acronym: FIDELIO-DKD

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

lead_sponsor: Bayer

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

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

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

ReferenceCitation: Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.

ReferenceCitation: Ruilope LM, Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Sarafidis P, Schmieder RE, Joseph A, Rethemeier N, Nowack C, Bakris GL; FIDELIO-DKD Investigators. Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes. Hypertension. 2022 Dec;79(12):2685-2695. doi: 10.1161/HYPERTENSIONAHA.122.19744. Epub 2022 Oct 12.

ReferenceCitation: Rossing P, Burgess E, Agarwal R, Anker SD, Filippatos G, Pitt B, Ruilope LM, Gillard P, MacIsaac RJ, Wainstein J, Joseph A, Brinker M, Roessig L, Scott C, Bakris GL; FIDELIO-DKD Investigators:; Augusto Vallejos (Argentina); Richard MacIsaac (Australia); Guntram Schernthaner (Austria); Pieter Gillard (Belgium); Maria Eugenia F. Canziani (Brazil); Theodora Temelkova-Kurktschiev (Bulgaria); Ellen Burgess and Sheldon Tobe (Canada); Fernando González (Chile); Zhi-Hong Liu (China); Andrés Ángelo Cadena Bonfanti and Carlos Francisco Jaramillo (Colombia); Martin Prazny (Czech Republic); Peter Rossing (Denmark); Jorma Strand (Finland); Michel Marre (France); Roland Schmieder and Christoph Wanner (Germany); Pantelis A. Sarafidis (Greece); Juliana Chan (Hong Kong); László Rosivall (Hungary); Joseph Eustace (Ireland); Ehud Grossman and Yoram Yagil (Israel); Giuseppe Remuzzi (Italy); Daisuke Koya and Takashi Wada (Japan); Magdalena Madero Rovalo (Mexico); Ron Gansevoort and Adriaan Kooy (Netherlands); Trine Finnes (Norway); Froilan De Leon (Philippines); Janusz Gumprecht (Poland); Fernando Teixeira e Costa (Portugal); Alexander Dreval (Russia); Anantharaman Vathsala (Singapore); Aslam Amod (South Africa); Sin Gon Kim and Byung Wan Lee (South Korea); Julio Pascual Santos (Spain); Bengt-Olov Tengmark (Sweden); Michel Burnier (Switzerland); Chien-Te Lee (Taiwan); Sukit Yamwong (Thailand); Ramazan Sari (Turkey); Kieran McCafferty (United Kingdom); Borys Mankovsky (Ukraine); Sharon Adler, Linda Fried, Robert Toto, and Mark Williams (United States); Tran Quang Khanh (Vietnam); National lead investigators:; Augusto Vallejos (Argentina); Richard MacIsaac (Australia); Guntram Schernthaner (Austria); Pieter Gillard (Belgium); Maria Eugenia F. Canziani (Brazil); Theodora Temelkova-Kurktschiev (Bulgaria); Ellen Burgess and Sheldon Tobe (Canada); Fernando González (Chile); Zhi-Hong Liu (China); Andrés Ángelo Cadena Bonfanti and Carlos Francisco Jaramillo (Colombia); Martin Prazny (Czech Republic); Peter Rossing (Denmark); Jorma Strand (Finland); Michel Marre (France); Roland Schmieder and Christoph Wanner (Germany); Pantelis A. Sarafidis (Greece); Juliana Chan (Hong Kong); László Rosivall (Hungary); Joseph Eustace (Ireland); Ehud Grossman and Yoram Yagil (Israel); Giuseppe Remuzzi (Italy); Daisuke Koya and Takashi Wada (Japan); Magdalena Madero Rovalo (Mexico); Ron Gansevoort and Adriaan Kooy (Netherlands); Trine Finnes (Norway); Froilan De Leon (Philippines); Janusz Gumprecht (Poland); Fernando Teixeira e Costa (Portugal); Alexander Dreval (Russia); Anantharaman Vathsala (Singapore); Aslam Amod (South Africa); Sin Gon Kim and Byung Wan Lee (South Korea); Julio Pascual Santos (Spain); Bengt-Olov Tengmark (Sweden); Michel Burnier (Switzerland); Chien-Te Lee (Taiwan); Sukit Yamwong (Thailand); Ramazan Sari (Turkey); Kieran McCafferty (United Kingdom); Borys Mankovsky (Ukraine); Sharon Adler, Linda Fried, Robert Toto, and Mark Williams (United States); Tran Quang Khanh (Vietnam); Diego Aizenberg; Inés Bartolacci; Diego Besada; Julio Bittar; Mariano Chahin; Alicia Elbert; Elizabeth Gelersztein; Alberto Liberman; Laura Maffei; Federico Pérez Manghi; Hugo Sanabria; Augusto Vallejos; Gloria Viñes; Alfredo Wassermann; Walter Abhayaratna; Shamasunder Acharya; Elif Ekinci; Darren Lee; Richard MacIsaac; Peak Mann Mah; Craig Nelson; David Packham; Alexia Pape; Simon Roger; Hugo Stephenson; Michael Suranyi; Gary Wittert; Elizabeth Vale; Martin Clodi; Christoph Ebenbichler; Evelyn Fliesser-Görzer; Ursula Hanusch; Michael Krebs; Karl Lhotta; Bernhard Ludvik; Gert Mayer; Peter Neudorfer; Bernhard Paulweber; Rudolf Prager; Wolfgang Preiß; Friedrich Prischl; Gerit-Holger Schernthaner; Harald Sourij; Martin Wiesholzer; Peter Doubel; Wendy Engelen; Pieter Gillard; Jean-Michel Hougardy; Jean-Marie Krzesinski; Bart Maes; Marijn Speeckaert; Koen Stas; Luc van Gaal; Hilde Vanbelleghem; Daniela Antunes; Roberto Botelho; Claudia Brito; Luis Canani; Maria Eugenia Canziani; Maria Cerqueira; Rogerio de Paula; Freddy Eliaschewitz; Carlos Eduardo Figueiredo; Adriana Forti; Miguel Hissa; Maurilo Leite Jr; Emerson Lima; Irene Noronha; Bruno Paolino; Nathalia Paschoalin; Raphael Paschoalin; Roberto Pecoits Filho; Marcio Pereira; Evandro Portes; Dalton Precoma; Rosangela Rea; Miguel Riella; Joao Eduardo Salles; Eduardo Vasconcellos; Sergio Vencio; Emiliya Apostolova; Radostina Boshnyashka; Ghassan Farah; Dimitar Georgiev; Valentina Gushterova; Neli Klyuchkova; Mariya Lucheva; Petya Manova; Dotska Minkova; Boyan Nonchev; Mariyana Pichmanova; Zhulieta Prakova; Rangel Rangelov; Rosen Rashkov; Pavel Stanchev; Bilyana Stoyanovska-Elencheva; Zhivko Tagarev; Theodora Temelkova-Kurktschieva; Svetla Vasileva; Mariana Yoncheva-Mihaylova; Paul Barre; Brian Carlson; James Conway; Serge Cournoyer; Richard Dumas; Sameh Fikry; Richard Goluch; Pavel Hamet; Randolph Hart; Sam Henein; Joanne Liutkus; Francois Madore; Valdemar Martinho; Giuseppe Mazza; Philip McFarlane; Dennis O'Keefe; Sean Peterson; Daniel Schwartz; Daniel Shu; Andrew Steele; Guy Tellier; Karthik Tennankore; Sheldon Tobe; George Tsoukas; Richard Tytus; Louise Vitou; Michael Walsh; Stanley Weisnagel; Igor Wilderman; Jean-Francois Yale; Jorge Cobos; Juan Godoy; Fernando González; Sergio Lobos; Juan Carlos Palma; Juan Carlos Prieto; Eliana Reyes; Carmen Romero; Victor Saavedra; Mario Vega; Ruifang Bu; Hanqing Cai; Nan Chen; Qinkai Chen; Dejun Chen; Jinluo Cheng; Youping Dong; Junwu Dong; Tianjun Guan; Chuanming Hao; Wen Huang; Fangfang Jiang; Minxiang Lei; Ling Li; Zhonghe Li; Xuemei Li; Jingmei Li; Yan Li; Xinling Liang; Bo Liang; Fang Liu; Yinghong Liu; Yuantao Liu; Zhihong Liu; Gang Long; Guoyuan Lu; Weiping Lu; Yibing Lu; Ping Luo; Jianhua Ma; Zhaohui Mo; Jianying Niu; Ai Peng; Jiansong Shen; Feixia Shen; Bingyin Shi; Qing Su; Zhuxing Sun; Shuifu Tang; Nanwei Tong; Hao Wang; Xinjun Wang; Lihua Wang; Guixia Wang; Jianqin Wang; Yangang Wang; Li Wang; Jiali Wei; Tianfeng Wu; Chaoqing Wu; Changying Xing; Fei Xiong; Xudong Xu; Ning Xu; Tiekun Yan; Jinkui Yang; Aiping Yin; Longyi Zeng; Hao Zhang; Yanlin Zhang; Ying Zhang; Wenjing Zhao; Zhiquan Zhao; Hongguang Zheng; Ling Zhong; Dalong Zhu; Yongze Zhuang; Clara Arango; Sandra Barrera; Nelly Beltrán López; Diego Benitez; Guillermo Blanco; Andrés Cadena; Julian Coronel; Carlos Cure; Carlos Durán; Alexander González; Gustavo Guzmán; Eric Hernández; Jaime Ibarra; Carlos Jaramillo; Nicolás Jaramillo; William Kattah; Dora Molina; Gregorio Sánchez; Mónica Terront; Freddy Trujillo; Miguel Urina; Ruben Vargas; Iván Villegas; Hernán Yupanqui; Dino Alferi; Michal Brada; Jiri Brezina; Petr Bucek; Tomas Edelsberger; Drahomira Gulakova; Jitka Hasalova Zapletalova; Olga Hola; Lucie Hornova; Jana Houdova; Helena Hrmova; David Karasek; Sarka Kopecka; Richard Kovar; Eva Krcova; Jiri Kuchar; Vlasta Kutejova; Hana Lubanda; Ivo Matyasek; Magdalena Mokrejsova; Libor Okenka; Martin Prazny; Jiri Pumprla; Pavel Tomanek; Jesper Bech; Jens Faber; Gunnar Gislason; Jørgen Hangaard; Grzegorz Jaroslaw Pacyk; Claus Juhl; Thure Krarup; Morten Lindhardt; Sten Madsbad; Joan Nielsen; Ulrik Pedersen-Bjergaard; Per Poulsen; Ole Rasmussen; Peter Rossing; Karoline Schousboe; Mikko Honkasalo; Kari Humaloja; Kristiina Kananen; Ilkka Kantola; Arvo Koistinen; Pirkko Korsoff; Jorma Lahtela; Sakari Nieminen; Tuomo Nieminen; Karita Sadeharju; Jorma Strand; Sakari Sulosaari; Bertrand Cariou; François Chantrel; Sylvaine Clavel; Christian Combe; Jean-Pierre Fauvel; Karim Gallouj; Didier Gouet; Bruno Guerci; Dominique Guerrot; Maryvonne Hourmant; Alexandre Klein; Christophe Mariat; Michel Marre; Rafik Mesbah; Yannick Le Meur; Arnaud Monier; Olivier Moranne; Pierre Serusclat; Benoit Vendrely; Bruno Verges; Philippe Zaoui; Christoph Axthelm; Andreas Bergmann; Andreas L. Birkenfeld; Hermann Braun; Klaus Busch; Christel Contzen; Stefan Degenhardt; Karl Derwahl; Thomas Giebel; Andreas Hagenow; Hermann Haller; Christoph Hasslacher; Thomas Horacek; Wolfgang Jungmair; Christof Kloos; Thorsten Koch; Thilo Krüger; Anja Mühlfeld; Joachim Müller; Andreas Pfützner; Frank Pistrosch; Ludger Rose; Lars Rump; Volker Schettler; Ingolf Schiefke; Heike Schlichthaar; Bernd Schröppel; Thomas Schürholz; Helena Sigal; Lutz Stemler; Georg Strack; Heidrun Täschner; Nicole Toursarkissian; Diethelm Tschöpe; Achim Ulmer; Markus van der Giet; Christoph Wanner; Bernhard R. Winkelmann; Ioannis Boletis; Erifili Hatziagelaki; Ioannis Ioannidis; Theodora Kounadi; Ioanna Makriniotou; Dorothea Papadopoulou; Aikaterini Papagianni; Ploumis Passadakis; Ioannis Stefanidis; Tai Pang Ip; Paul Lee; On Yan Andrea Luk; Angela Wang; Vincent Yeung; Dora Bajcsi; Peter Danos; Eleonora Harcsa; Szilvia Kazup; Katalin Keltai; Robert Kirschner; Julianna Kiss; Laszlo Kovacs; Beata Lamboy; Botond Literati-Nagy; Margit Mileder; Laszlo Nagy; Ebrahim Noori; Gabor Nyirati; Gizella Petro; Karoly Schneider; Albert Szocs; Szilard Vasas; Krisztina Wudi; Zsolt Zilahi; Marianna Zsom; Joe Eustace; John Holian; Donal Reddan; Yvonne O'Meara; Rosane Abramof Ness; Faiad Adawi; Zaher Armaly; Shaul Atar; Sydney Ben Chetrit; Noa Berar Yanay; Gil Chernin; Mahmud Darawsha; Shai Efrati; Mazen Elias; Evgeny Farber; Mariela Glandt; Ehud Grossman; Majdi Halabi; Khaled Khazim; Idit Liberty; Ofri Mosenzon; Assy Nimer; Doron Schwartz; Julio Wainstein; Yoram Yagil; Robert Zukermann; Aneliya Ilieva Parvanova; Angelo Avogaro; Giovanni Giorgio Battaglia; Maurizio Tiziano Bevilacqua; Enzo Bonora; Carlo Antonio Bossi; Paolo Calabrò; Franco Luigi Cavalot; Roberto Cimino; Mario Gennaro Cozzolino; Salvatore David; Michele Emdin; Enrico Fiaccadori; Paolo Fiorina; Carlo Bruno Giorda; Maria Cristina Gregorini; Gaetano La Manna; Davide Carlo Maggi; Roberta Manti; Giancarla Meregalli; Antonello Pani; Norberto Perico; PierMarco Piatti; Antonio Pisani; Antonio Ettore Pontiroli; Paola Ponzani; Gennaro Santorelli; Domenico Santoro; Renzo Scanziani; Ugo Teatini; Giancarlo Tonolo; Roberto Trevisan; Anna Maria Veronelli; Giorgio Luciano Viviani; Hideo Araki; Osamu Ebisui; Naruhiro Fujita; Ryuichi Furuya; Yoshiyuki Hamamoto; Masahiro Hatazaki; Terumasa Hayashi; Takayuki Higashi; Yoshihide Hirohata; Shuji Horinouchi; Masayuki Inagaki; Masao Ishii; Tamayo Ishiko; Hideaki Jinnouchi; Hidetoshi Kanai; Daisuke Kanda; Hideo Kanehara; Masayuki Kashima; Kiyoe Kato; Takeshi Katsuki; Katsunori Kawamitsu; Satsuki Kawasaki; Fumi Kikuchi; Hidetoshi Kikuchi; Kunihisa Kobayashi; Junko Koide; Miyuki Kubota; Yoshiro Kusano; Hajime Maeda; Sunao Matsubayashi; Kazunari Matsumoto; Yasuto Matsuo; Naoki Matsuoka; Hiroaki Miyaoka; Satoshi Murao; Mikihiro Nakayama; Jun Nakazawa; Takashi Nomiyama; Masayuki Noritake; Takayuki Ogiwara; Hiroshi Ohashi; Hideki Okamoto; Takeshi Osonoi; Nobuhiro Sasaki; Taiji Sekigami; Taro Shibasaki; Hirotaka Shibata; Junji Shinoda; Hiroshi Sobajima; Kazuya Sugitatsu; Toshiyuki Sugiura; Toru Sugiyama; Daisuke Suzuki; Hiroyuki Suzuki; Masaaki Suzuki; Asami Takeda; Asami Tanaka; Seiichi Tanaka; Izumi Tsunematsu; Makoto Ujihara; Daishiro Yamada; Masayo Yamada; Kazuo Yamagata; Ken Yamakawa; Fumiko Yamakawa; Yoshimitsu Yamasaki; Yuko Yambe; Taihei Yanagida; Hidekatsu Yanai; Tetsuyuki Yasuda; Dovile Kriauciuniene; Jurate Lasiene; Antanas Navickas; Lina Radzeviciene; Egle Urbanaviciene; Gediminas Urbonas; Audrone Velaviciene; Rohana Abd Ghani; Nor Azizah Aziz; Li Yuan Lee; Chek Loong Loh; Norhaliza Mohd Ali; Nurain Mohd Noor; Nik Nur Fatnoon Nik Ahmad; Jeyakantha Ratnasingam; Wan Hasnul Halimi Bin Wan Hasan; Wan Mohd Izani Wan Mohamed; Sandro Avila Pardo; Miriam Bastidas Adrian; Alfredo Chew Wong; Jorge Escobedo de la Peña; Guillermo Fanghänel Salmón; Guillermo González Gálvez; Ramiro Gutiérrez Ochoa; Saúl Irizar Santana; Magdalena Madero Rovalo; Gustavo Méndez Machado; Luis Nevarez Ruiz; Denisse Ramos Ibarra; Gabriel Ramos López; Leobardo Sauque Reyna; Gustavo Solache Ortiz; Rafael Valdez Ortiz; Juan Villagordoa Mesa; R.C. Bakker; J.N.M. Barendregt; A.H. Boonstra; Willem Bos; C.B. Brouwer; M. van Buren; Ron Gansevoort; Adriaan Kooy; Marielle Krekels; Ruud J.M. van Leendert; Louis A.G. Lieverse; P.T. Luik; E. Lars Penne; Peter Smak Gregoor; Liffert Vogt; John Baker; Veronica Crawford; Rick Cutfield; Peter Dunn; Jeremy Krebs; Kingsley Nirmalaraj; Russell Scott; Nine Smuts; Erik Eriksen; Trine Finnes; Hans Høivik; Thomas Karlsson; Peter Scott Munk; Maria Radtke; Knut Risberg; Jan Rocke; Leidulv Solnør; Aud-Eldrid Stenehjem; Anne-Beathe Tafjord; Glenda Pamugas; Araceli Panelo; Ronald Perez; Maribel Tanque; Louie Tirador; Michael Villa; Patrycja Butrymowicz; Kazimierz Ciechanowski; Grazyna Cieslik; Edward Franek; Janusz Gumprecht; Michal Hoffmann; Jolanta Krzykowska; Ilona Kurnatowska; Katarzyna Landa; Adam Madrzejewski; Katarzyna Madziarska; Stanislaw Mazur; Piotr Napora; Michal Nowicki; Anna Ocicka-Kozakiewicz; Barbara Rewerska; Teresa Rusicka; Jan Ruxer; Ewa Skokowska; Andrzej Stankiewicz; Tomasz Stompor; Agnieszka Tiuryn-Petrulewicz; Katarzyna Wasilewska; Bogna Wierusz-Wysocka; Renata Wnetrzak-Michalska; Edgar Almeida; Rosa Ballesteros; Carlos Barreto; Idalina Beirao; Rita Birne; Cesar Esteves; Jose Guia; Susana Heitor; Olinda Marques; Pedro Melo; Fernando Nolasco; Amalia Pereira; Cristina Roque; Francisco Rosario; Gil Silva; Ana Silva; Fernando Teixeira e Costa; Ana Vila Lobos; Gregorio Cortes-Maisonet; Amaury Roman-Miranda; Adrian Albota; Cornelia Bala; Hortensia Barbonta; Elena Caceaune; Doina Catrinoui; Ciprian Constantin; Adriana Dumitrescu; Nicoleta Mindrescu; Cristina Mistode; Gabriela Negrisanu; Adriana Onaca; Silvia Paveliu; Ella Pintilei; Lavinia Pop; Amorin Popa; Alexandrina Popescu; Gabriela Radulian; Iosif Szilagyi; Liana Turcu; Georgeta Vacaru; Adrian Vlad; Mikhail Antsiferov; Mikhail Arkhipov; Andrey Babkin; Olga Barbarash; Vitaliy Baranov; Elena Chernyavskaya; Arkadiy Demko; Alexander Dreval; Anton Edin; Polina Ermakova; Valentin Fadeev; Albert Galyavich; Leyla Gaysina; Ivan Gordeev; Irina Ipatko; Marina Kalashnikova; Yuriy Khalimov; Vadim Klimontov; Zhanna Kobalava; Elena Kosmacheva; Natalya Koziolova; Lyudmila Kvitkova Sergey Levashov; Roman Libis; Vyacheslav Marasaev; Natalia Malykh; Vladimir Martynenko; Sofya Malyutina; Imad Merai; Ashot Mkrtumyan; Galina Nechaeva; Nina Petunina; Shamil Palyutin; Leonid Pimenov; Elena Rechkova; Tatyana Rodionova; Oksana Rymar; Ruslan Sardinov; Olga Semenova; Alexander Sherenkov; Oleg Solovev; Elena Smolyarchuk; Leonid Strongin; Olga Ukhanova; Nadezhda Verlan; Natalya Vorokhobina; Davyd Yakhontov; Sergey Yakushin; Elena Zakharova; Alsu Zalevskaya; Olga Zanozina; Elena Zhdanova; Larisa Zhukova; Tatyana Zykova; Chee Fang Sum; Sufi Muhummad Suhail; Ru San Tan; Anantharaman Vathsala; Edmund Wong; Jana Babikova; Ingrid Buganova; Andrej Dzupina; Zuzana Ochodnicka; Dalibor Sosovec; Denisa Spodniakova; Fayzal Ahmed; Aslam Amod; Sindeep Bhana; Larry Distiller; Dirkie Jansen van Rensburg; Mukesh Joshi; Shaifali Joshi; Deepak Lakha; Essack Mitha; Gracjan Podgorski; Naresh Ranjith; Brian Rayner; Paul Rheeder; Mohamed Sarvan; Mary Seeber; Heidi Siebert; Mohammed Tayob; Julien Trokis; Dorothea Urbach; Louis van Zyl; Bum-Soon Choi; Moon Gi Choi; ChoonHee Chung; YouCheol Hwang; ChongHwa Kim; InJoo Kim; JaeHyeon Kim; SinGon Kim; SungGyun Kim; Tae Hee Kim; WooJe Lee; ByungWan Lee; Kang Wook Lee; Kook-Hwan Oh; Ji Eun Oh; Yun Kyu Oh; Dong-Jin Oh; Junbeom Park; Seok Joon Shin; Su-Ah Sung; Jae Myung Yu; Irene Agraz; Francisco Javier Ampudia; Hanane Bouarich; Francesca Calero; Cristina Castro; Secundino Cigarrán Guldris; Josep Cruzado Garrit; Fernando de Álvaro; Josep Galcerán; Olga González Albarrán; Julio Hernández Jaras; Meritxell Ibernón; Francisco Martínez Deben; Ma Dolores Martínez Esteban; José María Pascual Izuel; Judith Martins; Juan Mediavilla; Alfredo Michán; Julio Pascual Santos; Esteban Poch; Manuel Polaina Rusillo; Carlos Sánchez Juan; Rafael Santamaría Olmo; José Julián Segura de la Morena; Alfonso Soto; Maribel Troya; Annette Bruchfeld; Dan Curiac; Ken Eliasson; Malin Frank; Gregor Guron; Olof Hellberg; Margareta Hellgren; Hans Larnefeldt; Carl-Johan Lindholm; Magnus Löndahl; Erik Rein-Hedin; Inga Soveri; Jonas Spaak; Bengt-Olov Tengmark; Daniel Ackermann; Stefan Bilz; Michel Burnier; Christian Forster; Stefan Kalbermatter; Andreas Kistler; Antoinette Pechére-Bertschi; Bernd Schultes; Chiz-Tzung Chang; Cheng-Chieh Hung; Ju-Ying Jiang; Chien-Te Lee; Shuei-Liong Lin; Der-Cherng Tarng; Shih-Te Tu; Mai-Szu Wu; Ming-Ju Wu; Chaicharn Deerochanawong; Chagriya Kitiyakara; Vuddhidej Ophascharoensuk; Chatlert Pongchaiyakul; Bancha Satirapoj; Necmi Eren; Ibrahim Gul; Okan Gulel; Ismail Kocyigit; Abdulbaki Kumbasar; Idris Sahin; Ramazan Sari; Burak Sayin; Talat Tavli; Sedat Ustundag; Yavuz Yenicerioglu; Iryna Bondarets; Volodymyr Botsyurko; Viktoriia Chernikova; Oleksandra Donets; Ivan Fushtey; Mariia Grachova; Anna Isayeva; Dmytro Kogut; Julia Komisarenko; Nonna Kravchun; Kateryna Malyar; Borys Mankovsky; Liliya Martynyuk; Vitaliy Maslyanko; Halyna Myshanych; Larysa Pererva; Nataliia Pertseva; Oleksandr Serhiyenko; Ivan Smirnov; Liubov Sokolova; Vasyl Stryzhak; Maryna Vlasenko; Ahmad AbouSaleh; Jonathan Barratt; Cuong Dang; Hassan Kahal; Adam Kirk; Anne Kilvert; Sui Phi Kon; Kieran McCafferty; Dipesh Patel; Sam Rice; Arutchelvam Vijayaraman; Yuk-ki Wong; Martin Gibson; Mona Wahba; Reza Zaidi; Idalia Acosta; Atoya Adams; Sharon Adler; Dilawar Ajani; Slamat Ali; Radica Alicic; Amer Al-Karadsheh; Sreedhara Alla; D. Allison; Nabil Andrawis; Ahmed Arif; Ahmed Awad; Masoud Azizad; Michael Bahrami; Shweta Bansal; Steven Barag; Ahmad Barakzoy; Mark Barney; Joshua Barzilay; Khalid Bashir; Jose Bautista; Srinivasan Beddhu; Diogo Belo; Sabrina Benjamin; Ramin Berenji; Anuj Bhargava; Jose Birriel; Stephen Brietzke; Frank Brosius; Osvaldo Brusco; Anna Burgner; Robert Busch; Rafael Canadas; Maria Caramori; Jose Cardona; Christopher Case; Humberto Cruz; Ramprasad Dandillaya; Dalia Dawoud; Zia Din; Bradley Dixon; Ankur Doshi; James Drakakis; Mahfouz El Shahawy; Ashraf El-Meanawy; Mohammed El-Shahawy; John Evans; George Fadda; Umar Farooq; Roland Fernando; Raymond Fink; Brian First; David Fitz-Patrick; John Flack; Patrick Fluck; Leon Fogelfeld; Vivian Fonseca; Juan Frias; Claude Galphin; Luis Garcia-Mayol; Gary Goldstein; Edgar Gonzalez; Francisco Gonzalez-Abreu; Ashwini Gore; David Grant; Violet Habwe; Maxine Hamilton; Jamal Hammoud; Stuart Handelsman; Israel Hartman; Glenn Heigerick; Andrew Henry; German Hernandez; Carlos Hernandez-Cassis; Carlos Herrera; Joachim Hertel; Wenyu Huang; Rogelio Iglesias; Ali Iranmanesh; Timothy Jackson; Mahendra Jain; Kenneth Jamerson; Karen Johnson; Eric Judd; Joshua Kaplan; Zeid Kayali; Bobby Khan; Muhammad Khan; Sourabh Kharait; M. Sue Kirkman; Nelson Kopyt; Wayne Kotzker; Csaba Kovesdy; Camil Kreit; Arvind Krishna; Saeed Kronfli; Keung Lee; Derek LeJeune; Brenda Lemus; Carlos Leon-Forero; Douglas Linfert; Henry Lora; Alexander Lurie; Geetha Maddukuri; Alexander Magno; Louis Maletz; Sreedhar Mandayam; Mariana Markell; Ronald Mayfield; Caroline Mbogua; Dierdre McMullen; Carl Meisner; Stephen Minton; Bharat Mocherla; Rajesh Mohandas; Manuel Montero; Moustafa Moustafa; Salil Nadkarni; Samer Nakhle; Jesus Navarro; Nilda Neyra; Romanita Nica; Philip Nicol; Paul Norwood; Visal Numrungroad; Richard O'Donovan; A. Odugbesan; Jorge Paoli-Bruno; Samir Parikh; Rakesh Patel; Aldo Peixoto; Pablo Pergola; Alan Perlman; Karlton Pettis; Roberto Pisoni; Mirela Ponduchi; Jorge Posada; Sharma Prabhakar; Jai Radhakrishnan; Mahboob Rahman; Rupesh Raina; Anjay Rastogi; Efrain Reisin; Marc Rendell; David Robertson; Michael Rocco; Hugo Romeu; Sylvia Rosas; Jack Rosenfeld; Dennis Ross; Jeffrey Rothman; Lance Rudolph; Yusuf Ruhullah; Gary Ruoff; Jeffrey Ryu; Mandeep Sahani; Ramin Sam; Garfield Samuels; William Sanchez; Vladimir Santos; Scott Satko; Sanjeev Saxena; David Scott; Gilberto Seco; Melvin Seek; Harvey Serota; Tariq Shafi; Nauman Shahid; Michael Shanik; Santosh Sharma; Arjun Sinha; James Smelser; Mark Smith; Kyaw Soe; Richard Solomon; Eugene Soroka; Joseph Soufer; Bruce Spinowitz; Leslie Spry; Rosa Suarez; Bala Subramanian; Harold Szerlip; Aparna Tamirisa; Stephen Thomson; Tuan-Huy Tran; Richard Treger; Gretel Trullenque; Thomas Turk; Guillermo Umpierrez; Daniel Urbach; Martin Valdes; Shujauddin Valika; Damaris Vega; Peter Weissman; Adam Whaley-Connell; Jonathan Winston; Jonathan Wise; Alan Wynne; Steven Zeig; Phuong Chu; Lam Van Hoang; Tran Khanh; Nguyen Thi Phi Nga; Pham Nguyen Son; Lan Phuong Tran. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study. Diabetes Care. 2022 Apr 1;45(4):888-897. doi: 10.2337/dc21-1944.

ReferenceCitation: Rossing P, Filippatos G, Agarwal R, Anker SD, Pitt B, Ruilope LM, Chan JCN, Kooy A, McCafferty K, Schernthaner G, Wanner C, Joseph A, Scheerer MF, Scott C, Bakris GL; FIDELIO-DKD Investigators. Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. Kidney Int Rep. 2021 Oct 14;7(1):36-45. doi: 10.1016/j.ekir.2021.10.008. eCollection 2022 Jan.

ReferenceCitation: Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Ruilope LM, Boletis J, Toto R, Umpierrez GE, Wanner C, Wada T, Scott C, Joseph A, Ogbaa I, Roberts L, Scheerer MF, Bakris GL. Effects of canagliflozin versus finerenone on cardiorenal outcomes: exploratory post hoc analyses from FIDELIO-DKD compared to reported CREDENCE results. Nephrol Dial Transplant. 2022 Jun 23;37(7):1261-1269. doi: 10.1093/ndt/gfab336.

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

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

ReferenceCitation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.

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

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

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


type: Other Identifier

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

acronym: CONNECT-IBD

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

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

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

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

lead_sponsor: Pfizer

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

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

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Internisten am Markt Dres. Schwerdtfeger & Lehmann

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

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Hospital Universitario de Gran Canaria DR NEGRIN

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

location_facility: Hamburgisches Forschungsinstitut fur chronisch entzuendliche

location_facility: Fondazione Poliambulanza - Istituto Ospedaliero

location_facility: Medizinisches Versorgungszentrum Portal 10

location_facility: Gloucestershire Hospitals - NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

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

location_facility: Centrum péce o zažívací trakt, Vítkovická nemocnice

location_facility: Gastroenterologische Praxis Dr. med. B. Adami

location_facility: Onco Studies an der Onkologie Dreiländereck

location_facility: Azienda Ospedaliera - Universitaria di Modena Policlinico

location_facility: Ospedale Generale Provinciale di Macerata

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

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main

location_facility: Gastroenterologische Gemeinschaftspraxis am Germania-Campus

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen

location_facility: Groupe hospitalier mutualiste les portes du Sud

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: Azienda Ospedaliera Universitaria di PISA

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

location_facility: Szte szent-gyorgyi albert klinikai kozpont

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Clinico Universitario de Santiago

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

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

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

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Zentrum für Gastroenterologie Saarbrücken MVZ GmbH

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

location_facility: Azienda Ospedaliera per l'Emergenza Cannizzaro

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

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

location_facility: IKEM (Institut Klinické a Experimentální Medicíny)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


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

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

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.

ReferenceCitation: El-Chami MF, Garweg C, Iacopino S, Al-Samadi F, Martinez-Sande JL, Tondo C, Johansen JB, Prat XV, Piccini JP, Cha YM, Grubman E, Bordachar P, Roberts PR, Soejima K, Stromberg K, Fagan DH, Clementy N. Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2022 Feb;19(2):228-234. doi: 10.1016/j.hrthm.2021.10.023. Epub 2021 Oct 29.

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

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

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

lead_sponsor: Medtronic

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

intervention_type: Device

status_simplified: Ongoing


primary_purpose: Treatment

intervention_type: Radiation

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

lead_sponsor: Aragon Pharmaceuticals, Inc.

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceCitation: Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25.

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

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


ipd_sharing: Yes

acronym: APPRISE

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

lead_sponsor: Sanofi

ReferenceCitation: Cefalù AB, Garbelotto R, Mombelli G, Pirro M, Rubba P, Arca M, Borghi C, Bonomo K, Gonnelli S, Massaroni K, Tirone G, Averna M; ODYSSEY APPRISE Study Italian Investigators. A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort. Nutr Metab Cardiovasc Dis. 2022 Nov;32(11):2638-2646. doi: 10.1016/j.numecd.2022.07.020. Epub 2022 Aug 9.

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

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

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

summary:
Primary Objective:

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

Secondary Objectives:

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

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


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

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

time_perspective: Cross-Sectional

lead_sponsor: Boehringer Ingelheim

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

location_facility: Boehringer Ingelheim Investigational Site 26

location_facility: Boehringer Ingelheim Investigational Site 65

location_facility: Boehringer Ingelheim Investigational Site 18

location_facility: Boehringer Ingelheim Investigational Site 108

location_facility: Boehringer Ingelheim Investigational Site 37

location_facility: Boehringer Ingelheim Investigational Site 156

location_facility: Boehringer Ingelheim Investigational Site 76

location_facility: Boehringer Ingelheim Investigational Site 78

location_facility: Boehringer Ingelheim Investigational Site 47

location_facility: Boehringer Ingelheim Investigational Site 81

location_facility: Boehringer Ingelheim Investigational Site 92

location_facility: Boehringer Ingelheim Investigational Site 160

location_facility: Boehringer Ingelheim Investigational Site 102

location_facility: Boehringer Ingelheim Investigational Site 80

location_facility: Boehringer Ingelheim Investigational Site 19

location_facility: Boehringer Ingelheim Investigational Site 77

location_facility: Boehringer Ingelheim Investigational Site 93

location_facility: Boehringer Ingelheim Investigational Site 72

location_facility: Boehringer Ingelheim Investigational Site 97

location_facility: Boehringer Ingelheim Investigational Site 4

location_facility: Boehringer Ingelheim Investigational Site 42

location_facility: Boehringer Ingelheim Investigational Site 114

location_facility: Boehringer Ingelheim Investigational Site 24

location_facility: Boehringer Ingelheim Investigational Site 155

location_facility: Boehringer Ingelheim Investigational Site 16

location_facility: Boehringer Ingelheim Investigational Site 106

location_facility: Boehringer Ingelheim Investigational Site 38

location_facility: Boehringer Ingelheim Investigational Site 57

location_facility: Boehringer Ingelheim Investigational Site 91

location_facility: Boehringer Ingelheim Investigational Site 104

location_facility: Boehringer Ingelheim Investigational Site 29

location_facility: Boehringer Ingelheim Investigational Site 48

location_facility: Boehringer Ingelheim Investigational Site 107

location_facility: Boehringer Ingelheim Investigational Site 105

location_facility: Boehringer Ingelheim Investigational Site 59

location_facility: Boehringer Ingelheim Investigational Site 101

location_facility: Boehringer Ingelheim Investigational Site 152

location_facility: Boehringer Ingelheim Investigational Site 46

location_facility: Boehringer Ingelheim Investigational Site 143

location_facility: Boehringer Ingelheim Investigational Site 21

location_facility: Boehringer Ingelheim Investigational Site 119

location_facility: Boehringer Ingelheim Investigational Site 90

location_facility: Boehringer Ingelheim Investigational Site 54

location_facility: Boehringer Ingelheim Investigational Site 130

location_facility: Boehringer Ingelheim Investigational Site 118

location_facility: Boehringer Ingelheim Investigational Site 109

location_facility: Boehringer Ingelheim Investigational Site 45

location_facility: Boehringer Ingelheim Investigational Site 138

location_facility: Boehringer Ingelheim Investigational Site 98

location_facility: Boehringer Ingelheim Investigational Site 6

location_facility: Boehringer Ingelheim Investigational Site 68

location_facility: Boehringer Ingelheim Investigational Site 112

location_facility: Boehringer Ingelheim Investigational Site 70

location_facility: Boehringer Ingelheim Investigational Site 56

location_facility: Boehringer Ingelheim Investigational Site 123

location_facility: Boehringer Ingelheim Investigational Site 5

location_facility: Boehringer Ingelheim Investigational Site 44

location_facility: Boehringer Ingelheim Investigational Site 7

location_facility: Boehringer Ingelheim Investigational Site 113

location_facility: Boehringer Ingelheim Investigational Site 117

location_facility: Boehringer Ingelheim Investigational Site 10

location_facility: Boehringer Ingelheim Investigational Site 41

location_facility: Boehringer Ingelheim Investigational Site 52

location_facility: Boehringer Ingelheim Investigational Site 60

location_facility: Boehringer Ingelheim Investigational Site 131

location_facility: Boehringer Ingelheim Investigational Site 14

location_facility: Boehringer Ingelheim Investigational Site 31

location_facility: Boehringer Ingelheim Investigational Site 28

location_facility: Boehringer Ingelheim Investigational Site 66

location_facility: Boehringer Ingelheim Investigational Site 12

location_facility: Boehringer Ingelheim Investigational Site 20

location_facility: Boehringer Ingelheim Investigational Site 125

location_facility: Boehringer Ingelheim Investigational Site 127

location_facility: Boehringer Ingelheim Investigational Site 151

location_facility: Boehringer Ingelheim Investigational Site 35

location_facility: Boehringer Ingelheim Investigational Site 23

location_facility: Boehringer Ingelheim Investigational Site 3

location_facility: Boehringer Ingelheim Investigational Site 128

location_facility: Boehringer Ingelheim Investigational Site 157

location_facility: Boehringer Ingelheim Investigational Site 110

location_facility: Boehringer Ingelheim Investigational Site 142

location_facility: Boehringer Ingelheim Investigational Site 161

location_facility: Boehringer Ingelheim Investigational Site 25

location_facility: Boehringer Ingelheim Investigational Site 40

location_facility: Boehringer Ingelheim Investigational Site 58

location_facility: Boehringer Ingelheim Investigational Site 43

location_facility: Boehringer Ingelheim Investigational Site 100

location_facility: Boehringer Ingelheim Investigational Site 62

location_facility: Boehringer Ingelheim Investigational Site 103

location_facility: Boehringer Ingelheim Investigational Site 135

location_facility: Boehringer Ingelheim Investigational Site 139

location_facility: Boehringer Ingelheim Investigational Site 36

location_facility: Boehringer Ingelheim Investigational Site 94

location_facility: Boehringer Ingelheim Investigational Site 115

location_facility: Boehringer Ingelheim Investigational Site 159

location_facility: Boehringer Ingelheim Investigational Site 34

location_facility: Boehringer Ingelheim Investigational Site 61

location_facility: Boehringer Ingelheim Investigational Site 51

location_facility: Boehringer Ingelheim Investigational Site 79

location_facility: Boehringer Ingelheim Investigational Site 89

location_facility: Boehringer Ingelheim Investigational Site 1

location_facility: Boehringer Ingelheim Investigational Site 88

location_facility: Boehringer Ingelheim Investigational Site 87

location_facility: Boehringer Ingelheim Investigational Site 8

location_facility: Boehringer Ingelheim Investigational Site 148

location_facility: Boehringer Ingelheim Investigational Site 74

location_facility: Boehringer Ingelheim Investigational Site 2

location_facility: Boehringer Ingelheim Investigational Site 133

location_facility: Boehringer Ingelheim Investigational Site 122

location_facility: Boehringer Ingelheim Investigational Site 129

location_facility: Boehringer Ingelheim Investigational Site 111

location_facility: Boehringer Ingelheim Investigational Site 86

location_facility: Boehringer Ingelheim Investigational Site 120

location_facility: Boehringer Ingelheim Investigational Site 140

location_facility: Boehringer Ingelheim Investigational Site 55

location_facility: Boehringer Ingelheim Investigational Site 150

location_facility: Boehringer Ingelheim Investigational Site 63

location_facility: Boehringer Ingelheim Investigational Site 73

location_facility: Boehringer Ingelheim Investigational Site 13

location_facility: Boehringer Ingelheim Investigational Site 67

location_facility: Boehringer Ingelheim Investigational Site 132

location_facility: Boehringer Ingelheim Investigational Site 17

location_facility: Boehringer Ingelheim Investigational Site 32

location_facility: Boehringer Ingelheim Investigational Site 22

location_facility: Boehringer Ingelheim Investigational Site 9

location_facility: Boehringer Ingelheim Investigational Site 11

location_facility: Boehringer Ingelheim Investigational Site 95

location_facility: Boehringer Ingelheim Investigational Site 64

location_facility: Boehringer Ingelheim Investigational Site 69

location_facility: Boehringer Ingelheim Investigational Site 147

location_facility: Boehringer Ingelheim Investigational Site 39

location_facility: Boehringer Ingelheim Investigational Site 121

location_facility: Boehringer Ingelheim Investigational Site 144

location_facility: Boehringer Ingelheim Investigational Site 149

location_facility: Boehringer Ingelheim Investigational Site 126

location_facility: Boehringer Ingelheim Investigational Site 84

location_facility: Boehringer Ingelheim Investigational Site 153

location_facility: Boehringer Ingelheim Investigational Site 33

location_facility: Boehringer Ingelheim Investigational Site 53

location_facility: Boehringer Ingelheim Investigational Site 154

location_facility: Boehringer Ingelheim Investigational Site 50

location_facility: Boehringer Ingelheim Investigational Site 30

location_facility: Boehringer Ingelheim Investigational Site 145

location_facility: Boehringer Ingelheim Investigational Site 75

location_facility: Boehringer Ingelheim Investigational Site 99

location_facility: Boehringer Ingelheim Investigational Site 134

location_facility: Boehringer Ingelheim Investigational Site 96

location_facility: Boehringer Ingelheim Investigational Site 82

location_facility: Boehringer Ingelheim Investigational Site 137

location_facility: Boehringer Ingelheim Investigational Site 124

location_facility: Boehringer Ingelheim Investigational Site 49

location_facility: Boehringer Ingelheim Investigational Site 136

location_facility: Boehringer Ingelheim Investigational Site 116

location_facility: Boehringer Ingelheim Investigational Site 83

location_facility: Boehringer Ingelheim Investigational Site 146

location_facility: Boehringer Ingelheim Investigational Site 158

location_facility: Boehringer Ingelheim Investigational Site 85

location_facility: Boehringer Ingelheim Investigational Site 27

location_facility: Boehringer Ingelheim Investigational Site 71

location_facility: Boehringer Ingelheim Investigational Site 15

location_facility: Boehringer Ingelheim Investigational Site 141


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

acronym: STRIVE

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

status: Terminated

primary_purpose: Prevention

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

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

location_facility: Seton Brain and Spine Institute Williamson

location_facility: University of California Irvine Medical Center

location_facility: Mayo Clinic Rochester, Methodist Hospital Campus

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

location_facility: The Feinstein Institute for Medical Research

location_facility: Anne Arundel Health System Research Institute (AAHSRI)

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

location_facility: Foothills Medical Centre, University of Calgary

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Carilion Clinic Institute for Orthopaedics and Neurosciences

location_facility: Yale New Haven Hospital - Investigational Drug Services

location_facility: Milton S. Hershey Medical Center Pharmacy

location_facility: VCU Medical Center Investigational Drug Service

location_facility: Carilion Clinic - Department of Pharmacy

location_facility: Baylor College of Medicine - McNair Campus

location_facility: University of Miami Hospital and Clinics and Research Pharmacy

location_facility: University of Maryland, Medical Systems, Oriole Park

location_facility: Hospital Universitario Politecnico La Fe

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

location_facility: Pharmacy Service of Hospital Clinico de Valladolid

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

location_facility: St. David's Neuroscience and Spine Institute

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: University Medical Center of Southern Nevada

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

location_facility: The Clinical Research Unit at Mount Sinai

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

location_facility: University of Colorado Hospital, Lone Tree Health Center

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

location_facility: Boulder Community Health - Foothills Hospital

location_facility: Sentara Medical Group DBA Sentara Neurosurgery Specialists

location_facility: HonorHealth Scottsdale Osborn Medical Center

location_facility: Bingham Memorial Family Medicine & Specialty Clinic

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

location_facility: Cedars-Sinai Medical Center - Investigational Drug

location_facility: Mermorial Hermann - Memorial City Medical Center

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

location_facility: UMass Memorial Medical Center- Clinical Research Center

location_facility: Service de Chirurgie Orthopedique et Traumatologie

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

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

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

location_facility: Scott & White Memorial Hospital and Clinic

location_facility: Montreal Neurological Hospital Research Pharmacy

location_facility: Yale New Haven Hospital - St. Raphael campus

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

location_facility: Cleveland Clinic Foundation - Investigation Pharmacy

location_facility: Cleveland Clinic Foundation Center for Spine Health

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

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

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

location_facility: University of Maryland Medical Systems, Investigational Drug Services

location_facility: Rush University Medical Center Professional Office Building Infusion Pharmacy

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

location_facility: VCU Heatlh Neuroscience Orthopedic and Wellness Center

location_facility: Santa Monica UCLA Medical Center & Orthopaedic Hospital

location_facility: Orthopaedic Associates of Michigan - Research

location_facility: The Rothman Institute Marlton, NJ Office

location_facility: Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy

location_facility: WVU Medicine Physician Office Center Orthopaedic Surgery

location_facility: Thomas Jefferson University Hospital, Cardiovascular Associates

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

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: Montreal Neurological Institute and Hospital

location_facility: Klinikum rechts der Isar, Technische Universitat Munchen

location_facility: Hospital Universitari Germans Trias i Pujol

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

location_facility: Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital

location_facility: University of Massachusetts Medical Center Memorial Campus

location_facility: National Hospital Organization Murayama Medical Center

location_facility: Twin Cities Spine Surgeons dba Twin Cities Spine Center

location_facility: Dell Seton Medical Center at The University of Texas

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

location_facility: University of Michigan Investigational Pharmacy

location_facility: Anne Arundel Medical Center Infusion Center

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: The Rothman Institute Washington Township, NJ Office

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Hospital Clínico Universitario Santiago de Compostela

location_facility: Barnes Jewish Center for Advanced Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Abington Jefferson Health-Pharmacy Department

location_facility: Allina Health - Abbott Northwestern Hospital /

location_facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

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

location_facility: University of Colorado Clinical & Translational Research Center Clinic

location_facility: University of Maryland Medical Systems, Department of Neurosurgery

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

location_facility: The Johns Hopkins Hospital Investigational Drug Service

location_facility: Massachusetts General Hospital, Clinical Research Pharmacy

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

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

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of Colorado Denver, School of Medicine

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

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

intervention_type: Biological

status_simplified: Unknown


acronym: MANDARA

title: A Randomized, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy

lead_sponsor: AstraZeneca

ReferenceCitation: Serling-Boyd N, Wallace ZS. Management of primary vasculitides with biologic and novel small molecule medications. Curr Opin Rheumatol. 2021 Jan;33(1):8-14. doi: 10.1097/BOR.0000000000000756. Review.

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.

location_country:
United Kingdom
Italy
Canada
United States
France
Israel
Belgium
Japan
Germany

summary:
This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy.

All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).


title: A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

acronym: CheckMate 7G8

summary: A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
Netherlands
Russian Federation
Sweden
United States
Chile
China
France
Israel
Japan
Germany

location_facility:
Local Institution - 0155
Local Institution - 0138
Local Institution - 0011
Local Institution - 0157
Local Institution - 0127
Local Institution - 0128
Local Institution - 0093
Local Institution - 0042
Local Institution - 0038
Local Institution - 0103
Local Institution - 0075
Local Institution - 0016
Local Institution - 0073
Local Institution - 0108
Local Institution - 0001
Local Institution - 0159
Local Institution - 0052
Local Institution - 0081
Local Institution - 0149
Local Institution - 0097
Local Institution - 0050
Local Institution - 0164
Local Institution - 0066
Local Institution - 0124
Local Institution - 0117
Local Institution - 0147
Local Institution - 0107
Local Institution - 0106
Local Institution - 0040
Local Institution - 0162
Local Institution - 0165
Local Institution - 0062
Local Institution - 0010
Local Institution - 0122
Local Institution - 0144
Local Institution - 0141
Local Institution - 0161
Local Institution - 0060
Local Institution - 0064
Local Institution
Local Institution - 0121
Local Institution - 0002
Local Institution - 0045
Local Institution - 0055
Local Institution - 0058
Local Institution - 0104
The University Of Chicago
Local Institution - 0047
Local Institution - 0094
Local Institution - 0057
Local Institution - 0061
Local Institution - 0160
Local Institution - 0051
University Of Colorado Cancer Center
Local Institution - 0114
Local Institution - 0087
Local Institution - 0151
Local Institution - 0123
Local Institution - 0156
Local Institution - 0054
Local Institution - 0041
Local Institution - 0065
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0083
Local Institution - 0063
Local Institution - 0095
Local Institution - 0126
Local Institution - 0072
Local Institution - 0032
Local Institution - 0153
Local Institution - 0067
Local Institution - 0130
Local Institution - 0017
Local Institution - 0049
Local Institution - 0037
Local Institution - 0111
Local Institution - 0012
Local Institution - 0096
Local Institution - 0059
Local Institution - 0048
Local Institution - 0125
Local Institution - 0132
Local Institution - 0105
Local Institution - 0154
Local Institution - 0088
Local Institution - 0080
Local Institution - 0098
Local Institution - 0158
Local Institution - 0134
Local Institution - 0120
Local Institution - 0136
Local Institution - 0031
Local Institution - 0142
Local Institution - 0150
Local Institution - 0146
Local Institution - 0074
Local Institution - 0118
Local Institution - 0009
Local Institution - 0008
Local Institution - 0145
Local Institution - 0084


title: An Open-Label, Phase IIIb, Single Arm, Multicenter Safety Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

lead_sponsor: Hoffmann-La Roche

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

location_country: Poland Portugal Romania Slovenia Italy Spain Argentina Hungary France Chile Peru Mexico Czechia

location_facility: Presidio Ospedaliero di Summa-Perrino; Oncologia Medica

location_facility: USL Umbria 1 - Osp. Città di Castello; U.O. di Oncologia

location_facility: Hospital Central Fap Juan Benavides Dorich; Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Hospital Garcia de Orta; Servico de Oncologia Medica

location_facility: Institut de Cancérologie de Bourgogne; Oncologie Médicale

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Nemocnice na Bulovce; Ustav radiacni onkologie

location_facility: Hospital Nacional Cayetano Heredia; Hematology - Oncology

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Hospital de S. Francisco Xavier; Unidade de Oncologia Medica

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Onkologiai Osztaly

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Azienda Universitaria Magna Grecia; Dip. di Medicina Sperimentale e Clinica_U.O. Oncologia Medica

location_facility: Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: Hospital Cuf Descobertas; Unidade de Oncologia

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Pontificia Universidad Catolica de Chile; Centro Del Cáncer

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Univerzitetni klinični center Maribor; Oddelek za onkologijo

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

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

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Clinica Oncologica-Ospedali Riuniti Ancona

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: AULSS3 - Presidio di Mirano; Dip. di Oncologia

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

summary: Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.


title: A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

summary: To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Argentina
Puerto Rico
Israel
Sweden
Brazil
Canada
Germany
Denmark
Greece
France

location_facility: The University of Chicago Medical Center

location_facility: Altman Clinical and Translational Research Institute Center for Clinical Research

location_facility: Azienda Ospedaliera - Universitaria Sant' Andrea

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Centro Avançado de Pesquisa e Estudos para o Diagnóstico CAPED

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Centro Hospitalar Universitário de São João

location_facility: University of Colorado Hospital - Anschutz Medical Campus

location_facility: University Hospital - London Health Sciences Centre

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica

location_facility: The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

location_facility: Louisiana State University Health Sciences Center

location_facility: Emory Heart and Vascular Center - Emory Clifton Campus

location_facility: The University of North Carolina at Chapel Hill

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Institut Klinické a Experimentální Medicíny

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Instituto Dante Pazzanese de Cardiologia

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

location_facility: The Ohio State University College of Medicine

location_facility: Carl and Edyth Lindner Research Center at The Christ Hospital

location_facility: Froedtert & Medical College of Wisconsin

location_facility: Veterans Affairs Caribbean Healthcare System

location_facility: University Hospitals Cleveland Medical Center

location_facility: Instituto Cardiovascular de Buenos Aires

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

location_facility: The Westmead Institute for Medical Research

location_facility: Synexus - Scotland Clinical Research Centre

location_facility: New York University Langone Cardiology Associates

location_facility: Centro Hospitalar Universitário de Lisboa Central - Hospital de Santa Marta

location_facility: University of California, San Francisco (UCSF) - Medical Center

location_facility: Columbia University Irving Medical Center

location_facility: Synexus - Merseyside Clinical Research Centre

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Hospital Da Senhora da Oliveira - Guimarães

location_facility: Narodowy Instytut Kardiologii Stefana kardyna Wyszyskiego - Pastwowy Instytut Badawczy

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Tulane University Heart and Vascular Institute

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: A Beneficência Portuguesa de São Paulo - Unidade Mirante

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

location_facility: University of Texas Southwestern Medical Center

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawa II

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Universitaetsklinikum Heidelberg - Zentrum fur Innere Medizin

location_facility: Synexus - North Tees Clinical Research Centre


type: Registry Identifier

title: Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

summary:
This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma.

This study has 2 parts.

The main aims of the study are:

To check for side effects from treatment with TAK-981 given with rituximab.
To check how much TAK-981 participants can tolerate.
To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment.

Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons.

design_allocation: Non-Randomized

ReferenceCitation: Nakamura A, Grossman S, Song K, Xega K, Zhang Y, Cvet D, Berger A, Shapiro G, Huszar D. The SUMOylation inhibitor subasumstat potentiates rituximab activity by IFN1-dependent macrophage and NK cell stimulation. Blood. 2022 May 5;139(18):2770-2781. doi: 10.1182/blood.2021014267.

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

lead_sponsor: Takeda

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
China
Japan
Germany

location_facility: Mayo Clinic - Cancer Center - Rochester - PPDS

location_facility: Beatson West of Scotland Cancer Centre - PPDS

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Centre Hospitalier de l'Universite de Montreal

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

location_facility: City of Hope - Comprehensive Cancer Center (CCC)

location_facility: Ohio State University Wexner Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda


title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

lead_sponsor: Vertex Pharmaceuticals Incorporated

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.

location_country:
Denmark
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
United States
France
Belgium
Germany

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: University of Miami Miller School of Medicine

location_facility: Charite Paediatric Pulmonology Department

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Justus-Liebig-Universitaet Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Papworth Hospital NHS Foundation Trust, Papworth Everard

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: Banner University of Arizona Medical Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The University of Texas Southwestern Medical Center

location_facility: University of Utah / Primary Children's Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: University of California Davis Medical Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: University of California San Francisco, Lung Transplant Program

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Oklahoma Health Sciences Center

summary: This study will evaluate the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).


title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

ReferenceCitation: Barry PJ, Mall MA, Álvarez A, Colombo C, de Winter-de Groot KM, Fajac I, McBennett KA, McKone EF, Ramsey BW, Sutharsan S, Taylor-Cousar JL, Tullis E, Ahluwalia N, Jun LS, Moskowitz SM, Prieto-Centurion V, Tian S, Waltz D, Xuan F, Zhang Y, Rowe SM, Polineni D; VX18-445-104 Study Group. Triple Therapy for Cystic Fibrosis Phe508del-Gating and -Residual Function Genotypes. N Engl J Med. 2021 Aug 26;385(9):815-825. doi: 10.1056/NEJMoa2100665.

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing

location_country:
Denmark
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
United States
France
Israel
Belgium
Germany

location_facility: Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: Malattie Apparato Respiratorio 2 - Fibrosi Cistica

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: Charite Paediatric Pulmonology Department

location_facility: Justus-Liebig-Universitaet Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Northwell Health- Long Island Jewish Medical Center

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Banner University of Arizona Medical Center

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: University of Miami Miller School of Medicine

location_facility: Papworth Hospital NHS Foundation Trust, Papworth Everard

location_facility: The University of Iowa Hospitals and Clinics

summary: This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).


title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

lead_sponsor: ADC Therapeutics S.A.

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

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

location_facility: UCSF Health - Hematology and Blood and Marrow Transplant Clinic

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: University Hospitals Seidman Cancer Center

location_facility: City of Hope Comprehensive Cancer Center

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

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Norton Cancer Institute - Saint Matthews

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Memorial Sloan-Kettering Cancer Center - New York

summary: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).


title: A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country: Poland Hungary France Belgium Czechia

location_facility: CMed Rehabilitációs és Diagnosztikai Központ


title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study

acronym: BREACH

summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.

ReferenceCitation: Fornecker LM, Lazarovici J, Aurer I, Casasnovas RO, Gac AC, Bonnet C, Bouabdallah K, Feugier P, Specht L, Molina L, Touati M, Borel C, Stamatoullas A, Nicolas-Virelizier E, Pascal L, Lugtenburg P, Di Renzo N, Vander Borght T, Traverse-Glehen A, Dartigues P, Hutchings M, Versari A, Meignan M, Federico M, André M; LYSA-FIL-EORTC Intergroup. Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial. J Clin Oncol. 2022 Jul 22:JCO2101281. doi: 10.1200/JCO.21.01281. [Epub ahead of print]

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Denmark Croatia France Belgium Netherlands

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Radboud University Medical Center Nijmegen


title: An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

summary: The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other standard treatment option, nor did they qualify for another clinical study for PV

lead_sponsor: Novartis Pharmaceuticals

location_country: Portugal Austria Mexico Canada Thailand Sweden France Chile Belgium Norway Germany Bulgaria


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

acronym: COURSE

summary: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

location_country:
Denmark
Spain
United Kingdom
Netherlands
Canada
Korea, Republic of
United States
France
Israel
Germany


title: Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

summary: to evaluate the feasibility, safety and performance of the HighLife 28mm Transcatheter Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

lead_sponsor: HighLife SAS

location_country:
Poland
United Kingdom
Australia
France
Belgium
Germany

location_facility: University Hospital of Lord's Transfiguration

location_facility: Heart Center, University Hospital Dresden

location_facility: University Hospitals of Leicester NHS Trust

location_facility: University Heart Center Freiburg - Bad Krozingen

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

location_facility: Centre Hospitalo-Universitaire de Nantes


title: A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed

lead_sponsor: ViiV Healthcare

ReferenceType: background

ReferenceCitation: Llibre JM, Brites C, Cheng CY, Osiyemi O, Galera C, Hocqueloux L, Maggiolo F, Degen O, Taylor S, Blair E, Man C, Wynne B, Oyee J, Underwood M, Curtis L, Bontempo G, van Wyk J. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With HIV-1: Week 48 Results From the Phase 3, Non-inferiority SALSA Randomized Trial. Clin Infect Dis. 2022 Mar 2. pii: ciac130. doi: 10.1093/cid/ciac130. [Epub ahead of print]

ReferenceCitation: Masters MC, Cohn SE. Two-drug HIV regimens: more data still needed. Lancet HIV. 2021 Aug;8(8):e454-e455. doi: 10.1016/S2352-3018(21)00106-5.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Denmark
Taiwan
Brazil
Spain
Italy
Russian Federation
Mexico
United Kingdom
Argentina
Canada
Sweden
United States
France
China
South Africa
Belgium
Germany

summary: The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.


title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

summary: Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

location_country:
Saudi Arabia
Spain
United Kingdom
United States
Peru
South Africa
Philippines
Japan
Czechia
Poland
Portugal
Russian Federation
Argentina
India
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Colombia