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

acronym: SELECTION

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

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

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

lead_sponsor: Gilead Sciences

sponsor_collaborators:
Gilead Sciences
Galapagos NV

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

location_facility: Hyogo College of Medicine College Hospital

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

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Kitasato University Kitasato Institute Hospital

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

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

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

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

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

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

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: University of Louisville, Clinical Trials Unit

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

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

location_facility: Gastroenterology Associates of Central Georgia, LLC

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

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

location_facility: University Kebangsaan Malaysia Medical Centre

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Hospital Universitario Central de Asturias

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Toronto Digestive Disease Associates Inc.

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

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Grant Medical Foundation Ruby Hall Clinic

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

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

location_facility: Institute of Gastroenterology & Liver Disease, Sunshine Hospitals

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

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

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

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

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

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

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

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

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

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

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

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

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

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

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

location_facility: Colo-proctology Center Matsushima Clinic

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

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

location_facility: The University of Texas Health Science Center at Houston

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Centre Hospitalier Regional Universitaire de Lille

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

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Washington University School of Medicine

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Shiga University of Medical Science Hospital

location_facility: Baylor College of Medicine- Baylor Medical Center

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

location_facility: National Hospital Organization Sendai Medical Center

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

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

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

location_facility: Gastroenterology Research of San Antonio

location_facility: Medical Hospital, Tokyo Medical and Dental University

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

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

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

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

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Cabinet Particular Policlinic Algomed SRL

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

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: Digestive Health Specialists of the Southeast

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

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

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

location_facility: Fargo Gastroenterology and Hepatology Clinic

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

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

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

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

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

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

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

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

location_facility: Kitasato University Hospital, THE KITASATO INSTITUTE

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

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

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

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

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

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

location_facility: Gastroenterology Associates Of Tidewater

location_facility: University of Miami Crohn's and Colitis Center

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

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Vestre Viken Hospital Trust, Baerum Hospital

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

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

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Cambridge University Hospital NHS Foundation Trust

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

location_facility: University of Calgary, Heritage Medical Research Clinic

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

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


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

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

ReferenceType: derived

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

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

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

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

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

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

status: Completed

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

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

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

design_allocation: Randomized

study_completion_date_type: Actual

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

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


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

acronym: ATALANTE

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

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: ARCAGY/ GINECO GROUP

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Hoffmann-La Roche

location_country: Germany Israel Austria Belgium Spain Czechia France

location_facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung

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

location_facility: CHU Nîmes - Institut de Cancérologie du Gard

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Hospital Central Universitario Virgen de la Arrixaca

location_facility: Klinikum der Universität München - LMU, Campus Großhadern

location_facility: Klinikum rechts der Isar, Technischen Universität München

location_facility: Sainte-Catherine Institut du Cancer Avignon-Provence

location_facility: Krankenhaus der Barmherzigen Brüder Graz

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon

location_facility: Hospital Universitario Clínico San Carlos

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

location_facility: Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

status_simplified: Ongoing


acronym: INSPIRE

lead_sponsor: Onconova Therapeutics, Inc.

summary: The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

ReferenceType: background

ReferenceCitation: Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15.

publisher_dissemination: Informa

ReferenceType: result

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

location_facility: Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Minnesota Physicians Bone Marrow Transplant Clinic

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Klinički bolnicki centar Sestre milosrdnice

location_facility: Mid Florida Hematology and Oncology Centers

location_facility: Albert Einstein Medical Center, Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Skåne University Hospital, Department of Hematology

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità

location_facility: University Hospital and University of Bern; Inselspital Bern

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Adelaide and Meath Hospital, Incorporating the National Children's Hospital

location_facility: State Budgetary Healthcare Institution of Moscow City

location_facility: Cittá della Salute e della Scienza di Torino

location_facility: King's College Hospital NHS Foundation Trust

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

location_facility: Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa

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

location_facility: University Hospital Ostrava, Department of Hematooncology

location_facility: Hospital Duran i Reynals - Instituto Catalán de Oncología

location_facility: Somogy County Kaposi Mór Teaching Hospital

location_facility: National Hospital Organization Okayama Medical Center

location_facility: University of Wisconsin Clinical Science Center

location_facility: Institute Of Hematology And Transfusion Medicine

location_facility: University of Pécs 1st Department of Internal Medicine

location_facility: Tokai Central Hospital of the Mutual Aid Association of Public School Teachers

location_facility: Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology

location_facility: Niigata University Medical and Dental Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Greenville Health System (GHS) Cancer Institute

location_facility: Hospital of the University of Pennsylvania

location_facility: Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow

location_facility: Loyola University Chicago at Loyola University Medical Center

location_facility: Ospedale S. Eugenio - S. Eugenio Hospital

location_facility: State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",

location_facility: FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency"

status: Terminated

title: A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent

location_country:
Germany
Ireland
Poland
Australia
Japan
Croatia
Czechia
Canada
France
Hungary
Switzerland
United States
India
Belgium
Estonia
Italy
United Kingdom
Sweden
Austria
Spain
Russian Federation
Israel

status_simplified: Unknown


title: A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

summary: The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country: Canada France


title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

acronym: SPECTA

summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

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

location_country:
Germany
Poland
Croatia
Czechia
Serbia
France
Slovenia
Lithuania
Portugal
Switzerland
Romania
Belgium
Estonia
Italy
Cyprus
United Kingdom
Netherlands
Austria
Spain
Greece

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Institut de Cancerologie de la Loire Lucien Neuwirth

location_facility: Lithuanian Oncology Center-Nat. Cancer Inst

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

location_facility: IRCCS - Istituto Neurologico Carlo Besta

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Institut de Cancerologie Strasbourg Europe (formar Paul Strauss)

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

location_facility: Alma Mater Studiorium Universita di Bologna - Loc. Ospedala Sant'Orsolo

location_facility: University Clinic Centre Serbia - Pulmonoloy clinic

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: ICO L'Hospitalet- Hospital Universitari de Bellvitge

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Velindre NHS Trust - Velindre Cancer Centre

location_facility: Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-Andre - Hopital Saint-Andre

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Saint Antoine

location_facility: Betsi Cadwaladr University Health Board - Glan Clwyd District General Hospital

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: UniversitaetsSpital Zurich - Neurology Clinic

location_facility: Hopitaux Universitaires - Institut Jules Bordet

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Clinique Mutualiste de l'Estuaire - Centre d'oncologie

location_facility: CHU Montpellier-Hopital Arnaud De Villeneuve

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: University Hospitals Coventry and Warwickshire NHS Trust - University Hospital

location_facility: North Estonia Medical Centre - Mustamäe unit

location_facility: Maria S. Curie Memorial Institute-Gliwice Branche

location_facility: Groupe Hospitalier Paris Saint-Joseph - Hopital Saint Joseph

location_facility: University Clinical Center of Serbia - Clinic for ENT and MFH

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil - EPE

location_facility: Athens University - Attikon University General Hospital

location_facility: Centro Hospitalar de Lisboa Ocidental- San Francisco Xavier Hospital

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Centro Hospitalar do Porto- Hospital de Santo Antonio

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

location_facility: Hospital Clinico Universitaro De Valladolid

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro

location_facility: Universita Di Torino - Ospedale S. Luigi Gonzaga

location_facility: Radboud University Medical Center Nijmegen

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

location_facility: NIMTS - Veterans Administration Hospital

intervention_type: Genetic


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

acronym: RIETE

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

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

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

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

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

publisher_dissemination: SAGE Publications

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

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_normalized: Pure (Denmark)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

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

evidence: open (via free pdf)

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

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

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

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

unpaywall_oa_status: gold

publisher_dissemination: Wiley

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

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Universidad De Navarra - Deposito Academico Digital Universidad De Navarra

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

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

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

location_facility: Evanston NorthShore University HealthSystem

location_facility: College of Medicine - Jacksonville University of Florida

location_facility: Japanese Red Cross Wakayama Medical Center

location_facility: Hospital d'Olot i Comarcal de la Garrotxa

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Hospital General Universitari de Castelló

location_facility: Hospital Central de la Defensa Gómez Ulla

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Complejo Hospitalario Insular-Materno Infantil

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Hospital Universitario General de Cataluña

location_facility: Hospital Universitari i Politècnic La Fe

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

location_facility: Azienda ULSS 7 Pedemontana Regione Veneto

location_facility: Hospital Universitario Vithas Madrid La Milagrosa

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Ospedale SS. Giovanni e Paolo di Venezia

location_facility: Centro Hospitalar de Entre o Douro e Vouga

location_facility: Bach Mai Hospital Vietnam Heart Institue

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Ospedale Buon Consiglio Fatebenefratelli

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

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Rajaie Cardiovascular Medical and Research Center

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Hospital Universitario Fundación Santa Fé de Bogota

location_facility: Ain Shams University Specialized Hospital

location_facility: Peking University Cancer Hospital and Institute

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Municipal Hospital of Dresden Friedrichstadt

location_facility: Hematology Institute of ZIV Medical Center

location_facility: Azienda Ospedaliera Universitaria di Parma

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital Universitario San Vicente Fundación

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital General Universitario Reina Sofía

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Hospital General Universitario de Ciudad Real

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Hospital General Universitario Santa Lucía

location_facility: Hospital Universitario Virgen de las Nieves

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

location_facility: Althaia, Xarxa Assistencial Universitària de Manresa

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital General Universitario de Albacete

location_facility: PHI University Clinic of Pulmology and Allergy Skopje

location_facility: Hospital Universitario Clínic de Barcelona

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Clínico San Carlos

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

location_facility: Presidio Ospedaliero Santa Maria Delle Grazie


title: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

acronym: PREFER

summary: This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.

primary_purpose: Other

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

location_country:
Slovenia
Italy
Cyprus
Lithuania
Poland
Portugal
Hungary
Israel
Denmark
Norway
Malta
Belgium
Latvia
Spain
Croatia
Estonia
Russian Federation
France

intervention_type: Procedure


type: Other Identifier

title: A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

summary: The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

ReferenceCitation: Ackaert O, McDougall D, Perez-Ruixo C, Perez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.

ReferenceCitation: Orkin C, Eron JJ, Rockstroh J, Podzamczer D, Esser S, Vandekerckhove L, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Opsomer M; AMBER study group. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2020 Apr 1;34(5):707-718. doi: 10.1097/QAD.0000000000002463.

oa_host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: Ghent University - Ghent University Academic Bibliography

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;archive.ugent.be

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Rashbaum B, Spinner CD, McDonald C, Mussini C, Jezorwski J, Luo D, Van Landuyt E, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive patients with HIV-1: subgroup analyses of the phase 3 AMBER study. HIV Res Clin Pract. 2019 Feb;20(1):24-33. doi: 10.1080/15284336.2019.1608714. Epub 2019 May 29.

ReferenceCitation: Eron JJ, Orkin C, Gallant J, Molina JM, Negredo E, Antinori A, Mills A, Reynes J, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Vanveggel S, Opsomer M; AMBER study group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018 Jul 17;32(11):1431-1442. doi: 10.1097/QAD.0000000000001817.

location_country:
Germany
Poland
United Kingdom
Belgium
United States
Spain
Canada
Puerto Rico
Russian Federation
France


title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression

summary: The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

evidence: open (via crossref license)

ReferenceCitation: Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Finland
Lithuania
Poland
United Kingdom
Brazil
Sweden
Belgium
United States
Spain
South Africa
Bulgaria
France


title: Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting

summary: This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Ireland
Italy
Norway
United Kingdom
Denmark
Sweden
Austria
France

location_facility: Ospedale Morgagni-Pierantoni; U.O. Pneumologia

location_facility: Lungenklinik Lostau gGmbH; Klinik für Pneumologie II

location_facility: Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik

location_facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

location_facility: Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: University Hospital Aintree; Pulmonary Vascular Diseases Unit

location_facility: University College London Hospital; Respiratory Medicine

location_facility: Universitätsklinikum Freiburg, Abteilung Pneumologie

location_facility: HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie

location_facility: Southmead Hospital; Respiratory Department

location_facility: Universitaetsklinikum des Saarlandes; Innere Medizin V

location_facility: Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Gentofte Hospital, Lungemedicinsk Afdeling

location_facility: Aarhus University Hospital; Lungemed afd. B

location_facility: St. Johanns-Spital; Abt. Für Lungenkrankungen

location_facility: Carl-Thiem-Klinik Cottbus; Medizinische Klinik

location_facility: Odense Universitetshospital, Lungemedicinsk Afdeling J

location_facility: Haukeland Hospital - University Of Bergen: Department of Resp Med

location_facility: Studienzentrum/Praxis Dr. Keller Frankfurt

location_facility: Klinikum Klagenfurt; Abteilung für Pulmologie

location_facility: Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie

location_facility: Klinik Löwenstein gGmbH Medizinische Klinik II

location_facility: Hopital De La Maison Blanche;Maladies Respiratoires

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

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare

location_facility: Southampton General Hospital; Respiratory Department

location_facility: Queen Alexandra Hospital; Respiratory Centre

location_facility: Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

location_facility: University Hospital of North Staffordshire; ILD Clinic

location_facility: Akademiska Sjukhuset; Lungmedicinska Kliniken

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Klinik Donaustauf Zentrum für Pneumologie

location_facility: Karolinska Universitetssjukhuset Solna; Lung Allergikliniken

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Castle Hill Hospital; Respiratory Medicine

location_facility: Helsinki University Central Hospital; Dep. of Pulmonary Medicine

location_facility: Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik

location_facility: Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre

location_facility: Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie

location_facility: Galway University Hospital; Department of Respiratory Medicine

location_facility: KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin

location_facility: LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Universitätsklinikum Jena; Medizinische Klinik I

location_facility: Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie

location_facility: Medical University Graz; Department for Respiratory Diseases

location_facility: Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica

location_facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

location_facility: Papworth Hospital NHS Foundation Trust; Respiratory Department

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Turku University Hospital; Dept of Pulmonology

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo

location_facility: Oslo University Hospital Rikshospitalet; Lungeavdelingen

location_facility: Nottingham University Hospitals City Campus

location_facility: Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie

location_facility: Tampere University Hospital; Lung Clinic

location_facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

location_facility: RoMed Klinikum Rosenheim, Medizinische Klinik III


title: A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa

acronym: EVADE

summary: Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

primary_purpose: Prevention

ReferenceCitation: Chastre J, Francois B, Bourgeois M, Komnos A, Ferrer R, Rahav G, De Schryver N, Lepape A, Koksal I, Luyt CE, Sanchez-Garcia M, Torres A, Eggimann P, Koulenti D, Holland TL, Ali O, Shoemaker K, Ren P, Sauser J, Ruzin A, Tabor DE, Akhgar A, Wu Y, Jiang Y, DiGiandomenico A, Colbert S, Vandamme D, Coenjaerts F, Malhotra-Kumar S, Timbermont L, Oliver A, Barraud O, Bellamy T, Bonten M, Goossens H, Reisner C, Esser MT, Jafri HS; COMBACTE-MAGNET EVADE Study Group. Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial. Crit Care. 2022 Nov 15;26(1):355. doi: 10.1186/s13054-022-04204-9.

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

lead_sponsor: MedImmune LLC

collaborators: INNOVATIVE MEDICINES INITIATIVE and COMBACTE-MAGNET

collaborators: Antibacterial Resistance Leadership Group

collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Ireland
Portugal
Hungary
Israel
United Kingdom
Austria
Belgium
United States
Spain
Greece
Croatia
Turkey
Czechia
France


lead_sponsor: ViiV Healthcare

summary: The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

ReferenceCitation: Kozal M, Aberg J, Pialoux G, Cahn P, Thompson M, Molina JM, Grinsztejn B, Diaz R, Castagna A, Kumar P, Latiff G, DeJesus E, Gummel M, Gartland M, Pierce A, Ackerman P, Llamoso C, Lataillade M; BRIGHTE Trial Team. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020 Mar 26;382(13):1232-1243. doi: 10.1056/NEJMoa1902493.

ReferenceCitation: Gartland M, Cahn P, DeJesus E, Diaz RS, Grossberg R, Kozal M, Kumar P, Molina JM, Mendo Urbina F, Wang M, Du F, Chabria S, Clark A, Garside L, Krystal M, Mannino F, Pierce A, Ackerman P, Lataillade M. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0175121. doi: 10.1128/aac.01751-21. Epub 2022 May 3.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Anderson SJ, Murray M, Cella D, Grossberg R, Hagins D, Towner W, Wang M, Clark A, Pierce A, Llamoso C, Ackerman P, Lataillade M. Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals. Patient. 2022 Jan;15(1):131-143. doi: 10.1007/s40271-021-00534-y. Epub 2021 Jun 28.

ReferenceCitation: Lataillade M, Lalezari JP, Kozal M, Aberg JA, Pialoux G, Cahn P, Thompson M, Molina JM, Moreno S, Grinsztejn B, Diaz RS, Castagna A, Kumar PN, Latiff GH, De Jesus E, Wang M, Chabria S, Gartland M, Pierce A, Ackerman P, Llamoso C. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020 Nov;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X.

ReferenceCitation: Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis. Clin Transl Sci. 2020 Jul;13(4):769-776. doi: 10.1111/cts.12763. Epub 2020 Mar 19.

title: A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Colombia
Portugal
United States
Romania
Belgium
Peru
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa
Taiwan
Russian Federation


acronym: ESTAIR

lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.

location_facility:
Investigational Site Number 032007
Investigational Site Number 276005
Investigational Site Number 410004
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Investigational Site Number 376005
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 250009
Investigational Site Number 792006
Investigational Site Number 203002
Investigational Site Number 203003
Investigational Site Number 840020
Investigational Site Number 724005
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Investigational Site Number 208002
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Investigational Site Number 124002
Investigational Site Number 410002
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Investigational Site Number 410003
Investigational Site Number 152003
Investigational Site Number 792003
Investigational Site Number 124003
Investigational Site Number 840017
Investigational Site Number 724003
Investigational Site Number 840024
Investigational Site Number 380006
Investigational Site Number 620003
Investigational Site Number 032004
Investigational Site Number 792004
Investigational Site Number 152002
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 152007
Investigational Site Number 250004
Investigational Site Number 203004
Investigational Site Number 376001
Investigational Site Number 724006
Investigational Site Number 276002
Investigational Site Number 620004
Investigational Site Number 840022
Investigational Site Number 032005
Investigational Site Number 484003
Investigational Site Number 250005
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Investigational Site Number 376002
Investigational Site Number 792001
Investigational Site Number 840006
Investigational Site Number 376003
Investigational Site Number 276001
Investigational Site Number 032001
Investigational Site Number 276004
Investigational Site Number 036001
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 380005
Investigational Site Number 484002
Investigational Site Number 792002
Investigational Site Number 826001
Investigational Site Number 170001
Investigational Site Number 724002
Investigational Site Number 170005
Investigational Site Number 300001
Investigational Site Number 203001
Investigational Site Number 152004
Investigational Site Number 250006
Investigational Site Number 250001
Investigational Site Number 380001
Investigational Site Number 380004
Investigational Site Number 826002
Investigational Site Number 826003
Investigational Site Number 032009
Investigational Site Number 152001
Investigational Site Number 376004
Investigational Site Number 840010
Investigational Site Number 380002
Investigational Site Number 840011
Investigational Site Number 840015
Investigational Site Number 410001

title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

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:
Germany
Argentina
Australia
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Denmark
United States
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Israel


title: A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome

acronym: GEMINI ACS 1

summary: The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

ReferenceCitation: Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.

publisher_dissemination: American Medical Association

ReferenceCitation: Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Guray U, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.

repository_institution: Duke University - DukeSpace

ReferenceCitation: Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: Imperial College London - Spiral

sponsor_collaborators:
Janssen Research & Development, LLC
Bayer
Duke Clinical Research Institute
Harvard Medical School (HMS and HSDM)

location_country:
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
United States
Ukraine
Belgium
Netherlands
Korea, Republic of
Spain
Bulgaria
Russian Federation
Sweden


acronym: PRESIDE

lead_sponsor: Astellas Pharma Europe Ltd.

summary: The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone.

ReferenceCitation: Merseburger AS, Attard G, Astrom L, Matveev VB, Bracarda S, Esen A, Feyerabend S, Senkus E, Lopez-Brea Piqueras M, Boysen G, Gourgioti G, Martins K, Chowdhury S. Continuous enzalutamide after progression of metastatic castration-resistant prostate cancer treated with docetaxel (PRESIDE): an international, randomised, phase 3b study. Lancet Oncol. 2022 Nov;23(11):1398-1408. doi: 10.1016/S1470-2045(22)00560-5. Epub 2022 Oct 18.

sponsor_collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

location_facility:
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Site DE49003
Site NL31002
Site BE32003
Site IT39012
Site PL48002
Site FR33005
Site RU70001
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Site DE49017
Site CZ42004
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Site CH41009
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Site DE49015
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Site GB44002
Site CZ42003

title: A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Turkey
Czechia
Russian Federation
France


title: A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_concat: PubMed Central;figshare.com

publisher_dissemination: American Association for Cancer Research

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

intervention_type: Biological


title: A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population

acronym: EXTEND

summary: The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

ReferenceCitation: Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

ReferenceCitation: Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

sponsor_collaborators:
Astellas Pharma Europe Ltd.
Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Ireland
Poland
Turkey
Croatia
Czechia
France
Slovenia
Portugal
Hungary
Denmark
Switzerland
Romania
Belgium
Italy
United Kingdom
Austria
Spain
Greece
Russian Federation
Sweden

location_facility:
Site SE46001
Site DK45005
Site PT35104
Site PL48012
Site PL48002
Site FR33005
Site DE49011
Site GR30002
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Site RU70003
Site AT43003
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Site CZ42003


title: CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

acronym: CENTAUR

summary: The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

ReferenceCitation: Qian T, Fujiwara N, Koneru B, Ono A, Kubota N, Jajoriya AK, Tung MG, Crouchet E, Song WM, Marquez CA, Panda G, Hoshida A, Raman I, Li QZ, Lewis C, Yopp A, Rich NE, Singal AG, Nakagawa S, Goossens N, Higashi T, Koh AP, Bian CB, Hoshida H, Tabrizian P, Gunasekaran G, Florman S, Schwarz ME, Hiotis SP, Nakahara T, Aikata H, Murakami E, Beppu T, Baba H, Rew Warren, Bhatia S, Kobayashi M, Kumada H, Fobar AJ, Parikh ND, Marrero JA, Rwema SH, Nair V, Patel M, Kim-Schulze S, Corey K, O'Leary JG, Klintmalm GB, Thomas DL, Dibas M, Rodriguez G, Zhang B, Friedman SL, Baumert TF, Fuchs BC, Chayama K, Zhu S, Chung RT, Hoshida Y. Molecular Signature Predictive of Long-Term Liver Fibrosis Progression to Inform Antifibrotic Drug Development. Gastroenterology. 2022 Apr;162(4):1210-1225. doi: 10.1053/j.gastro.2021.12.250. Epub 2021 Dec 22. Erratum In: Gastroenterology. 2022 Aug;163(2):536.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ReferenceCitation: Nielsen MJ, Leeming DJ, Goodman Z, Friedman S, Frederiksen P, Rasmussen DGK, Vig P, Seyedkazemi S, Fischer L, Torstenson R, Karsdal MA, Lefebvre E, Sanyal AJ, Ratziu V. Comparison of ADAPT, FIB-4 and APRI as non-invasive predictors of liver fibrosis and NASH within the CENTAUR screening population. J Hepatol. 2021 Dec;75(6):1292-1300. doi: 10.1016/j.jhep.2021.08.016. Epub 2021 Aug 27.

repositories_concat: HAL

ReferenceCitation: Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22. No abstract available.

ReferenceCitation: Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_institution: University of Antwerp - Institutional Repository University of Antwerp

ReferenceCitation: Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.

repository_institution: Columbia University - Columbia Academic Commons

ReferenceCitation: Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.

location_country:
Germany
Italy
Poland
United Kingdom
Hong Kong
Australia
Belgium
United States
Spain
France


title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

summary: This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

ReferenceCitation: Courville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21.

ReferenceCitation: Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(R)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Zagreb - Repository of the Medical Faculty of the University of Zagreb

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

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:
Germany
Poland
Japan
Brazil
Thailand
Turkey
Croatia
France
Belarus
Portugal
Switzerland
United States
Ukraine
India
Romania
Lebanon
Belgium
Peru
Puerto Rico
Philippines
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Georgia
Russian Federation

location_facility: SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow

location_facility: Hopital Morvan-CHU Brest- Service Hematologie Clinique

location_facility: MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',

location_facility: Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Cancer Center,Northwestern Medicine, West Region

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas LTDA

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala

location_facility: N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences

location_facility: Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: FSBI 'Russian Research Centre of Radiology and Surgical Technologies

location_facility: Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de

location_facility: Klinikum Chemnitz gGmbH - Zentralapotheke

location_facility: Municipal Non-Profit Enterprise "Regional Oncology Centre"

location_facility: Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician

location_facility: Healthcare Institution "Brest Regional Oncologic Dispensary"

location_facility: Euromedic Wroclawskie Centrum Medyczne II

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""

location_facility: Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin

location_facility: Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary

location_facility: Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie

location_facility: Hospital Universitario Sanitas La Zarzuela

location_facility: Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

location_facility: Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,

location_facility: N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences

location_facility: Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

location_facility: Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'

location_facility: Branch office of LLC 'PET-Technology' at Ufa city

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Rocky Mountain Cancer Center-Lakewood (Laboratory)

location_facility: General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"

location_facility: Drs Sulman & Partners Specialist Radiologists

location_facility: Royal United Hospitals Bath NHS Foundation Trust

location_facility: Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

location_facility: Fukuoka Wajiro PET Diagnostic Imaging Clinic

location_facility: Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin

location_facility: FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'

location_facility: Showa University Northern Yokohama Hospital

location_facility: Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

location_facility: Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario

location_facility: Stauferklinikum Schwaebisch Gmuend, Apotheke

location_facility: Hammoud Hospital, University Medical Center

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Hospital Universitario Sanitas La Moraleja

location_facility: Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)

location_facility: IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica

location_facility: Russian Cancer Research Centre them N.N. Blokhin

location_facility: IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e

location_facility: PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

location_facility: University of Philippines Manila-Philippine General Hospital

location_facility: Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital

location_facility: University Hospital Center Zagreb, Department of Pathology and Cytology

location_facility: Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

location_facility: SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'

location_facility: City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital

location_facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

location_facility: Pathology Department, Unique Hospital Multispeciality & Research Institute

location_facility: Department of Radiology, Ramathibodi Hospital

location_facility: "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana

location_facility: State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"

location_facility: Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex

location_facility: Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie

location_facility: "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""

location_facility: SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre

location_facility: Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"

location_facility: Hospital universitario Virgen de la Victoria

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Centre Hospitalier Universitaire Cote de Nacre

location_facility: University Hospital Center Zagreb, Department of Radiology

location_facility: "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: San Antonio Military Medical Center- Department of Radiology

location_facility: Hospital Santa Izabel - Setor de Bioimagem

location_facility: Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"

location_facility: State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry

location_facility: Healthcare Institution 'Minsk City Clinical Oncology Dispensary'

location_facility: Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.

location_facility: High Technology Medical Center, University Clinic

location_facility: InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala

location_facility: South Valley Imaging Center (Imaging Only)

location_facility: Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: Vely Grupo Medico Quirurgico, S.A. de C.V.

location_facility: Podilskyy Regional Oncology Center, Chemotherapy Department

location_facility: Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Euromedic Wroclawskie Centrum Medyczne I

location_facility: SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori

location_facility: Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore

location_facility: Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.

location_facility: Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.

location_facility: Positron Emission Tomography (PET) Centre

location_facility: Global Cancer Research Institute (GCRI), Inc

location_facility: A.Tsyb Medical Radiological Research Centre -

location_facility: Department of Radiology, Curie Manavata Cancer Centre

location_facility: Radiodiagnostic CETIR - Clinica del Pilar

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT

location_facility: Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS

location_facility: Complejo Hospitalario de Ourense. Hematología

location_facility: Saint Francis Medical Center, Saint Francis Cancer Treatment Center

location_facility: State Healthcare Institution Republican Oncology Dispensary

location_facility: CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan

location_facility: The Oncology Institute of Hope and Innovation

location_facility: "LTD ""M. Zodelava's Hematology Centre"""

location_facility: Hospital e Maternidade Madre Theodora LTDA

location_facility: Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona

location_facility: EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.

location_facility: Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: R.K. Birla Cancer Center, Sawai Man Singh Hospital

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies

location_facility: Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"

location_facility: Servico de Radiologia do Hospital de Clinicas de Porto Alegre

location_facility: San Antonio Military Medical Center- Department of Pharmacy

location_facility: Brody School of Medicine at East Carolina University

location_facility: Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -

location_facility: Klinikum Stuttgart, Klinik fuer Nuklearmedizin

location_facility: SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov

location_facility: U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona

location_facility: FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF

location_facility: Kobe City Medical Center General Hospital

location_facility: U.O. Ematologia 1 - IRCCS AOU San Martino-IST

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"

location_facility: Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali

location_facility: Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG

location_facility: Policlinica de Diagnostic Rapid, Hematologie

location_facility: Padiglione 1, Torre delle medicine, 6 piano

location_facility: Saint Louise Regional Hospital Radiology Department (Radiology Only)

location_facility: Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

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

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection

location_facility: Hospital das Clinicas Universidade Federal de Minas Gerais

location_facility: Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"

location_facility: National Hospital Organization Nagasaki Medical Center

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

location_facility: LTD "Research Institute of Clinical Medicine"

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Seoul National University Bundang Hospital

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF

location_facility: Adnan Menderes University Medical Faculty

location_facility: Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates

location_facility: Private medical institution "Euromedservice"

location_facility: Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo

location_facility: Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony

location_facility: "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: GBUZ of Yaroslavl Region "Regional Clinical Hospital"

location_facility: Euromedic Wroclawskie Centrum Medyczne III

location_facility: Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta