ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

family: Singh

full_name: Dave Singh

given: Dave

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Siddiqui

full_name: Salman Siddiqui

given: Salman

family: de la Hoz

full_name: Alberto de la Hoz

given: Alberto

family: Xue

full_name: Wenqiong Xue

given: Wenqiong

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

journal_name: Respiratory Research

repository_institution: University of Dundee - Discovery Research Portal

repositories_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Watz H, Tetzlaff K, Magnussen H, Mueller A, Rodriguez-Roisin R, Wouters EFM, Vogelmeier C, Calverley PMA. Spirometric changes during exacerbations of COPD: a post hoc analysis of the WISDOM trial. Respir Res. 2018 Dec 13;19(1):251. doi: 10.1186/s12931-018-0944-3.

family: Watz

full_name: Henrik Watz

given: Henrik

family: Tetzlaff

full_name: Kay Tetzlaff

given: Kay

family: Mueller

full_name: Achim Mueller

given: Achim

family: Rodriguez-Roisin

full_name: Roberto Rodriguez-Roisin

given: Roberto

family: Wouters

full_name: Emiel F. M. Wouters

given: Emiel F. M.

family: Vogelmeier

full_name: Claus Vogelmeier

given: Claus

ReferenceCitation: Watz H, Tetzlaff K, Wouters EF, Kirsten A, Magnussen H, Rodriguez-Roisin R, Vogelmeier C, Fabbri LM, Chanez P, Dahl R, Disse B, Finnigan H, Calverley PM. Blood eosinophil count and exacerbations in severe chronic obstructive pulmonary disease after withdrawal of inhaled corticosteroids: a post-hoc analysis of the WISDOM trial. Lancet Respir Med. 2016 May;4(5):390-8. doi: 10.1016/S2213-2600(16)00100-4. Epub 2016 Apr 7.

ReferenceCitation: Magnussen H, Disse B, Rodriguez-Roisin R, Kirsten A, Watz H, Tetzlaff K, Towse L, Finnigan H, Dahl R, Decramer M, Chanez P, Wouters EF, Calverley PM; WISDOM Investigators. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014 Oct 2;371(14):1285-94. doi: 10.1056/NEJMoa1407154. Epub 2014 Sep 8.

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

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

title: Withdrawal of Inhaled Glucocorticoids and Exacerbations of COPD

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Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
South Africa
Netherlands
Philippines
Bulgaria
Hungary
China
Germany
United Kingdom
Italy
Brazil
Tunisia
New Zealand
Spain
Turkey

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title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy

summary: This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


title: Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.

summary:
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting.

This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country: Italy Austria Netherlands France Czechia Bulgaria Greece Israel Norway Romania Belgium

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Centres Hospitaliers Jolimont - Hopital de Jolimont

location_facility: Targu-Mures County Emergency Clinical Hospital

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila"

location_facility: Azienda Unita Sanitaria Locale Toscana Centro

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Azienda Ospedaliera Brotzu Presidio Ospedaliero A Businco Centro di Riferimento Oncologico Regionale

location_facility: Azienda Ospedaliera di Alessandro Manzoni Lecco

location_facility: Spitalul Clinic Dr Gavril Curteanu Oradea

location_facility: University General Hospital of Evros-Alexandroupolis District

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

location_facility: Presidio Ospedaliero San Giuseppe Moscati

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: Centre Hospitalier Wallonie Picarde - site imc

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: University of Athens School of Medicine Alexandra Hospital

location_facility: Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona

location_facility: Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas

location_facility: Azienda Ospedaliero Universitaria Integrata di Udine

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Profesor Dr Ion Chiricuta Institut of Oncology

location_facility: General Hospital of Patras Agios Andreas

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: Special Anticancer Hospital of Piraeus Metaxa

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

summary: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.

name: Institute of Cellular Medicine, Faculty of Medical Sciences Newcastle University Newcastle upon Tyne United Kingdom

name: The Liver Unit Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust Newcastle upon Tyne United Kingdom

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

sequence: first

name: Texas Liver Institute University of Texas Health San Antonio San Antonio TX

family: Lawitz

full_name: Eric J. Lawitz

given: Eric J.

sequence: additional

family: Alkhouri

full_name: Naim Alkhouri

given: Naim

name: Department of Medicine and Therapeutics The Chinese Hospital of Hong Kong Hong Kong

family: Wong

full_name: Vincent Wai‐Sun Wong

given: Vincent Wai‐Sun

name: Hospital Universitario Virgen del Rocio Seville Spain

family: Romero‐Gomez

full_name: Manuel Romero‐Gomez

given: Manuel

name: Saiseikai Suita Hospital Suita City, Osaka Japan

family: Okanoue

full_name: Takeshi Okanoue

given: Takeshi

name: Division of Gastroenterology and Hepatology Medical University of Vienna Vienna Austria

family: Trauner

full_name: Michael Trauner

given: Michael

family: Kersey

full_name: Kathryn Kersey

given: Kathryn

family: Li

full_name: Georgia Li

given: Georgia

family: Han

full_name: Ling Han

given: Ling

family: Jia

full_name: Catherine Jia

given: Catherine

family: Wang

full_name: Lulu Wang

given: Lulu

family: Chen

full_name: Guang Chen

given: Guang

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

family: Myers

full_name: Robert P. Myers

given: Robert P.

family: Djedjos

full_name: C. Stephen Djedjos

given: C. Stephen

name: The Institute for Liver Health Chandler AZ

family: Kohli

full_name: Anita Kohli

given: Anita

family: Bzowej

full_name: Natalie Bzowej

given: Natalie

family: Younes

full_name: Ziad Younes

given: Ziad

name: Institute of Liver and Biliary Sciences New Delhi Delhi India

family: Sarin

full_name: Shiv Sarin

given: Shiv

name: Bon Secours Liver Institute of Virginia Richmond VA

family: Shiffman

full_name: Mitchell L. Shiffman

given: Mitchell L.

name: Pinnacle Clinical Research San Antonio TX

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

name: Beth Israel Deaconess Medical Center and Harvard Medical School Boston MA

family: Afdhal

full_name: Nezam H. Afdhal

given: Nezam H.

ReferenceCitation: Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.

ReferenceCitation: Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

ReferenceCitation: Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3 and STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.

ReferenceCitation: Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.

location_country:
Malaysia
Australia
Belgium
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Switzerland
Singapore
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
New Zealand
Spain

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

location_facility: The University of Chicago Medical Center

location_facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant

location_facility: University of Minnesota Medical Center - Fairview

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik III

location_facility: VA Greater Los Angeles Healthcare System

location_facility: University of Iowa Hospitals and Clinics

location_facility: Indiana University Health - University Hospital

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)

location_facility: Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease

location_facility: Toronto Center for Liver Diseases (TCLD), Toronto General Hospital

location_facility: Kawasaki Medical School General Medical Center

location_facility: Gastroenterologisch- Hepatologisches Zentrum Kiel

location_facility: University of California San Francisco (UCSF)

location_facility: Walter Reed National Military Medical Center

location_facility: Institute of Post Graduate Medical Education and Research / SSKM Hospital

location_facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: National Center for Global Health and Medicine Hospital

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Duke University Medical Center - Duke South Clinics

location_facility: Banner University Medical Center-Phoenix

location_facility: University of North Carolina at Chapel Hill / UNC School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

location_facility: Kansas City Gastroenterology and Hepatology

location_facility: Hospital de Clínicas de Porto Alegre - HCPA/UFRGS

location_facility: University of California San Diego (UCSD)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Southern Therapy and Advanced Research LLC (STAR)

location_facility: CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

location_facility: The University of Vermont Medical Center

location_facility: Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Greenville Health System - Gastroenterology and Liver Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: CHOP_Complejo Hospitalrio Universitario de Pontevedra

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: National Cheng Kung University Hospitalv

location_facility: American Research Corporation, The Texas Liver Institute

location_facility: Uniklinikum des Saarlandes- Klinik fur Innere Medizin II

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Universitatsklinikum Frankfurt der Goethe-Universitat

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Baylor Scott & White All Saints Medical Center

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii

location_facility: Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)

location_facility: Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: University of Buffalo, Clinical and Translational Research Center

location_facility: University of California, Davis Medical Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)

location_facility: Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2

location_facility: National Health Insurance Service- Ilsan Hospital

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Phylasis Clinicas Research S. de RL de CV.

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Intermountain Liver Disease and Transplant Center

location_facility: Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

location_facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Tulane University Health Sciences Center

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Rutgers New Jersey Medical School- Doctors Office Center

location_facility: Huron Gastroenterology Associates/Center for Digestive Care

location_facility: Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)

location_facility: Northwell Health - Sandra Atlas Bass Center for Liver Diseases

location_facility: IRCCS Ospedale Casa Sollievo Della Soferrenza


type: Other Identifier

title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine

acronym: ADVOCATE

summary: The aim of the trial is to assess the safety and efficacy of the orally-administered, selective complement C5a receptor inhibitor CCX168 (avacopan) in inducing and sustaining remission in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).

ReferenceType: derived

ReferenceCitation: Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386.

name: From Addenbrooke’s Hospital, Cambridge, United Kingdom (D.R.W.J.); the University of Pennsylvania, Philadelphia (P.A.M.); and ChemoCentryx, Mountain View, CA (T.J.S., P.B.).

family: Jayne

full_name: David R.W. Jayne

given: David R.W.

family: Merkel

full_name: Peter A. Merkel

given: Peter A.

family: Schall

full_name: Thomas J. Schall

given: Thomas J.

family: Bekker

full_name: Pirow Bekker

given: Pirow

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

version: submittedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc. 2020 Apr 7;9(4):e16664. doi: 10.2196/16664.

full_name: Peter A Merkel

given: Peter A

full_name: David R Jayne

given: David R

full_name: Chao Wang

given: Chao

family: Hillson

full_name: Jan Hillson

given: Jan

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

title: Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody–Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial

ipd_sharing: No

lead_sponsor: ChemoCentryx

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Spain
Germany
France
Czechia
Japan
Norway
Hungary
Australia
Belgium
Ireland
New Zealand
Denmark
Canada
United Kingdom

intervention_type: Drug


title: NeuroVascular Product Surveillance Registry (PSR) Platform

acronym: INSPIRE

summary: Post market surveillance registry

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing_description: Only multi center data will be available

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Italy
South Africa
United Arab Emirates
Hong Kong
Spain
Switzerland
Finland
France
Poland
Greece
Israel
Slovakia
Hungary
Belgium
Argentina
Australia
Russian Federation
Denmark
Germany
United Kingdom

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Charité Universitätsmedizin Berlin -Campus Charite

location_facility: CHU Toulouse - Hôpital Pierre-Paul Riquet

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Barking, Havering and Redbridge University Hospitals - Queen's Hospital

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Military Medical Institute-Wojskowy Instytut Medyczny

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Almazov National Medical Research Centre

location_facility: Hospital Universitario Central de Asturias

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: Siberian Federal Biomedical Research Center

location_facility: Ziekenhuis Oost Limburg - Campus Sint-Jan

intervention_type: Device

status_simplified: Ongoing


title: Epidemiological Study of European Cardiovascular Risk Patients: Disease Prevention and Management in Usual Daily Practice

acronym: EURIKA

summary:
The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries.

The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office.

Study variables will be measured:

By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication.
By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment.
By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured.
CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.

time_perspective: Cross-Sectional

ReferenceCitation: Halcox JP, Banegas JR, Roy C, Dallongeville J, De Backer G, Guallar E, Perk J, Hajage D, Henriksson KM, Borghi C. Prevalence and treatment of atherogenic dyslipidemia in the primary prevention of cardiovascular disease in Europe: EURIKA, a cross-sectional observational study. BMC Cardiovasc Disord. 2017 Jun 17;17(1):160. doi: 10.1186/s12872-017-0591-5.

family: Halcox

full_name: Julian P. Halcox

given: Julian P.

family: Banegas

full_name: José R. Banegas

given: José R.

family: Roy

full_name: Carine Roy

given: Carine

family: Dallongeville

full_name: Jean Dallongeville

given: Jean

family: De Backer

full_name: Guy De Backer

given: Guy

family: Guallar

full_name: Eliseo Guallar

given: Eliseo

family: Perk

full_name: Joep Perk

given: Joep

family: Hajage

full_name: David Hajage

given: David

family: Henriksson

full_name: Karin M. Henriksson

given: Karin M.

family: Borghi

full_name: Claudio Borghi

given: Claudio

currency_apc_doaj: GBP

journal_name: BMC Cardiovascular Disorders

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Swansea University - Cronfa

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

publisher: Springer Science and Business Media LLC

ReferenceCitation: Borghi C, Rodriguez-Artalejo F, De Backer G, Dallongeville J, Medina J, Guallar E, Perk J, Banegas JR, Tubach F, Roy C, Halcox JP. The association between blood pressure and lipid levels in Europe: European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice. J Hypertens. 2016 Nov;34(11):2155-63. doi: 10.1097/HJH.0000000000001078.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Borghi C, Tubach F, De Backer G, Dallongeville J, Guallar E, Medina J, Perk J, Roy C, Banegas JR, Rodriguez-Artalejo F, Halcox JP. Lack of control of hypertension in primary cardiovascular disease prevention in Europe: Results from the EURIKA study. Int J Cardiol. 2016 Sep 1;218:83-88. doi: 10.1016/j.ijcard.2016.05.044. Epub 2016 May 13.

ReferenceCitation: Halcox JP, Tubach F, Lopez-Garcia E, De Backer G, Borghi C, Dallongeville J, Guallar E, Medina J, Perk J, Sazova O, Sweet S, Roy C, Banegas JR, Rodriguez-Artalejo F. Low rates of both lipid-lowering therapy use and achievement of low-density lipoprotein cholesterol targets in individuals at high-risk for cardiovascular disease across Europe. PLoS One. 2015 Feb 18;10(2):e0115270. doi: 10.1371/journal.pone.0115270. eCollection 2015.

title: Low Rates of Both Lipid-Lowering Therapy Use and Achievement of Low-Density Lipoprotein Cholesterol Targets in Individuals at High-Risk for Cardiovascular Disease across Europe

ReferenceCitation: Halcox JP, Roy C, Tubach F, Banegas JR, Dallongeville J, De Backer G, Guallar E, Sazova O, Medina J, Perk J, Steg PG, Rodríguez-Artalejo F, Borghi C. C-reactive protein levels in patients at cardiovascular risk: EURIKA study. BMC Cardiovasc Disord. 2014 Feb 24;14:25. doi: 10.1186/1471-2261-14-25.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - INSU

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENPC

ReferenceCitation: Halcox JP, Tubach F, Sazova O, Sweet S, Medina J; EURIKA steering committee. Reclassification of European patients' cardiovascular risk using the updated Systematic Coronary Risk Evaluation algorithm. Eur J Prev Cardiol. 2015 Feb;22(2):200-2. doi: 10.1177/2047487313507680. Epub 2013 Oct 3.

name: Wales Heart Research Institute, Cardiff University School of Medicine, UK

name: Assistance-Publique–Hôpitaux de Paris, France; Université Paris Diderot, France

name: Research Evaluation Unit, Oxford PharmaGenesis Ltd, UK

name: Observational Research Centre, AstraZeneca, Spain

journal_name: European Journal of Preventive Cardiology

title: Reclassification of European patients’ cardiovascular risk using the updated Systematic Coronary Risk Evaluation algorithm

ReferenceCitation: Schmieder RE, Goebel M, Bramlage P. Barriers to cardiovascular risk prevention and management in Germany--an analysis of the EURIKA study. Vasc Health Risk Manag. 2012;8:177-86. doi: 10.2147/VHRM.S29915. Epub 2012 Mar 15.

title: Barriers to cardiovascular risk prevention and management in Germany – an analysis of the EURIKA study

ReferenceCitation: Dallongeville J, Banegas JR, Tubach F, Guallar E, Borghi C, De Backer G, Halcox JP, Massó-González EL, Perk J, Sazova O, Steg PG, Artalejo FR; EURIKA Investigators. Survey of physicians' practices in the control of cardiovascular risk factors: the EURIKA study. Eur J Prev Cardiol. 2012 Jun;19(3):541-50. doi: 10.1177/1741826711407705. Epub 2011 Apr 18.

name: Service d’Epidemiologie et Santé Publique, Institut Pasteur de Lille; Inserm, U744; Univ Lille Nord de France; Lille Cedex 59019, France.

name: Department of Preventative Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid/IdiPaz, CIBER of Epidemiology and Public Health, Madrid, Spain.

name: Université Paris Diderot, Paris, F-75018, France; INSERM, CIE 801, Paris, F-75018, France; INSERM, UMR-S 738, Paris, F-75018, France; APHP, Hôpital Bichat-Claude Bernard, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, F-75018, France.

name: Departments of Epidemiology and Medicine and Welch Center for Prevention, Epidemiology, and Clinical Research, John Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

name: Department of Cardiovascular Epidemiology and Population Genetics, National Center for Cardiovascular Research (CNIC), Madrid, Spain.

name: Department of Internal Medicine, Ageing and Clinical Nephrology, University of Bologna, Bologna, Italy.

name: Department of Public Health, University of Gent, Gent, Belgium.

name: Wales Heart Research Institute, Cardiff University, Heath Park, Cardiff, UK.

name: Medical Department, AstraZeneca Farmacéutica Spain, SA, Madrid, Spain.

name: School of Health and Caring Sciences, Linnaeus University, Kalmar 391 82, Sweden.

name: Medical Department, AstraZeneca Europe, Zaventem, Belgium.

name: INSERM U698, Assistance Publique-Hôpitaux de Paris and Université Paris 7, Paris, France.

title: Survey of physicians’ practices in the control of cardiovascular risk factors: the EURIKA study

ReferenceCitation: Rodríguez-Artalejo F, Guallar E, Borghi C, Dallongeville J, De Backer G, Halcox JP, Hernández-Vecino R, Jiménez FJ, Massó-González EL, Perk J, Steg PG, Banegas JR; EURIKA Investigators. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA). BMC Public Health. 2010 Jun 30;10:382. doi: 10.1186/1471-2458-10-382.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

location_country:
Austria
Sweden
Switzerland
France
Greece
Norway
Belgium
Russian Federation
Spain
Turkey
Germany
United Kingdom


ReferenceCitation: Iwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, Chiu J, Ohtani S, Takahashi M, Miyaki T, Lu YS, Xu B, Yap YS, Bustam A, Yao B, Zhang B, Bryce R, Chan A. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer. Future Oncol. 2019 Jul;15(21):2489-2501. doi: 10.2217/fon-2019-0143. Epub 2019 May 29.

name: Department of Breast Oncology, Aichi Cancer Center, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

name: Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, 540-0006, Japan

family: Masuda

full_name: Norikazu Masuda

given: Norikazu

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KS013, Korea

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

name: Division of Breast Oncology, Saitama Cancer Center, Saitama, 362-0806, Japan

family: Inoue

full_name: Kenichi Inoue

given: Kenichi

name: Hakuaikai Medical Corporation Sagara Hospital, Kagoshima City, 892-0845, Japan

family: Rai

full_name: Yoshiaki Rai

given: Yoshiaki

name: Department of Breast Oncology, Jichi Medical University Hospital, Tochigi, 329-0498, Japan

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ReferenceCitation: Chia SKL, Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Mansi J, Barrios CH, Gnant M, Tomašević Z, Denduluri N, Šeparović R, Kim SB, Jakobsen EH, Harvey V, Robert N, Smith J 2nd, Harker G, Zhang B, Eli LD, Ye Y, Lalani AS, Buyse M, Chan A. PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial. Breast Cancer Res. 2019 Mar 11;21(1):39. doi: 10.1186/s13058-019-1115-2.

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ReferenceCitation: Mortimer J, Di Palma J, Schmid K, Ye Y, Jahanzeb M. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019 Feb 27;21(1):32. doi: 10.1186/s13058-019-1112-5.

ReferenceCitation: Delaloge S, Cella D, Ye Y, Buyse M, Chan A, Barrios CH, Holmes FA, Mansi J, Iwata H, Ejlertsen B, Moy B, Chia SKL, Gnant M, Smichkoska S, Ciceniene A, Martinez N, Filipović S, Ben-Baruch NE, Joy AA, Langkjer ST, Senecal F, de Boer RH, Moran S, Yao B, Bryce R, Auerbach A, Fallowfield L, Martin M. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol. 2019 Apr 1;30(4):567-574. doi: 10.1093/annonc/mdz016.

ReferenceCitation: Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomašević Z, Denduluri N, Šeparović R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13.

ReferenceCitation: Chan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SKL, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J 2nd, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-377. doi: 10.1016/S1470-2045(15)00551-3. Epub 2016 Feb 10.

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

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title: A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


ReferenceType: background

ReferenceCitation: Trněný M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trümper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-331. doi: 10.1016/S1470-2045(15)00559-8. Epub 2016 Feb 16.

ReferenceCitation: Hagner PR, Chiu H, Ortiz M, Apollonio B, Wang M, Couto S, Waldman MF, Flynt E, Ramsay AG, Trotter M, Gandhi AK, Chopra R, Thakurta A. Activity of lenalidomide in mantle cell lymphoma can be explained by NK cell-mediated cytotoxicity. Br J Haematol. 2017 Nov;179(3):399-409. doi: 10.1111/bjh.14866. Epub 2017 Aug 2.

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source: euctr

title: A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma

summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.


ReferenceCitation: Vergote I, du Bois A, Floquet A, Rau J, Kim JW, Del Campo JM, Friedlander M, Pignata S, Fujiwara K, Colombo N, Mirza MR, Monk BJ, Tsibulak I, Calvert PM, Herzog TJ, Hanker LC, Meunier J, Lee JY, Bologna A, Carrasco-Alfonso MJ, Harter P. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol. 2019 Nov;155(2):186-191. doi: 10.1016/j.ygyno.2019.08.024. Epub 2019 Sep 10.

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repository_normalized: LIRIAS (KU Leuven)

ReferenceCitation: Friedlander M, Rau J, Lee CK, Meier W, Lesoin A, Kim JW, Poveda A, Buck M, Scambia G, Shimada M, Hilpert F, King MT, Debruyne P, Bologna A, Malander S, Monk BJ, Petru E, Calvert P, Herzog TJ, Barrett C, du Bois A. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol. 2018 Mar 1;29(3):737-743. doi: 10.1093/annonc/mdx796.

title: Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters—patient-centered end points in trials of maintenance therapy

ReferenceCitation: Pulford DJ, Harter P, Floquet A, Barrett C, Suh DH, Friedlander M, Arranz JA, Hasegawa K, Tada H, Vuylsteke P, Mirza MR, Donadello N, Scambia G, Johnson T, Cox C, Chan JK, Imhof M, Herzog TJ, Calvert P, Wimberger P, Berton-Rigaud D, Lim MC, Elser G, Xu CF, du Bois A. Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Med Ethics. 2016 Oct 21;17(1):63.

ReferenceCitation: Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.

journal_name: International Journal of Gynecologic Cancer

ReferenceCitation: Floquet A, Vergote I, Colombo N, Fiane B, Monk BJ, Reinthaller A, Calvert P, Herzog TJ, Meier W, Kim JW, del Campo JM, Friedlander M, Pisano C, Isonishi S, Crescenzo RJ, Barrett C, Wang K, Mitrica I, du Bois A. Progression-free survival by local investigator versus independent central review: comparative analysis of the AGO-OVAR16 Trial. Gynecol Oncol. 2015 Jan;136(1):37-42. doi: 10.1016/j.ygyno.2014.11.074. Epub 2014 Nov 28.

title: Progression-free survival by local investigator versus independent central review: Comparative analysis of the AGO-OVAR16 Trial

ReferenceCitation: du Bois A, Floquet A, Kim JW, Rau J, del Campo JM, Friedlander M, Pignata S, Fujiwara K, Vergote I, Colombo N, Mirza MR, Monk BJ, Kimmig R, Ray-Coquard I, Zang R, Diaz-Padilla I, Baumann KH, Mouret-Reynier MA, Kim JH, Kurzeder C, Lesoin A, Vasey P, Marth C, Canzler U, Scambia G, Shimada M, Calvert P, Pujade-Lauraine E, Kim BG, Herzog TJ, Mitrica I, Schade-Brittinger C, Wang Q, Crescenzo R, Harter P. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014 Oct 20;32(30):3374-82. doi: 10.1200/JCO.2014.55.7348. Epub 2014 Sep 15.

name: Andreas du Bois, Rainer Kimmig, Klaus H. Baumann, Christian Kurzeder, Ulrich Canzler, Philipp Harter, AGO Ovarian Cancer Study Group (AGO); Andreas du Bois, Christian Kurzeder, Philipp Harter, Kliniken Essen Mitte; Rainer Kimmig, West German Tumor Center, University of Duisburg-Essen, Essen; Joern Rau, Carmen Schade-Brittinger, Coordinating Center for Clinical Trials, Philipps-University of Marburg; Klaus H. Baumann, University of Marburg, Marburg; Ulrich Canzler, University Hospitals Carl Gustav Carus,...

publisher: American Society of Clinical Oncology (ASCO)

title: Incorporation of Pazopanib in Maintenance Therapy of Ovarian Cancer

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
Austria
Sweden
Hong Kong
Spain
Germany
France
Japan
Norway
Ireland
Australia
Belgium
China
Denmark
United States
Korea, Republic of
Taiwan

title: A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

summary: This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.


lead_sponsor: Boehringer Ingelheim

location_country:
France
Bulgaria
Slovakia
Romania
Hungary
Russian Federation
Spain
United States
Czech Republic
Korea, Republic of
Ukraine

acronym: TEAMSTA Severe HTN

location_facility: 1235.20.461 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106D Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107E Boehringer Ingelheim Investigational Site

location_facility: 1235.20.459 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.262 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.309 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.408 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.006 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.103A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.511 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.301 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.307 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102C Boehringer Ingelheim Investigational Site

location_facility: 1235.20.516 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.409 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.522 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.306 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.002 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.005 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.052 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.057 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.527 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.058 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.310 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.503 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.109B Boehringer Ingelheim Investigational Site

location_facility: 1235.20.308 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.526 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.157 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.510 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.523 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.104A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.519 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.513 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.206 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.253 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.351 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.303 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.537 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.456 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.530 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.155 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.356 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.528 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.525 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.109F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.501 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.515 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.156 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.103F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102E Boehringer Ingelheim Investigational Site

location_facility: 1235.20.518 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.261 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.159 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.053 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.302 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.054 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108E Boehringer Ingelheim Investigational Site

location_facility: 1235.20.520 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.205 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.451 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.251 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.457 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.403 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.353 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.406 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.202 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.104D Boehringer Ingelheim Investigational Site

location_facility: 1235.20.507 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.254 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.103C Boehringer Ingelheim Investigational Site

location_facility: 1235.20.535 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.101C Boehringer Ingelheim Investigational Site

location_facility: 1235.20.304 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.517 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.007 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108C Boehringer Ingelheim Investigational Site

location_facility: 1235.20.204 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.256 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.101A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.003 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.201 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.512 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.455 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.105D Boehringer Ingelheim Investigational Site

location_facility: 1235.20.458 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.152 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.311 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.509 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107B Boehringer Ingelheim Investigational Site

location_facility: 1235.20.259 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.460 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.402 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.153 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.203 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.252 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.305 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.529 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.534 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.260 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.533 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.103E Boehringer Ingelheim Investigational Site

location_facility: 1235.20.009 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.004 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.453 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.508 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.105A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.059 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.108B Boehringer Ingelheim Investigational Site

location_facility: 1235.20.102F Boehringer Ingelheim Investigational Site

location_facility: 1235.20.505 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.207 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.521 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.001 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.106B Boehringer Ingelheim Investigational Site

location_facility: 1235.20.008 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.107G Boehringer Ingelheim Investigational Site

location_facility: 1235.20.355 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.055 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.452 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.506 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.158 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.354 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.051 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.154 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.109A Boehringer Ingelheim Investigational Site

location_facility: 1235.20.454 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.352 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.161 Boehringer Ingelheim Investigational Site

location_facility: 1235.20.101D Boehringer Ingelheim Investigational Site

title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

summary: The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.