location_country:
Peru
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain

acronym: ACOUSTICS

location_facility: Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council

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

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

location_facility: SI Research Centre of Radiation Medicine of AMSU

location_facility: State Institution of Pediatrics Obstetrics and Gynecology of NAMSU

location_facility: Centre de Recherche Applique En Allergie de Quebec

location_facility: Hospital Alemao Oswaldo Cruz; Pesquisa Clinica

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Hospital Infante D. Pedro; Servico de Imunoalergologia

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Dumfries and Galloway Royal Infirmary; Department of Paediatrics

location_facility: National Jewish Medical and Research Center

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

location_facility: Centro Integral de Medicina Respiratoria (CIMER)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: South Texas Allergy and Asthma Medical Professionals

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Hospital Dona Estefania; Servico de Imunoalergologia

location_facility: Municipal Medical Institution; Chernivtsi Regional Children's Hospital

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Municipal Institution Zaporizhzhya Regional Clinical Child Hospital

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: Hospital CUF Porto; Servico de Imunoalergologia

location_facility: Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia

location_facility: Colorado Children's Hospital; The Breathing Institute

location_facility: Allergy & Asthma Medical Group; Clinical Research Division

location_facility: National Hospital Organization Mie Hospital

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: GCT Mercantile; Clinical Research Centre

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n

location_facility: Instituto de Pesquisa Clínica e Medicina Avançada Ltda

location_facility: Hospital Particular do Algarve - Unidade de Faro

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine

location_facility: Allergy & Asthma Research Center of El Paso

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR

location_facility: Consultorio Especialidad Alergologia Pediatrica

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Clinical Research Inst. of Southern Oregon, Pc

location_facility: Cardinal Glennon Child's Hosp; Endrocrinology

location_facility: Allergy, Asthma, & Dermatology Research Center, Llc

location_facility: Investigaciones en Patologias Respiratorias

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Riley Hospital for Children; Pediatric Nephrology

location_facility: National Hospital Organization Shimoshizu National Hospital

title: A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma who are on inhaled corticosteroids and second controller medication.

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.


type: EudraCT Number

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

name: Southwest Asthma and Allergy Associates Houston TX USA

family: Chen

full_name: Meng Chen

given: Meng

sequence: first

name: University of South Florida Tampa FL USA

family: Shepard

full_name: Kirk Shepard

given: Kirk

sequence: additional

suffix: II

name: Genentech, Inc. South San Francisco CA USA

family: Yang

full_name: Ming Yang

given: Ming

family: Raut

full_name: Pranil Raut

given: Pranil

family: Pazwash

full_name: Hooman Pazwash

given: Hooman

family: Holweg

full_name: Cecile T.J. Holweg

given: Cecile T.J.

name: University of California San Francisco CA USA

family: Choo

full_name: Eugene Choo

given: Eugene

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical & Experimental Allergy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate‐to‐severe asthma

ReferenceCitation: N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.

family: Bauer

full_name: Rebecca N Bauer

given: Rebecca N

full_name: Xiaoying Yang

given: Xiaoying

family: Staton

full_name: Tracy L Staton

given: Tracy L

family: Olsson

full_name: Julie Olsson

given: Julie

full_name: Cecile T J Holweg

given: Cecile T J

family: Arron

full_name: Joseph R Arron

given: Joseph R

family: Matthews

full_name: John G Matthews

given: John G

family: Choy

full_name: David F Choy

given: David F

currency_apc_doaj: GBP

journal_name: BMJ Open Respiratory Research

oa_colors: green gold

ReferenceCitation: Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

location_country:
Peru
Romania
Belgium
Australia
Russian Federation
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Serbia
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés

location_facility: GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

location_facility: I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Medical Research Inst. of New Zealand; Respiratory

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Cotton O'Neil Clinic; Stormont-Vail Hlth Care

location_facility: Alergo Medical Specjalistyczna Przychodnia Lekarska

location_facility: Howard County Center for Lung and Sleep, LLC

location_facility: Integrity People Services Research Company

location_facility: Medical Research of Arizona; Allergy, Asthma & Immu

location_facility: MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council

location_facility: Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine

location_facility: EPIMRD, Inc. DBA Western Sky Medical Research

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research LLC

location_facility: SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

location_facility: Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

location_facility: Southern California Institute For Respiratory

location_facility: Royal Hallamshire Hospital; Department of Oncology

location_facility: Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

location_facility: Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon

location_facility: Diagnostic and Consulting Centre Mladost - M OOD

location_facility: Allergy and Clinical Immunology Associates

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth

location_facility: Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases

location_facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I

location_facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

location_facility: Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department

location_facility: Quality of Life Medical & Research Center

location_facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov

location_facility: KASMED, s.r.o.; Alergologie a klinicka imunologie

location_facility: Hikarigaoka Spellman Hospital; Rheumatology

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Canterbury Respiratory Research Group; Respiratory

location_facility: Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Yokohama City University Medical Center; Neurology

location_facility: Ordinace pro tuberkulozu a respiracni nemoci

location_facility: Allergy & Asthma Medical Group; Clinical Research Division

location_facility: Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases

location_facility: Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital

location_facility: National Multiprofile Hospital Tsar Boris III

location_facility: Baylor College of Medicine; Dept of Medicine

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Targu Mures Clinical Emergency County Hospital

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

location_facility: SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce

location_facility: Instituto Peruano de Investigacion en Ciencias Medicas

location_facility: Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic

location_facility: Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: SHATPD Sveta Sofia; Clin Pulmonary Diseases

location_facility: Seoul National University Hospital; Division of Allergy and Clinical Immunology

location_facility: Upstate Pharmaceutical Research; Greenville

location_facility: Del Carpio Jaime Dr - Allergiste & Immunologue

location_facility: Yaroslavl State Medical Academy - Clinical Hospital #2

location_facility: Penn State Milton S. Hershey Medical Center

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

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: Municipal Institution of Health Care City Clinical Hospital #13

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: University of Wisconsin;Allergy & Asthma Clinical Research

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Hospital Universitario la Paz; Servicio de Alergologia

location_facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Dr Anil Dhar Professional Medicine Corporation

location_facility: Concord Repatriation General Hospital; Department Thoracic Medicine

location_facility: City Clinical Hospital No.1; Therap Ukr Med Stom Acad

location_facility: Hadassah Medical Center; Pulmonary Institute

location_facility: Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9

location_facility: Multiprofile Hospital For Active Treatment prof Kirkovich

location_facility: Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta

location_facility: Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo

location_facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

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

location_facility: Hospital Nacional Adolfo; Guevara Velasco Essalud

location_facility: Saratov State Medical Univ; Clinical Immun & Allerg

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: Tohoku Medical and Pharmaceutical University Wakabayashi Hospital


title: A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue

summary: This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up. Participants may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for participants who previously have consented and donated RCR DNA samples) and medical record capture.

study_type: Observational

time_perspective: Other

ReferenceCitation: Wei L, Pavlovic V, Bansal AT, Chen X, Foster GR, He H, Kao JH, Lampertico P, Liaw YF, Motoc A, Papatheodoridis GV, Piratvisuth T, Plesniak R, Wat C. Genetic variation in FCER1A predicts peginterferon alfa-2a-induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B. J Viral Hepat. 2019 Sep;26(9):1040-1049. doi: 10.1111/jvh.13107. Epub 2019 Jul 23.

name: Peking University People’s Hospital Beijing China

name: Peking University Hepatology Institute Beijing China

family: Wei

full_name: Lai Wei

given: Lai

name: Roche Products Ltd Welwyn Garden City UK

family: Pavlovic

full_name: Vedran Pavlovic

given: Vedran

family: Bansal

full_name: Aruna T. Bansal

given: Aruna T.

name: Guangdong General Hospital Guangzhou China

full_name: Xiaoping Chen

given: Xiaoping

name: Queen Mary’s University of London Bart’s and The London School of Medicine London UK

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: He

full_name: Hua He

given: Hua

name: Department of Internal Medicine National Taiwan University Hospital Taipei Taiwan

family: Kao

full_name: Jia‐Horng Kao

given: Jia‐Horng

name: AM & A Migliavacca Center for Liver Disease, Gastroenterology and Hepatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Università degli Studi di Milano Milan Italy

family: Lampertico

full_name: Pietro Lampertico

given: Pietro

name: Liver Research Unit, Chang Gung Memorial Hospital Chang Gung University College of Medicine Taipei Taiwan

family: Liaw

full_name: Yun‐Fan Liaw

given: Yun‐Fan

name: Infectious and Tropical Diseases Hospital ‘Dr. Victor Babes’ Bucharest Romania

family: Motoc

full_name: Adriana Motoc

given: Adriana

name: Department of Gastroenterology, Medical School of National & Kapodistrian University of Athens Laiko General Hospital Athens Greece

family: Papatheodoridis

full_name: George V. Papatheodoridis

given: George V.

name: NKC Institute of Gastroenterology and Hepatology Prince of Songkla University Hat‐Yai Thailand

family: Piratvisuth

full_name: Teerha Piratvisuth

given: Teerha

name: Clinical Department Of Infectious Diseases, Faculty of Medicine University of Rzeszów Łańcut Poland

family: Plesniak

full_name: Robert Plesniak

given: Robert

family: Wat

full_name: Cynthia Wat

given: Cynthia

journal_name: Journal of Viral Hepatitis

oa_host_type: repository

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

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

title: Genetic variation inFCER1Apredicts peginterferon alfa‐2a‐induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
France
Bulgaria
Greece
Poland
Thailand
Romania
New Zealand
China
Germany
United Kingdom
Korea, Republic of
Taiwan
Portugal

location_facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie

location_facility: China Medical University Hospital; Department of Rheumatology

location_facility: Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale

location_facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia

location_facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny

location_facility: Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM

location_facility: University Hospital of Larissa; Pathological Clinic

location_facility: Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia

location_facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby

location_facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology

location_facility: The Hospital of Tropical and Infectious Disease Victor Babes

location_facility: National Taiwan Uni Hospital; Gastro-Enterology Dept.

location_facility: Uni Di Cagliari; Dept. Di Scienze Mediche

location_facility: Taipei Veterans General Hospital; Gastroenterology Division

location_facility: Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

location_facility: Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg

location_facility: Clinical Infectious Diseases Hospital Victor Babes

location_facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie

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

location_facility: Changhua Christian Hospital; Internal Medicine

location_facility: Hippokratio Hospital; 4Th Internal Medicine Dpt

location_facility: Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie

location_facility: Inje University Busan Paik Hospital; Nephrology

location_facility: Beijing 302 Hospital; No. 2 Infectious Disease Section

location_facility: The First Affiliate Hospital of Guangxi Medical University

location_facility: Songklanagarind Hospital; Division of Gastroenterology

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: The Third Hospital of Hebei Medical University

location_facility: The Second Affiliated Hospital, Chongqing Medical University

location_facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Az. Osp. S. Sebastiano; Divisione Malattie Infettive

location_facility: The 1st Affiliated Hospital of Harbin Medical University

location_facility: Az. Osp. Uni Ria Di Parma; Gastro-Enterology

location_facility: Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia

location_facility: Hospital For Infectious Diseases; Infectiology

location_facility: Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: The Eighth People's Hospital of Guangzhou

location_facility: Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti

location_facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

location_facility: Tri-Service Hospital; Dept. of Internal Medicine

location_facility: Nanjing No.2 Hospital; Liver Disease Department

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Mhat Sveta Marina; Clinic of Gastroenterology

location_facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby

location_facility: Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych

location_facility: Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: Xiangya Hospital of Centre-South University

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: Samsung Medical Center; Gastroenterology

location_facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie

location_facility: Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology

location_facility: Hospital de Sao Joao; Servico de Gastrenterologia

location_facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

location_facility: Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive

location_facility: General Hospital of Ningxia Medical University

location_facility: Ospedale de Bellis; Reparto Medicina Generale

location_facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

location_facility: Chiang Mai Uni Hospital; Faculty of Medicine

location_facility: Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.

location_facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

acronym: PEARL

summary:
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.

Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. The participants were no longer enrolled in the study, the follow ups on subjects were stopped and the collection and analysis of samples for further research purposes was stopped.

After the stop to recruitment, the study was unblinded, as per the amended protocol, the study treatment was continued and completed with the subjects of the active treatment group who were willing to continue. Subjects in the placebo group were withdrawn.

There was no longer an active follow-up of patients after discontinuation or completion of the treatment. The study ended 30 days after the last dose was administered.

As a result, primary and secondary objectives were not assessed as planned. All clinical and safety data collected in the study were analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing was not performed by default, except if a scientific rationale remained relevant despite the premature termination of the study.

ipd_sharing: Yes

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below).

lead_sponsor: GlaxoSmithKline

location_country:
United States
France
Japan
Poland
Russian Federation
Estonia
Germany
United Kingdom
Korea, Republic of

intervention_type: Biological


lead_sponsor: Allergan

location_country:
Italy
United States
France
Czechia
Poland
Belgium
Turkey
Canada

location_facility: William Beaumont Hospital Research Institute

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

location_facility: Washington University School of Medicine

location_facility: Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: CHU de Limoges - Hopital Mere et l'Enfant

source: euctr

title: BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

summary: This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.


title: Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE

acronym: DASFREE

summary: The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Other

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Spain
Germany
Canada

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Ucsf-Helen Diller Family Comprehensive Cancer Center

location_facility: Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Northwestern University, Feinberg School of Medicine

status_simplified: Unknown


title: A Two Arm Phase II Study of FOLFIRI in Combination With Standard or Escalating Dose of Cetuximab as First Line Treatment of K-Ras Wild Type Metastatic Colorectal Cancer: Everest 2

summary: The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Universitaire Ziekenhuizen Leuven

location_country: Austria France Hungary Belgium Spain

location_facility: Centre Hospitalier de Jolimont-Lobbes, Oncology Médicale

location_facility: Landeskrankenhaus Salzburg, Univ. Klinik für innere Medizin III, Universitätsklinikum der PMU

location_facility: Medical Center of the University of Pecs , National Institute Oncology

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Krankenanstalt Rudolfstiftung, 1 medizinishe Abteilung

location_facility: AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinishe Onkologie

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsklinik für Innere medizin, Klinishe abteilung für hämatologie und Onkologie

lead_sponsor_type: academique


title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis

summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

status: Active, not recruiting

ReferenceCitation: Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2021 Mar 16. doi: 10.1111/ene.14823. [Epub ahead of print]

name: Queen Mary University of London London UK

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

name: Research Center for Clinical Neuroimmunology and Neuroscience and MS Center University Hospital Basel and University of Basel Basel Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: University Hospital of Strasbourg Strasbourg France

family: Seze

full_name: Jerome Seze

given: Jerome

family: Hauser

full_name: Stephen L. Hauser

given: Stephen L.

name: F. Hoffmann‐La Roche Ltd Basel Switzerland

family: Overell

full_name: James Overell

given: James

family: Koendgen

full_name: Harold Koendgen

given: Harold

family: Manfrini

full_name: Marianna Manfrini

given: Marianna

family: Wang

full_name: Qing Wang

given: Qing

name: McGovern Medical School The University of Texas Health Science Center at Houston (UTHealth) Houston TX USA

family: Wolinsky

full_name: Jerry S. Wolinsky

given: Jerry S.

journal_name: European Journal of Neurology

oa_host_type: publisher

ReferenceCitation: Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Brochet

full_name: Bruno Brochet

given: Bruno

family: Naismith

full_name: Robert T. Naismith

given: Robert T.

family: Traboulsee

full_name: Anthony Traboulsee

given: Anthony

family: Belachew

full_name: Shibeshih Belachew

given: Shibeshih

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

name: University Hospital Basel, University of Basel, Basel, Switzerland

name: McGovern Medical School, The University of Texas Health Science Center at Houston, Houston

name: Queen Mary University of London, London, United Kingdom

name: McGill University, Montreal, Quebec, Canada

name: NeuroRx Research, Montreal, Quebec, Canada

name: F. Hoffmann–La Roche Ltd, Basel, Switzerland

name: Now with Biogen, Cambridge, Massachusetts

name: Weill Institute for Neurosciences, University of California, San Francisco, San Francisco

ReferenceCitation: Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: Tampere University - Tampere University Institutional Repository

location_country:
Peru
Finland
Australia
Belgium
Russian Federation
Ukraine
France
Poland
Lithuania
Slovakia
Argentina
South Africa
Chile
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Tunisia
Spain
Estonia
Latvia

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

location_facility: Chaim Sheba Medical Center; Neurology Department

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Neurologia

location_facility: P. Stradins Clinical University Hospital; Neurology

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Uni of Texas Health Science Center At Houston

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune

location_facility: Michigan Institute for Neurological Disorders

location_facility: Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie

location_facility: Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Multicare Research Institute; Multicare Neuroscience Center of Washington

location_facility: Hopital Universitaire Fattouma Bourguiba

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: The Ohio State University Wexner Medical Center

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Reg. SI of Health Care Smolensk Regional Clinical Hospital

location_facility: Maritime Medicine Centre of Latvia Hospital of Vecmilgravis; Department of Neurology

location_facility: Asklepiosklinik Barmbek; Abteilung Neurologie

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics

location_facility: Krajska zdravotni, a. s. - Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Walton Center For Neurology & Neurosurgery; Clinical Trials Unit

location_facility: Clinica Centenario Peruano Japonesa; Neurology

location_facility: Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren

location_facility: The MS Center; Advance Neurology and Pain

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"

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

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Northwestern University; Dept. of Neurology

location_facility: MRC for Oncology and Neurology Biotherapy

location_facility: Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: MMA of Ministry of Defense of Russia named after S.M. Kirov

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: Albert Einstein Medical Center; Depatment of Neurosensory sciences

location_facility: Cliniques Universitaires Saint-Luc; Neurology

location_facility: MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Southern California Permanente Medical Group

location_facility: Universitätsspital Basel; Neurologische Poliklinik

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: Carolinas Medical Center; Department of Neurology

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: Royal North Shore Hospital; Department of Neurology

location_facility: Azienda Socio Sanitaria Territoriale della Valle Olona (pres

location_facility: Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases

location_facility: Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Lviv Regional Clinical Hospital; Department of Neurology

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: St.-Peterburg State institution of health care City multifield hospital #2

location_facility: Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie

location_facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

location_facility: Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology

location_facility: Emory University; Department of Neurology

location_facility: University of California at San Francisco

location_facility: Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti


ReferenceCitation: Shieh PB, Elfring G, Trifillis P, Santos C, Peltz SW, Parsons JA, Apkon S, Darras BT, Campbell C, McDonald CM; Members of the Ataluren Phase IIb Study Group †; Members of the Ataluren Phase IIb Study Clinical Evaluator Training Group ‡; Members of the ACT DMD Study Group ¶; Members of the ACT DMD Clinical Evaluator Training Group §. Meta-analyses of deflazacort versus prednisone/prednisolone in patients with nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2021 Oct 25. doi: 10.2217/cer-2021-0018. [Epub ahead of print]

name: University of California at Los Angeles, Los Angeles, CA, USA

family: Shieh

full_name: Perry B Shieh

given: Perry B

name: PTC Therapeutics, Inc., South Plainfield, NJ, USA

family: Elfring

full_name: Gary Elfring

given: Gary

family: Trifillis

full_name: Panayiota Trifillis

given: Panayiota

family: Santos

full_name: Claudio Santos

given: Claudio

family: Peltz

full_name: Stuart W Peltz

given: Stuart W

name: University of Colorado School of Medicine, Aurora, CO, USA

family: Parsons

full_name: Julie A Parsons

given: Julie A

family: Apkon

full_name: Susan Apkon

given: Susan

name: Boston Children’s Hospital, Boston, MA, USA

family: Darras

full_name: Basil T Darras

given: Basil T

name: Children’s Hospital – London Health Sciences Centre, University of Western Ontario, London, ON, Canada

family: Campbell

full_name: Craig Campbell

given: Craig

name: University of California Davis Health, Sacramento, CA, USA

family: McDonald

full_name: Craig M McDonald

given: Craig M

family: Barohn

full_name: Richard J Barohn

given: Richard J

family: Bertini

full_name: Enrico Bertini

given: Enrico

family: Bushby

full_name: Kate Bushby

given: Kate

family: Chabrol

full_name: Brigitte Chabrol

given: Brigitte

family: Ciafaloni

full_name: Emma Ciafaloni

given: Emma

family: Columer

full_name: Jaume Columer

given: Jaume

family: Comi

full_name: Giacomi Pietro Comi

given: Giacomi Pietro

family: Connolly

full_name: Anne Connolly

given: Anne

family: Finkel

full_name: Richard S Finkel

given: Richard S

family: Flanigan

full_name: Kevin M Flanigan

given: Kevin M

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: Guglieri

full_name: Michela Guglieri

given: Michela

family: Iannaccone

full_name: Susan T Iannaccone

given: Susan T

family: Jones

full_name: Kristi J Jones

given: Kristi J

family: Kaufmann

full_name: Petra Kaufmann

given: Petra

full_name: Alexandra Prufer de Queiroz Campos Araujo

journal_name: Journal of Comparative Effectiveness Research

ReferenceCitation: Campbell C, Barohn RJ, Bertini E, Chabrol B, Comi GP, Darras BT, Finkel RS, Flanigan KM, Goemans N, Iannaccone ST, Jones KJ, Kirschner J, Mah JK, Mathews KD, McDonald CM, Mercuri E, Nevo Y, Péréon Y, Renfroe JB, Ryan MM, Sampson JB, Schara U, Sejersen T, Selby K, Tulinius M, Vílchez JJ, Voit T, Wei LJ, Wong BL, Elfring G, Souza M, McIntosh J, Trifillis P, Peltz SW, Muntoni F; PTC124-GD-007-DMD Study Group; ACT DMD Study Group; Clinical Evaluator Training Groups. Meta-analyses of ataluren randomized controlled trials in nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2020 Oct;9(14):973-984. doi: 10.2217/cer-2020-0095. Epub 2020 Aug 27.

name: Schulich School of Medicine & Dentistry, Western University, London, ON, N6A 5C1, Canada

name: University of Kansas Medical Center, Kansas City, KS 66160, USA

name: Bambino Gesù Children’s Research Hospital, Rome, 00146, Italy

name: Hôpital de la Timone, Unité de Médecine Infantile, Marseille, 13385, France

name: IRCCS Fondazione Ca'Granda Ospedale Maggiore Policlinico, Dino Ferrari Centre, Department of Pathophysiology & Transplantation, University of Milan, Milan, 20122, Italy

name: Boston Children’s Hospital, Harvard Medical School, Boston, MA 02115, USA

name: Children’s Hospital of Philadelphia, Philadelphia, PA 19104, USA

name: St. Jude Children’s Research Hospital, Memphis, TN 38105, USA

name: Nationwide Children’s Hospital, Columbus, OH 43205, USA

name: University Hospitals Leuven, KU Leuven, Leuven, 3000, Belgium

name: University of Texas Southwestern Medical Center, Dallas, TX 75390, USA

name: Kids Neuroscience, The Children’s Hospital at Westmead, Westmead, NSW, 2145, Australia

name: Department of Neuropediatrics & Muscle Disorders, Medical Center, University of Freiburg, Freiburg 79110, Germany

name: Department of Pediatrics, Division of Pediatric Neurology, Alberta Children’s Hospital, University of Calgary, Calgary, AB T3B 6A8, Canada

name: Departments of Pediatrics & Neurology, Division of Pediatric Neurology, University of Iowa Carver College of Medicine, Iowa City, IA 52242, USA

name: University of California Davis Health, Sacramento, CA 95817, USA

name: Department of Pediatric Neurology, Catholic University, Rome, 00168, Italy

name: Schneider Children’s Medical Center, Tel Aviv University, Tel Aviv, 6997801, Israel

name: Reference Centre for Neuromuscular Disorders AOC, Hôtel-Dieu, Nantes, 44000, France

name: Child Neurology Center of Northwest Florida, Gulf Breeze, FL 32561, USA

name: The Royal Children’s Hospital, Parkville, Victoria, 3052, Australia

name: Stanford University Medical Center, Department of Neurology & Neurological Sciences, Stanford, CA 94305, USA

name: Department of Pediatric Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, 45122, Germany

name: Karolinska University Hospital, Karolinska Institutet, Stockholm, 171 76, Sweden

name: Division of Neurology, British Columbia Children’s Hospital, Vancouver, BC, V6H 3N1, Canada

name: Gothenburg University, Queen Silvia Children’s Hospital, Gothenburg, 416 85, Sweden

name: Hospital Universitario y Politécnico La Fe, CIBERER, Valencia, 46026, Spain

name: NIHR Great Ormond Street Hospital Biomedical Research Centre, University College London & UCL Great Ormond Street Institute of Child Health, Great Ormond Street Hospital Trust, London, WC1N 1EH, UK

name: Harvard TH Chan School of Public Health, Harvard University, Boston, MA 02115, USA

name: University of Massachusetts Medical School, UMass, Worcester, MA 01655, USA

name: PTC Therapeutics Inc., South Plainfield, NJ 07080, USA

name: on behalf of the PTC124-GD-007-DMD Study Group

repository_normalized: University of Melbourne - Minerva Access

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

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

repository_institution: University College London - UCL Discovery

repositories: University of Melbourne - Minerva Access

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_institution: University College London - UCL Discovery

ReferenceCitation: McDonald CM, Campbell C, Torricelli RE, Finkel RS, Flanigan KM, Goemans N, Heydemann P, Kaminska A, Kirschner J, Muntoni F, Osorio AN, Schara U, Sejersen T, Shieh PB, Sweeney HL, Topaloglu H, Tulinius M, Vilchez JJ, Voit T, Wong B, Elfring G, Kroger H, Luo X, McIntosh J, Ong T, Riebling P, Souza M, Spiegel RJ, Peltz SW, Mercuri E; Clinical Evaluator Training Group; ACT DMD Study Group. Ataluren in patients with nonsense mutation Duchenne muscular dystrophy (ACT DMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Sep 23;390(10101):1489-1498. doi: 10.1016/S0140-6736(17)31611-2. Epub 2017 Jul 17.

location_country:
Italy
United States
Brazil
Chile
Sweden
Switzerland
Germany
France
Czechia
Poland
Israel
Belgium
Australia
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: Columbia University College of Physicians & Surgeons

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

location_facility: Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research

location_facility: Fondazione IRCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Hospital Universitari i Politecnic la Fe

location_facility: University Hospital Medical Center Freiburg

location_facility: Seattle Children's Hospital - Childhood Cancer and Blood Disorders

location_facility: University College London Institute of Child Health

location_facility: Universidade Federal do Rio de Janeiro - Instituto de Puericultura e Pediatria Martagao Gesteira

title: A Phase 3 Efficacy and Safety Study of Ataluren in Patients With Nonsense Mutation Dystrophinopathy

summary: Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy in approximately 10-15 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability. The effect of ataluren on physical function, quality of life, and activities of daily living will be evaluated. This study will also provide additional information on the long-term safety of ataluren.


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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
Brazil
Mexico
Netherlands
Germany
France
Japan
Poland
Israel
Belgium
Spain
Turkey
United States

location_facility: Children's Heathcare of Atlanta, Inc. at Egleston

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu

location_facility: Pronto Socorro Cardiologico de Pernambuco-PROCAPE

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie-Prokocimiu

location_facility: National Center For Child Health And Development

location_facility: Vanderbilt Univeristy School of Medicine

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Hopital Haut Leveque - Group hospitalier Sud

location_facility: Istituto Giannina Gaslini Ospedale Pediatrico I.R.C.C.S.

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Hacettepe University Faculty of Medicine

location_facility: Shizuoka Prefectural Children's Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Okinawa Prefectural Nanbu Medical Center & Children's Med Ct

type: Other Identifier

title: A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension

summary: The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.


title: International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve

summary: This study will further assess the performance and safety profile of the commercially available Portico Valve implanted, using the Delivery System and the Loading System, in patients with severe symptomatic aortic stenosis through 5 years of follow-up.

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Søndergaard L, Rodés-Cabau J, Hans-Peter Linke A, Fichtlscherer S, Schäfer U, Kuck KH, Kempfert J, Arzamendi D, Bedogni F, Asch FM, Worthley S, Maisano F. Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2859-2867. doi: 10.1016/j.jacc.2018.09.014. Epub 2018 Sep 24.

family: Søndergaard

full_name: Lars Søndergaard

given: Lars

family: Rodés-Cabau

full_name: Josep Rodés-Cabau

given: Josep

family: Hans-Peter Linke

full_name: Axel Hans-Peter Linke

given: Axel

family: Fichtlscherer

full_name: Stephan Fichtlscherer

given: Stephan

family: Schäfer

full_name: Ulrich Schäfer

given: Ulrich

family: Kuck

full_name: Karl-Heinz Kuck

given: Karl-Heinz

family: Kempfert

full_name: Joerg Kempfert

given: Joerg

family: Arzamendi

full_name: Dabit Arzamendi

given: Dabit

family: Bedogni

full_name: Francesco Bedogni

given: Francesco

family: Asch

full_name: Federico M. Asch

given: Federico M.

family: Worthley

full_name: Stephen Worthley

given: Stephen

family: Maisano

full_name: Francesco Maisano

journal_name: Journal of the American College of Cardiology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Abbott Medical Devices

location_country:
Italy
Switzerland
Netherlands
Germany
France
Lithuania
Israel
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Institut de Cardiologie de Quebec (Hospital Laval)

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino

location_facility: Morriston hospital-ABM University Health Board

location_facility: Herzzentrum Brandenburg Evangelisches Freikirchliches Krankenhaus - Herzchirurgie

location_facility: Vilnius University Hospital Santarisku KLinikos

location_facility: Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore

location_facility: Städtisches Klinikum Karlsruhe, Klinik für Innere Medizin IV

location_facility: UKE Hamburg (Universitatsklinik Eppendorf)

location_facility: Universitätsmedizn Berlin - Campus Benjamin

location_facility: Herzzentrum Göttingen der Georg-August-Universität

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: Klinikum der Friedrich Schiller Universität Jena

location_facility: Hospital Universitario Virgen de Arrixaca

location_facility: Institute Cardio, Paris Sud Institut Jacques Cartier

intervention_type: Device

status_simplified: Ongoing


title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

summary:
This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .

ReferenceType: background

ReferenceCitation: Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.

ReferenceCitation: Gulley JL, Rajan A, Spigel DR, Iannotti N, Chandler J, Wong DJL, Leach J, Edenfield WJ, Wang D, Grote HJ, Heydebreck AV, Chin K, Cuillerot JM, Kelly K. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol. 2017 May;18(5):599-610. doi: 10.1016/S1470-2045(17)30240-1. Epub 2017 Mar 31.

ReferenceCitation: Heery CR, O'Sullivan-Coyne G, Madan RA, Cordes L, Rajan A, Rauckhorst M, Lamping E, Oyelakin I, Marté JL, Lepone LM, Donahue RN, Grenga I, Cuillerot JM, Neuteboom B, Heydebreck AV, Chin K, Schlom J, Gulley JL. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017 May;18(5):587-598. doi: 10.1016/S1470-2045(17)30239-5. Epub 2017 Mar 31.

ReferenceCitation: Guigay J, Lee KW, Patel MR, Daste A, Wong DJ, Goel S, Gordon MS, Gutierrez M, Balmanoukian A, Le Tourneau C, Mita A, Vansteene D, Keilholz U, Schöffski P, Grote HJ, Zhou D, Bajars M, Penel N. Avelumab for platinum-ineligible/refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2021 Oct;9(10). pii: e002998. doi: 10.1136/jitc-2021-002998.

family: Guigay

full_name: Joël Guigay

given: Joël

family: Lee

full_name: Keun-Wook Lee

given: Keun-Wook

family: Patel

full_name: Manish R Patel

given: Manish R

family: Daste

full_name: Amaury Daste

given: Amaury

family: Wong

full_name: Deborah J Wong

given: Deborah J

family: Goel

full_name: Sanjay Goel

given: Sanjay

family: Gordon

full_name: Michael S Gordon

given: Michael S

family: Gutierrez

full_name: Martin Gutierrez

given: Martin

family: Balmanoukian

full_name: Ani Balmanoukian

given: Ani

family: Le Tourneau

full_name: Christophe Le Tourneau

given: Christophe

family: Mita

full_name: Alain Mita

given: Alain

family: Vansteene

full_name: Damien Vansteene

given: Damien

family: Keilholz

full_name: Ulrich Keilholz

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Grote

full_name: Hans Juergen Grote

given: Hans Juergen

family: Zhou

full_name: Dongli Zhou

given: Dongli

family: Bajars

full_name: Marcis Bajars

given: Marcis

family: Penel

full_name: Nicolas Penel

given: Nicolas

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

evidence: oa journal (via doaj)

ReferenceCitation: Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2). pii: e001427. doi: 10.1136/jitc-2020-001427.

ReferenceCitation: Verschraegen CF, Jerusalem G, McClay EF, Iannotti N, Redfern CH, Bennouna J, Chen FL, Kelly K, Mehnert J, Morris JC, Taylor M, Spigel D, Wang D, Grote HJ, Zhou D, Munshi N, Bajars M, Gulley JL. Efficacy and safety of first-line avelumab in patients with advanced non-small cell lung cancer: results from a phase Ib cohort of the JAVELIN Solid Tumor study. J Immunother Cancer. 2020 Sep;8(2). pii: e001064. doi: 10.1136/jitc-2020-001064.

ReferenceCitation: Del Rivero J, Donahue RN, Marté JL, Gramza AW, Bilusic M, Rauckhorst M, Cordes L, Merino MJ, Dahut WL, Schlom J, Gulley JL, Madan RA. A Case Report of Sequential Use of a Yeast-CEA Therapeutic Cancer Vaccine and Anti-PD-L1 Inhibitor in Metastatic Medullary Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Aug 7;11:490. doi: 10.3389/fendo.2020.00490. eCollection 2020.

ReferenceCitation: Vaishampayan U, Schöffski P, Ravaud A, Borel C, Peguero J, Chaves J, Morris JC, Kotecki N, Smakal M, Zhou D, Guenther S, Bajars M, Gulley JL. Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Oct 24;7(1):275. doi: 10.1186/s40425-019-0746-2.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Rajan A, Heery CR, Thomas A, Mammen AL, Perry S, O'Sullivan Coyne G, Guha U, Berman A, Szabo E, Madan RA, Ballester LY, Pittaluga S, Donahue RN, Tsai YT, Lepone LM, Chin K, Ginty F, Sood A, Hewitt SM, Schlom J, Hassan R, Gulley JL. Efficacy and tolerability of anti-programmed death-ligand 1 (PD-L1) antibody (Avelumab) treatment in advanced thymoma. J Immunother Cancer. 2019 Oct 21;7(1):269. doi: 10.1186/s40425-019-0723-9.

ReferenceCitation: Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.

name: Merck Institute of Pharmacometrics Merck Serono SA Lausanne Switzerland

title: Changing Body Weight–Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma

ReferenceCitation: Chung HC, Arkenau HT, Lee J, Rha SY, Oh DY, Wyrwicz L, Kang YK, Lee KW, Infante JR, Lee SS, Kemeny M, Keilholz U, Melichar B, Mita A, Plummer R, Smith D, Gelb AB, Xiong H, Hong J, Chand V, Safran H. Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Feb 4;7(1):30. doi: 10.1186/s40425-019-0508-1.

repository_institution: Yonsei University Medical Library - YUHSpace

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: Yonsei University Medical Library - YUHSpace

title: Avelumab (anti–PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial

ReferenceCitation: Disis ML, Taylor MH, Kelly K, Beck JT, Gordon M, Moore KM, Patel MR, Chaves J, Park H, Mita AC, Hamilton EP, Annunziata CM, Grote HJ, von Heydebreck A, Grewal J, Chand V, Gulley JL. Efficacy and Safety of Avelumab for Patients With Recurrent or Refractory Ovarian Cancer: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):393-401. doi: 10.1001/jamaoncol.2018.6258.

name: Department of Medicine, UW Medicine Cancer Vaccine Institute, University of Washington School of Medicine, Seattle

name: Knight Cancer Institute, Oregon Health and Science University, Portland

name: Davis Comprehensive Cancer Center, University of California, Sacramento

name: Medical Oncology, Highlands Oncology Group, Fayetteville, Arkansas

name: HonorHealth Research Institute, HonorHealth Virginia G. Piper Cancer Care Network, Scottsdale, Arizona

name: Peggy and Charles Stephenson Oklahoma Cancer Center/Sarah Cannon Research Institute, University of Oklahoma, Oklahoma City

name: Medical Oncology, Sarah Cannon Research Institute, Florida Cancer Specialists, Sarasota

name: Medical Oncology, Northwest Medical Specialties, Tacoma, Washington

name: Division of Oncology, Washington University School of Medicine, St Louis, Missouri

name: Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California

name: Medical Oncology, Tennessee Oncology, Sarah Cannon Research Institute, Nashville

name: Women’s Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland

name: Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt Germany

name: Global Biostatistics, Merck KGaA, Darmstadt, Germany

name: Global Clinical Development, EMD Serono, Billerica, Massachusetts

name: currently at Hematology, Norton Healthcare, Louisville, Kentucky

name: currently at Global Development, AstraZeneca Pharmaceuticals LP, Gaithersburg, Maryland

name: Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland

ReferenceCitation: Keilholz U, Mehnert JM, Bauer S, Bourgeois H, Patel MR, Gravenor D, Nemunaitis JJ, Taylor MH, Wyrwicz L, Lee KW, Kasturi V, Chin K, von Heydebreck A, Gulley JL. Avelumab in patients with previously treated metastatic melanoma: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Jan 16;7(1):12. doi: 10.1186/s40425-018-0459-y.

ReferenceCitation: Hassan R, Thomas A, Nemunaitis JJ, Patel MR, Bennouna J, Chen FL, Delord JP, Dowlati A, Kochuparambil ST, Taylor MH, Powderly JD, Vaishampayan UN, Verschraegen C, Grote HJ, von Heydebreck A, Chin K, Gulley JL. Efficacy and Safety of Avelumab Treatment in Patients With Advanced Unresectable Mesothelioma: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):351-357. doi: 10.1001/jamaoncol.2018.5428.

name: Thoracic and GI Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

name: Developmental Therapeutics Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

name: Division of Hematology and Oncology, University of Toledo College of Medicine, Toledo, Ohio

name: Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota

name: Department of Pneumology, Thoracic Oncology Unit, University Hospital of Nantes, Nantes, France

name: Novant Health Oncology Specialists, Winston-Salem, North Carolina

name: Institut Universitaire du Cancer-Oncopole, Toulouse, France

name: Division of Hematology and Oncology, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, Ohio

name: Virginia Piper Cancer Institute, Minneapolis, Minnesota

name: Knight Cancer Institute, Oregon Health & Science University, Portland

name: Carolina BioOncology Institute, Huntersville, North Carolina

name: Karmanos Cancer Institute, Wayne State University, Detroit, Michigan

name: Division of Medical Oncology, Ohio State University Comprehensive Cancer Center, Columbus

name: Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

name: Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

ReferenceCitation: Le Tourneau C, Hoimes C, Zarwan C, Wong DJ, Bauer S, Claus R, Wermke M, Hariharan S, von Heydebreck A, Kasturi V, Chand V, Gulley JL. Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial. J Immunother Cancer. 2018 Oct 22;6(1):111. doi: 10.1186/s40425-018-0424-9.

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

repositories_institution: Augsburg University - OPUS - Augsburg University Publication Server

ReferenceCitation: Patel MR, Ellerton J, Infante JR, Agrawal M, Gordon M, Aljumaily R, Britten CD, Dirix L, Lee KW, Taylor M, Schöffski P, Wang D, Ravaud A, Gelb AB, Xiong J, Rosen G, Gulley JL, Apolo AB. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018 Jan;19(1):51-64. doi: 10.1016/S1470-2045(17)30900-2. Epub 2017 Dec 5. Erratum in: Lancet Oncol. 2018 Jul;19(7):e335.

ReferenceCitation: Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, Heery CR, Gulley JL, Schlom J. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer. 2017 Feb 21;5:20. doi: 10.1186/s40425-017-0220-y. eCollection 2017.

location_country:
United States
France
Czechia
Poland
Belgium
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center - d/b/a The Mark H. Zangmeister Center

location_facility: Centre Paul Strauss - Service de Médecine Oncologique

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH - Innere Medizin II Haematologie / Onkologie

location_facility: Penn State Univ. Milton S. Hershey Medical Center - MSHMC Cardiology

location_facility: Columbia University College of Phys & Surgeons

location_facility: Scripps Health dba Scripps Clinical Research Services

location_facility: University of California Davis Health System

location_facility: University of North Carolina at Chapel Hill

location_facility: Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center

location_facility: Nemocnice Rudolfa a Stefanie Benesov, a.s.

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.

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

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Seoul National University Bundang Hospital

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

location_facility: Peachtree Hematology-Oncology Consultants, PC

location_facility: OSU - James Comprehensive Cancer Center - Division of Hematology

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Cancer Treatment Centers of America - Western Regional Medical Center

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

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

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie - Dept of Digestive System Oncology

location_facility: Georgetown University Medical Center- Research Parent

location_facility: Derriford Hospital - Dept of Oncology Clinical Trials

location_facility: Augusta University - formerly Georgia Regents University

location_facility: The Angeles Clinic and Research Institute - West LA

location_facility: University Hospitals Case Medical Center - Case Comprehensive Cancer Center

location_facility: California Cancer Associates for Research & Excellence, Inc


title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

summary: The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

ReferenceCitation: Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Büttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.

family: Glina

full_name: Sidney Glina

given: Sidney

family: Roehrborn

full_name: Claus G. Roehrborn

given: Claus G.

family: Esen

full_name: Adil Esen

given: Adil

family: Plekhanov

full_name: Alexey Plekhanov

given: Alexey

family: Sorsaburu

full_name: Sebastian Sorsaburu

given: Sebastian

family: Henneges

full_name: Carsten Henneges

given: Carsten

family: Büttner

full_name: Hartwig Büttner

given: Hartwig

family: Viktrup

full_name: Lars Viktrup

given: Lars

journal_name: The Journal of Sexual Medicine

title: Sexual Function in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia: Results of a 6‐Month, Randomized, Double‐Blind, Placebo‐Controlled Study of Tadalafil Coadministered with Finasteride

location_country:
Italy
United States
Brazil
Mexico
Germany
France
Poland
Greece
Belgium
Argentina
Russian Federation
Turkey
Canada

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


ReferenceCitation: Hézode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourlière M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Bräu N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.

family: Hézode

full_name: Christophe Hézode

family: Hirschfield

full_name: Gideon M Hirschfield

given: Gideon M

family: Ghesquiere

full_name: Wayne Ghesquiere

given: Wayne

family: Sievert

full_name: William Sievert

given: William

family: Rodriguez-Torres

full_name: Maribel Rodriguez-Torres

given: Maribel

family: Shafran

full_name: Stephen D Shafran

given: Stephen D

family: Thuluvath

full_name: Paul J Thuluvath

given: Paul J

family: Tatum

full_name: Harvey A Tatum

given: Harvey A

family: Waked

full_name: Imam Waked

given: Imam

family: Esmat

full_name: Gamal Esmat

given: Gamal

family: Lawitz

full_name: Eric J Lawitz

given: Eric J

family: Rustgi

full_name: Vinod K Rustgi

given: Vinod K

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Weis

full_name: Nina Weis

given: Nina

family: Pockros

full_name: Paul J Pockros

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

family: Vierling

full_name: John M Vierling

given: John M

family: Fried

full_name: Michael W Fried

given: Michael W

family: Weiland

full_name: Ola Weiland

given: Ola

family: Brunetto

full_name: Maurizia R Brunetto

given: Maurizia R

family: Everson

full_name: Gregory T Everson

given: Gregory T

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Kwo

full_name: Paul Y Kwo

given: Paul Y

family: Sulkowski

full_name: Mark Sulkowski

given: Mark

location_country:
Italy
United States
Sweden
Mexico
Germany
France
Australia
Puerto Rico
Egypt
Denmark
Canada

location_facility: Transplant Center And Hepatology Clinic, B-154

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of California, San Francisco/Sf General Hospital

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

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

location_facility: Upper Delaware Valley Infectious Diseases, Pc

title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

summary: To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


ReferenceCitation: Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandström T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.

family: Wedzicha

full_name: Jadwiga A Wedzicha

given: Jadwiga A

family: Decramer

full_name: Marc Decramer

family: Ficker

full_name: Joachim H Ficker

given: Joachim H

family: Niewoehner

full_name: Dennis E Niewoehner

given: Dennis E

family: Sandström

full_name: Thomas Sandström

given: Thomas

family: Taylor

full_name: Angel Fowler Taylor

given: Angel Fowler

family: D'Andrea

full_name: Peter D'Andrea

given: Peter

family: Arrasate

full_name: Christie Arrasate

given: Christie

family: Chen

full_name: Hungta Chen

given: Hungta

family: Banerji

full_name: Donald Banerji

given: Donald

journal_name: The Lancet Respiratory Medicine

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Finland
Greece
Russian Federation
Denmark
Czech Republic
India
France
Poland
Slovakia
Argentina
Canada
Colombia
South Africa
Netherlands
Philippines
Hungary
Ireland
Puerto Rico
United States
Germany
United Kingdom
Italy
Austria
Mexico
Israel
Spain
Estonia

acronym: SPARK

title: A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.


title: A 24-month, Multi-center, Open-label, Randomized, Controlled Trial to Investigate Efficacy, Safety and Evolution of Cardiovascular Parameters in de Novo Renal Transplant Recipients After Early Calcineurin Inhibitor to Everolimus Conversion

acronym: ELEVATE

summary: The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
India
France
Thailand
Lithuania
Norway
Argentina
Turkey
Netherlands
Portugal
Germany
Italy
Austria
Mexico
Spain
Estonia
Latvia


title: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes

summary: The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.

status: Terminated

location_country:
France
Czechia
Israel
Hungary
Australia
Puerto Rico
United States


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

family: Cai

full_name: Jennifer Cai

given: Jennifer

family: Delahanty

full_name: Linda M. Delahanty

given: Linda M.

family: Akapame

full_name: Sydney Akapame

given: Sydney

family: Slee

full_name: April Slee

given: April

family: Traina

full_name: Shana Traina

given: Shana

journal_name: The Patient - Patient-Centered Outcomes Research

repository_institution: PubMed Central - Europe PMC

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

family: Davies

full_name: Michael J. Davies

given: Michael J.

family: Merton

full_name: Katherine Merton

given: Katherine

family: Vijapurkar

full_name: Ujjwala Vijapurkar

given: Ujjwala

family: Yee

full_name: Jacqueline Yee

given: Jacqueline

family: Qiu

full_name: Rong Qiu

given: Rong

journal_name: Cardiovascular Diabetology

license: cc-by

license_normalized: cc-by

ReferenceCitation: Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

ReferenceCitation: Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

repository_institution: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

name: Janssen Research & Development, LLC, Raritan, NJ, USA;

name: Janssen Scientific Affairs, LLC, Raritan, NJ, USA

ReferenceCitation: John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

name: Providence Endocrine & Diabetes Specialty Centre  Trivandrum Kerala India

name: Hospital Cima Centro de Investigacíon Clínica San Agustín  San José Costa Rica

name: Centro de Estudios de Investigacíon Metabólicos y Cardiovasculares S.C.  Tampico Mexico

name: Rajavithi Hospital Rangsit Medical School  Bangkok Thailand

name: Dubai Hospital Dubai Health Authority  Dubai United Arab Emirates

name: Janssen Global Services, LLC  Raritan NJ USA

journal_name: International Journal of Clinical Practice

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Lavalle-González FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

name: aUniversidad Autonoma de Nuevo Leon, Monterrey, Mexico

name: bHospital Israelita Albert Einstein and CPClin Clinical Research Center, São Paulo, Brazil

name: cHospital Cima, Centro de Investigacíon Clínica San Agustín, San José, Costa Rica

name: dEndocrinología, Medicina Interna, Bogota, Colombia

name: eJanssen Research & Development, LLC, Raritan, NJ, USA

ReferenceCitation: Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

name: aOchsner Diabetes Clinical Research Unit, Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, LA, USA

name: bEndocrinology Section, Department of Internal Medicine, University of Manitoba, Winnipeg, Canada

name: cClinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium

name: dJanssen Research & Development LLC, Raritan, NJ, USA

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

name: aEmory University School of Medicine, Atlanta, GA, USA

name: bDiabetes Research Centre, University of Leicester, Leicester, UK

name: cJanssen Scientific Affairs LLC, Raritan, NJ, USA

ReferenceCitation: Cefalu WT, Stenlöf K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

ReferenceCitation: Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

name: Division of Nephrology; Department of Medicine; University of Maryland School of Medicine; Baltimore MD

name: Department of Hypertension; Institute of Cardiology; Warsaw Poland

name: University of Toronto; St. Michael's Hospital; Toronto ON Canada

name: Janssen Research & Development; LLC; Raritan NJ

title: Effect of Canagliflozin on Blood Pressure and Adverse Events Related to Osmotic Diuresis and Reduced Intravascular Volume in Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

title: Safety and Tolerability of Canagliflozin in Patients With Type 2 Diabetes Mellitus: Pooled Analysis of Phase 3 Study Results

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

name:
Division of Nephrology, University of Maryland School of Medicine
Baltimore, MDUSA

name: Janssen Research & Development, LLC Raritan, NJUSA

ReferenceCitation: Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

ReferenceCitation: Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

name:
Drexel University College of Medicine
Philadelphia, PAUSA

name:
Wayne State University School of Medicine
Detroit, MIUSA

name: Janssen Research & Development LLC Raritan, NJUSA

name: Janssen Research & Development LLC Titusville, NJUSA

location_country:
Guatemala
Mexico
Spain
France
Israel
Hungary
Belgium
Australia
Puerto Rico
Russian Federation
United States
United Kingdom