title: A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

acronym: ENSURE-AF

summary: The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

ReferenceCitation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

ReferenceCitation: Goette A, Kwong WJ, Ezekowitz MD, Banach M, Hjortshoj SP, Zamoryakhin D, Lip GYH. Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study. Europace. 2018 Dec 1;20(12):1936-1943. doi: 10.1093/europace/euy141.

ReferenceCitation: Goette A, Merino JL, Ezekowitz MD, Zamoryakhin D, Melino M, Jin J, Mercuri MF, Grosso MA, Fernandez V, Al-Saady N, Pelekh N, Merkely B, Zenin S, Kushnir M, Spinar J, Batushkin V, de Groot JR, Lip GY; ENSURE-AF investigators. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016 Oct 22;388(10055):1995-2003. doi: 10.1016/S0140-6736(16)31474-X. Epub 2016 Aug 30. Erratum in: Lancet. 2016 Oct 22;388(10055):1984.

ReferenceCitation: Lip GY, Merino J, Ezekowitz M, Ellenbogen K, Zamoryakhin D, Lanz H, Jin J, Al-Saadi N, Mercuri M, Goette A. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart J. 2015 May;169(5):597-604.e5. doi: 10.1016/j.ahj.2015.02.009. Epub 2015 Feb 21.

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:
Denmark
Poland
Romania
Spain
Italy
Austria
Netherlands
Russian Federation
United Kingdom
Ukraine
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Bulgaria
Czechia

location_facility:
First site in
Third site in
Bad Friedrichshall
Second site in


title: A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

summary: The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.

ReferenceCitation: Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Lithuania
Romania
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Norway
Sweden
Slovakia
Hungary
Germany
Denmark
Greece
Ireland
Estonia
Latvia
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: TIGRIS: Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable Coronary Artery dISease in Post Myocardial Infarction Patients

acronym: TIGRIS

summary: THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

status: Terminated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Bagai A, Ali FM, Gregson J, Alexander KP, Cohen MG, Sundell KA, Simon T, Westermann D, Yasuda S, Brieger D, Goodman SG, Nicolau JC, Granger CB, Pocock S. Multimorbidity, functional impairment, and mortality in older patients stable after prior acute myocardial infarction: Insights from the TIGRIS registry. Clin Cardiol. 2022 Nov 1. doi: 10.1002/clc.23915. [Epub ahead of print]

ReferenceCitation: Carnicelli AP, Owen R, Pocock SJ, Brieger DB, Yasuda S, Nicolau JC, Goodman SG, Cohen MG, Simon T, Westermann D, Hedman K, Andersson Sundell K, Granger CB. Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction. Open Heart. 2021 Dec;8(2). pii: e001726. doi: 10.1136/openhrt-2021-001726.

ReferenceCitation: Russo JJ, Yan AT, Pocock SJ, Brieger D, Owen R, Sundell KA, Bagai A, Granger CB, Cohen MG, Yasuda S, Nicolau JC, Brandrup-Wognsen G, Westermann D, Simon T, Goodman SG. Determinants of long-term dual antiplatelet therapy use in post myocardial infarction patients: Insights from the TIGRIS registry. J Cardiol. 2022 Apr;79(4):522-529. doi: 10.1016/j.jjcc.2021.10.024. Epub 2021 Nov 29.

ReferenceCitation: Pocock S, Brieger DB, Owen R, Chen J, Cohen MG, Goodman S, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Hedman K, Mellstrom C, Andersson Sundell K, Grieve R. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis. Open Heart. 2021 Feb;8(1):e001499. doi: 10.1136/openhrt-2020-001499.

ReferenceCitation: Nicolau JC, Brieger D, Owen R, Furtado RHM, Goodman SG, Cohen MG, Simon T, Westermann D, Granger CB, Grieve R, Yasuda S, Chen J, Hedman K, Mellström C, Brandrup-Wognsen G, Pocock SJ. Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction. Clin Cardiol. 2020 Dec;43(12):1352-1361. doi: 10.1002/clc.23476. Epub 2020 Nov 4.

ReferenceCitation: Westermann D, Goodman SG, Nicolau JC, Requena G, Maguire A, Chen JY, Granger CB, Grieve R, Pocock SJ, Blankenberg S, Vega AM, Yasuda S, Simon T, Brieger D; TIGRIS Study Investigators. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study. Clin Cardiol. 2017 Dec;40(12):1197-1204. doi: 10.1002/clc.22837. Epub 2017 Dec 16.

ReferenceCitation: Goodman SG, Nicolau JC, Requena G, Maguire A, Blankenberg S, Chen JY, Granger CB, Grieve R, Pocock SJ, Simon T, Yasuda S, Vega AM, Brieger D; TIGRIS Study Investigators. Longer-term oral antiplatelet use in stable post-myocardial infarction patients: Insights from the long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease (TIGRIS) observational study. Int J Cardiol. 2017 Jun 1;236:54-60. doi: 10.1016/j.ijcard.2017.02.062. Epub 2017 Feb 21.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Venezuela
United States
Romania
Belgium
Japan
Portugal
Australia
Argentina
India
Turkey
Mexico
Norway
Brazil
Canada
China
Germany
Denmark
Finland
Korea, Republic of
France
Colombia
Netherlands

status_simplified: Unknown


title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

summary: The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
United Kingdom
Italy
Canada
United States
France
Germany

location_facility: Cancer Center of Acadiana at Lafayette General Health

location_facility: Florida Cancer Specialists & Research Institute

location_facility: KentuckyOne Health and Oncology Associates

location_facility: Washington University School Of Medicine-St Louis

location_facility: University of Mississippi Medical Center

location_facility: Pottstown Hospital Tower Health - Oncology

location_facility: East Valley Hematology And Oncology Medical Group

location_facility: Indiana Blood and Marrow Transplantation LLC

location_facility: Dallas Presbyterian Hospital - Texas Oncology PA

location_facility: The Oncology Institute Of Hope And Innovation

status_simplified: Ongoing


type: Other Identifier

type: EudraCT Number

title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

acronym: PIONEER AF-PCI

summary: The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

ReferenceCitation: Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial. Circ Cardiovasc Interv. 2019 Nov;12(11):e008160. doi: 10.1161/CIRCINTERVENTIONS.119.008160. Epub 2019 Nov 11.

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

ReferenceCitation: Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Association of International Normalized Ratio Stability and Bleeding Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Feb;12(2):e007124. doi: 10.1161/CIRCINTERVENTIONS.118.007124.

ReferenceCitation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

ReferenceCitation: Chi G, Yee MK, Kalayci A, Kerneis M, AlKhalfan F, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention. J Thromb Thrombolysis. 2018 Oct;46(3):346-350. doi: 10.1007/s11239-018-1703-5.

ReferenceCitation: Kerneis M, Gibson CM, Chi G, Mehran R, AlKhalfan F, Talib U, Pahlavani S, Mir M, Bode C, Halperin JL, Nafee T, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Fox KAA, Cohen M. Effect of Procedure and Coronary Lesion Characteristics on Clinical Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the PIONEER AF-PCI Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):626-634. doi: 10.1016/j.jcin.2017.11.009. Epub 2018 Mar 14.

ReferenceCitation: Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, Korjian S, Daaboul Y, Lip GY, Cohen M, Husted S, Peterson ED, Fox KA. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi: 10.1056/NEJMoa1611594. Epub 2016 Nov 14.

ReferenceCitation: Gibson CM, Pinto DS, Chi G, Arbetter D, Yee M, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Burton P, van Eickels M, Korjian S, Daaboul Y, Jain P, Lip GY, Cohen M, Peterson ED, Fox KA. Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy. Circulation. 2017 Jan 24;135(4):323-333. doi: 10.1161/CIRCULATIONAHA.116.025783. Epub 2016 Nov 14. Erratum in: Circulation. 2017 Mar 21;135(12 ):e789.

ReferenceCitation: Gibson CM, Mehran R, Bode C, Halperin J, Verheugt F, Wildgoose P, van Eickels M, Lip GY, Cohen M, Husted S, Peterson E, Fox K. An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI). Am Heart J. 2015 Apr;169(4):472-8.e5. doi: 10.1016/j.ahj.2014.12.006. Epub 2014 Dec 20.

lead_sponsor: Janssen Scientific Affairs, LLC

location_country:
United Kingdom
Ukraine
United States
Romania
Belgium
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Turkey
Mexico
Sweden
Malaysia
Brazil
Canada
Germany
Bulgaria
Denmark
Taiwan
Korea, Republic of
France
Chile
Netherlands


acronym: CLARION

title: A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

lead_sponsor: Amgen

source: euctr

ReferenceType: background

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. Review.

ReferenceCitation: Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.

ReferenceCitation: Rosenthal A, Luthi J, Belohlavek M, Kortüm KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6:e384. doi: 10.1038/bcj.2015.112.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic

location_facility: "Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: National Center for Global Health and Medicine

location_facility: Kyiv Center for Bone Marrow Transplantation

location_facility: St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant

location_facility: Chonnam National University Hwasun Hospital

location_facility: CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)

location_facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department

location_facility: City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

location_facility: Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Varna

location_facility: Paoli Calmettes Institute, Department ofHematology 2

location_facility: Group Practice for Hematology and Oncology

location_facility: General University Hospital Prague, 1st Department of Medicine - Department of Hematology

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology

location_facility: Kharkiv Regional Clinical Oncology Center, Department of Hematology

location_facility: Bucharest Emergency University Hospital, Hematology Department

location_facility: University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: The First Affiliated Hospital of the Fourth Military Medical University of PLA

location_facility: St. Antonius Ziekenhuis, Department of Hematology

location_facility: Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología

location_facility: Iasi Regional Institute for Oncology, Medical Hematology Department

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital

location_facility: University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis

location_facility: Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology

location_facility: Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation

location_facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

location_facility: Medical University of Innsbruck, University Clinic for Internal Medicine V

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin

location_facility: Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau

location_facility: University Hospital Kralovske Vinohrady - Internal Hematology Clinic

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

location_facility: Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III

location_facility: A. Novak Zakarpattia Regional Clinical Hospital

location_facility: UO Clinica Ematologica, IRCCS A.O.U. San Martino

location_facility: Fujian Medical University Union Hospital

location_facility: Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles

location_facility: Beijing Chao Yang Hospital, Capital Medical University

location_facility: Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology

location_facility: Singapore Oncology Consultants, Gleneagles Hospital

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi

location_facility: University Hospital Brno, Department of Internal Hematology and Oncology

location_facility: Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III

location_facility: University of Athens, Alexandra Hospital

location_facility: Isala Clinics in Zwolle, Department of Oncology

location_facility: Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology

location_facility: CHRU Hopital Huriez, Departement of Hematology

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

location_facility: Centre Hospitalier Lyon Sud, Service d'hématologie Clinique

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Coltea Clinical Hospital, Hematology Department

location_facility: University College London, Cancer Centre

location_facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences

location_facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

location_facility: Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine

location_facility: City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

location_facility: Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2

location_facility: Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine

location_facility: Saint Joseph Clinic Arlon, Department of Hematology

location_facility: Maria Sklodowska-Curie Institute of Oncology

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital

location_facility: Fundeni Clinical Institute, Hematology Department

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

location_facility: Rambam Medical Center, Department of Hematology

location_facility: University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology

location_facility: State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center

location_facility: Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn

location_facility: Seoul National University Bundang Hospital

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical-Hospital

location_facility: National Hospitalization Organization Kyushu Cancer Center

location_facility: Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care

location_facility: AO Città della Salute e della Scienza di Torino, Division of Hematology

location_facility: Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University

location_facility: Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology

location_facility: Khmelnytskyi Regional Hospital, Hematology Department

location_facility: Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department

location_facility: Maggiore della Carita Hospital of Novara

location_facility: Independent Public Healthcare Facility University Hospital

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

location_facility: The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian

location_facility: Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic

location_facility: Ludwig Maximilians University Hospital - Medical Clinic III

location_facility: Fundacion Centro Oncologieo de Integracion Regional - COIR

location_facility: State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Brasov County Emergency Clinical Hospital, Hematology Department

location_facility: University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology

location_facility: Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology

location_facility: Hopital Saini Louis, Service d'immuno-Hematologie

location_facility: Ein Kerem Hospital, Department of Hematology

location_facility: State Higher Educational Institution St. Petersburg Pavlov State Medical University

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic

location_facility: Oxford University Hospitals NHS Trust, Churchill Hospital

summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).


status: Active, not recruiting

title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wülfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Czechia
Hong Kong
Austria
Argentina
Israel
Panama
Turkey
Mexico
Sweden
Brazil
Canada
Switzerland
Guatemala
China
Germany
Taiwan
Greece
Ireland
France
Colombia

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Lake Health/University Hospitals - Mentor Campus

location_facility: Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: University of Florida; Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

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

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Harbin Medical University Cancer Hospital

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Hospital Angeles Metropolitano; Room 220

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

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Batte Cancer Center - Carolinas Medical Center

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

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

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

location_facility: Mercy Medical Center; Medical Oncology & Hematology

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Houston Methodist Hospital Outpatient Center

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

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

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: US oncology research at Minnesota Oncology

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Uni of Pittsburgh; Magee-Women'S Hospital

location_facility: Medical University of South Carolina; Hollings Cancer Center

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Aultman Hospital; Aultman Hospital Cancer Center

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

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

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

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: UPCO - Unidade de Pesquisas Clínicas em Oncologia

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: PeaceHealth St. John Medical Center - Lower Columbia Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Centre Val Aurelle Paul Lamarque; Recherche Clinique

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

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

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Todd Cancer Institute at Long Beach Memorial Medical Center

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: The Ottawa Hospital; Division of Infectious Diseases

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Med Star Franklin Square Medical Center/Weinburg Cancer Institute

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie PD Dr. Bauer, Dr. Kremers

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Ohio State University, Arthur James Cancer Hospital

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

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

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital Nacional Guillermo Almenara Irigoyen; Oncology

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Rocky Mountain Cancer Centers - Colorado Springs (Circle)

location_facility: McGill University Health Centre - Glen Site

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.


title: A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

summary: E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).

ReferenceCitation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Cheng AL, Vogel A, Tovoli F, Ueshima K, Aikata H, López CL, Pracht M, Meng Z, Daniele B, Park JW, Palmer D, Tamai T, Saito K, Dutcus CE, Lencioni R. Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study. J Hepatol. 2022 Sep 20. pii: S0168-8278(22)03111-7. doi: 10.1016/j.jhep.2022.09.006. [Epub ahead of print]

ReferenceCitation: Huynh J, Cho MT, Kim EJ, Ren M, Ramji Z, Vogel A. Lenvatinib in patients with unresectable hepatocellular carcinoma who progressed to Child-Pugh B liver function. Ther Adv Med Oncol. 2022 Aug 24;14:17588359221116608. doi: 10.1177/17588359221116608. eCollection 2022.

ReferenceCitation: Vogel A, Qin S, Kudo M, Su Y, Hudgens S, Yamashita T, Yoon JH, Fartoux L, Simon K, López C, Sung M, Mody K, Ohtsuka T, Tamai T, Bennett L, Meier G, Breder V. Lenvatinib versus sorafenib for first-line treatment of unresectable hepatocellular carcinoma: patient-reported outcomes from a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):649-658. doi: 10.1016/S2468-1253(21)00110-2. Epub 2021 Jun 2.

ReferenceCitation: Okusaka T, Ikeda K, Kudo M, Finn R, Qin S, Han KH, Cheng AL, Piscaglia F, Kobayashi M, Sung M, Chen M, Wyrwicz L, Yoon JH, Ren Z, Mody K, Dutcus C, Tamai T, Ren M, Hayato S, Kumada H. Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT. J Gastroenterol. 2021 Jun;56(6):570-580. doi: 10.1007/s00535-021-01785-0. Epub 2021 May 4.

ReferenceCitation: Briggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8.

ReferenceCitation: Yamashita T, Kudo M, Ikeda K, Izumi N, Tateishi R, Ikeda M, Aikata H, Kawaguchi Y, Wada Y, Numata K, Inaba Y, Kuromatsu R, Kobayashi M, Okusaka T, Tamai T, Kitamura C, Saito K, Haruna K, Okita K, Kumada H. REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset. J Gastroenterol. 2020 Jan;55(1):113-122. doi: 10.1007/s00535-019-01642-1. Epub 2019 Nov 12.

ReferenceCitation: Evans TRJ, Kudo M, Finn RS, Han KH, Cheng AL, Ikeda M, Kraljevic S, Ren M, Dutcus CE, Piscaglia F, Sung MW. Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma. Br J Cancer. 2019 Jul;121(3):218-221. doi: 10.1038/s41416-019-0506-6. Epub 2019 Jun 28. Erratum in: Br J Cancer. 2019 Jul 30;:.

ReferenceCitation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

lead_sponsor: Eisai Limited

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

location_facility:
Facility # 3
Facility # 1
Facility # 6
Facility # 2
Facility # 8
Facility # 4
Facility # 7
Facility # 5


ipd_sharing: No

acronym: METIV-HCC

title: A Phase 3, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects With MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated With One Prior Systemic Therapy

ReferenceCitation: Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, Rota Caremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, López López C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J. Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study. Lancet Oncol. 2018 May;19(5):682-693. doi: 10.1016/S1470-2045(18)30146-3. Epub 2018 Apr 3.

location_country:
Brazil
Portugal
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
New Zealand
Switzerland
Sweden
United States
France
Belgium
Germany

summary: The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

summary: This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin & capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

ReferenceCitation: Catenacci DVT, Tebbutt NC, Davidenko I, Murad AM, Al-Batran SE, Ilson DH, Tjulandin S, Gotovkin E, Karaszewska B, Bondarenko I, Tejani MA, Udrea AA, Tehfe M, De Vita F, Turkington C, Tang R, Ang A, Zhang Y, Hoang T, Sidhu R, Cunningham D. Rilotumumab plus epirubicin, cisplatin, and capecitabine as first-line therapy in advanced MET-positive gastric or gastro-oesophageal junction cancer (RILOMET-1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1467-1482. doi: 10.1016/S1470-2045(17)30566-1. Epub 2017 Sep 25.

ReferenceCitation: Doshi S, Gisleskog PO, Zhang Y, Zhu M, Oliner KS, Loh E, Perez Ruixo JJ. Rilotumumab exposure-response relationship in patients with advanced or metastatic gastric cancer. Clin Cancer Res. 2015 Jun 1;21(11):2453-61. doi: 10.1158/1078-0432.CCR-14-1661. Epub 2015 Feb 24.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
South Africa
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Czech Republic
France

intervention_type: Other


title: An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C

summary: This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

design_allocation: Non-Randomized

location_country: Macedonia, The Former Yugoslav Republic of


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.

summary: The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

ReferenceCitation: Levi M, Vincent JL, Tanaka K, Radford AH, Kayanoki T, Fineberg DA, Hoppensteadt D, Fareed J. Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy. Crit Care Med. 2020 Aug;48(8):1140-1147. doi: 10.1097/CCM.0000000000004426.

ReferenceCitation: Vincent JL, Francois B, Zabolotskikh I, Daga MK, Lascarrou JB, Kirov MY, Pettilä V, Wittebole X, Meziani F, Mercier E, Lobo SM, Barie PS, Crowther M, Esmon CT, Fareed J, Gando S, Gorelick KJ, Levi M, Mira JP, Opal SM, Parrillo J, Russell JA, Saito H, Tsuruta K, Sakai T, Fineberg D; SCARLET Trial Group. Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1993-2002. doi: 10.1001/jama.2019.5358.

lead_sponsor: Asahi Kasei Pharma America Corporation

location_country:
Croatia
Serbia
Spain
United Kingdom
United States
Peru
Belgium
Czechia
Russian Federation
Australia
Argentina
India
Israel
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

location_facility: Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation

location_facility: Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases

location_facility: Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron

location_facility: King Edward Memorial Hospital & Research Centre

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Harper Hospital - Wayne State University School of Medicine

location_facility: University Hospital Brno, Department of Infectious Diseases

location_facility: Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto

location_facility: Keski-Suomen Keskussairaala (Central Finland Central Hospital)

location_facility: City Clinical Hospital #3 n.a. M.A. Pogorbunskiy

location_facility: Service de reanimation médicale. CHU Hotel Dieu

location_facility: Clinical Hospital Center Zagreb, Medical ICU

location_facility: Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia

location_facility: Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital)

location_facility: Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital)

location_facility: Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH))

location_facility: General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre

location_facility: Mazumdar Shaw Medical Centre (Unit of Narayana Health)

location_facility: Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph

location_facility: Maulana Azad Medical College and Associated L N Hospital

location_facility: Taichung Veterans General Hospital [Pulmonology]

location_facility: Hospital Universitario Mutua Terrassa Intensive Care

location_facility: Hospital Nacional Almenara Yrigoyen - EsSALUD

location_facility: Mechnikov North-Western State Medical University n.a. I.I. Mechnikov

location_facility: Clinic for Infectious Diseases, Clinical Center Nis

location_facility: University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care

location_facility: Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2)

location_facility: Centre Hospitalier Départemental de Vendée-Les Oudairies

location_facility: University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation

location_facility: Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv

location_facility: Szent Imre Hospital, Anesthesiology and Intensive Care Unit

location_facility: Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road

location_facility: KLES Dr. Prabhakar Kore Hospital & Medical Research Centre


status: No longer available

acronym: CONSIGN

title: An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

lead_sponsor: Bayer

study_type: Expanded Access

ReferenceCitation: Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, André T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for Patients with Metastatic Colorectal Cancer Who Progressed After Standard Therapy: Results of the Large, Single-Arm, Open-Label Phase IIIb CONSIGN Study. Oncologist. 2019 Feb;24(2):185-192. doi: 10.1634/theoncologist.2018-0072. Epub 2018 Sep 6.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Mexico
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Ireland
Finland
France
Netherlands

summary:
This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.

Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint of this study will be safety.


title: Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D

acronym: RESPOND-CRT

summary:
The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software.

This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method.

This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.

status: Unknown status

ReferenceCitation: Brugada J, Delnoy PP, Brachmann J, Reynolds D, Padeletti L, Noelker G, Kantipudi C, Rubin Lopez JM, Dichtl W, Borri-Brunetto A, Verhees L, Ritter P, Singh JP; RESPOND CRT Investigators. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur Heart J. 2017 Mar 7;38(10):730-738. doi: 10.1093/eurheartj/ehw526.

ReferenceCitation: Brugada J, Brachmann J, Delnoy PP, Padeletti L, Reynolds D, Ritter P, Borri-Brunetto A, Singh JP. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND CRT) trial. Am Heart J. 2014 Apr;167(4):429-36. doi: 10.1016/j.ahj.2013.12.007. Epub 2013 Dec 19. Review.

lead_sponsor: MicroPort CRM

location_country:
Portugal
Slovenia
Italy
Austria
Australia
Netherlands
Spain
United Kingdom
Switzerland
United States
France
Germany

location_facility: A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U

location_facility: CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

location_facility: Universitätsklinik Münster Innere Medizin C

location_facility: Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera

location_facility: Centro Hospitalar do Porto CHP Hospital de Santo Antonio

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste

location_facility: Azienda Ospedaliera S. Anna e S. Sebastiano

location_facility: Hospital General Universitario de Alicante

location_facility: Az. Osp. Univ. S. Maria della Misericordia

location_facility: Ashford and St. Peter's Hospitals NHS Trust

location_facility: Hospital Universitario Marques de Valdecilla Sur

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T

location_facility: The University of Chicago Medicine Hospital

location_facility: Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)

location_facility: Providence Cardiology d/b/a South Caroline Heart Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Brookwood Medical Center CardioVascular Associates

location_facility: KH Hietzing,4. Medizinische Abteilung Mit Kardiologie

location_facility: Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi

intervention_type: Device


title: A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C

summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

ReferenceCitation: Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Ireland
Italy
Australia
United Kingdom
Argentina
Canada
Sweden
Korea, Republic of
United States
France
Puerto Rico
Mexico
Japan
Germany

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc.

location_facility: University Of Pennsylvania School Of Medicine

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of North Carolina At Chapel Hill School Of Med

location_facility: Instituto Centralizado De Asistencia E Investigacion Clinica

location_facility: University Of Colorado Denver & Hospital


title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

summary: The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

location_country:
Denmark
Poland
Taiwan
Spain
Greece
Austria
Australia
Ireland
Argentina
Canada
Italy
New Zealand
Sweden
Korea, Republic of
United States
France
United Kingdom
Mexico
Germany

location_facility: Washington University School Of Medicine

location_facility: University Of Colorado Denver And Hospital

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: North Shore Long Island Jewish Health System


title: A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

acronym: TIME

summary:
This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC).

TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen.

TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.

ReferenceCitation: Tosch C, Bastien B, Barraud L, Grellier B, Nourtier V, Gantzer M, Limacher JM, Quemeneur E, Bendjama K, Préville X. Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC. J Immunother Cancer. 2017 Sep 19;5(1):70. doi: 10.1186/s40425-017-0274-x.

ReferenceCitation: Quoix E, Lena H, Losonczy G, Forget F, Chouaid C, Papai Z, Gervais R, Ottensmeier C, Szczesna A, Kazarnowicz A, Beck JT, Westeel V, Felip E, Debieuvre D, Madroszyk A, Adam J, Lacoste G, Tavernaro A, Bastien B, Halluard C, Palanché T, Limacher JM. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial. Lancet Oncol. 2016 Feb;17(2):212-223. doi: 10.1016/S1470-2045(15)00483-0. Epub 2015 Dec 23.

lead_sponsor: Transgene

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

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: CH Mulhouse Hopital Emile Muller Moenchsberg

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Centre Hospitalier Intercommunal de la Haute Saone

location_facility: START Madrid. Centro Integral Oncologico Clara Campal

location_facility: Hôpital Pasteur - Service de médecine F- Pavillon 43

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Kenezy Korhaz-Rendelointezet Eu Szolgaltato Nonprofit Kft

location_facility: Azienda Ospedaliera di Perugia Ospedale S.Maria della Miseri

location_facility: Institut Paoli-Calmettes, Service d'oncologie médicale

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Southampton University Hospitals NHS Trust

location_facility: Tolna Megyei Onkormanyzat Balassa Janos Korhaza

location_facility: Abington Hematology Oncology Associates Inc

location_facility: CHU de Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

intervention_type: Biological


title: A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

summary: This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

ReferenceCitation: Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, Warne C, Musselman D, Brockwell L, Shittu E, Klearman M, Fleming TR. Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):31-40. doi: 10.1002/art.41095.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Austria
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Bosnia and Herzegovina
Canada
Hungary
Germany
Greece
Latvia
Ecuador
France
Chile
Netherlands

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Groote Schuur Hospital; Rheumatology Unit

location_facility: Groupe de Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Krankenhaus Hietzing; 2.Med.Abteilung, Pav.3A

location_facility: Hospital de Merida ;Servicio de Reumatologia

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Hospital Privado San Jose de Ciudad Obregon SA de CV

location_facility: Nashua Rheumatology - Foundation Medical Partners

location_facility: Hospital Clinico Pontificia Universidad Catolica de Chile

location_facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

location_facility: Whipps Cross Hospital; Rheumatology Dept

location_facility: P. Stradins Clinical University Hospital

location_facility: Clinical Interventions Research Institute

location_facility: Hospital Christus Muguerza del Parque; Reumatologia

location_facility: Universitaetsklinikum Hamburg-Eppendorf; Medizinische Klinik Nephrologie/Rheumatologie

location_facility: State institution of healthcare "Regional hospital for war veterans"

location_facility: Spitalul Clinic Sf. Maria; Dept Interna si Reumatologie

location_facility: Centrul de Boli Reumatismale Dr. Ioan Stoia

location_facility: Southampton General Hospital; Rheumatology

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Hospital General de Castellon; Servicio de Reumatologia

location_facility: Russells Hall Hospital; Rheumatology Department

location_facility: Hospital Central Dr. Ignacio Morones Prieto

location_facility: Fakultni Thomayerova nemocnice s poliklinikou

location_facility: Centro de Investigaciones Reumatologicas y Osteologicas

location_facility: SEI of HPE "Altay State Medical University of Roszdrav"

location_facility: Siauliai Republican Hospital Public Institution

location_facility: Hôpital Edouard Herriot; Service de Rhumatologie

location_facility: CHU de Rouen, Hopital de Bois Guillaume; Service de Rhumatologie

location_facility: Hospital de Cruces; Servicio de Reumatologia

location_facility: Vilnius District Central Outpatient Clinic, Public Institution

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Arthritis Health Associates; Clinical Research

location_facility: Slaski Szpital Reumatologiczno; Rehabilitacyjny; Iii Oddzial Reumatologiczny

location_facility: Arizona Arthritis & Rheumatology Research, Pllc

location_facility: Alytus Regional S. Kudirkos Hospital, Public Institution

location_facility: Euromedica Kyanous Stavros General Hospital

location_facility: Arthritis Rheumatic & Back Disease Associates

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: Southend Hospital; Rheumatology Department

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Royal London Hospital Outpatients Department

location_facility: Hôpital Saint-Antoine; Service de Psychiatrie

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza Radeckiego

location_facility: Rheumazentrum Ruhrgebiet; St. Josefs-Krankenhaus

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs

location_facility: Jacksonville Center For Clinical Research

location_facility: Atencion Integral En Reumatologia Buenos Aires

location_facility: St. Joseph'S/Candler Health System, Inc.; Office of Research

location_facility: Rheumatology Associates of North Alabama

location_facility: Ospedale San Giovanni Bosco; Divisione di Reumatologia

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: CEIM Consultorios Especializados en Investigaciones Médicas

location_facility: CHU d'Amiens Hôpital Nord; Pharmacie Clinique

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Leading Edge Research, PA; Office of Dr. Burbano

location_facility: Charité Universitaetsmedizin Berlin, Campus Charité Mitte

location_facility: Shanahan Rheumatology & Immunology, PLLC

location_facility: Unidad de Atencion Medica e Investigacion en Salud S.C.

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Special Hospital for Medical Rehabilitation

location_facility: Centre for Arthritis and Rheumatic Diseases

location_facility: Arthritis & Osteoporosis Medical Associates, Pllc

location_facility: Allergy & Rheumatology Medical Clinic, Inc

location_facility: Szpital Specjalistyczny Im J. Dietla Malopolskie Centrum Reumat; Oddzial Rumatologii

location_facility: University Hospitals Case Medical Center

location_facility: Comite Mexicano Para la Prevencion de Osteoporosis AC

location_facility: Head Clinical Hospital of Internal Affair Ministry of Russia

location_facility: University of Pittsburgh Medical Center Health System; Infectious Disease

location_facility: Fondazione Salvatore Maugeri IRCCS; Istituto Scientifico di Riabilitazione di Telese

location_facility: Rheumatology, P.C.; Medical Arts Building

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Arthritis and Rheumatic Disease Associates

location_facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

location_facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Columbia Arthritis Center (Partnership Practice)

location_facility: Riga East Clinical University Hospital; Clinic Gailezers

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Memorial Medical Group Clinical Research

location_facility: Gemeinschaftspraxis Dr. Von Hinueber/Dr. Demary; Rheumatologie

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

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: St. Luke's Intermountain Research Center

location_facility: Leningradskaya Regional Clinical Hospital; Rheumatology Dept

location_facility: Centro de Estudios Clinicos V Region Limitada

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Hospital Infanta Sofia; Servicio de Reumatologia

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Clinica de Medicina Muncii

location_facility: OrthoArkansas; Orthopedics & Sports Medicine

location_facility: FSBI Scientific Research Institute of Clinical Immunology of SB of RAMS

location_facility: Scientific and research medical complex Your Health

location_facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research

location_facility: Praxisgemeinschaft Rheumatologie-Nephrologie Erlangen PGRN

location_facility: Specialty Medical Clinic and Research Center

location_facility: University General Hospital of Heraklion

location_facility: Chris Hani Baragwanath Hospital; Rheumatology Department

location_facility: Euroclinic of Athens; Internal Medicine & Immunology Dept.

location_facility: Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: Instituto Centralizado de Asistencia e Investigaci

location_facility: Landesklinikum Weinviertel Stockerau; Rheumatologie

location_facility: Uni Of Alabama,Birmingham; Medicine - Rheumatology

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: MCHI Medical Sanitary Unit of Yaroslavl Diesel Apparatus Plant

location_facility: Cebu Doctors' University Hospital- North General Hospital

location_facility: Inland Rheumatology; Clinical Trials, Inc.

location_facility: Hospital Municipal Nuestra Sra. de Lujan

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

location_facility: Országos Fizioterápiás És Reumatológiai Intézet; I. Reumatológiai És Metabolikus Osteológiai Osztály

location_facility: Universitätsklinikum Köln, Klinik I für Innere Medizin

location_facility: Clinical Hospital Centre Rijeka; Department of Rheumatology and Clinical Immunology

location_facility: SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

location_facility: University of Pretoria; Clinical Trial Unit

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Centro de Investigaciones Reumatologicas Tucuman

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Moscow State Medical Stomatological University

location_facility: University General Hospital of Larissa; Rheumatology Unit

location_facility: Centro de Investigacion y Atencion Integral Durango CIAID

location_facility: Markhot Ferenc Eu. Szolg. Nonprofit Kiem. Kozh. Kft.

location_facility: Hospital General de Agudos Dr. J. M. Ramos Mejia


title: A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

summary: The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

ReferenceCitation: Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

ReferenceCitation: Castagna A, Maggiolo F, Penco G, Wright D, Mills A, Grossberg R, Molina JM, Chas J, Durant J, Moreno S, Doroana M, Ait-Khaled M, Huang J, Min S, Song I, Vavro C, Nichols G, Yeo JM; VIKING-3 Study Group. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014 Aug 1;210(3):354-62. doi: 10.1093/infdis/jiu051. Epub 2014 Jan 19.

lead_sponsor: ViiV Healthcare

location_country:
Portugal
Spain
Italy
Canada
United States
France
Belgium