title: An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

summary: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Taiwan
Brazil
Hong Kong
Spain
Greece
Italy
Netherlands
Argentina
Canada
Ukraine
Korea, Republic of
United States
France
China
Turkey
Belgium
Japan
Germany

location_facility: The University of Chicago Medical Center

location_facility: CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology

location_facility: Universitair Medisch Centrum Groningen (UMCG) - Parent

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR

location_facility: National Cancer Center Hospital - Dept of Respiratory Medicine

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: IRCCS Centro di Riferimento Oncologico - Oncologia Medica A

location_facility: Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada

location_facility: Kocaeli University Research and Application Hospital

location_facility: General Hospital Papageorgiou-2nd Department of Dermatalogy

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department

location_facility: Oncology Specialties, PC; Clearview Cancer Institute

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia

location_facility: Universitaetsklinikum Schleswig- Holstein Campus Luebeck

location_facility: General Hospital of Athens of Chest Disease "SOTIRIA"

location_facility: Medizinische Hochschule Hannover - Pneumologie

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: The Chinese University of Hong Kong - Emergency Medicine

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT

location_facility: Decatur Memorial Hospital - Clinical Research

location_facility: NHO Hokkaido Cancer Center - Dept of Respiratory Medicine

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I

location_facility: Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic

location_facility: Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II

location_facility: Adana Numune Training and Research Hospital - Cardiology Department

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie

location_facility: University General Hospital of Heraklion "PAGNI"

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

location_facility: Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica

location_facility: CHU Rennes - Hopital Pontchaillou - service de pneumologie

location_facility: Trakya University Medical Faculty - Medical Oncology

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account

location_facility: CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Cancer Specialists, LLC - Department of Clinical Research

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: Hospital Regional Universitario de Malaga

location_facility: Stronach Regional Cancer Centre - at Southlake

location_facility: Vivantes Klinikum Am Urban - Haematologie und Onkologie

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: Maastricht University Medical Center - Dept of Medical Oncology

location_facility: Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Saitama Medical University International Medical Center - Dept of Respiratory Medicine

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia

location_facility: Communal Non-profit Enterprise Regional Center of Oncology - Parent


status: Completed

primary_purpose: Treatment

acronym: NOVA

intervention_type: Drug

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

study_completion_date_type: Actual

lead_sponsor: Janssen Research & Development, LLC

type: EudraCT Number

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Actual

location_country:
Denmark
Netherlands
Canada
United States
France
Germany

location_facility: York Dermatology Clinic and Research Centre

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: Dr Wei Jing Loo Medicine Professional Corporation

location_facility: University of Pittsburgh Department of Dermatology

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

acronym: RHINE

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

ReferenceType: derived

ReferenceCitation: Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.

ReferenceCitation: Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
United States
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Turkey
Singapore
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Thailand
Korea, Republic of
France

location_facility: Northern California Retina Vitreous Associates

location_facility: Fisabio-Ofalmologia Medica; Servicio de Oftalmología

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: University Health Network Toronto Western Hospital

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Southwest Hospital , Third Military Medical University; Ophthalmology

location_facility: Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

location_facility: University of Colorado; dept of ophthalmology

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Hôpital PURPAN - CHU TOULOUSE; Ophtalmologie

location_facility: Universitätsklinikum Würzburg, Augenklinik und Poliklinik

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Third Affiliated Hospital of Third Military Medical University; Ophthalmology

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: Rajavithi Hospital; Ophthalmology Department

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Hospital Clinico San Carlos; Servicio de oftalmologia

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital

location_facility: University of Rochester Flaum Eye Institute

location_facility: Vitreous Retina Macula Specialists of Toronto

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Seoul National University Bundang Hospital

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: King Chulalongkorn Memorial Hospital; Ophthalmology Department

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Semmelweis Egyetem Szemészeti Vizsgálóhely

location_facility: National University Hospital; Ophthalmology Department

location_facility: James Paget University Hospitals NHS Foundation Trust

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: FN Hradec Králové, Oční klinika; Ophthalmology clinic

intervention_type: Procedure


title: Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial

lead_sponsor: Sanofi

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

location_country:
Netherlands
Argentina
Canada
United States
France
Israel
South Africa
Belgium
Japan
Germany

location_facility:
Investigational Site Number :392142
Investigational Site Number :840004
Investigational Site Number :840907
Investigational Site Number :392005
Investigational Site Number :392152
Investigational Site Number :250008
Investigational Site Number :840073
Investigational Site Number :032003
Investigational Site Number :840068
Investigational Site Number :840126
Investigational Site Number :276011
Investigational Site Number :124017
Investigational Site Number :840018
Investigational Site Number :392044
Investigational Site Number :392038
Investigational Site Number :392106
Investigational Site Number :840055
Investigational Site Number :840027
Investigational Site Number :840087
Investigational Site Number :840023
Investigational Site Number :392021
Investigational Site Number :392158
Investigational Site Number :392153
Investigational Site Number :032006
Investigational Site Number :376001
Investigational Site Number :840062
Investigational Site Number :840070
Investigational Site Number :392008
Investigational Site Number :840032
Investigational Site Number :840102
Investigational Site Number :032001
Investigational Site Number :392007
Investigational Site Number :392030
Investigational Site Number :840402
Investigational Site Number :124014
Investigational Site Number :840132
Investigational Site Number :392168
Investigational Site Number :840099
Investigational Site Number :276006
Investigational Site Number :392034
Investigational Site Number :376002
Investigational Site Number :840922
Investigational Site Number :392169
Investigational Site Number :710007
Investigational Site Number :840077
Investigational Site Number :250002
Investigational Site Number :392163
Investigational Site Number :392006
Investigational Site Number :392112
Investigational Site Number :392170
Investigational Site Number :710006
Investigational Site Number :250010
Investigational Site Number :392155
Investigational Site Number :056003
Investigational Site Number :392043
Investigational Site Number :710092
Investigational Site Number :840008
Investigational Site Number :840091
Investigational Site Number :392132
Investigational Site Number :392040
Investigational Site Number :124012
Investigational Site Number :710011
Investigational Site Number :124007
Investigational Site Number :392119
Investigational Site Number :840064
Investigational Site Number :840115
Investigational Site Number :032002
Investigational Site Number :376005
Investigational Site Number :392108
Investigational Site Number :392122
Investigational Site Number :392164
Investigational Site Number :392045
Investigational Site Number :840951
Investigational Site Number :392029
Investigational Site Number :392146
Investigational Site Number :250005
Investigational Site Number :124018
Investigational Site Number :032005
Investigational Site Number :840121
Investigational Site Number :392144
Investigational Site Number :392002
Investigational Site Number :840942
Investigational Site Number :392042
Investigational Site Number :392020
Investigational Site Number :840035
Investigational Site Number :124016
Investigational Site Number :392177
Investigational Site Number :276005
Investigational Site Number :032009
Investigational Site Number :528001
Investigational Site Number :250009
Investigational Site Number :840079
Investigational Site Number :392004
Investigational Site Number :124002
Investigational Site Number :392185
Investigational Site Number :032010
Investigational Site Number :840130
Investigational Site Number :392130
Investigational Site Number :392010
Investigational Site Number :710001
Investigational Site Number :124001
Investigational Site Number :392011
Investigational Site Number :250006
Investigational Site Number :392173
Investigational Site Number :032091
Investigational Site Number :840059
Investigational Site Number :392133
Investigational Site Number :840052
Investigational Site Number :032097
Investigational Site Number :124013
Investigational Site Number :392012
Investigational Site Number :392013
Investigational Site Number :032012
Investigational Site Number :124010
Investigational Site Number :276009
Investigational Site Number :032096
Investigational Site Number :840067
Investigational Site Number :840057
Investigational Site Number :710091
Investigational Site Number :392162
Investigational Site Number :276010
Investigational Site Number :032004
Investigational Site Number :840124
Investigational Site Number :392014
Investigational Site Number :392165
Investigational Site Number :124006
Investigational Site Number :250001
Investigational Site Number :392036
Investigational Site Number :710009
Investigational Site Number :392127
Investigational Site Number :840403
Investigational Site Number :392167

summary:
Primary Objective:

To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).


title: A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia

summary: This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: GlycoMimetics Incorporated

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

location_facility: IRCCS Casa Sollievo della Sofferenza Hospital

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

location_facility: Washington University School of Medicine

location_facility: University of California, Los Angeles - UCLA

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of Alberta Princess Margaret Hospital

location_facility: Università Cattolica del Sacro Cuore (UNICATT)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)

location_facility: University Hospital Cleveland Medical Center

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

location_facility: Columbia University Herbert Irving Comprehensive Cancer Center

location_facility: University Health Network (UHN) - Princess Margaret Cancer Centre

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Vanderbilt-Ingram Cancer Center Clinical Trials Office

location_facility: Hospital Universitario Fundación Jiménez Diaz

location_facility: University Hospital of Hospital Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Radcliffe Hospitals and University of Oxford

location_facility: Fondazione Policlinico Tor Vergata, U.O.C. Ematologia

location_facility: Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: The Leukemia/BMT Program of BC Vancouver General Hospital

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Charles A. Sammons Cancer Center at Dallas

status_simplified: Ongoing


title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Incyte Corporation

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

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: London Health Sciences Centre Lhsc - South Street Hospital

location_facility: Royal Cornwall Hospital Truro Sunrise Centre

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Hospital General Universitario Vall D Hebron

location_facility: HOPITAL CHARLES NICOLLE CHU ROUEN - Hï¿½PITAL DE BOIS-GUILLAUME

location_facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Szte Borgyogyszati Es Allergologiai Klinika

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr

location_facility: McGill University Health Centre/Glen Site/Cedars Cancer Centre

location_facility: University of California San Francisco Comprehensive Cancer Center

location_facility: ONCOLOGIA ï¿½ IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA

location_facility: Centre Hospitalier Universitaire Vaudois (Chuv)

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie


primary_purpose: Prevention

acronym: REACT

title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Assess the Efficacy and Safety of Clazosentan in Preventing Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI), in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH)

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Denmark
Poland
Spain
Italy
Austria
Canada
Finland
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Columbia University Medical Center Dept. of Neurology - Neurological Intensive Care Unit

location_facility: Bezirkskrankenhaus Günzburg - Klinik für Neurochirugie

location_facility: Medizinische Universität Innsbruck; Universitätsklinik für Neurologie und Psychiatrie

location_facility: Odense Universitets Hospital Neurokirurgisk afdelning

location_facility: Ústřední vojenská nemocnice Praha Neurochirurgická klinika

location_facility: Vanderbilt University Medical Center - Department of Neurosurgery

location_facility: Azienda Ospedaliero Universitaria di Parma, struttura complessa Neurochirurgia

location_facility: Charite Universitätsmedizin Berlin - Klinik und Poliklinik für Neurochirurgie

location_facility: Oklahoma University Health Sciences Center - Department of Neurology

location_facility: University Hospital of Hamburg-Eppendorf, Dpt. of Neurosurgery

location_facility: Hospital Vall d'Hebron Departamento Neuroradiología

location_facility: Lunds Universitetssjukhus, Neurokirurgiska avd. NIVA

location_facility: Helsingin yliopistollinen keskussairaala Neurokirurgian klinikka

location_facility: Rambam Healthcare Campus, Neurology Department

location_facility: Royal University Hospital Department of Neurology

location_facility: Linköping Universitetssjukhuset, Neurokirurgiska kliniken

location_facility: University Hospitals Case Medical Center - Department of Neurosurgery

location_facility: Virginia Commonwealth University, Department of Neurosurgery

location_facility: Hôpital Pitié-Salpêtrière, Service de neuroréanimation chirurgicale Babinski

location_facility: Asklepios Klinik St. Georg - Neurochirugie

location_facility: Hospital Universitario 12 de Octubre, Departamento Neurosurgery Division Neuroradiology

location_facility: Neurology Department, University Hospital

location_facility: Hospital Universitario Germans Trias i Pujol - Neurology Department

location_facility: University of Erlangen-Nürnberg, Dpt. of Neurosurgery

location_facility: University of Maryland Medical Systems - Neurosurgery

location_facility: Beilinson Hospital, Rabin Medical Center, Department of Neurosurgery

location_facility: ASST Monza, Hospital San Gerardo, TERAPIA INTENSIVA Neurochirurgica

location_facility: Halifax Infirmary, Nova Scotia Health Authority

location_facility: University Hospital of Gran Canaria Dr. Negrin

location_facility: Corporació Sanitària Parc Taulí, Hospital Parc Taulí

location_facility: University Hospital of Essen, Department of Neurosurgery

location_facility: University Hospital in Pilsen, Department of Neurosurgery

location_facility: Univ Hosp Toulouse, University Hospital Purpan Pierre Paul Riquet Hospital

location_facility: Winnipeg Regional Health Authority Health Sciences Centre

location_facility: Boston University School of Medicine / Boston University Medical Center

location_facility: Heinrich-Heine Universität Düsseldorf -Klinik für Neurochirugie

location_facility: Neurochirurgische Universitätklinik des Heidelberg, Dept of Neurosurgery

location_facility: Stanford Hospital & Clinics - Stanford School of Medicine Dept. of Neurosurgery

location_facility: The Chaim Sheba Medical Centre - Neurosurgery

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Fakultní nemocnice Ostrava Neurochirurgická klinika

location_facility: Klinik für Diagnostische Radiologie und Neuroradiologie, Augsburg

location_facility: Northwell Health, Department of Neurosurgery

location_facility: University of Alberta Hospital Department of Neurological Surgery

location_facility: Fakultní nemocnice Brno Neurochirurgická klinika

location_facility: Universitätsklinikum Rostock, Abteilung für Neurochirurgie

location_facility: Azienda Ospedaliera Padova-Università degli Studi di Padova - Istituto di Anestesia e Rianimazione

location_facility: Oddział Neurochirurgii i Neurotraumatologii z Pododdziałem Leczenia Chorób Naczyniowych Centralnego Układu Nerwowego

location_facility: The Ohio State University - Wexner Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore, UOS Terapia Intensiva Neurochirurgic

location_facility: Kepler Universitätsklinikum, Universitätsklinik für Neurochirurgie

location_facility: University Regensburg, Dpt. of Neurosurgery

location_facility: Sahlgrenska Universitetssjukhuset, Verksamheten för neurokirurgi, Neurosjukvården

location_facility: Hospital - Cliniques Universitaires Saint-Luc, Service de Neurochirurgie

location_facility: Hospital Erasme, Service de Soins Intensifs

location_facility: Masarykova nemocnice v Ústí nad Labem Neurochirurgie

location_facility: Turku University Hospital Neurosurgery, T-hospital

location_facility: Beth Israel Deaconess Medical Center Dept of Neurosurgery

location_facility: Hôpital de la Timone 2, Intensive Care Unit SAR 1

location_facility: Universitätsklinik Frankfurt, Klinik und Poliklinik für Neurochirurgie, Dept of neurosurgery

location_facility: Universitätsklinikum Schleswig Hollstein Lübeck (UKSH) Klinik für Neurochirugie

location_facility: Pécsi Tudományegyetem Klinikai Központ, Idegsebészeti Klinika

location_facility: Penn State Milton S Hershey Medical Center, Neurosurgery

location_facility: Tampereen yliopistollinen sairaala Neurokirurgian klinika

location_facility: University of Illinois - Department of Neurosurgery

location_facility: Hôpital Gabriel Montpied, ICU DEPT, Neuro reanimation departement

location_facility: Hôpital neurologique Pierre Wertheimer Service de Reanimation

location_facility: Katedra i Klinika Neurochirurgii Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

summary: This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.


type: Registry Identifier

title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

acronym: STEP 1

summary: This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

ReferenceType: background

ReferenceCitation: Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.

ReferenceType: result

ReferenceCitation: Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

ReferenceCitation: Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2022 Oct 6. doi: 10.1111/dom.14890. Online ahead of print.

ReferenceCitation: Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.

ReferenceCitation: Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.

ReferenceCitation: O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
Poland
Taiwan
United Kingdom
Russian Federation
Mexico
Argentina
Canada
Finland
Puerto Rico
United States
France
India
Belgium
Japan
Germany
Bulgaria


title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

enrollment_type: Anticipated

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
New Zealand
Argentina
Canada
Puerto Rico
United States
France
Israel
Germany
Czechia

location_facility: Northern California Retina Vitreous Associates

location_facility: Retina Institute of California dba Acuity Eye Grp

location_facility: Emanuelli Research and Development Center

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS

location_facility: Florida Eye Microsurgical Institute, Inc.

location_facility: Charlotte Eye Ear Nose and Throat Associates, PS

location_facility: University Hospital Kralovske Vinochrady

location_facility: Retina Consultants of Southern California

location_facility: Byers Eye Institute at Standford, Stanford School of Medicine

location_facility: Retina Specialists of Michigan / Foundation for Vision

location_facility: London North West University Hospital Trust

location_facility: Retina Institute of California Medical Group

location_facility: Vitreous Retina Macula Consultants of NY

location_facility: Retina Associates of New Jersey (NJ Retina)

location_facility: Instituto da Visão - Hospital de Olhos Ltda

location_facility: University of South Florida (USF) Eye Institute

location_facility: Retina Consultants of Austin (Retina Research Center)

location_facility: The Gavin Herbert Eye Institute/UC Irvine

location_facility: Eye Clinic, Acre Mill Outpatients, Huddersfield Royal Infirmary

location_facility: Danbury Eye Physicians & Surgeons, P.C. - Danbury

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Cumberland Valley Retina Consultants, PC

location_facility: Retina Vitreous Associates Medical Group

intervention_type: Other


title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

lead_sponsor: Vertex Pharmaceuticals Incorporated

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

location_country:
United Kingdom
Greece
Austria
Australia
Italy
Canada
Netherlands
Sweden
United States
France
Belgium
Germany
Czechia

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center

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

location_facility: CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: University of Virginia Primary Care Center

location_facility: Children's Specialty Services at North Druid Hills

location_facility: Centre Hospitalier De L'Universite Laval

location_facility: Children's Hospital of the King's Daughters

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Children's Hospital of Richmond at VCU, Children's Pavilion

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

location_facility: Dell Children's Medical Center of Central Texas

location_facility: Ann & Robert Lurie Children's Hospital of Chicago

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Banner University of Arizona Medical Center

location_facility: The University of Texas Southwestern Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: General Hospital of Attika "Sismanoglio"(Adult CF center, NHS)

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Oklahoma Health Sciences Center

location_facility: Tampa General Hospital Cardiac and Lung Transplant Clinic

location_facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center

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

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

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Joe DiMaggio Cystic Fibrosis & Pulmonary Center

location_facility: Azienda Ospedaliero Universitaria Ospendali Riuniti

location_facility: UNM Clinical and Translational Science Center

location_facility: The Cystic Fibrosis Center, Mount Sinai Beth Israel

location_facility: Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota

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

location_facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: University of California Davis Medical Center

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

summary: This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation


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

ReferenceCitation: Middleton PG, Mall MA, Dřevínek P, Lands LC, McKone EF, Polineni D, Ramsey BW, Taylor-Cousar JL, Tullis E, Vermeulen F, Marigowda G, McKee CM, Moskowitz SM, Nair N, Savage J, Simard C, Tian S, Waltz D, Xuan F, Rowe SM, Jain R; VX17-445-102 Study Group. Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele. N Engl J Med. 2019 Nov 7;381(19):1809-1819. doi: 10.1056/NEJMoa1908639. Epub 2019 Oct 31.

location_facility: LKH - Universitätsklinikum der PMU Salzburg

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

location_facility: CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital

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

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: University of Virginia Primary Care Center

location_facility: Centre Hospitalier De L'Universite Laval

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Children's Hospital of the King's Daughters

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Children's Hospital of Richmond at VCU, Children's Pavilion

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

location_facility: Miller Children's Hospital/ Long Beach Memorial

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

location_facility: Ann & Robert Lurie Children's Hospital of Chicago

location_facility: Banner University of Arizona Medical Center

location_facility: The University of Texas Southwestern Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Children's Speciality Services at North Druid Hills

location_facility: General Hospital of Attika "Sismanoglio"(Adult CF center, NHS)

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Oklahoma Health Sciences Center

location_facility: Tampa General Hospital Cardiac and Lung Transplant Clinic

location_facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital

location_facility: Saint Francis Medical Center/ Children's Hospital of Illinois/OSF

location_facility: The Royal Belfast Hospital for Sick Children

location_facility: Valley Children's Hospital/ Children's Hospital of Central California

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gathuisberg

location_facility: Massachusetts General Hospital Cystic Fibrosis Center

location_facility: University of New Mexico Clinical & Translational Science Center

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

summary: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).


acronym: VISION

title: VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

lead_sponsor: Endocyte

ReferenceCitation: Iravani A, Violet J, Azad A, Hofman MS. Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):38-52. doi: 10.1038/s41391-019-0174-x. Epub 2019 Oct 8. Review.

ReferenceCitation: Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Pérez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.

ReferenceCitation: Sundlöv A, Sjögreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12.

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:
Denmark
United Kingdom
Netherlands
Canada
Sweden
Puerto Rico
United States
France
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Institute Claudius Regaud, Toulouse Cancer Research Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Yale Cancer Center, Clinical Trials Office

location_facility: Sahlgrenska University Hospital, Department of Oncology

location_facility: Aalborg University Hospital Klinik Kirurgi-Kræft Clinical Research Unit Department of Oncology

location_facility: Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine

location_facility: University Hospital Muenster, Department of Nuclear Medicine

location_facility: Rigshospitalet - University Hospital Copenhagen, Department of Oncology

location_facility: Duke University School of Medicine, Duke Cancer Institute

location_facility: VA Greater Los Angeles Healthcare System

location_facility: London Health Sciences Centre, Division of Nuclear Medicine

location_facility: New Mexico Oncology & Hematology Consultants

location_facility: University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Centre d'Investigations et de Recherche Clinique en Oncologie Hospital SAINT-LOUIS

location_facility: University Hospital Essen, Clinic for Nuclear Medicine

location_facility: University of Michigan Medical Center, Division of Nuclear Medicine

location_facility: Royal Surrey County Hospital NHS Foundation Trust

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

location_facility: John Cochran St. Louis Veterans Medical Center

location_facility: Precision Cancer Research/ Dayton Physicians Network

location_facility: The Lank Center for Genitourinary Oncology

location_facility: Washington DC VA Medical Center, Nuclear Medicine Service

location_facility: University of Iowa Hospitals and Clinics Cancer Center Research

location_facility: Oregon Health and Science University Nuclear Medicine Department

location_facility: St Bartholomew's Hospital, West Smithfield

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: Royal Free London NHS Foundation Trust Royal Free Hospital

location_facility: GU Research Network/ Urology Cancer Center

location_facility: Hospital rechts der Isar, Department of Nuclear Medicine

location_facility: University College London Hospitals NHS Foundation Trust

summary: The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.


title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery

summary: This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

status: Terminated

ReferenceCitation: Thielmann M, Corteville D, Szabo G, Swaminathan M, Lamy A, Lehner LJ, Brown CD, Noiseux N, Atta MG, Squiers EC, Erlich S, Rothenstein D, Molitoris B, Mazer CD. Teprasiran, a Small Interfering RNA, for the Prevention of Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery: A Randomized Clinical Study. Circulation. 2021 Oct 5;144(14):1133-1144. doi: 10.1161/CIRCULATIONAHA.120.053029. Epub 2021 Sep 3.

ReferenceCitation: Hinze C, Karaiskos N, Boltengagen A, Walentin K, Redo K, Himmerkus N, Bleich M, Potter SS, Potter AS, Eckardt KU, Kocks C, Rajewsky N, Schmidt-Ott KM. Kidney Single-cell Transcriptomes Predict Spatial Corticomedullary Gene Expression and Tissue Osmolality Gradients. J Am Soc Nephrol. 2021 Feb;32(2):291-306. doi: 10.1681/ASN.2020070930. Epub 2020 Nov 25.

lead_sponsor: Quark Pharmaceuticals

location_country:
Spain
United Kingdom
Austria
Australia
New Zealand
Canada
United States
France
Belgium
Germany
Czechia

location_facility: London Health Sciences Center, University Hospital

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital - Soltero Cardiovasular

location_facility: McGill University Health Center - Royal Victoria Hospital

location_facility: Foothills Medical Centre, Libin Cardiovascular Institute of Alberta, University of Calgary

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Universitatsklinikum Heidelberg und Medizinische Fakultat

location_facility: Fakulni nemocnice Hradec Kralove, Kardiochirurgicka klinika

location_facility: CHU Besancon-Service de Chirurgie Thoracique et Cardiovasculaire

location_facility: Fakultni nemocnice Motol a 2. LF UK, Klinika kariovaskularni chirurgie 2. LF. UK

location_facility: Institut Universitaire de cardiologie et de pneomologie de Quebec, Universite Laval

location_facility: Universitatklinicum Essen Westdeutsches Herzzentrum Essen

location_facility: Hospital Clinic Universitario de Valencia

location_facility: CHU Toulouse - Hospital Rangueil-Service de Chirurgie Cadriovasculaire

location_facility: Krankenhaus der Barmherzigen Bruder Trier

location_facility: Klinikum der Friedrich-Schiller-Universitat Jena

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

location_facility: East Carolina Heart Institute at East Carolina University

location_facility: Hospital Clinico Universitario de Santiago-CHUS

location_facility: Horizon Health Network, Saint John Regional Hospital

location_facility: Cardiac & Vascular Research Center of Northern Michigan

location_facility: Indiana/ Ohio Heart, a division of Luthern Medical Group, LLC

location_facility: University of Louisville Physicians (ULP)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hopitaux Universitaires de Strasbourg - Service de Chirurgie Cardiovasculaire

location_facility: Jacksonville Center for Clinical Research

location_facility: Universitasklinikum Giessen und Marburg GmbH

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Lubeck

location_facility: University of Alberta Hospital / Mazankowski Alberta Heart Institute

location_facility: Royal Jubilee Hospital (Victoria Island Health Authority)

location_facility: Indiana University Health-Methodist Hospital

location_facility: Virginia Commonwealth University Medical Center

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: University of Alabama at Birmingham Hospital

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Universitatsklinikum "Carl Gustav Carus" der Technischen Universitat Dresden Klinik fur Herzchirurgle

location_facility: Hospital Universitario Central de Asturias

location_facility: Institut klinicke a experimenalni mediciny, Klinika kardiovaskularni chirurgie

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

status_simplified: Unknown


title: Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 Trial.

summary:
This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting.

Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1.

The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. Enrollment will continue until and for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode.

The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.

lead_sponsor: Milestone Pharmaceuticals Inc.

location_country:
Poland
Spain
Netherlands
Canada
Hungary
United States
France
Belgium
Germany

location_facility: American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii

location_facility: Cardiology Associates of Fairfield County

location_facility: Revival Research Institute, LLC - Southgate, MI

location_facility: CHRU de Brest - Hopital de la Cavale Blanche

location_facility: X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji

location_facility: Clinical Trials of America, LLC - Monroe, LA

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Amphia Ziekenhuis - Locatie Breda Molengracht

location_facility: IHC Health Services Inc. DBA Intermountain Medical Center

location_facility: Cardiovascular Associates of the Delaware Valley - Elmer

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Generalitat Valenciana Conselleria De Sanitat

location_facility: Prywatny Specjalistyczny Gabinet Internistyczny

location_facility: SP ZOZ Szpital Specjalistyczny w Pulawach

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Medical University of South Carolina (MUSC)

location_facility: Universite Libre de Bruxelles (ULB) - Hopital Erasme

location_facility: University of Manitoba, St Boniface General Hospital

location_facility: Osrodek Badan Klinicznych CLINSANTE S.C.

location_facility: Dalhousie University - QEII Health Sciences Centre

location_facility: Medical Arts Health Research Group - North Vancouver

location_facility: Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: McGill University Health Center - Research Institute

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Scott & White Memorial Hospital: Baylor Scott & White Research Institute

location_facility: Hospital Universitario Clínico Lozano Blesa

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid

location_facility: CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur

location_facility: Georgia Arrythmia Consultants&Research Institute

location_facility: Libin Cardiovascular Institute of Alberta - University of Calgary

location_facility: Hospital Clinico Universitario de Santiago

location_facility: NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych

location_facility: Meander Medisch Centrum - Locatie Amersfoort

location_facility: Franciscus Gasthuis & Vlietland - Locatie Vlietland

location_facility: Victoria Cardiac Arrhythmia Trials, Inc.

location_facility: Kliniczny Szpital Wojewódzki nr 2, Rzeszów

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi

location_facility: University of Arkansas for Medical Sciences

location_facility: Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

location_facility: MedStar Health Research Institute - Chesapeake Cardiovascular Associates

location_facility: The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

location_facility: AMITA Health Medical Group Heart & Vascular Elk Grpve Village

location_facility: Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

location_facility: Zentrum fuer Praevention und Rehabilitation

location_facility: UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)

location_facility: The Ohio State University (OSU) Wexner Medical Center


title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

summary:
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

location_country:
Spain
Italy
United Kingdom
Ukraine
Kazakhstan
United States
Romania
Japan
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Egypt
Bosnia and Herzegovina
Hungary
North Macedonia
China
Germany
Denmark
Taiwan
Belarus
Greece
Thailand
Korea, Republic of
France

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitari Vall d'Hebron; Oncology

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

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Almaty Oncology Center; Chemotherapy department

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital Universitario Donostia: Oncology Service

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

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: University of Pecs; 1St Department of Medicine

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

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Fujian Medical University Union Hospital

location_facility: Az. Osp. Monaldi; 1 Pneumologia Oncologica

location_facility: PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

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

location_facility: Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii

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

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

location_facility: Prof Dr I Chiricuta Institute of Oncology; Oncology Department

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Izmir Suat Seren Chest Diseases and Surgery Research Hospital

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Healthcare Institution "Gomel Regional Clinical Oncologic Dispensary"

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Healthcare Institution Grodno University Hospital; Regional Oncologic Dispensary

location_facility: Chang Gung Memorial Foundation - Kaohsiung

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: Private Health Organization Acibadem Sistina Hospital

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

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Seoul National University Bundang Hospital

location_facility: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Ankara Ataturk Chest Diseases Training and Research Hospital

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: Azienda Osp. Univ di Modena; Dept Onc & Hem

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: National Hospital Organization Himeji Medical Center


title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed

summary:
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a >=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200.

This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel- group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.

ReferenceCitation: van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

ReferenceCitation: van Wyk J, Ait-Khaled M, Santos J, Scholten S, Wohlfeiler M, Ajana F, Jones B, Nascimento MC, Tenorio AR, Smith DE, Wright J, Wynne B. Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):794-800. doi: 10.1097/QAI.0000000000002655.

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

lead_sponsor: ViiV Healthcare

location_country:
Spain
United Kingdom
Australia
Netherlands
Canada
United States
France
Belgium
Japan
Germany


acronym: LET vs VGCV for Prevention of CMV disease in Kidney Transplant Recipients

title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Spain
Colombia
Austria
Australia
Italy
Argentina
Canada
Mexico
New Zealand
United Kingdom
Hungary
United States
France
Belgium
Germany

location_facility: Hospital Universitari Vall de Hebron ( Site 0112)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0226)

location_facility: Hospital Italiano de Buenos Aires ( Site 0188)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 0098)

location_facility: Wake Forest University Baptist Medical Center ( Site 0260)

location_facility: Hospital San Vicente Fundación - Rionegro ( Site 0205)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0256)

location_facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 0093)

location_facility: Hospital Universitari de Bellvitge IDIBELL ( Site 0114)

location_facility: Universitair Ziekenhuis Antwerpen ( Site 0041)

location_facility: Duke University Medical Center ( Site 0243)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 0044)

location_facility: Universitaetsklinikum Essen ( Site 0074)

location_facility: University of Nebraska Medical Center ( Site 0272)

location_facility: Hopital Henri Mondor du Creteil ( Site 0063)

location_facility: Hospital El Cruce Nestor Carlos Kirchner ( Site 0351)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0214)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0096)

location_facility: Hospital Universitario Miguel Servet ( Site 0118)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0170)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0071)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0210)

location_facility: Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 0042)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0209)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 0136)

location_facility: Hospital Clinic i Provincial de Barcelona ( Site 0113)

location_facility: Medical University of South Carolina ( Site 0257)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0162)

location_facility: Medizinische Hochschule Hannover ( Site 0073)

location_facility: University of Maryland Medical Center ( Site 0234)

location_facility: University of California-San Francisco ( Site 0236)

location_facility: Royal Prince Alfred Hospital ( Site 0005)

location_facility: The Ohio State University Wexner Medical Center ( Site 0264)

location_facility: Szpital Wojewodzki w Poznaniu ( Site 0168)

location_facility: Allgemeines Krankenhaus Universitaetskliniken Wien ( Site 0032)

location_facility: University of Alberta Hospital ( Site 0221)

location_facility: University of Washington Medical Center ( Site 0246)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0201)

location_facility: Azienda Ospedaliera di Padova U.O.C. Trapianti Rene e Pancreas ( Site 0091)

location_facility: Virginia Commonwealth University ( Site 0245)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 0055)

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0213)

location_facility: Medizinische Universitat Innsbruck ( Site 0033)

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 0276)

location_facility: Sociedad de Cirugia de Bogota Hospital de San Jose ( Site 0203)

location_facility: Columbia University Medical Center ( Site 0255)

location_facility: Vanderbilt University Medical Center ( Site 0275)

location_facility: Pomorski Uniwersytet Medyczny ( Site 0167)

location_facility: Szpital Kliniczny Dzieciatka Jezus ( Site 0165)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0354)

location_facility: Instituto de Nefrologia Nephrology S.A. ( Site 0182)

location_facility: Saint Barnabas Medical Center ( Site 0250)

location_facility: Instituto de Cardiología de Corrientes Juana F. Cabral ( Site 0181)

location_facility: Princess Alexandra Hospital ( Site 0004)

location_facility: Instituto Mexicano de Trasplantes S C ( Site 0212)

location_facility: Hospital Universitario Mayor Mederi CIMED ( Site 0206)

location_facility: Monash Health-Monash Medical Centre ( Site 0008)

location_facility: Centenario Hospital Miguel Hidalgo ( Site 0215)

summary: The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.


title: Safety, Tolerability and Efficacy of Rapid Optimization, Helped by NT-proBNP testinG, of Heart Failure Therapies

acronym: STRONG-HF

summary: STRONG-HF is a multicenter, randomized, parallel group study designed to evaluate the efficacy and safety of up-titration of standard oral heart failure medications during hospitalization for acute heart failure. Patients admitted for acute heart failure will be randomized within 2 days before discharge to either usual care or intensification of treatment with a beta-blocker, a renin-angiotensin system blocker, and a mineralocorticoid receptor blocker ("high intensity care" arm). In the "high intensity care" arm, patients' clinical signs and symptoms of heart failure will be assessed, and routine laboratory measures and biomarkers will be measured, at frequent post-discharge visits. When these measures indicate that it is safe to do so, the doses of the oral heart failure medications will be increased to optimal levels. Patients will be followed through 180 days from randomization. Patients assigned to the usual care group will be followed by their general physician and/or cardiologist according to local medical standards. Patients who were screened but did not meet eligibility criteria will be followed for 90-day outcome. Randomized patients will be contacted at 180 days to assess outcomes.

status: Recruiting

ReferenceCitation: Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Nov 4. pii: S0140-6736(22)02076-1. doi: 10.1016/S0140-6736(22)02076-1. [Epub ahead of print]

ReferenceCitation: Cotter G, Davison B, Metra M, Sliwa K, Voors AA, Addad F, Celutkiene J, Chioncel O, Cohen Solal A, Diaz R, Damasceno A, Duengen HD, Filippatos G, Goncalvesova E, Merai I, Ponikowski P, Privalov D, Sani MU, Takagi K, Shogenov Z, Saidu H, Mebazaa A. Amended STRONG-HF study design. Eur J Heart Fail. 2021 Nov;23(11):1981-1982. doi: 10.1002/ejhf.2348. Epub 2021 Oct 4.

ReferenceCitation: Kimmoun A, Cotter G, Davison B, Takagi K, Addad F, Celutkiene J, Chioncel O, Solal AC, Diaz R, Damasceno A, Duengen HD, Filippatos G, Goncalvesova E, Merai I, Metra M, Ponikowski P, Privalov D, Sliwa K, Sani MU, Voors AA, Shogenov Z, Mebazaa A. Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study. Eur J Heart Fail. 2019 Nov;21(11):1459-1467. doi: 10.1002/ejhf.1575. Epub 2019 Aug 19.

ipd_sharing: Undecided

lead_sponsor: Heart Initiative

location_country:
Mozambique
Austria
Nigeria
Russian Federation
Argentina
Tunisia
Hungary
France
Israel
South Africa
Colombia
Slovakia

location_facility: SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department

location_facility: Mavalane Hospital, National Institute of Health

location_facility: Federal State Budget Educational Institution of Higher Education "North-West state medical university n.a. I.I. Mechnikov under the Ministry of Health of the Russian Federation"

location_facility: Russian National Research Medical University n.a. N.I.Pirogov based at City Clinical hospital n.a. V.M.Buyanov DZM

location_facility: V. Internal Clinic, LFUK and UNB Bratislava

location_facility: Primary Healthcare Unit of the RF Ministry of Internal Affairs in Moscow

location_facility: State Budget HealthCare Institution of Vladimir Region "City Hospital 4 of Vladimir"

location_facility: Diagnostic and Treatment Medical Clinic SA

location_facility: Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

location_facility: Rosario Clinical Research Institute - Delta

location_facility: Center Hospital Regional University of Tours Trousseu Hospital

location_facility: Clin. Dep. Internal Med 3, University Hospital St. Poelten

location_facility: State Budget HealthCare Institution "First City clinical hospital named after E.E. Volosevich"

location_facility: Department of Internal Medicine UVN SNP-FN

location_facility: Internal Department, Hospital with Polyclinic Lucenec

location_facility: Buda Hospital of the Hospitaller Order of Saint John of God

location_facility: Saint-Petersburg State Budget Healthcare Institution City Hospital 15

location_facility: Dep. Of Cardiology, Medical Univ. Vienna

location_facility: Saint-Petersburg State Budget HealthCare Institution "City hospital 38 n.a. N.A. Semashko"

location_facility: Internal Department Hospital Arm General L. Svobodu Svidnik

location_facility: State Budget HealthCare Institution of Moscow "City clinical hospital 29 n.a. N.E. Bauman under Department of HealthCare of Moscow"

location_facility: Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital

location_facility: First Internal Clinic, Faculty Hospital with Polyclinic Nove Zamky

location_facility: State Budget HealthCare Institution of Moscow "City clinical hospital 15 n.a. O.M. Filatov under Department of HealthCare of Moscow"

location_facility: State Budget Institution "Saint Petersburg state budget research institution of first aid named after I. I. Dzhanelidze"

location_facility: Dept of Medicine Research unit, Maputo Central Hospital

location_facility: Regional budget Healthcare Institution "Cardiological dispensary"

location_facility: National Institute of Cardio and Vascular Diseases

location_facility: Internal Department, Dolnooravian Hospital of Dr. L.N.Jege

location_facility: Internal Med. 1, St. Josef Hospital Braunau

location_facility: Federal State Budget Educational Institution of Higher Education "Moscow State Medico-Dental University n.a. A.I. Evdokimov", under Ministry of Health of the Russian Federation

location_facility: Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after academician I.P. Pavlov"

location_facility: Internal Department, NsP Spisska Nova Ves

location_facility: State Institution of Healthcare of Yaroslavl Region "Clinical Hospital 8"

location_facility: State Budget HealthCare Institution of Mosocw "City clinical hospital 51 under Department of HealthCare of Moscow"

location_facility: Cardiomet Pereira Clinical Research Center Foundation

location_facility: Hôpitaux Universitaires Saint-Louis-Lariboisière, University Paris Diderot

location_facility: Department of Internal Medicine Hospital Rimavska Sobota

location_facility: Internal Department, Hospital with Polyclinic Brezno

location_facility: Cardiology Department at Hietzing Hospital with Neurological Center Rosenhugel

location_facility: Federal State Budget Educational Institution of Higher Education "Moscow State University n.a. M.V. Lomonosov", independent division Medical research Educational Centre

location_facility: Nelson Mandela Academic Hospital, Walter Sisulu University

location_facility: Municipal Government-financed Institution of Healthcare "City Emergency Hospital" of Rostov-on-Don City


acronym: ARISE

title: A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

lead_sponsor: UCB Biopharma S.P.R.L.

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

location_country:
Poland
Portugal
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Lithuania
Hungary
United States
France
Turkey
Belgium
Japan
Germany
Bulgaria
Slovakia
Czechia

summary: The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


title: A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)

lead_sponsor: Merck KGaA, Darmstadt, Germany

ReferenceCitation: de Stefano N, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Roy S; MAGNIFY-MS Study Group. Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS. Neurol Neuroimmunol Neuroinflamm. 2022 Jun 14;9(4). pii: e1187. doi: 10.1212/NXI.0000000000001187. Print 2022 Jul. Erratum in: Neurol Neuroimmunol Neuroinflamm. 2022 Oct 20;9(6):.

ReferenceCitation: Schmierer K, Wiendl H, Oreja-Guevara C, Centonze D, Chudecka A, Roy S, Boschert U. Varicella zoster virus and influenza vaccine antibody titres in patients from MAGNIFY-MS who were treated with cladribine tablets for highly active relapsing multiple sclerosis. Mult Scler. 2022 Nov;28(13):2151-2153. doi: 10.1177/13524585221099413. Epub 2022 Jun 7.

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Finland
Canada
Sweden
Hungary
France
Israel
Germany
Czechia

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5

location_facility: IRCSS Neuromed Istituto Neurologico Mediterraneo

location_facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

location_facility: CHU Montpellier-Nîmes - Hôpital Caremeau

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Seconda Univesità degli Studi di Napoli, AOU

summary: The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).


title: A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

summary: This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

ReferenceCitation: Knupp KG, Scheffer IE, Ceulemans B, Sullivan JE, Nickels KC, Lagae L, Guerrini R, Zuberi SM, Nabbout R, Riney K, Shore S, Agarwal A, Lock M, Farfel GM, Galer BS, Gammaitoni AR, Davis R, Gil-Nagel A. Efficacy and Safety of Fenfluramine for the Treatment of Seizures Associated With Lennox-Gastaut Syndrome: A Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):554-564. doi: 10.1001/jamaneurol.2022.0829.

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

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_country:
Denmark
Poland
Spain
Italy
Australia
Mexico
Canada
Netherlands
Sweden
United States
France
Belgium
Japan
Germany

location_facility: Institute of Neurology and Neurosurgery at St. Barnabas

location_facility: AP-HM - CHU TIMONE ENFANTS Service de Neurologie Pédiatrique

location_facility: Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital

location_facility: MultiCare Institute for Research & Innovation

location_facility: Hôpital Universitaire Necker-Enfants Malades Service de neurologie pédiatrique

location_facility: Ann & Robert Lurie Children's Hospital of Chicago

location_facility: Hôpital Robert Debré Pédiatrie Médicale Service Neurologie Et Maladies Métaboliques Robert-debré

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Hôpital Universitaire Des Enfants Reine Fabiola

location_facility: Hospital Ruber Internacional Servicio de Neurologia

location_facility: Schoen Klinik Vogtareuth - Klinik fuer Neuropediatrie und Neurologische Rehabilitation

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Universitätsklinikum Jena - Klinik für Neuropädiatrie /SPZ

location_facility: Clinical Integrative Research Center of Atlanta, Panda Neurology

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Istituto Scienze Neurologiche di Bologna, Ospedale Bellaria

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Tokyo Women's Medical University Hospital

location_facility: AOU Anna Meyer Clinica di Neurologia Pediatrica

location_facility: Massachusetts General Hospital For Children

location_facility: Universitätsklinikum Freiburg Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: Hôpital des enfants- Pellegrin- CIC Pédiatrique

location_facility: CHRU de Lille Hopital Roger Salengro Neurophysiologie Clinique (RDC)