ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

family: Bennett

full_name: Hayley Bennett

given: Hayley

family: McEwan

full_name: Phil McEwan

given: Phil

family: Hamilton

full_name: Karina Hamilton

given: Karina

family: O’Reilly

full_name: Karl O’Reilly

given: Karl

currency_apc_doaj: GBP

journal_name: BMC Nephrology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Thimmappa ND, Blumenfeld JD, Cerilles MA, Dunning A, Donahue SL, Bobb WO, Zhang HL, Prince MR. Cisterna chyli in autosomal dominant polycystic kidney disease. J Magn Reson Imaging. 2015 Jan;41(1):142-8. doi: 10.1002/jmri.24527. Epub 2014 Jan 27.

name: Department of Radiology; Weill Cornell Medical Center; New York New York USA

family: Thimmappa

full_name: Nanda Deepa Thimmappa

given: Nanda Deepa

name: Department of Medicine; Weill Cornell Medical Center; New York New York USA

name: The Rogosin Institute; New York New York USA

family: Blumenfeld

full_name: Jon D. Blumenfeld

given: Jon D.

family: Cerilles

full_name: Michelle Ann C. Cerilles

given: Michelle Ann C.

name: Department of Public Health; Weill Cornell Medical Center; New York New York USA

family: Dunning

full_name: Allison Dunning

given: Allison

family: Donahue

full_name: Stephanie L. Donahue

given: Stephanie L.

family: Bobb

full_name: Warren O. Bobb

given: Warren O.

family: Zhang

full_name: Hong Lei Zhang

given: Hong Lei

name: Department of Radiology; Columbia University Medical Center; New York New York USA

family: Prince

full_name: Martin R. Prince

given: Martin R.

journal_name: Journal of Magnetic Resonance Imaging

ReferenceCitation: Blumenfeld JD, Tepler J, Mauer A, Coller B, Bichet DG, Smith B. Tolvaptan inhibition of desmopressin effects on coagulation factors in a patient with decreased von Willebrand factor and polycystic kidney disease. Blood. 2011 Jul 14;118(2):474-6. doi: 10.1182/blood-2011-04-347328.

name: The Rogosin Institute and the Department of Medicine, Weill Cornell Medical College, New York, NY

family: Tepler

full_name: Jeffrey Tepler

given: Jeffrey

name: The Rockefeller University, New York, NY

family: Mauer

full_name: Andreas Mauer

given: Andreas

name: Departments of Medicine and Physiology, University of Montreal, Hôpital du Sacré-Coeur, Montréal, QC

name: The Rogosin Institute and the Department of Surgery, Weill Cornell Medical College, New York, NY

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Romania
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom

title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

summary: To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.


ReferenceType: derived

ReferenceCitation: Aldosterone contributes to hypertension in male mice inducibly overexpressing human endothelin-1 in endothelium: Erratum. J Hypertens. 2021 Nov 1;39(11):2333. doi: 10.1097/HJH.0000000000003017.

bso_classification: Biology (fond.)

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Hypertension

oa_host_type: publisher

evidence: open (via free article)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Idorsia Pharmaceuticals Ltd.

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
Denmark
Ukraine
France
Poland
Lithuania
Canada
Korea, Republic of
Netherlands
Hungary
China
United States
Germany
United Kingdom
Italy
Czechia
Israel
Spain

acronym: PRECISION

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Yonsei University Wonju Severance Christian Hospital Division of Cardiology - Dept. of Internal Medicine

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Federal State Autonomous Institution of Higher Education "Kazan (Volga Region) Federal University"

location_facility: Maastricht University Medical Center, Dept. of Medicine

location_facility: General Hospital Konstantopouleio -Patision

location_facility: Azienda Ospedaliero Universitaria PisanA - Department Clinical and Experimental Medicine

location_facility: St. George Hospital, Dept. Renal Medicine

location_facility: FN U Sv.Anny Brno, kardiologická klinika

location_facility: State Healthcare Institution "Regional Clinical Cardiology Dispensary"

location_facility: International Medical Center "SOGAZ", LLC

location_facility: Turku University Central Hospital - Turun yliopistollinen keskussairaala Sisätautien klinikka

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Curtin University, Faculty of Health Sciences, School of Public Health

location_facility: Hospital Virgen de las Nieves - Internal Medicine Department

location_facility: The First Affiliated Hospital of Baotou Medical College of Inner Mongolia

location_facility: National Medical Research Center for Preventive Medicine

location_facility: University Hospitals Cleveland Medical Center - Neurological Institute

location_facility: Municipal non-profit enterprise "Regional Clinical Hospital named after AF Gerbachevsky" of Zhytomyr Regional Council

location_facility: Stephen S. Chow Medicine Professional Corporation

location_facility: University of Alabama at Birmingham Vascular Biology and Hypertension Program

location_facility: Clinical Research Centre The University of Edinburgh Centre for Cardiovascular Science

location_facility: Hospital Clínic Universitari de València

location_facility: State Institution "National Scientific Center "M.D. Strazhesko Institute of Cardiology" of the National Academy of Medical Sciences of Ukraine"

location_facility: Horizon Research Group of Opelousas, LLC

location_facility: Hospital Virgen del Rocio Departamento de Medicina Interna

location_facility: Azienda Ospedaliera S. Andrea di Roma - Division of Cardiology and of Cardiothoracic and Vascular Science Department -

location_facility: Kyiv Municipal Clinical Emergency Hospital

location_facility: KO-MED. CentraKliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Lublinie II

location_facility: Federal State Budget Scientific Institution "Federal Research Center Institute of Cytology and Genetics of Siberian Department of Russian Academy of Sciences"

location_facility: Communal Non-profit Enterprise "Vinnytsya regional Clinical Hospital named after. N.I. Pirogov Vinnytsia Regional Council"/ National Pirogov Memorial Medical University, Vinnytsya

location_facility: Herzzentrum Leipzig Universitätsklinik für Kardiologie

location_facility: University of Oulu, Medical Research Center

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Klinika Nadciśnienia Tętniczego i Diabetologii

location_facility: Scientific Research Institute - Regional Clinical Hospital №1

location_facility: Federal State Budget Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"

location_facility: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

location_facility: SIU School of Medicine Center for Clinical Research

location_facility: Hôpital Européen Georges Pompidou- Centre d' Investigation Clinique

location_facility: Hôpital Saint-André - Service de Cardiologie et Hypertension Artérielle

location_facility: Jewish General Hospital - Cardiovascular Prevention Center

location_facility: Federal State Budget Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"

location_facility: Regional State Budget Healthcare Institution "Krasnoyarsk Interdistrict Clinical Hospital for Emergency Medical Care n.a. N.S Karpovich", Nephrology Department

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

location_facility: KO-MED. Centra Kliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Puławach

location_facility: Municipal Noncommercial Enterprise "Lviv City Clinical Hospital #5"

location_facility: Metrolina Internal Medicine/Internal Medicine Research

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

location_facility: State Institution "D.F. Chebotarev Institute of Gerontology, National Academy of Medical Science of Ukraine"

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Universitätsklinikum Düsseldorf Klinik für Nephrologie

location_facility: Glasgow Clinical Research Facility (CRF)

location_facility: Regional Hospital Holstebro Department of Medicine University Clinic in Nephrology and Hypertension at Holstebro

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Municipal Autonomous Healthcare Institution City Clinical Hospital #6, Gastroenterology Department

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Hypertension Clinic, Internal Medicine, Hospital Clinico, University of Valencia, Valencia

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w

location_facility: Royal Perth Hospital Unit - The University of Western Australia

location_facility: Hospital Clinico San Carlos - Istituto de Investigacion Sanitaria San Carlos (IdISSC)

location_facility: University Brescia Department Clinical and Experimental Science

location_facility: Hainan NO.3 Provincial people's Hospital

location_facility: Centre Hospitalier Universitaire du Sart-Tilman

location_facility: State budget healthcare institution of Novosibirsk region "City clinical hospital #34"

location_facility: State Institution "Institute of Gerontology named after D.F. Chebotarev of National Academy of Medical Sciences of Ukraine"

location_facility: Aberdeen Royal Infirmary, Clinical Pharmacology Unit

location_facility: National and Kapodistrian University of Athens, School of Medicine Third Department of Medicine, Sotiria Hospital

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital n.a. E.E. Volosevich"

location_facility: SCU Medicina Interna e Centro Ipertensione arteriosa. Dipartimento di Scienze Mediche Università di Torino, Aou Citta' Salute E Scienza Torino

location_facility: TAYS RDI center (Tampere University Hospital,Specialist Internal Medicine, Rare Diseases)

location_facility: Federal State Budget Educational Institution of Higher Education "Saratov State Medical University n.a. V.I. Razumovskiy" of the Ministry of Healthcare of the Russian Federation

location_facility: Seoul National University Hospital Division of Cardiology, Department of Internal Medicine

location_facility: Hypertension and Nephrology Association PA

location_facility: Municipal Enterprise "Lutsk City Clinical Hospital", Volyn Regional Center for Cardiovascular Pathology

location_facility: Krajska zdravotni, a.s. - Nemocnice Decin, o.z.

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II w Zamościu

location_facility: Federal State Military Educational Institution of Higher Professional Education, Military Medical Academy named for S. M. Kirov of the Ministry of Defense of the Russian Federation

location_facility: Federal State Budget Institution "National Medical Research Center n.a. V.A. Almazov" of the Ministry of healthcare of the Russian Federation

location_facility: Clinique Universitaires de Saint Luc, Departement cardio-vasculaires intensives

location_facility: State Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"

location_facility: SBHI of Moscow "City clinical hospital #52" of Moscow healthcare department / city nephrology center

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Cardiovascular Research of Northwest Indiana, L.L.C.

location_facility: State Budgetary Educational Institution of Higher Professional Education Smolensk State Medical Academy

location_facility: Municipal non-profit enterprise "Clinical Hospital # 8"of Kharkiv City Council

location_facility: Universitätsklinikum Erlangen Klinische Forschungsstation (CRC)

location_facility: University Hospitals of Leicester NHS Trust Dept of Chemical Pathology and Metabolic Diseases

location_facility: Amarillo Heart Clinical Research Institute, Inc.

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

summary: The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)

summary: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia

status: Completed

study_completion_date_type: Actual

lead_sponsor: ChemoCentryx

location_country:
Italy
United States
France
Poland
Australia
New Zealand
Canada
United Kingdom

location_facility: Salford Royal NHS Foundation Trust Manchester

location_facility: University of Texas Health Sciences Center

location_facility: Uniwersytecki Szpital Kliniczny Klinika Nefrologii i Medycyny Transplantacyjnej

location_facility: Los Angeles Biomedical Research Institute

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnez Centralny Szpital

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Sunnybrook Health Sciences Centre (Odette Cancer Center)

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - II Klinika Nefrologii z Oddzialem Leczenia Nadcisnienia Tetniczego i Pododdzialem Dializoterapii

location_facility: CISSS de la Monteregie-Centre - Hopital Charles LeMoyne

location_facility: Presidio Ospedaliero di Montichiari-A.O. Spedali Civili di Brescia

location_facility: Cambridge University - Addenbrooke's Hospital

intervention_type: Other

status_simplified: Completed


title: An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

summary: This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.

enrollment_type: Anticipated

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
United States
Serbia
Hong Kong
Germany
France
Bulgaria
Japan
Malaysia
Thailand
Singapore
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Investigative Clinical Research of Indiana

location_facility: Hospital Center Chalon Sur Saone William Morey

location_facility: Hospital Univ. de Gran Canaria Dr.Negrin

location_facility: Essen University Hospital Department of Hematology

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Centre Hospitalier Annecy Genevois - Site Annecy

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Therapeutic hospital of regional clinical hospital #1

location_facility: Hospital Universitario Politecnico La Fe

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases


title: A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

summary: Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.

ReferenceType: background

ReferenceCitation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortüm KM, Rodríguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

ReferenceCitation: Prawitz T, Popat R, Suvannasankha A, Sarri G, Hughes R, Wang F, Hogea C, Ferrante SA, Gorsh B, Willson J, Kapetanakis V. DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. Adv Ther. 2021 Nov;38(11):5501-5518. doi: 10.1007/s12325-021-01884-7. Epub 2021 Sep 24.

family: Prawitz

full_name: Thibaud Prawitz

given: Thibaud

sequence: first

family: Popat

full_name: Rakesh Popat

given: Rakesh

sequence: additional

family: Suvannasankha

full_name: Attaya Suvannasankha

given: Attaya

family: Sarri

full_name: Grammati Sarri

given: Grammati

family: Hughes

full_name: Rachel Hughes

given: Rachel

family: Wang

full_name: Feng Wang

given: Feng

family: Hogea

full_name: Cosmina Hogea

given: Cosmina

family: Ferrante

full_name: Shannon Allen Ferrante

given: Shannon Allen

family: Gorsh

full_name: Boris Gorsh

given: Boris

family: Willson

full_name: Jenny Willson

given: Jenny

family: Kapetanakis

full_name: Venediktos Kapetanakis

given: Venediktos

bso_classification: Medical research

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Sborov D, Suvannasankha A, Weisel K, Voorhees PM, Womersley L, Baron J, Piontek T, Lewis E, Opalinska J, Gupta I, Cohen AD. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27.

name: Winship Cancer InstituteEmory University Atlanta Georgia

family: Lonial

full_name: Sagar Lonial

given: Sagar

name: Department of Lymphoma/Myeloma The University of Texas MD Anderson Cancer Center Houston Texas

family: Lee

full_name: Hans C. Lee

given: Hans C.

name: Greenebaum Cancer Center, Bone Marrow Transplant Program University of Maryland at Baltimore Baltimore Maryland

family: Badros

full_name: Ashraf Badros

given: Ashraf

name: Princess Margaret Cancer Center Toronto Ontario Canada

family: Trudel

full_name: Suzanne Trudel

given: Suzanne

family: Nooka

full_name: Ajay K. Nooka

given: Ajay K.

name: Icahn School of Medicine at Mount Sinai New York New York

family: Chari

full_name: Ajai Chari

given: Ajai

name: University of Kansas Cancer Center Fairway Kansas

name: Carbone Cancer Center University of Wisconsin Madison Wisconsin

name: Huntsman Cancer InstituteUniversity of Utah Salt Lake City Utah

name: Indiana University Cancer Center Indianapolis Indiana

name: Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology University Medical Center of Hamburg‐Eppendorf Hamburg Germany

name: Levine Cancer InstituteAtrium Health Charlotte North Carolina

name: GlaxoSmithKline Stockley Park United Kingdom

name: GlaxoSmithKline Upper Providence Pennsylvania

name: GlaxoSmithKline Research Triangle Park North Carolina

name: Abramson Cancer Center, University of Pennsylvania Philadelphia Pennsylvania

title: Longer term outcomes with single‐agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13‐month follow‐up from the pivotal DREAMM‐2 study

ReferenceCitation: Lonial S, Nooka AK, Thulasi P, Badros AZ, Jeng BH, Callander NS, Potter HA, Sborov D, Zaugg BE, Popat R, Degli Esposti S, Byrne J, Opalinska J, Baron J, Piontek T, Gupta I, Dana R, Farooq AV, Colby K, Jakubowiak A. Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J. 2021 May 26;11(5):103. doi: 10.1038/s41408-021-00494-4.

ReferenceCitation: Farooq AV, Degli Esposti S, Popat R, Thulasi P, Lonial S, Nooka AK, Jakubowiak A, Sborov D, Zaugg BE, Badros AZ, Jeng BH, Callander NS, Opalinska J, Baron J, Piontek T, Byrne J, Gupta I, Colby K. Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. Ophthalmol Ther. 2020 Dec;9(4):889-911. doi: 10.1007/s40123-020-00280-8. Epub 2020 Jul 25. Erratum in: Ophthalmol Ther. 2020 Sep 12;:.

title: Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody–Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study

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

location_country:
Italy
United States
Germany
France
Australia
Spain
Canada
United Kingdom


title: A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.

acronym: Erasme-POF

summary:
Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4.52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered.

Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients.

The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.

primary_purpose: Prevention

ReferenceCitation: Demeestere I, Brice P, Peccatori FA, Kentos A, Gaillard I, Zachee P, Casasnovas RO, Van Den Neste E, Dechene J, De Maertelaer V, Bron D, Englert Y. Gonadotropin-releasing hormone agonist for the prevention of chemotherapy-induced ovarian failure in patients with lymphoma: 1-year follow-up of a prospective randomized trial. J Clin Oncol. 2013 Mar 1;31(7):903-9. doi: 10.1200/JCO.2012.42.8185. Epub 2012 Nov 5.

name: Isabelle Demeestere, Julie Dechene, Yvon Englert, and Vivianne De Maertelaer, Université Libre de Bruxelles; Alain Kentos and Yvon Englert, Erasme Hospital; Eric Van Den Neste, St Luc Hospital; Dominique Bron, J. Bordet Institute, Brussels; Pierre Zachee, Algemeen Ziekenhuis Stuivenberg, Antwerpen, Belgium; Pauline Brice, St Louis Hospital, Assistance Publique–Hôpitaux de Paris; Isabelle Gaillard, Hôpital Henri Mondor, Paris; Rene-Olivier Casasnovas, Centre Hospitalier Universitaire de Dijon, Dijon,...

family: Demeestere

full_name: Isabelle Demeestere

given: Isabelle

family: Brice

full_name: Pauline Brice

given: Pauline

family: Peccatori

full_name: Fedro A. Peccatori

given: Fedro A.

family: Kentos

full_name: Alain Kentos

given: Alain

family: Gaillard

full_name: Isabelle Gaillard

family: Zachee

full_name: Pierre Zachee

given: Pierre

family: Casasnovas

full_name: Rene-Olivier Casasnovas

given: Rene-Olivier

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: Dechene

full_name: Julie Dechene

given: Julie

family: De Maertelaer

full_name: Vivianne De Maertelaer

given: Vivianne

family: Bron

full_name: Dominique Bron

given: Dominique

family: Englert

full_name: Yvon Englert

given: Yvon

journal_name: Journal of Clinical Oncology

oa_host_type: repository

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

publisher: American Society of Clinical Oncology (ASCO)

title: Gonadotropin-Releasing Hormone Agonist for the Prevention of Chemotherapy-Induced Ovarian Failure in Patients With Lymphoma: 1-Year Follow-Up of a Prospective Randomized Trial

lead_sponsor: Erasme University Hospital

location_country: Italy Belgium France

location_facility:
CHRU Lille
Hôpital Hotel Dieu
Instituto Europeo di oncologia
Henry-Mondor Hospital
AZ-VUB
Centre Henri Beckerel
CHU St Antoine
St Louis Hospital
AZ St Jan
Bordet
St Luc University
CHU Dijon
CHU Nancy
Algemeen Ziekenhuis Stuivenberg
Erasme Hospital

lead_sponsor_type: academique


title: A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

summary: BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

ReferenceCitation: Ascierto PA, Minor D, Ribas A, Lebbe C, O'Hagan A, Arya N, Guckert M, Schadendorf D, Kefford RF, Grob JJ, Hamid O, Amaravadi R, Simeone E, Wilhelm T, Kim KB, Long GV, Martin AM, Mazumdar J, Goodman VL, Trefzer U. Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma. J Clin Oncol. 2013 Sep 10;31(26):3205-11. doi: 10.1200/JCO.2013.49.8691. Epub 2013 Aug 5.

ReferenceCitation: Hauschild A, Ascierto PA, Schadendorf D, Grob JJ, Ribas A, Kiecker F, Dutriaux C, Demidov LV, Lebbé C, Rutkowski P, Blank CU, Gutzmer R, Millward M, Kefford R, Haas T, D'Amelio A Jr, Gasal E, Mookerjee B, Chapman PB. Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. Eur J Cancer. 2020 Jan;125:114-120. doi: 10.1016/j.ejca.2019.10.033.

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Grob

full_name: Jean Jacques Grob

given: Jean Jacques

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Kiecker

full_name: Felix Kiecker

given: Felix

family: Dutriaux

full_name: Caroline Dutriaux

given: Caroline

family: Demidov

full_name: Lev V. Demidov

given: Lev V.

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Blank

full_name: Christian U. Blank

given: Christian U.

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Millward

full_name: Michael Millward

given: Michael

family: Kefford

full_name: Richard Kefford

given: Richard

family: Haas

full_name: Tomas Haas

given: Tomas

family: D'Amelio

full_name: Anthony D'Amelio

given: Anthony

suffix: Jr.

family: Gasal

full_name: Eduard Gasal

given: Eduard

family: Mookerjee

full_name: Bijoyesh Mookerjee

given: Bijoyesh

family: Chapman

full_name: Paul B. Chapman

given: Paul B.

journal_name: European Journal of Cancer

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

name: GlaxoSmithKline; Research Triangle Park; NC USA

title: Population pharmacokinetics of dabrafenib, a BRAF inhibitor: Effect of dose, time, covariates, and relationship with its metabolites

location_country:
Italy
United States
France
Australia
Germany


title: A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia

acronym: CLAVELA

summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).

ReferenceCitation: Roboz GJ, Rosenblat T, Arellano M, Gobbi M, Altman JK, Montesinos P, O'Connell C, Solomon SR, Pigneux A, Vey N, Hills R, Jacobsen TF, Gianella-Borradori A, Foss Ø, Vetrhusand S, Giles FJ. International randomized phase III study of elacytarabine versus investigator choice in patients with relapsed/refractory acute myeloid leukemia. J Clin Oncol. 2014 Jun 20;32(18):1919-26. doi: 10.1200/JCO.2013.52.8562. Epub 2014 May 19.

name: Gail J. Roboz, Weill Cornell Medical College and the New York Presbyterian Hospital; Todd Rosenblat, Columbia University Medical Center, New York, NY; Martha Arellano, Winship Cancer Institute at Emory University; Scott R. Solomon, The Blood and Marrow Transplant Group of Georgia, Atlanta, GA; Jessica K. Altman, Francis J. Giles, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Casey O'Connell, University of Southern California Norris Comprehensive Cancer Center and...

family: Roboz

full_name: Gail J. Roboz

given: Gail J.

family: Rosenblat

full_name: Todd Rosenblat

given: Todd

family: Arellano

full_name: Martha Arellano

given: Martha

family: Gobbi

full_name: Marco Gobbi

given: Marco

family: Altman

full_name: Jessica K. Altman

given: Jessica K.

family: Montesinos

full_name: Pau Montesinos

given: Pau

family: O'Connell

full_name: Casey O'Connell

given: Casey

family: Solomon

full_name: Scott R. Solomon

given: Scott R.

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

family: Vey

full_name: Norbert Vey

given: Norbert

family: Hills

full_name: Robert Hills

given: Robert

family: Jacobsen

full_name: Tove Flem Jacobsen

given: Tove Flem

family: Gianella-Borradori

full_name: Athos Gianella-Borradori

given: Athos

family: Foss

full_name: Øivind Foss

given: Øivind

family: Vetrhusand

full_name: Sylvia Vetrhusand

given: Sylvia

family: Giles

full_name: Francis J. Giles

given: Francis J.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: International Randomized Phase III Study of Elacytarabine Versus Investigator Choice in Patients With Relapsed/Refractory Acute Myeloid Leukemia

lead_sponsor: Clavis Pharma

location_country:
Italy
United States
Germany
France
Poland
Norway
Ireland
Belgium
Australia
Romania
Spain
Canada
United Kingdom

location_facility: Universitätsklinikum Münster, Medisinische Klinik & Poliklinik A

location_facility: The Blood and Marrow Transplant Group of GA

location_facility: Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant

location_facility: Wake Forest University, Health Sciences Section on Hematology and Oncology

location_facility: Charité-Campus B. Franklin Med. Klinik Haematology

location_facility: Christie Hospital, Haematology and Transplant Day Unit

location_facility: USC/Norris Comprehensive Cancer Center and Hospital

location_facility: Hospital Universitario La Fé, Servicio de Hematología

location_facility: III. Medizinische Klinik und Poliklinik;Hämatologie, Onkologie und Pneumologie

location_facility: Evangelische Kliniken Johanniter- und Waldkrankenhaus Bonn GmbH

location_facility: Universitätsklinikum Ulm, Klinik für Innere Medizin III, Comprehensive Cancer Center Ulm (CCCU)

location_facility: Gartnavel General Hospital: Beatson WOS Cancer Centre

location_facility: Rocky Mountain Blood and Bone Marrow Transplant Program

location_facility: Heinrich-Heine Universität Düsseldorf, Klinik für Hämatologie/Onkolog. und Klin. Immunologie

location_facility: UCLA School of Medicine, Division of Hematology/Oncology

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: St. Spiridon" University Hospital, Hematology Department

location_facility: Oncology Institute ,,Ion Chiricuta" Cluj Napoca , Hematology dept.

location_facility: Froedtert Hospital, Medical College of Wisconsin

location_facility: New York Presbyterian Hospital, Weill-Cornell Medical College


title: Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

acronym: PRECIOSA

summary: This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

status: Recruiting

ReferenceCitation: Fernández J, Clària J, Amorós A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Güell M, Nuñez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Árbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Bañares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos García-Pagán J, Pavesi M, Jalan R, Bernardi M, Moreau R, Páez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.

family: Fernández

full_name: Javier Fernández

given: Javier

family: Clària

full_name: Joan Clària

given: Joan

family: Amorós

full_name: Alex Amorós

given: Alex

family: Aguilar

full_name: Ferrán Aguilar

given: Ferrán

family: Castro

full_name: Miriam Castro

given: Miriam

family: Casulleras

full_name: Mireia Casulleras

given: Mireia

family: Acevedo

full_name: Juan Acevedo

given: Juan

family: Duran-Güell

full_name: Marta Duran-Güell

given: Marta

family: Nuñez

full_name: Laura Nuñez

given: Laura

family: Costa

full_name: Montserrat Costa

given: Montserrat

family: Torres

full_name: Mireia Torres

family: Horrillo

full_name: Raquel Horrillo

given: Raquel

family: Ruiz-del-Árbol

full_name: Luis Ruiz-del-Árbol

given: Luis

family: Villanueva

full_name: Cándido Villanueva

given: Cándido

family: Prado

full_name: Verónica Prado

given: Verónica

family: Arteaga

full_name: Mireya Arteaga

given: Mireya

family: Trebicka

full_name: Jonel Trebicka

given: Jonel

family: Angeli

full_name: Paolo Angeli

given: Paolo

family: Merli

full_name: Manuela Merli

given: Manuela

family: Alessandria

full_name: Carlo Alessandria

given: Carlo

family: Aagaard

full_name: Niels Kristian Aagaard

given: Niels Kristian

family: Soriano

full_name: German Soriano

given: German

family: Durand

full_name: François Durand

given: François

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

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

repository_institution: University College London - UCL Discovery

repositories_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

location_country:
Italy
Germany
France
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ohio State University Wexner Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

location_facility: Royal Free NHS Foundation Trust Hospital

location_facility: CHRU de Strasbourg - Hôpital Hautepierre

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico - S.Orsola

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Hospital Universitario Politecnico La Fe


title: A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

summary: The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Italy
Brazil
Sweden
Netherlands
Germany
France
Norway
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada
Ukraine

location_facility: Centre Regional de Lutte contre le Cancer Val d'Aurelle

location_facility: Institut Gustave-Roussy - Centre de Lutte Contre le Cancer

location_facility: "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department

location_facility: National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Border Medical Oncology, Murray Valley Private Hospital

location_facility: Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I

location_facility: Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department

location_facility: Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)

location_facility: Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1

location_facility: Instituto Especializado Alexander Fleming

location_facility: Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München

location_facility: Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6

location_facility: State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department

location_facility: Klinik der Otto-Von-Guericke-Universität Magdeburg

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Southern Medical Day Oncology Care Centre

location_facility: Instituto Oncologico Veneto, Oncologia Medica 1

location_facility: Mechnikov St. Petersburg State Medical Academy

location_facility: Hôpital Saint André, Service d'Oncologie Médicale

location_facility: Mykolayiv Regional Oncology Center, Surgery Department #1

location_facility: Policlínica Privada Instituto de Medicina Nuclear

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology


ReferenceCitation: White PL, Posso R, Parr C, Price JS, Finkelman M, Barnes RA. The Presence of (1→3)-β-D-Glucan as Prognostic Marker in Patients After Major Abdominal Surgery. Clin Infect Dis. 2021 Oct 5;73(7):e1415-e1422. doi: 10.1093/cid/ciaa1370.

name: Mycology Reference Laboratory, Microbiology Cardiff, Public Health Wales, Cardiff, United Kingdom

family: White

full_name: P Lewis White

given: P Lewis

family: Posso

full_name: Raquel Posso

name: Infection, Immunity and Biochemistry, School of Medicine, Cardiff University, Cardiff, United Kingdom

family: Parr

full_name: Christian Parr

given: Christian

family: Price

full_name: Jessica S Price

given: Jessica S

name: Associates of Cape Cod, Inc, East Falmouth, Massachusetts, USA

family: Finkelman

full_name: Malcolm Finkelman

given: Malcolm

family: Barnes

full_name: Rosemary A Barnes

given: Rosemary A

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Knitsch W, Vincent JL, Utzolino S, François B, Dinya T, Dimopoulos G, Özgüneş İ, Valía JC, Eggimann P, León C, Montravers P, Phillips S, Tweddle L, Karas A, Brown M, Cornely OA. A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections. Clin Infect Dis. 2015 Dec 1;61(11):1671-8. doi: 10.1093/cid/civ707. Epub 2015 Aug 13.

family: Knitsch

full_name: Wolfgang Knitsch

given: Wolfgang

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

family: Utzolino

full_name: Stefan Utzolino

given: Stefan

family: François

full_name: Bruno François

given: Bruno

family: Dinya

full_name: Tamás Dinya

given: Tamás

family: Dimopoulos

full_name: George Dimopoulos

given: George

family: Özgüneş

full_name: İlhan Özgüneş

given: İlhan

family: Valía

full_name: Juan Carlos Valía

given: Juan Carlos

family: Eggimann

full_name: Philippe Eggimann

given: Philippe

family: León

full_name: Cristóbal León

given: Cristóbal

family: Montravers

full_name: Philippe Montravers

family: Phillips

full_name: Stephen Phillips

given: Stephen

family: Tweddle

full_name: Lorraine Tweddle

given: Lorraine

family: Karas

full_name: Andreas Karas

given: Andreas

family: Brown

full_name: Malcolm Brown

family: Cornely

full_name: Oliver A. Cornely

given: Oliver A.

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL
reroDoc Digital Library

title: A Randomized, Placebo-controlled Trial of Preemptive Antifungal Therapy for the Prevention of Invasive Candidiasis Following Gastrointestinal Surgery for Intra-abdominal Infections

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Italy
Austria
Switzerland
Finland
France
Greece
Israel
Romania
Hungary
Belgium
Spain
Turkey
Denmark
Germany
United Kingdom

title: An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study

summary: Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.


design_allocation: Non-Randomized

intervention_type: Radiation

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Brazil
South Africa
Guatemala
Mexico
Netherlands
Germany
France
Czechia
Spain
United States
United Kingdom
Korea, Republic of
Colombia

location_facility: Hospital Infantil Universitario Nino Jesus ( Site 0433)

location_facility: Columbia University/Herbert Irving Cancer Center ( Site 0063)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510)

location_facility: Fakultni nemocnice v Motole ( Site 0356)

location_facility: Hospital Pablo Tobon Uribe-Hematology ( Site 0565)

location_facility: Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054)

location_facility: Hospital Universitari Vall d Hebron ( Site 0432)

location_facility: Kaiser Permanente Downey Medical Center ( Site 0024)

location_facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507)

location_facility: Albert Alberts Stem Cell Transplant Centre ( Site 0324)

location_facility: Arkansas Children's Hospital ( Site 0046)

location_facility: Hospital Universitario La Paz ( Site 0434)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0413)

location_facility: St. Francis Hospital Cancer Center ( Site 0001)

location_facility: University of Louisville-Norton Children's Hospital ( Site 0059)

location_facility: Children's Hospital - Colorado ( Site 0028)

location_facility: Azienda Ospedaliera Santobono - Pausilipon ( Site 0402)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 0035)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400)

location_facility: Dell Children's Medical Center Of Central Texas ( Site 0058)

location_facility: Alliance for Childhood Diseases ( Site 0064)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0404)

location_facility: Hackensack University Medical Center ( Site 0026)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0027)

location_facility: Ospedale Infantile Regina Margherita ( Site 0401)

location_facility: Children's Hospital of Michigan ( Site 0056)

location_facility: Hematologica Alta Especialidad ( Site 0532)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411)

location_facility: Children's Hospitals and Clinics of Minnesota ( Site 0036)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 0454)

location_facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048)

location_facility: University of Kentucky Markey Cancer Center ( Site 0057)

location_facility: Unidad Nacional de Oncologia Pediatrica ( Site 0542)

location_facility: Kaiser Permanente - Santa Clara ( Site 0079)

location_facility: Hospital Infantil de Mexico Federico Gomez ( Site 0535)

location_facility: St. Louis Children's Hospital ( Site 0038)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 0447)

location_facility: UMAE Hospital de Especialidades - CMN La Raza ( Site 0536)

location_facility: UNC Lineberger Comprehensive Cancer ( Site 0044)

location_facility: CHU de Marseille Hopital de la Timone Enfants ( Site 0449)

location_facility: Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500)

location_facility: Riley Hospital for Children ( Site 0091)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0060)

location_facility: Nationwide Children's Hospital ( Site 0037)

location_facility: Cohen Children's Medical Center of New York ( Site 0052)

location_facility: Kaiser Permanente - Roseville ( Site 0080)

location_facility: Roswell Park Cancer Institute ( Site 0040)

location_facility: Institut d'Hematologie-Oncologie Pediatrique (IHOP) ( Site 0448)

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit

location_facility: Connecticut Children's Medical Center ( Site 0045)

location_facility: Children's Healthcare of Atlanta at Egleston ( Site 0033)

location_facility: Kaiser Permanente - Oakland ( Site 0047)

location_facility: Hopital d'Enfants Armand Trousseau ( Site 0443)

location_facility: Universitaetsklinikum Essen ( Site 0415)

location_facility: Hopital Universitaire Robert Debre ( Site 0446)

location_facility: Universita degli Studi di Roma La Sapienza ( Site 0403)

location_facility: Severance Hospital Yonsei University Health System ( Site 0221)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0531)

location_facility: Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)

location_facility: Children's Hospital of Alabama ( Site 0023)

ipd_sharing: Yes

title: An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)

summary: This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.


title: A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

summary: The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
South Africa
Sweden
Mexico
Spain
Germany
France
Bulgaria
Japan
Korea, Republic of
Poland
Belgium
Argentina
Australia
Russian Federation
United States
Canada
Taiwan
Ukraine

location_facility: Barwon Health - University Hospital Geelong

location_facility: Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

location_facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

location_facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

location_facility: Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

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

location_facility: IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Hospital Universitario Prof Edgard Santos

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: AllinaHealth - Abbott Northwestern Hospital (13520)

location_facility: Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

location_facility: Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

location_facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas

location_facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

location_facility: Policlinic of State Joint Stock Holding Company 'Artem'

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

location_facility: SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD

location_facility: Diagnostic Consultation Centre 'Alexandrovska' EOOD

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis

location_facility: Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: City Polyclinic #25 of the Nevsky District of SPB

location_facility: Medical Center of LL Company 'Scientific Medical Center-Your Doctor'

location_facility: Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education

location_facility: Universidade Federal de Santa Catarina/Clínica Médica

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Dr Anil K Gupta Medicine Professional Corporation

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni


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

location_country:
Finland
Greece
Romania
Belgium
Australia
Denmark
Croatia
France
Japan
Lithuania
Poland
Slovakia
Canada
Turkey
Bulgaria
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Spain
Estonia

title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

summary: The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.


title: A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma

acronym: MIRAGE

summary: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

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

location_country:
Austria
United States
Switzerland
Netherlands
Germany
France
Norway
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Aarhus University Hospitals - Aarhus University Hospital (440)

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: QEII Health Sciences Centre-Capital District Health Authority

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: Penn State College of Medicine, Hershey Medical Center-Penn State Neuroscience Institute

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Universitaetsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: Montreal Neurological Institute and Hospital McGill University

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: University Health Network - Oci / Princess Margaret Hospital

location_facility: CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

location_facility: Hamilton Health Sciences, Juravinski Cancer Centre

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospitals Copenhagen - Rigshospitalet

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

location_facility: Regional Cancer Program of Hopital Reg. de Sudbury Reg. Hospital

location_facility: Centre hospitalier regional de Trois-Rivieres

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

location_facility: Universitaetsklinik Erlangen-Neurologische Klinik (3031)

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie

location_facility: Radboud University Medical Center Nijmegen

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Clinica Universidad de Navarra - Clinica Universitaria De Navarra

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Universitaetsklinikum Tuebingen- Crona Kliniken


title: A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

summary: A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

lead_sponsor: Opthea Limited

location_country:
Italy
United Kingdom
France
Czechia
Poland
Israel
Hungary
Spain
United States
Latvia

location_facility:
Opthea Study Site
Opthea Investigationa Site
Opthea Investigational Site


lead_sponsor: Hoffmann-La Roche

location_country:
France
Israel
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: Morpheus Lung

location_facility: Institut Régional du Cancer de Montpellier

location_facility: South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro

location_facility: University Hospitals Case Medical Center; Seidman Cancer Center

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: Hospital Regional Universitario de Malaga

location_facility: University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

location_facility: Chaim Sheba Medical Center; Oncology Dept

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

location_facility: National Cheng Kung University Hospital; Gasterointestinal

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: Hospital Clinico Universitario de Valencia

title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: the first-line (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.


title: A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
United States
Germany
France
Japan
Australia
Denmark
Canada

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 167824

location_facility: St Vincent's Hospital Melbourne /ID# 165853

location_facility: Univ of Colorado Cancer Center /ID# 167331

location_facility: Atrium Health Carolinas Medical Center /ID# 164948

location_facility: Beth Israel Deaconess Medical Center /ID# 210904

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 164767

location_facility: Dana-Farber Cancer Institute /ID# 166886

location_facility: Matsuyama Red Cross Hospital /ID# 225196

location_facility: Universitaetsklinikum Freiburg /ID# 166036

location_facility: Emory University, Winship Cancer Institute /ID# 165427

location_facility: The University of Chicago Medical Center /ID# 165429

location_facility: Nagoya City University Hospital /ID# 225273

location_facility: Roswell Park Comprehensive Cancer Center /ID# 169615

location_facility: CHRU Tours - Hopital Bretonneau /ID# 164795

location_facility: Oregon Health & Science University /ID# 166822


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

summary: The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 280 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Arm A and Arm B will be double-blinded and Arm C will be open-labeled. The open-label arm will provide a qualitative reference to standard therapy. Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks. Double-blinded phase will be for 52-weeks with subjects from Arm A and B who cannot tolerate discontinuation of immunosuppressant or taper of corticosteroids. Subjects in Arm C will continue to receive belimumab SC and their stable immunosuppressant during Weeks 53 through 104.

ReferenceCitation: Teng YKO, Bruce IN, Diamond B, Furie RA, van Vollenhoven RF, Gordon D, Groark J, Henderson RB, Oldham M, Tak PP. Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol. BMJ Open. 2019 Mar 20;9(3):e025687. doi: 10.1136/bmjopen-2018-025687.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Parodis I, Lopez Benavides AH, Zickert A, Pettersson S, Möller S, Welin Henriksson E, Voss A, Gunnarsson I. The Impact of Belimumab and Rituximab on Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2019 Jun;71(6):811-821. doi: 10.1002/acr.23718.

name: Karolinska Institutet and Karolinska University Hospital Stockholm Sweden

family: Parodis

full_name: Ioannis Parodis

given: Ioannis

name: Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, and Odense University Hospital Odense Denmark

family: Lopez Benavides

full_name: Angie H. Lopez Benavides

given: Angie H.

family: Zickert

full_name: Agneta Zickert

given: Agneta

family: Pettersson

full_name: Susanne Pettersson

given: Susanne

family: Möller

full_name: Sonia Möller

given: Sonia

name: Karolinska Institutet, Stockholm, and Linköping University Linköping Sweden

family: Welin Henriksson

full_name: Elisabet Welin Henriksson

given: Elisabet

family: Voss

full_name: Anne Voss

given: Anne

family: Gunnarsson

full_name: Iva Gunnarsson

given: Iva

journal_name: Arthritis Care & Research

title: The Impact of Belimumab and Rituximab on Health‐Related Quality of Life in Patients With Systemic Lupus Erythematosus

lead_sponsor: GlaxoSmithKline

location_country:
Brazil
United States
Mexico
Netherlands
Germany
France
Argentina
Russian Federation
Spain
Canada
Korea, Republic of


location_country:
Italy
France
Poland
Lithuania
Romania
Hungary
Spain
Denmark
United States

title: A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years

summary: This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.


ReferenceType: result

ReferenceCitation: Freemantle N, Mamdani M, Vilsbøll T, Kongsø JH, Kvist K, Bain SC. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015 Dec;6(4):573-591. Epub 2015 Nov 18.

ReferenceCitation: Kumar S, Jang HC, Demirağ NG, Skjøth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017 Feb;34(2):180-188. doi: 10.1111/dme.13125. Epub 2016 Jul 28.

name: Department of Diabetes; Diabetes Care Centre; Thiruvananthapuram India

family: Kumar

full_name: S. Kumar

given: S.

name: Department of Internal Medicine; Seoul National University Bundang Hospital; Gyeonggi-do South Korea

family: Jang

full_name: H. C. Jang

given: H. C.

name: Department of Endocrinology; Baskent University Hospital, Altunizade; Istanbul Turkey

family: Demirağ

full_name: N. G. Demirağ

given: N. G.

name: Department of Medical and Science, Liraglutide and Obesity; Novo Nordisk A/S; Søborg Denmark

family: Skjøth

full_name: T. V. Skjøth

given: T. V.

name: Department of R&D Insight; Novo Nordisk A/S; Bagsvaerd Denmark

family: Endahl

full_name: L. Endahl

given: L.

name: Atlanta Diabetes Associates; Atlanta GA USA

family: Bode

full_name: B. Bode

given: B.

journal_name: Diabetic Medicine

lead_sponsor: Novo Nordisk A/S

location_country:
South Africa
Sweden
India
Croatia
France
Poland
Turkey
United States
Korea, Republic of

acronym: BOOST™

title: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.


title: Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

summary: The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

ReferenceCitation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

name: Graduate Institute of Clinical Medicine; National Taiwan University College of Medicine and Hepatitis Research Center; National Taiwan University Hospital; Taipei Taiwan

family: Kao

full_name: Jia-Horng Kao

given: Jia-Horng

name: Center for Liver Diseases; University of Chicago Medical Center; Chicago IL USA

family: Jensen

full_name: Donald M. Jensen

given: Donald M.

name: Hannover Medical School; Hannover Germany

name: German Center for Infection Research; Hannover-Braunschweig Germany

family: Manns

full_name: Michael P. Manns

given: Michael P.

name: Department of Medicine at Mount Sinai Beth Israel Medical Center; New York NY USA

family: Jacobson

full_name: Ira Jacobson

given: Ira

family: Kumada

full_name: Hiromitsu Kumada

given: Hiromitsu

name: Sapporo-Kosei General Hospital; Sapporo Japan

family: Toyota

full_name: Joji Toyota

given: Joji

name: College of Medicine; Pusan National University and Medical Research Institute; Pusan National University Hospital; Busan South Korea

family: Heo

full_name: Jeong Heo

given: Jeong

name: Veterans Affairs Medical Center; Baylor College of Medicine; Houston TX USA

family: Yoffe

full_name: Boris Yoffe

given: Boris

name: Monash Health and Monash University; Melbourne Victoria Australia

family: Sievert

full_name: William Sievert

given: William

name: Hospital Provincial del Centenario; Servicio de Gastroenterología y Hepatología; Universidad Nacional de Rosario; Rosario Argentina

family: Bessone

full_name: Fernando Bessone

given: Fernando

name: School of Medicine; China Medical University; Taichung Taiwan

family: Peng

full_name: Cheng-Yuan Peng

given: Cheng-Yuan

name: Alfred Hospital and Monash University; Melbourne Victoria Australia

family: Roberts

full_name: Stuart K. Roberts

given: Stuart K.

name: Inje University Busan Paik Hospital; Busan South Korea

family: Lee

full_name: Youn-Jae Lee

given: Youn-Jae

name: Bristol-Myers Squibb Research and Development; Princeton NJ USA

family: Bhore

full_name: Rafia Bhore

given: Rafia

family: Mendez

full_name: Patricia Mendez

given: Patricia

family: Hughes

full_name: Eric Hughes

given: Eric

family: Noviello

full_name: Stephanie Noviello

given: Stephanie

journal_name: Liver International

ReferenceCitation: McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.

name: Research and Development; Bristol-Myers Squibb; Wallingford; CT

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Hernandez

full_name: Dennis Hernandez

given: Dennis

family: Yu

full_name: Fei Yu

given: Fei

family: Ueland

full_name: Joseph Ueland

name: Research and Development; Bristol-Myers Squibb; Hopewell; NJ

ReferenceCitation: Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.

title: Preliminary Study of Two Antiviral Agents for Hepatitis C Genotype 1

location_facility: University Of Colorado Denver & Hospital


title: A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

summary: This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

ReferenceCitation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Blanco R, Kadva A, Dimonaco S. Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial. Ann Rheum Dis. 2017 Jul;76(7):1279-1284. doi: 10.1136/annrheumdis-2016-210561. Epub 2017 Apr 7.

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Rigby

full_name: William F Rigby

given: William F

family: van Vollenhoven

full_name: Ronald F van Vollenhoven

given: Ronald F

family: Kay

full_name: Jonathan Kay

given: Jonathan

family: Rubbert-Roth

full_name: Andrea Rubbert-Roth

given: Andrea

family: Blanco

full_name: Ricardo Blanco

given: Ricardo

family: Kadva

full_name: Alysha Kadva

given: Alysha

family: Dimonaco

full_name: Sophie Dimonaco

given: Sophie

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016 Jun;75(6):1081-91. doi: 10.1136/annrheumdis-2015-207628. Epub 2015 Oct 28.

family: Kelman

full_name: Ariella Kelman

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Markhot Ferenc Hospital; Dep. of Rheumatology

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: Centro Paulista de Investigacao Clinica - CEPIC

location_facility: Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"

location_facility: Adelaide and Meath Hospital; Rheumatology Department

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

location_facility: Centro Internacional de Pesquisa; Reumatologia

location_facility: Haywood Hospital; Staffordshire Rheumatology Centre

location_facility: Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

location_facility: Karolinska Sjukhuset; Reumatologkliniken D2-1

location_facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Uni of Santo Tomas Hospital; Rheumatology

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Royal Victoria Infirmary; Clinical Research Facility

location_facility: Centro Medico Privado de Reumatologia; Reumathology

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Budai Irgalmasrendi Kórház KHT. II. Reumatológia

location_facility: Inst. de Rehabilitacion Psicofisica; Reumathology

location_facility: Kaiser Franz Josef Spital; Ii. Medizinische Abt.

location_facility: Policlinico Umberto I - Universita' La Sapienza ; Cattedra Di Reumatologia - Dept. Terapia Medica

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Istituto Ortopedico Rizzoli; Unità di Reumatologia

location_facility: QUEEN MARY HOSPITAL; Division of Rheumatology & Clinical Immunology

location_facility: Krankenhaus der stadt wien hietzing; ii. Med. Abt. / zentrum für rheumatologie

location_facility: Phramongkutklao Hospital; Dept. of Medicine, Rheumatology

location_facility: Uni of California - San Diego; Division of Rheumatology

location_facility: Maidstone Hospital; Dept of Rheumatology

location_facility: Chaim Sheba Medical Center; Interna Dept B

location_facility: Waikato Hospital; Rheumatology Outpatients

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

location_facility: Ospedale Di Magenta Fornaroli; U.O. Di Reumatologia

location_facility: ASST FATEBENEFRATELLI SACCO; Reumatologia (Sacco)

location_facility: National University Hospital; Dept of Medicine

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

location_facility: SBIH of Moscow "City clinical hospital #1 n.a. N.I. Pirogov" of Moscow Healthcare Department

location_facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia

location_facility: North Shore Hospital, STAR Unit; Rheumatology Department

location_facility: Hospital de Merida ;Servicio de Reumatologia

location_facility: Clinica Medica Del Dr Eduardo Alfredo Samayoa

location_facility: Klinikum der Universität München; Bereich Pettenkoferstr.; Rheumaeinheit der medizinischen Klinik IV

location_facility: Medyczne Centrum Hetmanska; Indywidualna Specjalistyczna Praktyka Lekarska

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

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

location_facility: St.Vincent's University Hospital; Rheumatology Department

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Instytut Reumatologii im. Prof. Dr hab. Eleonory Reicher; Oddzial Wczesnej Diagnostyki Stawow

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Reumatologia

location_facility: Clnical & Translational Reseach Center for Alabama, PC

location_facility: Centro especializado de rehabilitacion fisica y del dolor cerfid - unidad de inv. En reumatologia

location_facility: Hospital Universitario de la Princesa; Servicio de Reumatologia

location_facility: Policlinico Universitario; Cattedra Di Reumatologia, Edificio 3

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum; Belgyógyászati Intézet, Reumatológiai Tanszék

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Rheumatology

location_facility: Tuen Mun Hospital; Medicine & Geriatrics

location_facility: St. Joseph'S Health Care Centre; Rheumatology

location_facility: Chulalongkorn Hospital; Division of Rheumatology - Medicine

location_facility: Wojewodzki Szpital Zespolony; Oddzial Reumatologii

location_facility: State Institution of Healthcare of Tula Region "Tula Regional Clinical Hospital"

location_facility: Ramathibodi Hospital, Mahidol Uni ; Allergy, Immunology & Rheumatology, Dept of Medicine

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Arthritis Health Associates; Clinical Research

location_facility: Hopital Maisonneuve- Rosemont; Rheumatology

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

location_facility: Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Campus Bio-Medico; Immunologia e Allergologia

location_facility: Philippine General Hospital; Rheumatology

location_facility: Addenbrooke'S Hospital; Rheumatology Research Unit

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Hopital Porte Madeleine; Service de Rhumatologie

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

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: University General Hospital of Larissa; Rheumatology Unit

location_facility: Centro de Investigación Clínica de Morelia, S.C.; Reumatologia

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Centro de Infusion Marbella; Consultorios Royal Center Num 214

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica

location_facility: Russells Hall Hospital; Rheumatology Department

location_facility: Schön Klinik Hamburg-Eilbek Klinik für Rheumatologie

location_facility: Hospital e Maternidade Celso Pierro - PUCCamp; Reumatologia

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Centro de Estudos em Terapias Inovadoras - CETI

location_facility: Sjællands Universitetshospital, Køge; Reumatologisk Afdeling

location_facility: FSBI "National medico-surgical Centre n.a. N.I. Pirogov" of the Ministry of Healthcare

location_facility: Sunshine Coast Rheumatology Research Unit

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

location_facility: Royal Prince Alfred Hospital; Rheumatology

location_facility: Ohio State University; Dept of Immunology

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

location_facility: Iu Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali; Romatoloji Bilim Dali

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Reumatologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Hospital Infanta Sofia; Servicio de Reumatologia

location_facility: Arthrocare, Arthritis Care and Research, P.C.

location_facility: Valerius Medical Group & Research Ctr of Greater Long Beach

location_facility: Hospital de Sao Joao; Servico de Reumatologia

location_facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

location_facility: Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases

location_facility: Szpital Specjalistyczny Nr 1; Oddzial Reumatologii I Rehabilitacji

location_facility: Hadassah University Hospital, Ein Karem; Rheumatology

location_facility: Pamela Youde Nethersole Eastern Hospital; Department of Medicine

location_facility: North Mississippi Medical Ctr; Internal Medicine Associates

location_facility: Clinic of Rheumatology; Clinical Centre Skopje

location_facility: Royal Hallamshire Hospital; Rheumatology

location_facility: Hospital General Universitario de Guadalajara; Servicio de Reumatologia

location_facility: Unidad De Enfermedades; Cronico Degenerativas, SC.

location_facility: Campus Charité Mitte Charité Centrum 12. Med.Klinik Abt.Rheumatologie u.Klin.Immunologie

location_facility: Rheuma-Zentrum Baden-Baden Gmbh; Klinik Für Innere Medizin-Rheumatologie

location_facility: Hadassah Mount Scopus Hospital; Rheumatology

location_facility: Hospital de Santa Maria; Servico de Reumatologia

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

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Helsinki University Central Hospital; Rheumatology Clinic

location_facility: Unidad de Enfermedades Reumaticas y Cronicodegenerativas

location_facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

location_facility: Karolinska University Hospital, Huddinge; Rheumatology

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Southwest Rheumatology & Research Group, LLC

location_facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

location_facility: Rheumatology Associates of North Alabama

location_facility: Arthritis & Osteoporosis Associates, LLP

location_facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

location_facility: SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"

location_facility: FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"


title: A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

acronym: GENERATION

summary: This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.

ReferenceCitation: Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on β-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.

family: Perl

full_name: Shira Perl

given: Shira

family: Cook

full_name: William Cook

given: William

family: Wei

full_name: Cheryl Wei

given: Cheryl

family: Ohman

full_name: Peter Ohman

given: Peter

family: Hirshberg

full_name: Boaz Hirshberg

given: Boaz

journal_name: Clinical Therapeutics

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Schernthaner G, Durán-Garcia S, Hanefeld M, Langslet G, Niskanen L, Östgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.

name: Department of Medicine I; Rudolfstiftung Hospital; Vienna Austria

family: Schernthaner

full_name: G. Schernthaner

given: G.

name: Unidad de Gestion de Endocrinología y Nutrición, Hospital Universitario de Valme; Sevilla Spain

family: Durán-Garcia

full_name: S. Durán-Garcia

given: S.

name: Study centre Professor Hanefeld, GWT-TUD GmbH; Dresden Germany

family: Hanefeld

full_name: M. Hanefeld

given: M.

name: Lipid Clinic; Oslo University Hospital; Oslo Norway

family: Langslet

full_name: G. Langslet

name: Endocrinology and Metabolism, Abdominal Center; Helsinki University Hospital, University of Helsinki; Helsinki Finland

family: Niskanen

full_name: L. Niskanen

given: L.

name: Department of Medical and Health Sciences; Linköping University; Linköping Sweden

family: Östgren

full_name: C. J. Östgren

given: C. J.

family: Malvolti

full_name: E. Malvolti

given: E.

family: Hardy

full_name: E. Hardy

journal_name: Diabetes, Obesity and Metabolism

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
Sweden
Mexico
Finland
France
Greece
Norway
Hungary
Spain
Denmark
Germany
United Kingdom


title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

acronym: PROMPT

summary: The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

ReferenceCitation: Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jörgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.

name:
Endocrinologie et Nutrition, Cliniques universitaires Saint-Luc
BrusselsBelgium

family: Hermans

full_name: Michel P. Hermans

given: Michel P.

name:
Ankara Diskapi Training and Research Hospital
AnkaraTurkey

family: Delibasi

full_name: Tuncay Delibasi

given: Tuncay

name:
The Surgery
Stanwell Road, AshfordUK

family: Farmer

full_name: Ian Farmer

given: Ian

name:
AstraZeneca
SödertäljeSweden

family: Lohm

full_name: Leif Lohm

given: Leif

name:
AstraZeneca
BrusselsBelgium

family: Maheux

full_name: Pierre Maheux

given: Pierre

name:
San Raffaele Scientific Institute
MilanItaly

family: Piatti

full_name: PierMarco Piatti

given: PierMarco

name:
Bristol-Myers Squibb
ParisFrance

full_name: Elmas Malvolti

given: Elmas

name:
Aptiv Solutions
KölnGermany

family: Jörgens

full_name: Silke Jörgens

given: Silke

name: Clinique d’Endocrinologie, University of Nantes France

family: Charbonnel

full_name: Bernard Charbonnel

given: Bernard

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country:
Italy
France
Belgium
Spain
Turkey
Germany
United Kingdom