title: A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

acronym: BRUIN CLL-322

summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Denmark
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
Sweden
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Singapore
Czechia

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

location_facility: University of California Irvine Medical Center

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: American Oncology Partners of Maryland, PA

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Shengjing Hospital of China Medical University

location_facility: A.O.U. Citta' della Salute e della Scienza di Torino

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Pole Regionalde Cancérologie(CHU de Poitiers)

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Kliniska forsknings- och utvecklingsenheten

location_facility: L'Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: The First People's Hospital of Yunnan Province

location_facility: Kyoto Furitsu Medical University Hospital

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

location_facility: The First Affiliated Hospital Of University Of South China

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

location_facility: First Affiliated Hosp of College of Med, Zhejiang University


type: Registry Identifier

type: EudraCT Number

title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)

summary:
The primary objectives of the study are:

To assess the safety profile of the study vaccines in each study intervention group.

To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.

To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster.

The secondary objectives of the study are:

To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.

To assess the neutralizing and binding antibody responses of booster vaccination.

To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.

To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.

ipd_sharing: Yes

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

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country:
Kenya
Spain
United Kingdom
Australia
New Zealand
Honduras
United States
France
Panama
Mexico

location_facility: Columbia University Irving Medical Center-Site Number:8400203

location_facility: Optimal Research Texas-Site Number:8400191

location_facility: Synexus Clinical Research Evansville-Site Number:8400272

location_facility: New York University Langone Vaccine Center-Site Number:8400230

location_facility: Synexus - Clinical Research Advantage, Inc.-Site Number:8400271

location_facility: Optimal Research, LLC-Site Number:8400057

location_facility: Brigham and Women's Hospital-Site Number:8400199

location_facility: Synexus - Clinical Research Advantage, Inc.-Site Number:8400270

location_facility: Baptist Health Center for Clinical Research-Site Number:8400077

location_facility: Emory University Decatur-Site Number:8400201

location_facility: Synexus Clinical Research US, Inc. - Orlando-Site Number:8400179

location_facility: University of Pittsburgh-Site Number:8400233

location_facility: Chicago Clinical Research Institute, Inc.-Site Number:8400269

location_facility: Black Hills Center for American Indian Health, Inc.-Site Number:8400204

location_facility: Holy Name Medical Center-Site Number:8400072

location_facility: University of Rochester-Site Number:8400207

location_facility: Peninsula Research Associates, Inc.-Site Number:8400094

location_facility: The George Washington University-Site Number:8400212

location_facility: Optimal Research, LLC Rockville-Site Number:8400048

location_facility: Coastal Carolina Research Center-Site Number:8400097

location_facility: Meridian Clinical Research-Site Number:8400030

location_facility: Charles R. Drew University of Medicine and Science-Site Number:8400220

location_facility: Research Centers of America-Site Number:8400089

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

summary: This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.

status: Recruiting

primary_purpose: Treatment

enrollment_type: Anticipated

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
Italy
United Kingdom
Belgium
Japan
Poland
Hong Kong
Portugal
Russian Federation
Argentina
Israel
Turkey
Singapore
Hungary
China
Germany
Taiwan
Ireland
Korea, Republic of
France
Chile

location_facility: Institut de Recherche en Cancerologie de Montpellier IRCM

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Private Medical Institution "Euromedservice"

location_facility: Velindre NHS Trust - Velindre Cancer Centre VCC

location_facility: Fudan University - Shanghai Cancer Center

location_facility: SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

location_facility: Kobe City Medical Center General Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Fujian Medical University - Fujian Provincial Cancer Hospital

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

location_facility: The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science Centre

location_facility: Zhejiang Medical University - Zhejiang Cancer Hospital

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University of Dundee - Ninewells Hospital and Medical School

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Instituto Portugues De Oncologia Do Porto Francisco Gentil, E.P.E.

location_facility: National Taiwan University Hospital NTUH

location_facility: Xiamen University - The First Affiliated Hospital

location_facility: Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

location_facility: Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

location_facility: Xinjiang Medical University - Cancer Hospital

location_facility: The Sixth Affiliated Hospital of Sun Yat-Sen University

intervention_type: Drug

lead_sponsor_type: industriel


title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

acronym: Tailored-AF

summary:
Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

ReferenceType: background

ReferenceCitation: Seitz J, Bars C, Théodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

ipd_sharing: No

lead_sponsor: Volta Medical

location_country:
Netherlands
United States
France
Belgium
Germany

location_facility: Hôpital Louis Pradel - Hospices Civils de Lyon

intervention_type: Procedure


title: A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD)

acronym: FJORD

summary: The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Spain
Greece
Italy
Australia
United States
France
China
Israel
Japan
Germany
Bulgaria


title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Hoffmann-La Roche

source: euctr

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 the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Flinders Medical Centre; Medical Oncology

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Presbyterian Rust Medical Center/Jorgensen Cancer Center

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: the First Affiliated Hospital of Bengbu Medical College

location_facility: Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology

location_facility: Memorial Sloan Kettering Cancer Center at Bergen

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

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

location_facility: Uzsoki Utcai Korhaz; Onkoradiológiai Osztály

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Medipol University MF; Oncology Department

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Peterborough City Hospital; Oncology Research Department 018

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Memorial Sloan Kettering Cancer Center at Nassau

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Ryazan Regional clinical oncology dispensary

location_facility: Affiliated Hospital of Hebei University; Department of medical oncology

location_facility: 19 Mayis University Medical Faculty; Medical Oncology Department

location_facility: Seoul National University Bundang Hospital

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Southwest Hospital , Third Military Medical University

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: CEMER Centro Medico de Enfermedades Respiratorias

location_facility: Städtisches Klinikum Brandenburg GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: New Mexico Oncology Hematology Consultants

location_facility: Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Coventry and Warwickshire Partnership NHS Trust

location_facility: West China Hospital, Sichuan University; Department of Breast

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

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

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Velindre Cancer Centre; Clinical Trials Unit

location_facility: Texas Oncology, P.A.; Duke Slayton Cancer Center

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: New York Cancer and Blood Specialists-Eastchester Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: US oncology research at Minnesota Oncology

location_facility: Mackay Memorial Hospital; Dept of Surgery

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

location_facility: Humanitas Centro Catanese Di Oncologia; Oncologia Medica

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

location_facility: China Medical University Hospital; Surgery

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

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

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

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

location_facility: Strongsville Hospital; Cleveland Clinic Cancer Center

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: Podolsk City Clinical Hospital; Hematology

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

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

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

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

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Centro Oncológico de Chihuahua, Hospital Angeles Chihuahua

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe

location_facility: Fujian Medical University Union Hospital

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: The First Affiliated Hospital, Sun Yat-sen University; Thyroid and Breast Surgery

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Texas Oncology Cancer Center - Sugarland

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: New York Cancer and Blood Specialists - New Hyde Park

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Kaiser Permanente - San Francisco Medical Center

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

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Sociedad de Metabolismo y Corazón (SOMECO)

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Klinikum Magdeburg gGmbH, Brustzentrum; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: New York Cancer and Blood Specialists-Central Park Hematology & Oncology

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: Woj. Wielospecjalistyczne Centrum Onkol. i Traumat. im.M.Kopernika; Woj. Przychodnia Onkologiczna

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, PA

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Bon Secours St. Francis Medical Center Oncology Research

location_facility: The First Affiliated Hospital to Henan University of Science and Technology

location_facility: Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: North Shore Hematology Oncology Associates, d.b.a. New York Cancer and Blood Specialists

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

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Leicester Royal Infirmary; Infectious Disease Unit

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Fiona Stanley Hospital - Medical Oncology

location_facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

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

location_facility: Kyungpook National University Medical Center

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Shengjing Hospital of China Medical University

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: University of Miami; Dept Sylvester Cancer Center

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Kaiser Permanente - Moanalua Medical Center

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Hillcrest Hospital; Hirsch Cancer Center

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Centro de Investigacion Clinica de Oaxaca

summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

summary: This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

ReferenceCitation: Ramalingam SS, Thara E, Awad MM, Dowlati A, Haque B, Stinchcombe TE, Dy GK, Spigel DR, Lu S, Iyer Singh N, Tang Y, Teslenko I, Iannotti N. JASPER: Phase 2 trial of first-line niraparib plus pembrolizumab in patients with advanced non-small cell lung cancer. Cancer. 2022 Jan 1;128(1):65-74. doi: 10.1002/cncr.33885. Epub 2021 Sep 3.

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

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Belgium
Poland
Russian Federation
Australia
Argentina
Turkey
Mexico
Norway
Sweden
Brazil
Switzerland
Hungary
Germany
Bulgaria
Greece
Ireland
Korea, Republic of
France
Chile
Colombia
Netherlands


acronym: NOTUS

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

lead_sponsor: Sanofi

location_country:
Serbia
Spain
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Mexico
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Greece
Latvia
France
Chile
Colombia
Netherlands

location_facility: Scottsboro Quick Care Clinic-Site Number:8400116

location_facility: Biopharma Informatic, LLC-Site Number:8400055

location_facility: Frontier Clinical Research, LLC-Site Number:8400049

location_facility: St. Francis Sleep, Allergy and Lung Institute-Site Number:8400020

location_facility: Herman Clinical Research LLC-Site Number:8400078

location_facility: Quality Clinical Research, Inc.-Site Number:8400073

location_facility: Weillington Medical Care Associates, LLC-Site Number:8400100

location_facility: Clinical Research of Central PA-Site Number:8400009

location_facility: Montana Medical Research-Site Number:8400019

location_facility: Tryon Medical Research-Site Number:8400076

location_facility: Florida Pulmonary Research Center-Site Number:8400001

location_facility: Chest Disease NW Pennsylvania-Site Number:8400046

location_facility: Prospective Research Innovations, Inc.-Site Number:8400063

location_facility: Family Medical Specialists of Florida, PA-Site Number:8400077

location_facility: Innovative Clinical Research-Site Number:8400018

location_facility: Physicians Research Group-Site Number:8400065

location_facility: Diagnostics Research Group-Site Number:8400038

location_facility: DL Research Solutions Inc-Site Number:8400089

location_facility: Reed Medical Research-Site Number:8400123

location_facility: Lake Norman Pulmonary and Sleep Medicine - Mooresville-Site Number:8400006

location_facility: Henry Ford Health System-Site Number:8400053

location_facility: Toledo Institute of Clinical Research-Site Number:8400024

location_facility: Phoenix Medical Group-Site Number:8400061

location_facility: Allergy, Asthma and Clinical Research Center-Site Number:8400127

location_facility: Helix Biomedics, LLC-Site Number:8400035

location_facility: Optimed Research, LTD-Site Number:8400082

location_facility: Great Lakes Medical Research-Site Number:8400044

location_facility: Onsite Clinical Solutions LLC-Site Number:8400042

location_facility: Pioneer Clinical Research-Site Number:8400043

location_facility: Southeast Lung Associates-Site Number:8400003

location_facility: Pulmonary & Sleep Associates of Jasper PC-Site Number:8400090

location_facility: Institute of HealthCare Assessment, Inc.-Site Number:8400015

location_facility: Carolina Medical Research, LLC-Site Number:8400026

location_facility: Infinity Medical Research-Site Number:8400004

location_facility: Great Lakes Research Institute-Site Number:8400096

location_facility: Avant Research Associates LLC-Site Number:8400118

location_facility: Houston Pulmonary and Sleep Associates-Site Number:8400011

location_facility: Central Florida Pulmonary Group, PA-Site Number:8400102

location_facility: Allergy, Asthma & Sinus Center, S.C.-Site Number:8400088

location_facility: Genesis Clinical Research & Consulting-Site Number:8400050

location_facility: Direct Helpers Medical Center Inc-Site Number:8400079

location_facility: MultiSpecialty Clinical Research-Site Number:8400110

location_facility: Medical Advancement Center of Arizona-Site Number:8400107

location_facility: Innovation Medical Research Center-Site Number:8400114

location_facility: Qualmedica Research, LLC-Site Number:8400119

location_facility: Northlake Medical Group-Site Number:8400099

location_facility: Florida Institute for Clinical Research-Site Number:8400129

location_facility: Southeastern Research Center-Site Number:8400068

location_facility: Central Florida Pulmonary Group, PA-Site Number:8400101

location_facility: De La Cruz Research Center, LLC-Site Number:8400075

location_facility: Pulmonary & Sleep Institute, PA - San Antonio-Site Number:8400080

location_facility: Mt. Olympus Medical Research-Site Number:8400115

location_facility: Beautiful Minds Clinical Research Center-Site Number:8400081

location_facility: Monroe Biomedical Research-Site Number:8400087

location_facility: Allianz Research Institute-Site Number:8400007

location_facility: Medical Centre of Conyers-Site Number:8400064

location_facility: Winthrop Pulmonary Associates PC-Site Number:8400054

location_facility: Cullman Research Center, LLC-Site Number:8400095

location_facility: Prolato Clinical Research Center-Site Number:8400128

location_facility: Omni Clinical Research-Site Number:8400091

location_facility: Gwinnett Biomedical Research-Site Number:8400052

location_facility: Renaissance Research and Medical Group, Inc-Site Number:8400092

location_facility: Clinrx Research, LLC-Site Number:8400069

location_facility: Appalachian Clinical Research-Site Number:8400048

location_facility: Mid Hudson Medical Research PLLC-Site Number:8400037

location_facility: Coastal Pulmonary And Critical Care-Site Number:8400013

location_facility: Columbus Clinical Services-Site Number:8400062

location_facility: Clinical Trials Center of Middle Tennessee-Site Number:8400066

location_facility: Omega Research Consultants, LLC-Site Number:8400021

location_facility: Phoenix Medical Research, LLC-Site Number:8400012

location_facility: Asthma and Allergy Institute-Site Number:8400022

location_facility: River Birch Research, LLC-Site Number:8400045

location_facility: Vanguard Clinical Research-Site Number:8400047

location_facility: Coastal Carolina Health Care, P.A.-Site Number:8400025

location_facility: DCOL Center for Clinical Research-Site Number:8400028

location_facility: Pioneer Research Solutions, Inc.-Site Number:8400070

location_facility: Somnos Clinical Research-Site Number:8400016

location_facility: Clinical Research of Gastonia-Site Number:8400010

location_facility: Finlay Medical Research-Site Number:8400071

location_facility: Revive Research Institute-Site Number:8400120

location_facility: Pulmonary Research of Abingdon, LLC-Site Number:8400030

location_facility: Clinical Research Partners-Site Number:8400040

location_facility: Lapis Clinical Research At BlueSkies Family Medicine-Site Number:8400117

summary:
Primary Objective:

To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

Annualized rate of acute moderate or severe COPD exacerbation (AECOPD)

Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)
Pre-bronchodilator FEV1 over 52 weeks compared to placebo
Lung function assessments
Moderate and severe COPD exacerbations
To evaluate safety and tolerability
To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)


title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

acronym: CheckMate 74W

summary: The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Puerto Rico
Singapore
Brazil
Canada
Switzerland
China
Germany
Taiwan
Korea, Republic of
France

location_facility: Centre Hospitalier Affilie Universitaire - Hotel-Dieu de Quebec

location_facility: Kyoto Prefectural University of Medicine KPUM - University Hospital

location_facility: Hospital Clinico Universitario de Santiago de Compostela

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

location_facility: Cliniques Univ St Luc - Gastro-Enterology

location_facility: A.M.Granovs Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Parc Tauli Sabadell Hospital Universitari

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: University of Louisville-James Graham Brown Cancer Center

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Universitatsklinikum St. Polten - Lilienfeld Standort St. Polten


title: A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment

summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

ReferenceCitation: Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.

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

location_country:
Denmark
Poland
Spain
Greece
Italy
Australia
Russian Federation
Argentina
Canada
United Kingdom
Korea, Republic of
United States
France
Japan
Germany

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Chonnam National University Hwasun Hospital

location_facility: A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

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

location_facility: A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria

location_facility: Pusan National University Yangsan Hospital

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Virginia Cancer Specialists - Gainsville

location_facility: New York Oncology Hematology,P.C.-Albany

location_facility: Hospital Universitario de Burgos; Oncología

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

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

location_facility: Tokyo Women's Medical University Hospital

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Branch of the company "Hadassah Medical LTD"

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital Alvaro Cunqueiro; Servicio de Oncologia

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: National Medical Research Center for Surgery named after A.V. Vishnevsky

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Seoul National University Bundang Hospital

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

location_facility: St-Petersburg Regional Oncology Dispensary; Oncology

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

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

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

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

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"


title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)

summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).

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: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Taiwan
Georgia
Estonia
Finland
Korea, Republic of
France
Colombia
Netherlands

location_facility:
Research Site 456
Research Site 506
Research Site 222
Research Site 337
Research Site 552
Research Site 351
Research Site 643
Research Site 503
Research Site 576
Research Site 359
Research Site 381
Research Site 402
Research Site 156
Research Site 404
Research Site 501
Research Site 464
Research Site 534
Research Site 305
Research Site 162
Research Site 102
Research Site 426
Research Site 382
Research Site 629
Research Site 231
Research Site 342
Research Site 635
Research Site 303
Research Site 390
Research Site 711
Research Site 430
Research Site 272
Research Site 675
Research Site 612
Research Site 673
Research Site 128
Research Site 475
Research Site 104
Research Site 613
Research Site 476
Research Site 568
Research Site 700
Research Site 463
Research Site 171
Research Site 340
Research Site 365
Research site 715
Research Site 362
Research Site 369
Research Site 290
Research Site 653
Research Site 218
Research Site 663
Research Site 619
Research Site 161
Research Site 270
Research Site 465
Research Site 473
Research Site 317
Research Site 436
Research Site 243
Research Site 286
Research Site 312
Research Site 266
Research Site 274
Research Site 282
Research Site 366
Research Site 103
Research Site 567
Research Site 652
Research Site 133
Research Site 547
Research Site 331
Research Site 437
Research Site 651
Research Site 478
Research Site 432
Research Site 176
Research Site 642
Research Site 614
Research Site 649
Research Site 654
Research Site 216
Research Site 335
Research Site 616
Research Site 353
Research Site 407
Research Site 438
Research Site 579
Research Site 423
Research Site 701
Research Site 474
Research Site 620
Research Site 424
Research Site 177
Research Site 129
Research Site 389
Research Site 178
Research Site 611
Research Site 633
Research Site 194
Research Site 676
Research Site 569
Research Site 704
Research Site 356
Research Site 421
Research Site 211
Research Site 250
Research Site 565
Research Site 179
Research Site 151
Research Site 641
Research Site 304
Research Site 648
Research Site 370
Research Site 510
Research Site 451
Research Site 192
Research Site 363
Research Site 361
Research Site 623
Research Site 561
Research Site 163
Research Site 172
Research Site 248
Research Site 271
Research Site 263
Research Site 154
Research Site 615
Research Site 261
Research Site 462
Research Site 357
Research Site 215
Research Site 461
Research Site 403
Research Site 544
Research Site 224
Research Site 632
Research Site 572
Research Site 213
Research Site 264
Research Site 562
Research Site 425
Research Site 502
Research Site 471
Research Site 630
Research Site 173
Research Site 574
Research Site 667
Research Site 289
Research Site 247
Research Site 217
Research Site 262
Research Site 267
Research Site 509
Research Site 591
Research Site 631
Research Site 291
Research Site 504
Research Site 564
Research Site 367
Research Site 409
Research Site 410
Research Site 566
Reserach Site 505
Research Site 245
Research Site 467
Research Site 639
Research Site 664
Research Site 457
Research Site 338
Research Site 307
Research Site 408
Research Site 320
Research Site 124
Research Site 549
Research Site 242
Research Site 624
Research site 713
Research Site 383
Research Site 246
Research Site 368
Research Site 281
Research Site 223
Research Site 511
Research Site 109
Research Site 628
Research Site 174
Research Site 107
Research Site 491
Research Site 315
Research Site 360
Research Site 597
Research Site 273
Research Site 308
Research Site 197
Research Site 134
Research Site 180
Research Site 388
Research Site 311
Research Site 625
Research Site 401
Research Site 626
Research Site 627
Research Site 314
Research Site 405
Research Site 319
Research Site 644
Research Site 531
Research Site 617
Research Site 466
Research Site 385
Research Site 637
Research Site 318
Research Site 427
Research Site 284
Research Site 355
Research Site 321
Research Site 358
Research Site 244
Research Site 428
Research Site 677
Research Site 406
Research Site 275
Research Site 232
Research Site 341
Research Site 650
Research Site 265
Research Site 621
Research Site 285
Research Site 429
Research Site 600
Research Site 313
Research Site 422
Research Site 249
Research Site 472
Research Site 647
Research Site 532
Research Site 636
Research Site 212
Research Site 126
Research Site 634
Research Site 656
Research Site 268
Research Site 125
Research Site 672
Research Site 668
Reasearch Site 175
Research Site 269
Research Site 288
Research Site 411
Research site 645
Research Site 241
Research Site 322
Research Site 571
Research Site 193
Research Site 339
Research Site 507
Research Site 662
Research Site 332
Research Site 219
Research Site 535
Research Site 384
Research Site 577
Research Site 563
Research Site 336
Research Site 638
Research Site 431
Research Site 220
Research Site 195
Research Site 508
Research Site 354
Research Site 592
Research Site 316
Research site 714
Research Site 352
Research Site 435
Research Site 153
Research Site 101
Research Site 301


ipd_sharing: Undecided

status: Completed

acronym: PACIFIC-STROKE

intervention_type: Other

title: Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke

study_completion_date_type: Actual

lead_sponsor: Bayer

ReferenceCitation: Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.

ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Sweden
Slovakia
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Finland
France
Netherlands

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni

location_facility: University of Pittsburgh Medical Center Hamot

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital de la Santa Creu i de Sant Pau | Neurologia

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

location_facility: Vseobecna nemocnica s poliklinikou Levoca, a.s.

location_facility: Centre Hospitalier Universitaire - Le Kremlin Bicêtre

location_facility: Klinik Favoriten - Sozialmedizinisches Zentrum Süd

location_facility: Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm

location_facility: Railway clinical hospital on the station Novosibirsk-Glavniy

location_facility: Svet zdravia, a.s. Vseobecna nemocnica v Ziari nad Hronom

location_facility: CHUC - Hospitais da U. Coimbra - Servico de Neurologia

location_facility: Hospital Universitari i Politecnic La Fe | Neurologia

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: First Multiprofile Hospital for Active Treatment Sofia EAD

location_facility: Eastern Clinical Research Unit - Box Hill

location_facility: Hospital Clinico Universitario San Carlos | Neurologia

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Univ.of South Florida College of Medicine

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Clinical Inter-District Hospital of Vsevolozhsk

location_facility: Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves

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

location_facility: Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego

location_facility: Turun yliopistollinen keskussairaala, kantasairaala

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino

location_facility: Hyogo Prefectural HarimaHimeji General Medical Center

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Sci-Res. Institute of Complex Cardiovascular Disorders

location_facility: Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota

location_facility: Fakultna nemocnica s poliklinikou Skalica, a.s.

location_facility: Krankenhaus der Barmherzigen Brüder Eisenstadt

location_facility: Hospital Clínico Universitario de Valladolid

summary: The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

status_simplified: Completed


acronym: CRISTALLO

title: A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

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

location_country:
Spain
Italy
Australia
United States
France

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Hospital de Navarra, Servicio de Hematología

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Medical Center of Aurora; Rocky Mountain Cancer Centers

location_facility: Peter MacCallum Cancer Centre; Department of Haematology

location_facility: Oncology & Hematolgy Associates of SW Va Inc. - Roanoke

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

location_facility: Asl Le-Ospedale "Vito Fazzi";U.O. Ematologia

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: CHU de Caen, Institut d'Hématologie de Basse-Normandie

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Hopital De Haut Leveque; Hematologie Clinique

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

location_facility: Hopital Saint Jean : Pole Santé du Rousillon; Unité de Recherche clinique

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Consultants in Medical Oncology and Hematology, P.C.

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

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

location_facility: Canberra Hospital; Haematology Department

location_facility: Royal North Shore Hospital; Haematology Department

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

summary: This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).


acronym: SURPASS-CVOT

title: The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)

lead_sponsor: Eli Lilly and Company

type: Other Identifier

ReferenceCitation: Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16. Review.

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

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical University

location_facility: Tianjin Medical University General Hospital

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

location_facility: Atrium Health - Department of Family Medicine Research

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Milan Kvapil s.r.o., Diabetologicka ambulance

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: ClinPhenomics GmbH & Co KG, Studienzentrum

location_facility: Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob

location_facility: Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

location_facility: Ukrainian State Research Institute of medical and social problems of disability

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

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

location_facility: Batra Hospital & Medical Research Centre

location_facility: South Texas Veterans Administration Health Care

location_facility: Polyclinic of Communal 4th city clinical hospital

location_facility: Diabet2 s.r.o., Diabetologicka a interni ambulance

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: CHU de Bordeaux, Hopital du Haut Leveque

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Illawarra Shoalhaven Local Health District

location_facility: Diabetes & Endocrinology Consultants of Pennsylvania, LLC

location_facility: Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello

location_facility: Praxis Oedeme - Diabetologische Schwerpunktpraxis

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Instituto de Pesquisa clinica de Campinas

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen

location_facility: NS ZOZ Osrodek Diabetologiczny " Popula"

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Northeast Endocrine Metabolic Associates

location_facility: LEC Communal Inst Hc Kharkiv City Clinical Hosp #8

location_facility: Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

location_facility: The People's Hospital of Liaoning Province

location_facility: Municipal non-profit enterprise "Consultative-diagnostic center №20" of Odesa city council

location_facility: Fondazione Salvatore Maugeri Clinica del lavoro

location_facility: University of Alabama at Birmingham Medical Center

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: St Cloud Hospital/Central Minnesota Heart Center

location_facility: International Institute of Clinical Trials LLC

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Investigacion en Salud y Metabolismo S.C

location_facility: Instituto de Investigaciones Clínicas Bahia Blanca

location_facility: Lahoja Asociación para la Investigación y Farmacovigilancia S.C.

location_facility: Centro de Investigación Médica Integral S.C.

location_facility: Interni a diabetologicka ordinace, s.r.o.

location_facility: Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

location_facility: Siberian State Medical University of Roszdrav

location_facility: Centro Periférico de Especialidades Bola Azul

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

location_facility: Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Cardiology Partners Clinical Research Institute - Wellington

location_facility: Beijing Friendship Hospital Affiliate of Capital University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels

location_facility: Beijing Anzhen Hospital, Capital Medical University

location_facility: Jacksonville Center for Clinical Research

location_facility: Centro De Estudios Clinicos De Queretaro S.C.

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Centro Medico Privado San Vicente Diabetes

location_facility: Franciscus Gasthuis Rotterdam - Cardiologie

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: M. F. Vladimirskiy Moscow Regional Research Clinical Institute

location_facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

location_facility: Consultorio de Medicina especializada del Sector Privado

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: AKP - Avdelningen för Kliniska Prövningar

location_facility: CEIM Hospital Universitario y Politecnico la Fe

location_facility: Diabetologische Schwerpunktpraxis Marck Linn Pickel

location_facility: MUDr. Barbora Diepoltova, Diabetologie Praha 9

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

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

location_facility: Ryazan Regional Clinical Cardiology Dispensary

location_facility: The First Hospital of Lanzhou University

location_facility: Centro Universitario de Investigación en Farmacologia Clínic

location_facility: Institute of Diabetes and Endocrinology Kaplan Medical Center

location_facility: Instituto de Diabetes, Obesidad y Nutricion

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: National Endocrinology Research Center of the Ministry of Health

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: PMG Research Inc., d/b/a PMG of Piedmont Healthcare

location_facility: Hospital da Clinicas da Faculdade de Medicina da USP

location_facility: Cardiology Partners Clinical Research Institute, LLC-Palm Beach Gardens

location_facility: General Hospital of Ningxia Medical University

location_facility: The First Afflicated Hospital of Xian Jiaotong University

location_facility: Southern Adelaide Diabetes & Endocrine Services

location_facility: FSBI "National Medical Research Center of Cardiology" of MOH of Russian Federation

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

location_facility: Institut für klinische Forschung und Entwicklung

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Eskisehir Osmangazi Universitesi Tıp Fakultesi

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders

location_facility: Lviv Regional State Clinical Treatment and Diagnostic Endocrinology Center

location_facility: MVZ Riesa, Medizinisches Versorgungzentrum am Klinikum Döbel

location_facility: CECIP - Centro de Estudos do Interior Paulista

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Azienda Ospedaliera Policlinico Consorziale

location_facility: Pirogov Russian National Research Medical University

location_facility: Arkhangelsk First City Clinical Hospital n.a. E.E. Volosevich

location_facility: Black Hills Cardiovascular Research Group

location_facility: Centro Especialidades San Jose Obrero (Barbarela)

location_facility: Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

location_facility: Sumy State University/Sumy Regional Clinical hospital

location_facility: Cardiovascular Research Institute of Dallas

location_facility: UMC Utrecht, Dept. of Internal Medicine, MDL

location_facility: Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta

location_facility: UCSD Clinical & Translational Research Institute

location_facility: Clalit Health Services -Diabetes and Endocrinology Clinic Jerusalem

location_facility: Hospital Universitario Central de Asturias

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

location_facility: Diabetes and Thyroid Center of Ft. Worth

location_facility: LLC Medical Consultations and Research center - PRAKTIKA

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani

location_facility: North York Diagnostic and Cardiac Centre

location_facility: Diabeteszentrum DO, Diabetische Schwerpunktpraxis Dortmund

location_facility: Academy of Diabetes, Thyroid and Endocrine

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

location_facility: Groupe Hospitalier Paris Saint Joseph - Site Saint-Michel

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

location_facility: NZOZ Regionalna Poradnia Diabetologiczna

location_facility: Praxis für Innere Medizin Toralf Schwarz

location_facility: PHREI - Pacific Health Research and Education Institute - VA Pacific Islands Health Care System

location_facility: Private Practice - Dr. Osvaldo A. Brusco

location_facility: Diseno y Planeacion en Investigacion Medica

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitario Principe de Asturias

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Fundacion Cardiovascular de Aguascalientes A.C.

location_facility: SN ZOZ Lege Artis Poradnia Diabetologiczna

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Cotton O'Neil Diabetes and Endocrinology Center

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Zentrum für klinische Studien Dr Hanusch Gmbh

location_facility: Regional Public Institution "Chernivtsi Regional Endocrinology Center"

location_facility: CEPIC - Centro Paulista de Investigação Clínica

location_facility: Diabetologicka a obezitologicka ambulance

location_facility: Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C

location_facility: Russian Medical Military Academy n.a. S.M. Kirov

location_facility: The Institute of Medical Science, Asahi Life Foundation

location_facility: Accel Research Sites - St. Petersburg Clinical Research Unit

location_facility: Universitair Medisch Centrum St Radboud Nijmegen

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Institutul National de Diabet Nutritie si Boli Metabolice

location_facility: Riverside County Regional Medical Center

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Instituto Jalisciense de Investigacion en Diabetes y Obesida

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: Fatih Sultan Mehmet Training and Research Hospital

location_facility: Ospedale san Giovanni di Dio-Diabetologia

location_facility: Diabetologische Schwerpunktpraxis Diabetologikum Speyer

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Austin Health - Heidelberg Repatriation Hospital

location_facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

location_facility: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

location_facility: Clalit Health Services - Sakhnin Community Clinic

location_facility: FSBI "National Medical Research Center for Preventive Medicine" of MOH of Russian Fed

location_facility: Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.

location_facility: NorCal Endocrinology and Internal Medicine - Roseville

location_facility: Amsterdam AMC - Research Vasculaire Geneeskunde

location_facility: Monterey Endocrine & Diabetes Institute, Inc.

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

summary: The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.


title: EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

lead_sponsor: Novartis Pharmaceuticals

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
Lebanon
Netherlands
Canada
Thailand
Sweden
Hungary
United States
France
China
Israel
Belgium
Singapore
Malaysia
Turkey
Slovakia
Czechia

location_facility: Texas Oncology Baylor Charles A Sammons Cancer Ctr

location_facility: Clinical Research Alliance Administrative Office

location_facility: Texas Oncology Flower Mound Texas Oncology, PA

location_facility: University of Wisconsin Regulatory Contact

location_facility: Texas Oncology P A TX Onc - Med City Dallas

location_facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)

location_facility: Memorial Sloan Kettering Cancer Center Drug Ship - 2

location_facility: Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp

summary: The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.


status: Enrolling by invitation

acronym: A long-term study to assess the safety and efficacy of nemolizumab in subjects with PN

title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

lead_sponsor: Galderma R&D

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Sweden
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Galderma Investigational Galderma Investigational Site

location_facility: Galderma I Galderma Investigational Site

summary: The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

status_simplified: Unknown


title: VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

acronym: VOYAGE

summary: The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.

lead_sponsor: Viking Therapeutics, Inc.

location_country:
Belgium
Puerto Rico
United States
France
Mexico

location_facility:
Viking Clinical Site 101
Viking Clinical Site 601
Viking Clinical Site 304
Viking Clinical Site 166
Viking Clinical Site 142
Viking Clinical Site 156
Viking Clinical Site 221
Viking Clinical Site 153
Viking Clinical Site 206
Viking Clinical Site 503
Viking Clinical Site 317
Viking Clinical Site 129
Viking Clinical Site 112
Viking Clinical Site 121
Viking Clinical Site 144
Viking Clinical Site 152
Viking Clinical Site 125
Viking Clinical Site 111
Viking Clinical Site 109
Viking Clinical Site 607
Viking Clinical Site 226
Viking Clinical Site 215
Viking Clinical Site 421
Viking Clinical Site 116
Viking Clinical Site 139
Viking Clinical Site 130
Viking Clinical Site 137
Viking Clinical Site 104
Viking Clinical Site 217
Viking Clinical Site 305
Viking Clinical Site 128
Viking Clinical Site 107
Viking Clinical Site 115
Viking Clinical Site 154
Viking Clinical Site 213
Viking Clinical Site 102
Viking Clinical Site 141
Viking Clinical Site 302
Viking Clinical Site 312
Viking Clinical Site 224
Viking Clinical Site 316
Viking Clinical Site 204
Viking Clinical Site 314
Viking Clinical Site 502
Viking Clinical Site 227
Viking Clinical Site 310
Viking Site 155
Viking Clinical Site 132
Viking Clinical Site 161
Viking Clinical Site 117
Viking Clinical Site 209
Viking Clinical Site 110
Viking Clinical Site 131
Viking Clinical Site 311
Viking Clinical Site 133
Viking Clinical Site 146
Viking Clinical Site 609
Viking Clinical Site 148
Viking Clinical Site 120
Viking Clinical Site 611
Viking Clinical Site 603
Viking Clinical Site 205
Viking Clinical Site 150
Viking Clinical Site 218
Viking Clinical Site 105
Viking Clinical Site 108
Viking Clinical Site 211
Viking Clinical Site 147
Viking Clinical Site 103
Viking Clinical Site 201
Viking Clinical Site 214
Viking Clinical Site 219
Viking Clinical Site 608
Viking Clinical Site 604
Viking Clinical Site 402
Viking Clinical Site 212
Viking Clinical Site 145
Viking Clinical Site 202
Viking Clinical Site 216
Viking Clinical Site 301
Viking Clinical Site 118
Viking Clinical Site 602
Viking Clinical Site 422
Viking Clinical Site 307
Viking Clinical Site 159
Viking Clinical Site 106
Viking Clinical Site 160
Viking Clinical Site 143
Viking Clinical Site 158
Viking Clinical Site 223
Viking Clinical Site 315
Viking Clinical Site 134
Viking Clinical Site 225
Viking Clinical Site 313
Viking Clinical Site 163
Viking Clinical Site 501
Viking Clinical Site 401
Viking Clinical Site 605
Viking Clinical Site 135
Viking Clinical Site 126
Viking Clinical Site 612
Viking Clinical Site 208
Viking Clinical Site 306
Viking Clinical Site 151
Viking Clinical Site 113
Viking Clinical Site 127
Viking Clinical Site 610
Viking Clinical Site 220


title: An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)

acronym: RE-MIND

summary: This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

study_type: Observational

time_perspective: Retrospective

lead_sponsor: MorphoSys AG

location_country:
United States
Italy
Spain
France

location_facility:
MorphoSys Research Site
MorphoSys Research State


title: A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)

acronym: TALON

summary: The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.

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:
Taiwan
Portugal
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
Switzerland
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Malaysia
Belgium
Germany
Czechia


title: A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

acronym: IXchange

summary: The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).

lead_sponsor: InflaRx GmbH

location_country:
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Switzerland
Sweden
France
Belgium
Germany
Czechia

location_facility:
Clinical site
Clinical Site


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

location_country:
Italy
United States
Peru
Philippines
Japan
Poland
Hong Kong
Austria
Australia
Russian Federation
Puerto Rico
India
Turkey
Singapore
Egypt
Brazil
Canada
China
Germany
Taiwan
Thailand
Vietnam
Korea, Republic of
France

summary: A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.


title: An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

summary: The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Brazil
Romania
United Kingdom
Italy
Russian Federation
Australia
Argentina
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Germany
Czechia

location_facility: Clínica Universitaria Privada Reina Fabiola

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

location_facility: Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization

location_facility: Centre Oscar Lambret - Service d'Oncologie medicale

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

location_facility: Osaka Habikino Medical Center - Dept of Pulmonary Oncology

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A

location_facility: Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centre Hospitalier de l'Ardenne - Pharmacie

location_facility: University of California Davis Health System - Comprehensive Cancer Center

location_facility: Centre Paul Strauss - Service de Médecine Oncologique

location_facility: Medical University of South Carolina (MUSC)

location_facility: University of Vermont Medical Center - Fletcher Allen Gastroenterology

location_facility: Hopital Larrey - Service de Pneumologie et Oncologie Thoracique

location_facility: Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly

location_facility: CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III

location_facility: Osaka University Hospital - Dept of Gastrointestinal Surgery

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: Kansas City Research Institute, LLC - Phase I Unit

location_facility: Oncology/Hematology Care Clinical Trials, LLC

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires

location_facility: ICO - Site René Gauducheau - Service d'Oncologie medicale

location_facility: Norwalk Hospital - The Whittingham Cancer Center

location_facility: Kurume University Hospital - Dept of Lung Cancer Center

location_facility: Osaka City General Hospital - Dept of Clinical Oncology

location_facility: FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent

location_facility: Mersin University Medical Faculty - Medical Oncology

location_facility: Derriford Hospital - Dept of Oncology Clinical Trials

location_facility: Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent

location_facility: Universitaetsklinikum Essen - Westdeutsches Tumorzentrum

location_facility: Institut Curie - site de Paris - Service d'Oncologie Médicale

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: University of Texas Southwestern Medical Center

location_facility: Masarykuv onkologicky ustav - 300176866 Parent

location_facility: Hacettepe University Medical Faculty - Oncology

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

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology

location_facility: Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

location_facility: Centre Antoine Lacassagne - Service d'Hématologie Oncologie

location_facility: CHU Bordeaux - Service d'Oncologie Médicale

location_facility: National Cancer Center Hospital - Dept of Gastrointestinal Oncology

location_facility: Pavlov First Saint Petersburg State Medical University - PARENT