title: Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

summary: This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

lead_sponsor: Allergan

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
Romania
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Malaysia
Singapore
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Latvia
Thailand
Korea, Republic of
France
Colombia

location_facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia

location_facility: Indiana University Health University Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: Victoria Hospital Bangalore Medical College and Research Ins

location_facility: State Institution Ukrainian State Research Institute

location_facility: IRCCS S.Matteo Hospital Foundation, University of Pavia

location_facility: "Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia"

location_facility: West Visayas State University Medical Center

location_facility: Southern Illinois University School of Medicine

location_facility: NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,

location_facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

location_facility: Professional Research Network of Kansas, LLC

location_facility: Universidade de Sao Paulo (USP) - Hospital das Clinicas da F

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Centre Hospitalier de l'Universite de Montreal - CHUM

location_facility: Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology

location_facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

location_facility: Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology

location_facility: Specjalistyczny Gabinet Neurologiczny Marta Banach

location_facility: Municipal Institution-Zaporizhzhia Regional Clinical Hospital

location_facility: Lifecare Clinic and Research Centre - Internal Med/Diabetolo

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Ivano-Frankivsk National Medical University

location_facility: Instituto de Investigaciones Clínicas de Rosario

location_facility: Troy Gastroenterology, PC dba Center for Digestive Health

location_facility: Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology

location_facility: Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo

location_facility: Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Centro Universitario de Investigacion en Farmacologia Clinic

location_facility: SAGACT PLLC., San Antonio Gastroenterology Associates, PA

location_facility: Family Medical Associates, Research Department

location_facility: San Juan De Dios Educational Foundation, Inc.

location_facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

location_facility: Gastroenterology Associates of Fairfield County, P.C.

location_facility: North-Western State Medical University named after I. I. Mechnikov

location_facility: M.V. Hospital for Diabetes & Diabetes Research Centre

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre

location_facility: Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

location_facility: Scientific Institute of Clinical and Experimental Lymphology

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: ClinTrial Medical Center, Pulmonology Department

location_facility: Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi

location_facility: NYU Winthrop Hospital, Clinical Trials Center

location_facility: Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine

location_facility: Centro Especializado en Investigación Clínica S.C.

location_facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

location_facility: City Hospital #1, department of endocrinology, c. Mykolayiv

location_facility: Preferred Primary Care Physicians, Jacob Murphy

location_facility: "State Institution "National Institute of Therapy named after. L.T. Maloi NAMNU" / Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Department of the study of diseases of the digestive

location_facility: Hospital Universitário João de Barros Barreto - UFPA

location_facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

location_facility: S.P.Medical College & Group of Hospitals Bikaner

location_facility: Carolina Digestive Health Associates, PA

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: 6th City Clinical Hospital, c. Zaporizhzhia

location_facility: Gruppo Humanitas - Humanitas Research Hospital

location_facility: Madras Medical College & Rajiv Gandhi Govt. General Hospital

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

location_facility: DRRI-Vinnytsia National Pirogov Memorial Medical University

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Surat Institute of Digestive Sciences Hospitals

location_facility: Innovative Research of West Florida, Inc.

location_facility: Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department

location_facility: Communal Institution Kherson City Clinical Hospital

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Texas Tech University Health Sciences, Center Division of Gastroenterology

location_facility: Cotton-O'Neil Clinical Research Center - Digestive Health

location_facility: Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Toronto Western Hospital, University Health Network

location_facility: "Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Clinical Applications Laboratories, Inc.

location_facility: CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

location_facility: Woodholme Gastroenterology Associates, P.A.

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Sanggye Paik Hospital, Inje University College of Medicine

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

location_facility: S.R. Kalla Memorial Gastro and General Hospital

location_facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

location_facility: Service d'hépato-gastroentérologie - 7°D

location_facility: Saint-Petersburg City Pokrovskaya Hospital

location_facility: Regional Public Organization Chernivtsi Regional Endocrinology Center

location_facility: Rocky Mountain Diabetes and Osteoporosis Center, PA

location_facility: Long Island Gastrointestinal Research Group LLP

location_facility: Szpital Uniwestytetu Medycznego w Bialymstoku

location_facility: Digestive Health Specialist of the South East

location_facility: Universita' Di Salerno- Aou Ruggi D'aragona

location_facility: Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute

location_facility: Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C

location_facility: Instituto de hematología y medicina clínica "Dr. Rubén Dávoli"

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Biopharma Informatic Inc., Research Center

location_facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates

location_facility: Instituto Catarinense de Endocrinologia e Diabetes (ICED)

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herrriot

location_facility: Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

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

location_facility: Valley View Wellness and Medical Center - VVCRD Clinical Research

location_facility: Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department

location_facility: M. S. Ramaiah medical College and Hospitals - Gastroenterolo

location_facility: Private Small-Scale Enterprise Medical Center Pulse

location_facility: Instituto de Pesquisa Clínica em Campinas

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine

location_facility: Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.

location_facility: FSBI National medical endocrinology research centre

location_facility: Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion

location_facility: Unidad de Investigación Clínica Cardiometabolica de Occidente

location_facility: B. J. Government Medical College and Sassoon General Hospitals

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Unidad de Investigación clínica y atención Médica HEPA S.C.

location_facility: Mid Essex Hospital Services NHS Trust Broomfield Hospital

location_facility: Hospital Universitario Principe de Asturias

location_facility: Baylor College of Medicine Medical Center

location_facility: First Department of Medicine, University of Szeged

location_facility: Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC

location_facility: Instituto de Diabetes Obesidad y Nutrición SC

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: The Ohio State University, Wexner Medical Center

location_facility: Maffei Centro Medico-Investigacion Clinica Aplicada

location_facility: Municipal Institution Lutsk City Clinical Hospital

location_facility: Millitary-medical Academy, department of hospital therapy

location_facility: Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv

location_facility: Moscow Regional Research Clinical Institute named by MF Vladimirski

location_facility: Connecticut Clinical Research Foundation

location_facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res

location_facility: Centro de Investigacion Morales Vargas - CIMOVA

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.


type: EudraCT Number

title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

summary: Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.

ipd_sharing: Undecided

lead_sponsor: QED Therapeutics, Inc.

location_country:
Taiwan
Portugal
Spain
Italy
United Kingdom
Australia
Canada
Thailand
Korea, Republic of
United States
France
China
Puerto Rico
Belgium
Germany

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute

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

location_facility: National Taiwan University Hospital - YunLin Branch

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille

location_facility: Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE

location_facility: Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

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

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (ASST)

location_facility: Hospital Oncologico, Puerto Rico Medical Center

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Seoul National University Bundang Hospital

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clinico

location_facility: Instituto Catalan de Oncologio ICO I'Hospitalet

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Texas Southwestern Medical Center

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Hospital Universitario Germans Trias i Pujol

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

acronym: IMbrella B

summary: This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

status: Recruiting

ipd_sharing: No

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Mexico
Norway
Singapore
Slovakia
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
Thailand
Korea, Republic of
France
Chile

location_facility: The Prince Charles Hospital; Oncology Dept.

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

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

location_facility: Levine Cancer Institute-Carolinas Medical Center; Levine Cancer Institute-Carolinas Medical Center

location_facility: SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)

location_facility: Universitätsklinikum Freiburg;Klinik für Innere Medizin I

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

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

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: University Hospital of Larissa; Oncology

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

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Petz Aladar Megyei Oktato Korhaz; Pulmonologiai Osztaly

location_facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

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

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai Osztaly

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Szegedi Tudományegyetem; Onkoterápiás Klinika

location_facility: National Cancer Institute MOH of Ukraine

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

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

location_facility: Pontificia Universidad Catolica de Chile; Centro Del Cáncer

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: University of Texas Health Sciences Center in San Antonio

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Ivanovo Regional Oncology Dispensary; Chemotherapy Department

location_facility: Yale University School Of Medicine; Yale Cancer Center

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: University of Washington - Seattle Cancer Care Alliance; Medical Oncology

location_facility: Lungenfachklinik Immenhausen; Zentrum fur Pneumologie

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: University of Pittsburgh Medical Center Cancer Center; Investigational Drug Service

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical Oncology

location_facility: Memorial Sloan Kettering - Basking Ridge

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Hospital General Universitario Gregorio Mara

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

location_facility: Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai Központ

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

location_facility: CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med Inst

location_facility: Asan Medical Center; Internal Dept / Gastorenterology

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

location_facility: Riga's East Hosp Latvian Oncol; Medical Oncology

location_facility: University Hospital Bratislava; Department of Oncology

location_facility: St. Joseph Mercy Hospital; Cancer Care Center.

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Phylasis Clinicas Research S de RL de CV; Sucursal Toluca

location_facility: Seoul National University College of Medicine, Liver Research Institute

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: Mercy Hospital, a Campus of Plantation General Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

location_facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department


status: Completed

acronym: PINTA

title: A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis

study_completion_date_type: Actual

lead_sponsor: Galapagos NV

source: euctr

ReferenceType: background

ReferenceCitation: Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020.

enrollment_type: Actual

location_country: Croatia Oman Finland Ukraine France Romania Sweden Bulgaria Slovakia

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: Helsinki University Hospital Heart and Lung Center

location_facility: Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"

location_facility: Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

location_facility: Institutul de Pneumoftiziologie Marius Nasta

location_facility: Spitalul Clinic de Pneumoftiziologie Iasi

location_facility: Communal Nonprofit Enterprise City Clinical Hospital

location_facility: Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca

location_facility: Specialized Hospital for Active Treatment Pleven

location_facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

location_facility: Acibadem City Clinic Tokuda Hospital, EAD

location_facility: National Oncology Centre - The Royal Hospital Muscat

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine

location_facility: Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman

location_facility: National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery

location_facility: Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6

location_facility: Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros

location_facility: The Ivano-Frankivsk National Medical Univeristy

summary: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).

status_simplified: Completed


title: A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (DESTINATION)

acronym: DESTINATION

summary: Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.

ReferenceCitation: Menzies-Gow A, Ponnarambil S, Downie J, Bowen K, Hellqvist Å, Colice G. DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 21;21(1):279. doi: 10.1186/s12931-020-01541-7.

lead_sponsor: AstraZeneca

location_country:
Poland
Taiwan
Brazil
Saudi Arabia
Austria
Australia
Russian Federation
Argentina
Canada
Vietnam
Ukraine
Korea, Republic of
United States
France
Israel
Turkey
South Africa
Germany

intervention_type: Biological


ipd_sharing: Yes

intervention_type: Other

acronym: SPROUT

title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

lead_sponsor: Amgen

type: Registry Identifier

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

location_country:
Spain
Italy
Russian Federation
Canada
France
United States
Israel
Belgium
Netherlands
Czechia

location_facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

location_facility: Centre Hospitalier Victor Dupouy Argenteuil

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

location_facility: Centre Hospitalier de Cornouaille - Hopital Laennec

location_facility: Republican Clinical Dermatology and Venerology Dispensary

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: National Medical Research Center for Children's Health

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital General Universitario de Alicante

location_facility: State Scientific Center for Dermatovenereology and Cosmetology

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: University of South Florida Health Morsani Center for Advanced Healthcare

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: J Woodson Dermatology and Associates Ltd

location_facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary

location_facility: Azienda Ospedaliera Universitaria di Cagliari

location_facility: Pierre Wolkenshtein Skin Diseases Clinic LLC

summary:
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.


title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

ReferenceCitation: Stannard HL, Mifsud EJ, Wildum S, Brown SK, Koszalka P, Shishido T, Kojima S, Omoto S, Baba K, Kuhlbusch K, Hurt AC, Barr IG. Assessing the fitness of a dual-antiviral drug resistant human influenza virus in the ferret model. Commun Biol. 2022 Sep 28;5(1):1026. doi: 10.1038/s42003-022-04005-4.

ReferenceCitation: Kumar D, Ison MG, Mira JP, Welte T, Hwan Ha J, Hui DS, Zhong N, Saito T, Katugampola L, Collinson N, Williams S, Wildum S, Ackrill A, Clinch B, Lee N. Combining baloxavir marboxil with standard-of-care neuraminidase inhibitor in patients hospitalised with severe influenza (FLAGSTONE): a randomised, parallel-group, double-blind, placebo-controlled, superiority trial. Lancet Infect Dis. 2022 May;22(5):718-730. doi: 10.1016/S1473-3099(21)00469-2. Epub 2022 Jan 24.

ReferenceCitation: Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26.

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

location_country:
Serbia
Spain
Ukraine
United States
Peru
Belgium
Japan
Romania
Czechia
Hong Kong
Australia
Argentina
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
China
Germany
Bulgaria
Estonia
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: Washington University School of Medicine

location_facility: Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi

location_facility: Salem Veterans Affairs Medical Center - NAVREF; Pharmacy

location_facility: Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie

location_facility: London Health Sciences Center; Pharmacy Dept.

location_facility: Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología

location_facility: Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Oulun Yliopistollinen Sairaala; Teho-osasto

location_facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy

location_facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy

location_facility: Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: First Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy

location_facility: New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine

location_facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Baruch Padeh Poria Medical Center; Pharmacy

location_facility: ZIV Medical Center; Department Of Internal Medicine A

location_facility: Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases

location_facility: Centro de Estudos Clinicos do Interior Paulista

location_facility: Ternopil City Municipal Emergency Hospital; Infectious Department

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Multiprofile Hospital for Active Treatment - Samokov EOOD

location_facility: Kuopion Yliopistollinen Sairaala; Silmätaudit

location_facility: Canisius Wilhelmina Ziekenhuis; Department Hematology

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: Cliniques Universitaires Saint-Luc; Hematology

location_facility: Japan Community Health care Organization Nihonmatsu hospital

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa

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

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz

location_facility: MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy

location_facility: National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases

location_facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department

location_facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: Nagata Hospital; Department of pulmonary medicine

location_facility: General Hospital Dr Radivoj Simonovic Sombor

location_facility: Hospital General Universitario Reina Sofia; Servicio de Nefrologia

location_facility: Skånes Universitetssjukhus Malmö; Infektionskliniken

location_facility: Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Local incorporated administrative agency Shizuoka City Shizuoka Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

location_facility: Uniklinik Koln; Klinik I fur Innere Medizin

location_facility: Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Municipal Institution City Clinical Infectious Diseases Hospital

location_facility: National Hospital Organaization Shibukawa Medical Center

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital

location_facility: Royal Brisbane & Womens Hospital; Pharmacy Department

location_facility: Social Corporation Keigakukai Minamiosaka Hosupital

location_facility: Selcuk University Medical Faculty; Internal Medicine

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Temple University Hospital ; Lung Center

location_facility: National Hospital Organization Minami Kyoto Hospital

location_facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia

location_facility: Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy

location_facility: Sf. Ioan cel Nou Emergency County Hospital

location_facility: Toronto East General Hospital; Main Pharmacy G Wing Basement

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.


title: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

acronym: ReSTORE

summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).

ReferenceCitation: Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217. Review.

lead_sponsor: Cidara Therapeutics Inc.

location_country:
Taiwan
Spain
Colombia
Greece
Australia
Italy
Argentina
Thailand
Korea, Republic of
United States
France
China
Israel
Belgium
Singapore
Germany
Turkey
Bulgaria

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: General University Hospital Gregorio Maranon

location_facility: Hospital del Mar, Department of Infectious Diseases

location_facility: Integrated University Health Authority of Trieste

location_facility: Hotel Dieu Hospital Nantes University Hospital Center

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Alexander Fleming Specialized Medical Institute

location_facility: University Polyclinic Foundation Agostino Gemelli - IRCCS

location_facility: Johannes Gutenberg University Medical Center

location_facility: General Hospital of Tianjin Medical University

location_facility: Marseille University Hospital Center - North Hospital

location_facility: Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants

location_facility: ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department

location_facility: University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU

location_facility: The Second Hospital of Anhui Medical University

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

location_facility: University Hospitals Leuven, Campus Gasthuisberg

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: University and Polytechnic Hospital La Fe

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tours University Hospital Center, Bretonneau Hospital

location_facility: Centre Hospitalier Victor Dupouy - Argenteuil

location_facility: University Polyclinic Hospital of Modena

location_facility: Paris University Hospitals Center - Cochin Hospital

location_facility: University of Mississippi Medical Center

location_facility: Huashan Hospital Affiliated Fudan University

location_facility: General Hospital of Athens "Laikon", Infectious Diseases Unit

location_facility: Amiens Picardie University Hospital - South

location_facility: General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

location_facility: University Hospital Germans Trias i Pujol

location_facility: Integrated University Hospital "Santa Maria della Misericordia" of Udine

location_facility: University of Pittsburgh Falk Medical Center

location_facility: University Hospital Vall d'Hebron (HUVH)

location_facility: Multiprofile Hospital for Active Treatment Puls

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

location_facility: University of Milano-Bicocca - San Gerardo Hospital

location_facility: University Hospital Puerta de Hierro Majadahonda

location_facility: The Second Xiangya Hospital of Central South University

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery


title: A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)

acronym: Ri-CoDIFy 2

summary:
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin.

A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted.

The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

ReferenceCitation: Carlson TJ, Endres BT, Bassères E, Gonzales-Luna AJ, Garey KW. Ridinilazole for the treatment of Clostridioides difficile infection. Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26. Review.

lead_sponsor: Summit Therapeutics

location_country:
Romania
Belarus
Spain
Latvia
Georgia
Estonia
Mexico
Canada
Lithuania
United States
Chile
France
Israel
Belgium
Peru
Germany
Czechia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Washington University School of Medicine

location_facility: Rambam Health Care Campus, Internal ward A

location_facility: Hospital Universitario Dr. José Eleuterio González

location_facility: Wright State University and Premier Health Clinical Trials Research Alliance

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Vitebsk regional clinical infectious diseases hospital

location_facility: Vidant Multispecialty Clinic - Kinston, Attn. Research Department

location_facility: DiGiovanna Institute For Medical Education

location_facility: University Texas MD Anderson Cancer Center

location_facility: Vancouver Island Health Authority, Research and Capacity Building

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Meir Medical Center, Infection Diseases Unit

location_facility: Multi-Specialty Research Associates Inc.

location_facility: Western Michigan University Homer Stryker M.D.

location_facility: LTD "Israeli-Georgian Medical research Clinic Helsicore"

location_facility: Grodno City Clinical Hospital of Emergency Care

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

location_facility: Klinikum St. Georg - Klinik für Infektiologie, Tropenmedizin, Nephrologie unfd Rheumatologie

location_facility: L&C Professional Medical Research Institute

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: City Clinical Hospital of Infectious Diseases

location_facility: Hospital Nacional Alberto Sabogal Sologuren

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie

location_facility: Institutul Regional de Gastroenterologie şi Hepatologie

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: JSC"Infectious Diseases, Aids and Clinical Immunology Research Center"

location_facility: CH Intercommunal de Cornouaille (CHIC) QUIMPER / MIIS

location_facility: Spitalul Clinic de Boli Infectioase Cluj-Napoca

location_facility: Infectious Diseases & Infection Control Unit

location_facility: Groupe Hospitalier Bretagne Sud Hopital du Scorff

location_facility: Horizon Research Group of Opelousas, LLC

location_facility: Uni. Klinik Tübingen Innere Medizin I Hepatologische Therapie- und Studienambulanz

location_facility: Unité de maladies infectieuses - RDJ Ouest - Hôpital Huriez

location_facility: Fakultni nemocnice Brno, Klinika infekcnich chorob

location_facility: University of Alberta, Division of Gastroenterology

location_facility: LTD "Acad. G. Chapidze Emergency Cardiology Center"

location_facility: St. David's Healthcare Office of Research

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


title: GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

summary: The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Denmark
Poland
Spain
Greece
Austria
Italy
United Kingdom
Canada
Finland
Switzerland
Sweden
United States
France
Israel
Belgium
Germany

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: University of Arizona Cancer Center - Out Pt.

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Nottingham University Hospitals Nhs Trust

location_facility: Advocate Lutheran General Hospital - Oncology Specislists Sc

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University of Rochester, James P. Wilmot Cancer Center

location_facility: King'S College Hospital (Nhs Foundation)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: St. George'S University Hospitals Nhs Foundation Trust

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Hospital Universitario Y Politcnico de La Fe

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen

location_facility: University Hospital of West Attica - Attikon

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Augusta University - Medical College of Georgia

location_facility: I.R.C.C.S. Casa Sollievo Della Sofferenza

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Universitaetsklinikum Erlangen - Medizinische Klinik 5

location_facility: Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia

location_facility: CLINICA DI EMATOLOGIA, UNIVERSITï¿½ POLITECNICA DELLE MARCHE

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of California San Diego Medical Center, Moores Cancer Center

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University Medical Centre Hamburg-Eppendorf Centre of Oncology

location_facility: Winship Cancer Institute of Emory University

location_facility: University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

location_facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Chu de Grenoble - Hopital Albert Michallon

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

location_facility: CENTRE HOSPITALIER UNIVERSITAIRE DE LIï¿½GE - SART TILMAN

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Hospital Clinico de Santiago de Compostela


acronym: TROPHY U-01

title: A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

lead_sponsor: Gilead Sciences

design_allocation: Non-Randomized

ReferenceCitation: Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Fléchon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.

location_country:
United States
France

location_facility: Hospitaux Universitaires de Strasbourg - Hopital Civil

location_facility: University of Wisconsin Clinical Science Center

location_facility: Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: Thompson Oncology Group - Knoxville West

location_facility: Hopital European Georges-Pompidou (HEGP)

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Winship Cancer Institute, Emory University

location_facility: Centre Hospitalier Regional Universitaire Brest

location_facility: Precision Cancer Research / New Mexico Oncology & Hematology Consultants

location_facility: The University of Arizona Cancer Center-North Campus

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: University of Utah - Huntsman Cancer Hospital (IP Shipping Address)

location_facility: Drug Shipping Address: New York-Presbyterian Hospital

location_facility: Houston Methodist Hospital, Houston Methodist Cancer Center

summary: The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).


title: A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas

summary: A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

ReferenceCitation: Philip PA, Buyse ME, Alistar AT, Rocha Lima CM, Luther S, Pardee TS, Van Cutsem E. A Phase III open-label trial to evaluate efficacy and safety of CPI-613 plus modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) in patients with metastatic adenocarcinoma of the pancreas. Future Oncol. 2019 Oct;15(28):3189-3196. doi: 10.2217/fon-2019-0209. Epub 2019 Sep 12.

lead_sponsor: Cornerstone Pharmaceuticals

location_country:
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: The Chaim Sheba Medical Center - Sheba Cancer Research Center (SCRC)

location_facility: The University of Kansas Cancer Center - Clinical Research Center - Fairway Office Park

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center

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

location_facility: University of Pittsburgh-Hillman cancer ceter

location_facility: Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

location_facility: University Hospitals - Seidman Cancer Center

location_facility: New York University Langone Medical Center

location_facility: The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

location_facility: University of Cincinnati Cancer Institute

location_facility: Severance Hospital - Yonsei Cancer Center

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center-Henry-Joyce Cancer Clinic

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Northwestern Memorial Hospital - Arkes Family Pavilion

location_facility: L'ICM, Institut régional du Cancer de Montpellier

location_facility: Kyungpook National University Chilgok Hospital

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Gustave Roussy Cancer Campus Grand Paris (Institut de Cancerologie Gustave-Roussy)

location_facility: Seoul National University Bundang Hospital


title: A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)

summary: The primary objective of the trial is to investigate the effect of the use of inhaled colistimethate sodium, administered twice daily via the I-neb for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the frequency of pulmonary exacerbations.

primary_purpose: Prevention

lead_sponsor: Zambon SpA

location_country:
Poland
Portugal
Greece
Italy
Australia
New Zealand
Argentina
Canada
United States
France
Israel
Germany

location_facility:
Zambon investigative Site
Zambon Investigative Site
ZambonInvestigative Site
Zambon Investgative Site


acronym: A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

lead_sponsor: Corbus Pharmaceuticals Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Poland
Portugal
Austria
Russian Federation
Sweden
Slovakia
Canada
Hungary
Germany
Bulgaria
Greece
France
Netherlands

location_facility: Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow

location_facility: Children's faculty hospital with polyclinic Banska Bystrica

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

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

location_facility: Clinical for Pulmonary Diseases, Clinical Center of Serbia

location_facility: Institute for Mother and Child, Department of CF for Children's and Youth

location_facility: University Hospital and UW Health Clinics

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy

location_facility: Scientfic Research Institute of Pulmonology

location_facility: Cardiff and Vale University Health Board

location_facility: Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant

location_facility: Pediatric Pulmonology, Törökbálint, Hungary

location_facility: University of Debrecen - Kenezy Gyula University Hospital

location_facility: Wolfson Cystic Fibrosis Centre City Hospital Campus

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Klinikum der Ludwig Maximilian Universität München

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: First St. Petersburg State Pavlov Medical University

location_facility: Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

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

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: Centro Regionale Toscano di Riferimento per la Fibrosi Cistica

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

location_facility: Unidad de Fibrosis Quistica y Transplante Pulmonar

location_facility: Institute for Child and Youth Health Care of Vojvodina

location_facility: National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis

location_facility: Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis

location_facility: Dartmouth-Hitchcock Manchester (satellite site)

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Verona

location_facility: Centre de Recherche en Explorations Fonctionnelles (CREF)

location_facility: Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology

location_facility: Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation

location_facility: Service de Pediatrie Medico-Chirurgicale et Genetique

location_facility: University Medicine Essen Ruhrlandklinik

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: Catholic Hospital Bochum - St. Josef-Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: Dartmouth-Hitchcock Medical Center (main location)

location_facility: Medial Center for Ambulatory Diagnosis and Treatment

summary:
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.


title: A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

summary: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

ReferenceCitation: Kaseb AO, Guan Y, Gok Yavuz B, Abbas AR, Lu S, Hasanov E, Toh HC, Verret W, Wang Y. Serum IGF-1 Scores and Clinical Outcomes in the Phase III IMbrave150 Study of Atezolizumab Plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2022 Oct 11;9:1065-1079. doi: 10.2147/JHC.S369951. eCollection 2022.

ReferenceCitation: Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.

ReferenceCitation: Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.

ReferenceCitation: Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.

ReferenceCitation: Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.

ReferenceCitation: Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.

ReferenceCitation: Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

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

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
China
Singapore
Japan
Germany
Czechia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: University of California Irvine Medical Center

location_facility: A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

location_facility: Chonnam National University Hwasun Hospital

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital Universitario Miguel Servet; Servicio de Oncologia Medica

location_facility: Veterans General Hospital; Cancer Center

location_facility: Centre hospitalier de l'Universite de Montreal (CHUM)

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Harbin Medical University Cancer Hospital

location_facility: Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica

location_facility: Uni of California - San Diego; Cancer Center & Dept of Medicine

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Hopital Timone Adultes; Gastro Enterologie

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

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

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: M.D Anderson Cancer Center; Uni of Texas At Houston

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: Nanfang Hospital, Southern Medical University

location_facility: The First Affiliated Hospital of Anhui Medical University

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

location_facility: CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

location_facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Institut Gustave Roussy; Gastro-Enterologie

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Severance Hospital, Yonsei University Health System

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: The 900th Hospital of PLA joint service support force

location_facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Med. Hochschule Hannover; Gastroenterologie

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Hopital Charles Nicolle; Gastroenterologie

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"; Clinical Biotechnologies

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

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

location_facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology

location_facility: Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: General Hospital of Jinan Military Command of PLA

location_facility: McGill University Health Centre - Glen Site

location_facility: SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY

location_facility: Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

location_facility: Hôpital d'Adultes; Service hépato-gastro-entérologie


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine

lead_sponsor: Eli Lilly and Company

type: Other Identifier

ReferenceCitation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Oct 18. doi: 10.1007/s13555-022-00828-5. [Epub ahead of print]

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Poland
Brazil
Spain
Italy
Austria
Netherlands
Russian Federation
Finland
United Kingdom
Switzerland
France
Belgium
Japan
Germany

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Queen's Square Dermatology and Allergology

location_facility: Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd

location_facility: Hospital da Clinicas da Faculdade de Medicina da USP

location_facility: Fondazione IRCCS Osp.Maggiore Policlinico - Dermatologia

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

summary: The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.


title: A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)

summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

ReferenceType: result

ReferenceCitation: Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Zhang P, Gumuscu B, Swaby RF, Hughes BGM. Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629). J Clin Oncol. 2020 Sep 1;38(25):2916-2925. doi: 10.1200/JCO.19.03054. Epub 2020 Jul 16.

ReferenceCitation: Hughes BGM, Mendoza RG, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Chirovsky D, Zhang P, Gumuscu B, Swaby RF, Grob JJ. Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629. Dermatol Ther (Heidelb). 2021 Oct;11(5):1777-1790. doi: 10.1007/s13555-021-00598-6. Epub 2021 Sep 23.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
United Kingdom
Australia
Canada
United States
France
Israel
Mexico
Norway
Germany

location_facility: Lombardi Comprehensive Cancer Center ( Site 0360)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 0804)

location_facility: Royal Brisbane and Women s Hospital ( Site 0407)

location_facility: Princess Margaret Cancer Centre ( Site 0102)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0901)

location_facility: Southern Medical Day Care Centre ( Site 0408)

location_facility: St. Joseph Heritage Healthcare ( Site 0350)

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)

location_facility: CHU Reims - Hopital Robert Debre ( Site 0610)

location_facility: Universitaetsklinikum Essen ( Site 0650)

location_facility: Universitatsklinikum Tübingen ( Site 0651)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 0754)

location_facility: Hospital General de Valencia ( Site 0752)

location_facility: Dr. Leon Richard Oncology Centre ( Site 0100)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8001)

location_facility: Medizinische Hochschule Hannover ( Site 0652)

location_facility: Universitaetsklinikum Mannheim GmbH ( Site 0654)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0356)

location_facility: Princess Alexandra Hospital ( Site 0405)

location_facility: University of Kansas Cancer Center ( Site 0361)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0605)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0364)

location_facility: The Ottawa Hospital Cancer Centre ( Site 0101)

location_facility: Sunnybrook Research Institute ( Site 0105)

location_facility: Hospital Duran i Reinals ICO de Hospitalet ( Site 0751)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)

location_facility: Institut Gustave Roussy (IGR) ( Site 0602)

location_facility: Massachusetts General Hospital ( Site 0362)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 0600)

location_facility: Stanford University Medical Center ( Site 0366)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)

location_facility: Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)

location_facility: University College Hospital NHS Foundation Trust ( Site 0801)

location_facility: Haukeland Universitetssykehus ( Site 0902)

location_facility: Moores UC San Diego Cancer Center ( Site 0352)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)

location_facility: Universitaets-Hautklinik Kiel ( Site 0656)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0308)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0753)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0800)


title: A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.

location_country:
Taiwan
Brazil
Spain
Ireland
Italy
Australia
New Zealand
Canada
Russian Federation
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
Chile
France
Norway
Turkey
Japan
Germany

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: Chonnam National University Hwasun Hospital

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council

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

location_facility: Chang Gung Med Foundation. Kaohsiung Branch

location_facility: Universitaetsklinikum Magdeburg. Klinik fuer Urologie

location_facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Central Clinical Hospital with outpatient Clinic

location_facility: National Medical Research Radiology Centre

location_facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec

location_facility: Ankara Numune Education and Research Hospital

location_facility: Universitetssykehuset i Nord Norge. Kreftavdelingen

location_facility: Hopital Prive Toulon Hyeres Sainte Marguerite

location_facility: Instituto do Cancer de Sao Paulo - ICESP

location_facility: MI Precarpathian Clinical Oncology Center

location_facility: UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: Sunnybrook Health Sciences, Odette Cancer Centre

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Kingston Health Sciences Centre - KGH Site

location_facility: Centro Avancado de Tratamento Oncologico - CENANTRON -

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC

location_facility: RMI Sumy Regional Clinical Oncology Dispensary

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Saitama Medical University International Medical Center

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

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Istanbul Medeniyet Universitesi Goztepe EAH

location_facility: University of Tennessee Erlanger Oncology & Hematology

location_facility: Severance Hospital Yonsei University Health System

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.


title: A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

summary:
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene [ESR1] Y537S mutation).

ReferenceCitation: Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERα Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.

lead_sponsor: Eisai Inc.

location_country:
United States
United Kingdom
France

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta


title: An International, Multicentre, Prospective, Non-interventional Observational Registry for Patients With X-Linked Hypophosphatemia (XLH)

acronym: XLH Registry

summary: This is an international, multicentre, prospective, non-interventional, observational Registry of patients with X-Linked hypophosphatemia (XLH). The main objective of this XLH Registry is to collect data to characterise the treatment, progression and long-term outcomes of XLH in both adult and paediatric settings.

study_type: Observational

time_perspective: Other

ReferenceCitation: Brandi ML, Ariceta G, Beck-Nielsen SS, Boot AM, Briot K, de Lucas Collantes C, Emma F, Giannini S, Haffner D, Keen R, Levtchenko E, Mӓkitie O, Nilsson O, Schnabel D, Tripto-Shkolnik L, Zillikens MC, Liu J, Tudor A, Mughal MZ. Post-authorisation safety study of burosumab use in paediatric, adolescent and adult patients with X-linked hypophosphataemia: rationale and description. Ther Adv Chronic Dis. 2022 Sep 5;13:20406223221117471. doi: 10.1177/20406223221117471. eCollection 2022.

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Denmark
Portugal
Slovenia
Ireland
Italy
Latvia
Netherlands
Spain
United Kingdom
Switzerland
Sweden
Hungary
France
Israel
Belgium
Norway
Germany
Bulgaria
Slovakia
Czechia

location_facility: Great Ormond Street Hospital for Children

location_facility: Oslo Universitetssykehus HF, Aker Sykehus

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Institute of Childrenś Health NUDCH

location_facility: NHS Greater Glasgow & Clyde - South Glasgow University Hosp Division

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: Klinikum Ernst-von-Bergmann Potsdam und Bad Belzig

location_facility: Presidio Ospedaliero Di Summa Antonio Perrino

location_facility: Hospital General Universitario Santa Lucía

location_facility: "Hopital Pierre-Paul Riquet Centre de Rhumatologie"

location_facility: Hopital Universitaire des Enfants Reine Fabiola

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

location_facility: Royal Belfast Hospital for Sick Children

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

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Århus Universitetshospital - Aarhus sygehus

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Istituto Auxologico Italiano -I.R.C.C.S.

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital Dona Estefânia

location_facility: Complejo Hospitalario Universitario Insular Materno-Infantil

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Presidio Sant'Anna)

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino


title: A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide

acronym: OCEAN

summary: This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients with RRMM following 2-4 lines of prior therapy and who are refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients will receive either melflufen+dex or pomalidomide+dex.

ReferenceCitation: Schjesvold FH, Dimopoulos MA, Delimpasi S, Robak P, Coriu D, Legiec W, Pour L, Špička I, Masszi T, Doronin V, Minarik J, Salogub G, Alekseeva Y, Lazzaro A, Maisnar V, Mikala G, Rosiñol L, Liberati AM, Symeonidis A, Moody V, Thuresson M, Byrne C, Harmenberg J, Bakker NA, Hájek R, Mateos MV, Richardson PG, Sonneveld P; OCEAN (OP-103) Investigators. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study. Lancet Haematol. 2022 Feb;9(2):e98-e110. doi: 10.1016/S2352-3026(21)00381-1. Epub 2022 Jan 12.

lead_sponsor: Oncopeptides AB

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Czechia
Poland
Austria
Russian Federation
Israel
Norway
Hungary
Denmark
Taiwan
Greece
Estonia
Korea, Republic of
France
Netherlands


acronym: PARALLAX

title: A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

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:
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
Romania
Czechia
Portugal
Austria
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Guatemala
Hungary
Germany
Bulgaria
Denmark
Latvia
Estonia
Thailand
France
Colombia
Netherlands

summary: The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).