St. Louis Heart and Vascular, P.C.-Clinical Trials Unit ( Site 0029)

location_facility: West China Hospital Sichuan University ( Site 0904)

location_facility: Kardiologische Gemeinschaftspraxis ( Site 1460)

location_facility: Yitzhak Shamir Medical Center-Cardiology ( Site 2060)

location_facility: OEC Clinical Research - Zalaegerszeg ( Site 1864)

location_facility: Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi ( Site 4063)

location_facility: Fundación Cardiovascular de Aguascalientes A.C. ( Site 2473)

location_facility: Severance Hospital, Yonsei University Health System ( Site 3552)

location_facility: Hospital Germans Trias i Pujol ( Site 3664)

location_facility: Kocaeli Üniversitesi-Cardiology ( Site 4060)

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 42

location_facility: Lutsk City Clinical Hospital-Center for Cardiovascular Disease ( Site 4255)

location_facility: Lanzhou university second hospital-Lanzhou university second hospital ( Site 0863)

location_facility: IPS Centro Científico Asistencial S.A.S ( Site 0952)

location_facility: HOSPITAL CLINICO DE VALENCIA ( Site 3656)

location_facility: Franciscan Physician Network - Indiana Heart Physicians ( Site 0087)

location_facility: Pokrovskaya Municipal Hospital-1-st cardiology department ( Site 3251)

location_facility: Konstantopoulio General Hospital-Cardiology Clinic ( Site 1553)

location_facility: Georgia Arrhythmia Consultants and Research Institute ( Site 0042)

location_facility: Ryazan State Medical University named after Academician I.P. Pavlova ( Site 3260)

location_facility: Aarhus Universitetshospital, Skejby ( Site 1160)

location_facility: Cherkasy Regional Hospital-Cardiorheumatology ( Site 4283)

location_facility: Ivanovo Regional Healthcare Institution Cardiology Dispensary ( Site 3265)

location_facility: Hospital Tengku Ampuan Afzan ( Site 2353)

location_facility: Universitaetsklinikum Heidelberg-Klinik für Kardiologie, Angiologie und Pneumologie ( Site 1475)

location_facility: Gemeinschaftspraxis Dr. Fabian Krämer, Dr. Ulrich Overhoff ( Site 1459)

location_facility: Excel Medical Clinical Trials ( Site 0008)

location_facility: Eskisehir Osmangazi University-Cardiology ( Site 4052)

location_facility: SP ZOZ w Puławach- Oddział Kardiologii ( Site 3071)

location_facility: Svendborg Hospital Odense Universitets hospital-Kardiologisk Forskningsenhed ( Site 1156)

location_facility: Hospital Universitario La Paz ( Site 3665)

location_facility: The Second Affiliated Hospital Chongqing Medical University-Department of Cardiology ( Site 0908)

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 2165)

location_facility: Krankenhaus St. Josef Braunau ( Site 0354)

location_facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain

location_facility: Cardiovascular Research Center of South Florida ( Site 0074)

location_facility: Fundación Centro de Investigación Clínica CIC ( Site 0955)

location_facility: European Interbalkan Medical Center-2nd Department of Cardiology ( Site 1557)

location_facility: Chongqing Three Gorges Central Hospital ( Site 0913)

location_facility: Carient Heart & Vascular - Manassas ( Site 0059)

location_facility: Dokuz Eylül Üniversitesi-CARDIOLOGY ( Site 4055)

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 4257)

location_facility: Sheba Medical Center-Leviev Heart Center ( Site 2064)

location_facility: Ege University Medicine of Faculty-Cardilogy Department ( Site 4054)

location_facility: Waikato Hospital-Cardiology Clinical Trials Unit ( Site 2654)

location_facility: Oakville Cardiovascular Research LP ( Site 0657)

location_facility: Pokrovskaya Municipal Hospital ( Site 3252)

location_facility: Christchurch Heart Institute ( Site 2651)

location_facility: Guangdong Provincial People's Hospital-Cardiology ( Site 0852)

location_facility: University Hospital of Ioannina-2nd Department of Cardiology ( Site 1554)

location_facility: Hygeia Hospital-6th cardiology clinic ( Site 1560)

location_facility: The First Affiliated Hospital, Zhejiang University ( Site 0907)

location_facility: Karolinska Universitetssjukhuset Solna-Heart and Vascular theme ( Site 3759)

location_facility: Centrum Medyczne Zdrowa J. Trebacz, W. Zajdel Sp. J. ( Site 3061)

location_facility: Hospital Universitario Ramón y Cajal ( Site 3662)

location_facility: Clinical Research Chile SpA ( Site 0761)

location_facility: Zakarpattya Regional Clinical Cardiology Dispensary-Dept. of Hospital Therapy, Uzhhorod National Un

location_facility: Medical Care and Research SA de CV ( Site 2461)

location_facility: Central clinical hospital - Ukrzalisnytsia-2nd Cardiology ( Site 4306)

location_facility: Cambridge Cardiac Care Centre ( Site 0658)

location_facility: Dominion Medical Associates, Inc. ( Site 0089)

location_facility: Rostov State Medical University ( Site 3259)

location_facility: University Hospital Coventry & Warwickshire-Research & Development ( Site 4170)

location_facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer ( Site 1352)

location_facility: Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 4284)

location_facility: Medifarma 98 Kft-Outpatient Clinic ( Site 1859)

location_facility: Hospital Universitari de Bellvitge-Unitat Multidisciplinar d'Insuficiència Cardíaca Comunitària (UM

location_facility: Affiliated Hospital of Jiangsu University-Cardiology Department ( Site 0917)

location_facility: Omsk Regional Clinical Health Service Number 9 ( Site 3296)

location_facility: Ascension Providence Hospital ( Site 0094)

location_facility: General Hospital of Athens Hippokratio ( Site 1552)

location_facility: Almazov National Medical Research Centre ( Site 3320)

location_facility: Dunedin Hospital-Cardiology Department ( Site 2653)

location_facility: Sygehus Vendsyssel Hjoerring ( Site 1164)

location_facility: Cardiovascular Institute of the South, 3 ( Site 0096)

location_facility: Beijing Tsinghua Changgung Hospital ( Site 0911)

location_facility: Hutt Valley District Health board HVDHB-Cardiology Research Unit ( Site 2652)

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí ( Site 2453)

location_facility: Medivest Centro de Investigación Integral ( Site 2460)

location_facility: IRCCS San Raffaele Pisana-riabilitazione cardiologica ( Site 2156)

location_facility: First Pavlov State Medical University of Saint Petersburg-Сardiology department ( Site 3257)

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0909)

location_facility: Alliance for Multispecialty Research, LLC ( Site 0143)

location_facility: Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0754)

location_facility: Ustredni vojenska nemocnice-Oddeleni kardiologie ( Site 1054)

location_facility: ProMedica Toledo Hospital-ProMedica Heart Failure Clinic ( Site 0061)

location_facility: Vojenská Nemocnice Brno-Internal department ( Site 1055)

location_facility: Doylestown Hospital-Cardiology ( Site 0030)

location_facility: Bacs-Kiskun Megyei Korhaz-I. Belgyógyászat - Kardiológia ( Site 1873)

location_facility: Fundación Cardiovascular de Colombia ( Site 0961)

location_facility: Perm Regional Hospital for War Veterans ( Site 3272)

location_facility: St. John of God Subiaco Hospital ( Site 0457)

location_facility: Cardiovascular Research of Northwest Indiana ( Site 0036)

location_facility: Beata Miklaszewicz & Dariusz Dabrowski CARDIAMED s.j. ( Site 3070)

location_facility: Universitas Private Hospital-Cardiology Research ( Site 3453)

location_facility: Southeastern Cardiology and Cardiovascular-Duke HC CRU - Lumberton ( Site 0134)

location_facility: VA West Los Angeles Medical Center-Cardiology ( Site 0149)

location_facility: China-Japan Union Hospital-department of cardiology ( Site 0916)

location_facility: Consultorio de Medicina Especilizada del Sector Privado ( Site 2455)

location_facility: Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 3151)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-U.O.C. Cardiologia ( Site 2161)

location_facility: Alexandra Hospital-HEART FAILURE AND CARDIO-ONCOLOGY UNIT ( Site 1559)

location_facility: University Malaya Medical Centre ( Site 2351)

location_facility: Aleris Specialistvård Sabbatsberg ( Site 3762)

location_facility: Consultative - Diagnostic Centre of Pechersky District-Therapeutic department ( Site 4307)

location_facility: Ninewells Hospital and Medical School-Cardiology ( Site 4164)

location_facility: University General Hospital of Larissa ( Site 1555)

location_facility: DRC Gyógyszervizsgáló Központ ( Site 1869)

location_facility: Aultman Hospital-Cardiology Clinical Trials ( Site 0064)

location_facility: Centro de Investigaciones Clinicas SAS ( Site 0957)

location_facility: Centro de Investigacion Cardiovascular y Metabólica ( Site 2465)

location_facility: Centro de Estudios de Alta Especialidad de Sinaloa ( Site 2463)

location_facility: The First Hospital of Harbin Medical University-Cardiology ( Site 0903)

location_facility: Communal nonprofit enterprise "City Hospital #9" of Zaporizhzhia City Council ( Site 4251)

location_facility: Medicus MFC Research Clinic ( Site 0676)

location_facility: South Texas Cardiovascular Consultants, PLLC-Research ( Site 0020)

location_facility: Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo-Naczyniowe ( Site 3062)

location_facility: State Institution National Scientific Center M.D. Strazhesko-Resuscitation and Intensive care ( Site

location_facility: Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 3753)

location_facility: University Of Alberta Hospital ( Site 0669)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 2457)

location_facility: The Third Xiangya Hospital of Central South University-Cardiology ( Site 0860)

location_facility: Centro Cardiologico Monzino-Heart Failure Unit ( Site 2153)

location_facility: North Shore Hospital-Cardiology Research ( Site 2656)

location_facility: South Florida Research Solutions ( Site 0058)

location_facility: New York Presbyterian Medical Group Hudson Valley Cardiology ( Site 0127)

location_facility: NSHA-QEII Health Sciences Centre-Dickson Bldg-Cardiology ( Site 0664)

location_facility: IPS Médicos Internistas de Caldas ( Site 0959)

location_facility: Private Practice - Dr. Yolanda Figueroa-Torres ( Site 3156)

location_facility: Hospital Sultanah Bahiyah-Department of Cardiology ( Site 2355)

location_facility: Northern Jiangsu People's Hospital ( Site 0861)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1556)

location_facility: Khmelnytskyi Regional Cardiovascular Center-department of invasive cardiology and interventional ra

location_facility: Shanghai Yangpu District Central Hospital-Cardiology ( Site 0876)

location_facility: Fundacion Valle del Lili- CIC-Internal Medicine ( Site 0962)

location_facility: Praktyka Lekarska Lidia Pawlowicz ( Site 3053)

location_facility: University of Alabama at Birmingham - School of Medicine-Cardiology ( Site 0153)

location_facility: Centrum Medyczne Dr Sudnik s.c. Wanda i Jerzy Sudnik ( Site 3073)

location_facility: Maryland Cardiovascular Specialists ( Site 0056)

location_facility: Galilee Medical Center-Cardiology ( Site 2051)

location_facility: East Coast Institute for Research - St. Augustine ( Site 0016)

location_facility: Kaplan Medical Center-Heart Institution ( Site 2054)

location_facility: Assuta Ashdod Medical Center-Cardiology ( Site 2063)

location_facility: East Coast Institute for Research, LLC ( Site 0047)

location_facility: The Second Hospital of Tianjin Medical University-Endocrinology ( Site 0902)

location_facility: Amici Clinical Research LLC-Research ( Site 0037)

location_facility: Shaare Zedek Medical Center-Cardiology ( Site 2055)

location_facility: Tianjin Chest Hospital-Cardiology ( Site 0901)

location_facility: Interregional Clinical Diagnostic Center-Department of Clinical Trials ( Site 3307)

location_facility: Seoul National University Hospital ( Site 3557)

location_facility: Falu Lasarett-Dep of Cardiology ( Site 3756)

location_facility: MultiCare Health System-MultiCare Cardiology - Inland Northwest ( Site 0102)

location_facility: Instituto Del Corazón De Bucaramanga ( Site 0960)

location_facility: University of Cincinnati Medical Center-Cardiology ( Site 0071)

location_facility: St. James's Hospital-Cardiology ( Site 1951)

location_facility: Hillel Yaffe Medical Center-Heart Institute ( Site 2058)

location_facility: State Institution National Scientific Center M.D. Strazhesko-Essential Hypertension ( Site 4259)

location_facility: Cardiovascular Associates of the Delaware Valley ( Site 0097)

location_facility: Hospital Universitario Virgen de Valme ( Site 3654)

location_facility: Corcare-Corcare Cardiovascular Research ( Site 0660)

location_facility: First Pavlov State Medical University of Saint Petersburg ( Site 3288)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Cardiolggy

location_facility: Cardiocent de Guadalajara S.C. ( Site 2464)

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur-Service cardiologie ( Site 1353)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 2474)

location_facility: Rabin Medical Center-Cardiology - CHF ( Site 2052)

location_facility: Kawartha Cardiology Clinical Trials ( Site 0654)

location_facility: The University of Mississippi Medical Center-Cardiovascular ( Site 0073)

location_facility: Cattinara Hospital-Cardiovascular Department ( Site 2162)

location_facility: St. George's Hospital-Cardiology Clinical Academic Group ( Site 4156)

location_facility: INOVA Fairfax Medical Campus ( Site 0136)

location_facility: Cardiovascular Institute of the South ( Site 0081)

location_facility: Municipal Non-commercial Enterprise "Ivano-Frankivsk Regional Clinical Cardiology Center of Ivano-Fr

location_facility: Changhua Christian Hospital ( Site 3857)

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0010)

location_facility: Vanderbilt University Medical Center-Vanderbilt Heart and Vascular Institue ( Site 0060)

location_facility: General Hospital of Athens "G. Gennimatas"-General Hospital of Athens "G.Gennimatas" ( Site 1561)

location_facility: Shaanxi provincial people's hospital ( Site 0853)

location_facility: Chungnam national university hospital ( Site 3554)

location_facility: Chesterfield Royal Hospital ( Site 4159)

location_facility: Pulse Heart Institute - Puyallup ( Site 0119)

location_facility: Beijing Friendship Hospital-Cardology ( Site 0865)

location_facility: Southwest Family Medicine Associates ( Site 0131)

location_facility: St. Boniface General Hospital ( Site 0667)

location_facility: Rostov-on-Don City Emergency Hospital ( Site 3271)

location_facility: Herlev and Gentofte Hospital-Department of Cardiology ( Site 1158)

location_facility: Oaxaca Site Management Organization ( Site 2459)

location_facility: The Heart Center of Lake County Research Institute-Research ( Site 0147)

location_facility: Royal Adelaide Hospital-Cardiology ( Site 0456)

location_facility: University Hospital of North Tees ( Site 4172)

location_facility: Pusan National University Hospital-Internal Medicine ( Site 3553)

location_facility: CMed Rehabilitacios es Diagnosztikai Kozpont ( Site 1877)

location_facility: Azienda Ospedaliero Universitaria S.Anna ( Site 2152)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Cardiology- Day Hospital ( Site 2154)

location_facility: Krasnodar Regional Clinical Hospital Number 1 S.V. Ochapovskogo ( Site 3281)

location_facility: Instytut Chorób Serca, Zakład Badań Klinicznych Chorób Układu Krążenia ( Site 3057)

location_facility: Gottsegen György Országos Kardiológiai Intézet ( Site 1851)

location_facility: Medizinische Universität Graz-Department of Cardiology ( Site 0351)

location_facility: Taipei Veterans General Hospital-General Clinical Research Center ( Site 3851)

location_facility: Hospital de Messejana Dr Carlos Alberto Studart Gomes ( Site 0560)

location_facility: Chonnam National University Hospital ( Site 3558)

location_facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu-Oddz.Klin.Kardiologii i Int.T.Kard. ( Si

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Cardiology ( Site 1878)

location_facility: Kaohsiung Medical University Hospital ( Site 3856)

location_facility: The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit

location_facility: Rambam Health Care Campus-Cardiology ( Site 2053)

location_facility: The Affiliated Hospital of Xuzhou Medical College ( Site 0910)

location_facility: Universitetssjukhuset Örebro-Heart-Lung-Physiology Clinic ( Site 3754)

location_facility: Unidad biomedica avanzada monterrey ( Site 2462)

location_facility: Indago Research and Health Center Inc ( Site 0011)

location_facility: Methodist Medical Center of Illinois ( Site 0098)

location_facility: Mercy Gilbert Medical Center-Dignity Health Cardiology ( Site 0075)

location_facility: Cardiovascular Consultants of South Georgia, LLC ( Site 0137)

location_facility: IRCCS - AOU di Bologna-Dept. of Medical and Surgical sciences ( Site 2158)

location_facility: Katholisches Krankenhaus St. Johann Nepomuk ( Site 1462)

location_facility: Instituto Jalisciense de Metabolismo SC ( Site 2467)

location_facility: National University Heart Centre, Singapore-Department of Cardiology ( Site 3355)

location_facility: Kliniken Maria Hilf-Klinik für Kardiologie ( Site 1454)

location_facility: Yonsei University-Wonju Severance Christian Hospital ( Site 3555)

location_facility: Antalya Egitim ve Arastırma Hastanesi-Cardiology ( Site 4064)

location_facility: Clinical Trials of America - 1100 North 18th Street ( Site 0112)

status_simplified: Ongoing


title: Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

lead_sponsor: Novo Nordisk A/S

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

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Puerto Rico
India
Turkey
Malaysia
Singapore
Canada
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France

summary:
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).

NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own.

The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH.

Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine.

The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor.

Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment.

Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


title: TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

acronym: TRANSFORM

summary: The primary objective of this study is to evaluate the effect of setanaxib on biochemical response at Week 52 in participants with primary biliary cholangitis (PBC) and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

ipd_sharing: No

lead_sponsor: Calliditas Therapeutics Suisse SA

location_country:
Poland
Spain
Greece
Austria
Australia
Italy
Canada
New Zealand
United Kingdom
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Wake Forest University Baptist Medical Center

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Gastroenterology Associates - Crystal River

location_facility: Hospital General Universitari d'Alicante

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Kansas Medical Clinic - Gastroenterology

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Semmelweis Egyetem - I. Sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika

location_facility: New York University Hepatology Associates

location_facility: University of California Davis Medical Center

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

location_facility: Centricity Research (LMC Manna Research) - London

location_facility: Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Brugmann - Site Victor Horta

location_facility: Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Summit - Southern Therapy and Advanced Research

location_facility: University General Hospital of Heraklion (PAGNI)

location_facility: University of Miami Leonard M. Miller School of Medicine


title: A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours

summary: The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

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

lead_sponsor: AstraZeneca

location_country:
Spain
Canada
Korea, Republic of
United States
France


title: An Interventional, Phase III, Double-blind, Randomized, Controlled, Parallel-group, Multi-site, Clinical Trial Evaluating the Efficacy and Safety of Qutenza® in Subjects With Post-surgical Neuropathic Pain

summary: This is an interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe postsurgical neuropathic pain (PSNP).

lead_sponsor: Averitas Pharma, Inc.

location_country:
Poland
Spain
United Kingdom
United States
France
Netherlands

location_facility: Centre Hospitalier Departemental Vendee - Centre d'evaluation et de Traitement de la Douleur

location_facility: Cochin Hospital-Paris Descartes University

location_facility: International Spine, Pain, and Performance Center

location_facility: Accellacare - (MeDiNova Limited) - North London

location_facility: University Clinical Research - DeLand Clinical Research Unit

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Aberdeen Royal Infirmary (ARI) - NHS Grampian

location_facility: University of Rochester Medical Center (URMC)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Accellacare - (MeDiNova Limited) - Yorkshire

location_facility: MeDiNova South London Quality Research Site

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Accellacare - (MeDiNova Limited) - Northamptonshire


title: A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

acronym: VITALIZE

summary: This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

lead_sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

location_country:
Poland
Spain
New Zealand
Australia
Canada
United States
France
Romania

location_facility: Brody School of Medicine at East Carolina University

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Christus St. Vincent Regional Cancer Center

location_facility: SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Allegheny Health Network (AHN) West Penn Hospital

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

location_facility: Tulane Cancer Center Office of Clinical Research

location_facility: The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.


title: A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer's Disease (AD), Followed by an Open-Label Extension Period

summary: The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).

status: Active, not recruiting

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

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

intervention_type: Biological


acronym: ONWARDS 3

title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

ReferenceType: result

ReferenceCitation: Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2022 Sep 15. doi: 10.1111/dom.14871. [Epub ahead of print]

location_country:
Denmark
Taiwan
Brazil
Austria
Argentina
Canada
Puerto Rico
United States
France
China
Mexico
Czechia

summary:
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.

Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

acronym: PRIMALung

summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

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

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Switzerland
France
Belgium
Germany

location_facility: CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Medical University of Graz - Radio-oncology

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

location_facility: Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: CHU de Grenoble - La Tronche - Hopital A. Michallon (UNICANCER)

location_facility: Universitaet Rostock - Univ. Rostock-Zentrum fur Radiologie mit Klinik und Poliklinik fur Strahlentherapie

location_facility: Fondazione IRCCS - Policlinico San Matteo

location_facility: Institut de Cancerologie Strasbourg Europe (UNICANCER)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds

location_facility: Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

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

intervention_type: Radiation


title: A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia

summary: The primary objective of this study is to compare the efficacy of magrolimab + azacitidine versus venetoclax + azacitidine in adults with previously untreated TP53 mutant acute myeloid leukemia (AML) who are appropriate for non-intensive therapy as measured by overall survival (OS).

lead_sponsor: Gilead Sciences

location_country:
Hong Kong
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
Sweden
United States
France
Belgium
Japan
Germany

location_facility: Department of Hematology and Oncology, Braunschweig Community Hospital

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV

location_facility: Dept. of Medicine II, University Hospital Hamburg-Eppendorf

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Froedtert Hospital / Medical College of Wisconsin

location_facility: Westmead Hospital / Department of Haematology and Bone Marrow Transplantation

location_facility: UNC Hospitals, The University of North Carolina at Chapel Hill

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center

location_facility: Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie

location_facility: SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia

location_facility: The Ohio State University Wexner Medical Center/ James Cancer Hospital

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Complejo Asistencial Universitario de Salamanca - Hsopital Clinico

location_facility: United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road

location_facility: Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation

location_facility: Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin

location_facility: Andrew Love Cancer Centre, University Hospital Geelong

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica

location_facility: Prince of Wales Hospital, The Chinese University of Hong Kong

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

location_facility: MidAmerica Division, Inc., c/o Research Medical Center

location_facility: The University of Chicago Medical Centre

location_facility: SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern

location_facility: Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum

location_facility: Oxford University Hospital NHS Foundation Trust

location_facility: Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie

location_facility: Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie

location_facility: University College London Hospitals NHS Foundation Trust


title: Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: SELECTION

summary:
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

ReferenceCitation: Feagan BG, Danese S, Loftus EV Jr, Vermeire S, Schreiber S, Ritter T, Fogel R, Mehta R, Nijhawan S, Kempiński R, Filip R, Hospodarskyy I, Seidler U, Seibold F, Beales ILP, Kim HJ, McNally J, Yun C, Zhao S, Liu X, Hsueh CH, Tasset C, Besuyen R, Watanabe M, Sandborn WJ, Rogler G, Hibi T, Peyrin-Biroulet L. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021 Jun 19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021 Jun 3.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Georgia
Ireland
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Washington University School of Medicine

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: Institute of Gastroenterology & Liver Disease, Sunshine Hospitals

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: Santa Familia, Centrum Badan, Profilaktyki i Leczenia

location_facility: L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: PCR-Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Vestre Viken Hospital Trust, Baerum Hospital

location_facility: Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Gastroenterology Research of San Antonio

location_facility: University Kebangsaan Malaysia Medical Centre

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

location_facility: Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: The University of Texas Health Science Center at Houston

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

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

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Yonsei University Health System, Severance Hospital

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J.

location_facility: Gastroenterology Associates Of Tidewater

location_facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Hyogo College of Medicine College Hospital

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Shiga University of Medical Science Hospital

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: University of Wisconsin Hospital & Clinics

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

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

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Centrum Innowacyjnych Terapii Sp. z o.o.

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

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

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: Digestive Health Specialists of the Southeast

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Colo-proctology Center Matsushima Clinic

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

location_facility: Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: Kitasato University Hospital, THE KITASATO INSTITUTE

location_facility: General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department

location_facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii


title: A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab

acronym: ATALANTE

summary: This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).

lead_sponsor: ARCAGY/ GINECO GROUP

location_country: Spain Austria France Israel Belgium Germany Czechia

location_facility: Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Hospital Central Universitario Virgen de la Arrixaca

location_facility: Krankenhaus der Barmherzigen Brüder Graz

location_facility: CHU Nîmes - Institut de Cancérologie du Gard

location_facility: Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

location_facility: Klinikum rechts der Isar, Technischen Universität München

location_facility: Sainte-Catherine Institut du Cancer Avignon-Provence

location_facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Klinikum der Universität München - LMU, Campus Großhadern

location_facility: Hospital Universitari de Girona ICO Girona (Dr. Josep Trueta)

location_facility: Institut Curie - Hopital Claudius Régaud


title: An International Survey on Aminoglycoside Practices in Critically Ill Patients: AMINO III Survey

summary: This is an international observational cohort study on current aminoglycoside practices in intensive care units. Clinical and demographic data, dosing and therapeutic drug monitoring data will be collected during the first week of aminoglycoside (tobramycin, amikacin or gentamicin) administration in different countries over a year. A minimum of ten consecutive patients will be enrolled at each site.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country:
United Kingdom
Greece
Australia
France
Chile

location_facility: Centre Hospitalier de Toulon, Hopital Sainte Musse

location_facility: Centre Hospitalier La Rochelle-Hopital Saint Louis

location_facility: University Critical Care Department Aghioi Anargyroi Hospital

intervention_type: Other

lead_sponsor_type: academique


title: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

lead_sponsor: Daiichi Sankyo, Inc.

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

location_country:
Taiwan
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Korea, Republic of
United States
France
China
Singapore
Belgium
Japan
Germany
Bulgaria

location_facility: National University Cancer Institute National University Hospital

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: University of Electronic Science & Technology of China (UESTC) - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: University of Colorado Denver - Anschutz Medical Campus

location_facility: Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

location_facility: OncoCare Cancer Centre- Gleneagles Medical Centre

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

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital

location_facility: Henry Ford Cancer Institute/Henry Ford Hospital

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: University Hospital Birmingham NHS Trust

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Fudan University - Shanghai Cancer Center FUSCC

location_facility: Karl Landsteiner Institut fÃ¼r Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

location_facility: The First Hospital of China Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO

location_facility: National Taiwan University Hospital NTUH

location_facility: Hospital Clinico Universitario Lozano Bleza

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: General Hospital of Eastern Theater Command

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Massachusetts General Hospital (MGH) - Hematology/Oncology

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University Hospital of Nantes - Thoracic Oncology

location_facility: Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Union Hospital of Tongji Medical College Huazhong University of Science and Technology

summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.


title: Computerized Registry of Patients With Venous Thromboembolism (RIETE)

acronym: RIETE

summary:
The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism.

The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events.

As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications.

The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

ReferenceCitation: Prandoni P, Pesavento R, Bilora F, Fernández Reyes JL, Madridano O, Soler S, Monreal M. No difference in outcome between therapeutic and preventive anticoagulation in patients with superficial vein thrombosis involving the saphenous-femoral junction. Vasc Med. 2022 Jun;27(3):290-292. doi: 10.1177/1358863X211066962. Epub 2022 Jan 30.

ReferenceCitation: Bikdeli B, Moustafa F, Nieto JA, Lee AI, Ruíz-Giménez N, Lorenzo A, Schellong S, Soler S, Ortíz S, Morales MDV, Bosevski M, Gavín O, Lip GYH, Monreal M; RIETE Investigators. Clinical characteristics, time course, and outcomes of major bleeding according to bleeding site in patients with venous thromboembolism. Thromb Res. 2022 Mar;211:10-18. doi: 10.1016/j.thromres.2022.01.007. Epub 2022 Jan 14.

ReferenceCitation: Martínez-Urbistondo D, de la Garza RG, Villares-Fernández P, Font C, Schellong S, López-Núñez JJ, Gil-Díaz A, Del Carmen Díaz-Pedroche M, Hirmerova J, Monreal M; RIETE Investigators. Liver status and outcomes in patients without previous known liver disease receiving anticoagulant therapy for venous thromboembolism. Intern Emerg Med. 2022 Apr;17(3):725-734. doi: 10.1007/s11739-021-02858-x. Epub 2021 Oct 9.

ReferenceCitation: Expósito-Ruiz M, Arcelus JI, Caprini JA, López-Espada C, Bura-Riviere A, Amado C, Loring M, Mastroiacovo D, Monreal M; RIETE Investigators. Timing and characteristics of venous thromboembolism after noncancer surgery. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):859-867.e2. doi: 10.1016/j.jvsv.2020.11.017. Epub 2020 Nov 26.

ReferenceCitation: Camporese G, Simioni P, Di Micco P, Fernández-Capitán C, Rivas A, Font C, Sahuquillo JC, Villares P, Prandoni P, Monreal M; RIETE Investigators. Edoxaban for the Long-Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised? Clin Transl Sci. 2021 Jan;14(1):335-342. doi: 10.1111/cts.12876. Epub 2020 Oct 10.

ReferenceCitation: Jiménez D, Bikdeli B, Quezada A, Muriel A, Lobo JL, de Miguel-Diez J, Jara-Palomares L, Ruiz-Artacho P, Yusen RD, Monreal M; RIETE investigators. Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study. BMJ. 2019 Jul 29;366:l4416. doi: 10.1136/bmj.l4416.

ReferenceCitation: Mellado M, Trujillo-Santos J, Bikdeli B, Jiménez D, Núñez MJ, Ellis M, Marchena PJ, Vela JR, Clara A, Moustafa F, Monreal M; RIETE Investigators. Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism. Intern Emerg Med. 2019 Oct;14(7):1101-1112. doi: 10.1007/s11739-019-02077-5. Epub 2019 May 3. Erratum in: Intern Emerg Med. 2019 Jun 20;:. Intern Emerg Med. 2020 Oct;15(7):1357.

ipd_sharing: Undecided

lead_sponsor: Manuel Monreal

location_country:
Spain
Italy
United Kingdom
Honduras
United States
Belgium
Japan
Czechia
Portugal
Austria
Argentina
Israel
Egypt
Brazil
Switzerland
North Macedonia
China
Germany
Greece
Ireland
Iran, Islamic Republic of
Latvia
Ecuador
Vietnam
France
Colombia
Morocco

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Centro Hospitalar de Entre o Douro e Vouga

location_facility: Hospital Universitario Fundación Santa Fé de Bogota

location_facility: Hospital Universitario General de Cataluña

location_facility: Ain Shams University Specialized Hospital

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Abu-Ali- Sina Organ Transplant Center (OCT)

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Peking University Cancer Hospital and Institute

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Rajaie Cardiovascular Medical and Research Center

location_facility: Botucatu Medical School - São Paulo State University (UNESP)

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Ospedale Buon Consiglio Fatebenefratelli

location_facility: Hospital Universitario Clínic de Barcelona

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Ospedale SS. Giovanni e Paolo di Venezia

location_facility: Hospital General Universitario Santa Lucía

location_facility: Bach Mai Hospital Vietnam Heart Institue

location_facility: Hospital Pedro Hispano - Unidade Local de Saúde de Matosinhos

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Japanese Red Cross Wakayama Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Clínico Universitario de Valencia

location_facility: PHI University Clinic of Pulmology and Allergy Skopje

location_facility: Hospital General Universitario de Albacete

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Hospital General Universitario de Alicante

location_facility: Municipal Hospital of Dresden Friedrichstadt

location_facility: Hospital General Universitario de Ciudad Real

location_facility: Hospital Regional Universitario de Málaga

location_facility: Complejo Hospitalario Insular-Materno Infantil

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Azienda U.S.L. Di Ravenna - O.C. Di Faenza

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Azienda Ospedaliera Universitaria di Parma

location_facility: Hematology Institute of ZIV Medical Center

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Hospital General Universitari de Castelló

location_facility: Hospital Central de la Defensa Gómez Ulla

location_facility: Hospital d'Olot i Comarcal de la Garrotxa

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Evanston NorthShore University HealthSystem

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

summary: This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in patients with recurrent or metastatic head and neck cancer.

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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Brazil
Canada
Switzerland
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Netherlands


acronym: ARASENS

title: A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

lead_sponsor: Bayer

ReferenceCitation: Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Manarite J, Muslin D, Farrington T, Tombal B. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3. Review.

ReferenceCitation: Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino Á, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Méndez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Israel
Mexico
Sweden
Brazil
Canada
China
Germany
Bulgaria
Taiwan
Finland
Korea, Republic of
France
Netherlands

summary: The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.