location_country:
Greece
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Argentina
Slovenia
Korea, Republic of
Sweden
Netherlands
Portugal
Germany
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Serbia
Mexico
Egypt
Spain
Turkey

acronym: MODUL

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Ijsselland Ziekenhuis; Inwendige Geneeskunde

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Ch De Montbeliard;Chir Generale Digestive

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

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

location_facility: Acibadem University School of Medicine, Adana Hospital; General Surgery

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

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

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

location_facility: University Hospital of Patras Medical Oncology

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: DRK Kliniken Berlin Köpenick Darmzentrum

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

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

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

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

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Hopital Saint Antoine; Oncologie Medicale

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

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

location_facility: Regionshospitalet Herning; Onkologisk afdeling

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

location_facility: Städt. Klinikum München GmbH Klinikum Neuperlach Klinik f.Hämatologie u.Onkologie

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: Klinikum Wetzlar-Braunfels, Klinik für Hämatologie/Onkologie und Palliativmedizin

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

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

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

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

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Royal Marsden Hospital; Dept. of Medicine

location_facility: Albert Schweitzer Ziekenhuis - loc Dordrecht

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

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

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Klinik der Ruhr-Uni Bochum; Marien-Hospital Herne

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

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

location_facility: A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Chu Estaing; Chir Generale Digestive A Et B

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Klinikum Magdeburg gGmbH Klinik für Allgemein- und Viszeralchirurgie

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Studienzentrale der II. Med. Klinik

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

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

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

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

location_facility: Humanitas Gavazzeni;U.O. Oncologia Medica

location_facility: Studienzentrum Onkologie Ravensburg; Onkologie Ravensburg

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

title: A Multi-Centre Randomised Clinical Trial of Biomarker-Driven Maintenance Treatment for First-Line Metastatic Colorectal Cancer (MODUL)

summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.


type: Other Identifier

title: Gaucher Disease Registry Protocol

summary:
The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The objectives of the Registry are:

To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
To characterize the Gaucher disease population.
To evaluate the long-term effectiveness of imiglucerase and of eliglustat.

Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: El-Beshlawy A, Tylki-Szymanska A, Vellodi A, Belmatoug N, Grabowski GA, Kolodny EH, Batista JL, Cox GF, Mistry PK. Long-term hematological, visceral, and growth outcomes in children with Gaucher disease type 3 treated with imiglucerase in the International Collaborative Gaucher Group Gaucher Registry. Mol Genet Metab. 2017 Jan - Feb;120(1-2):47-56. doi: 10.1016/j.ymgme.2016.12.001. Epub 2016 Dec 6.

ReferenceCitation: Mistry PK, Batista JL, Andersson HC, Balwani M, Burrow TA, Charrow J, Kaplan P, Khan A, Kishnani PS, Kolodny EH, Rosenbloom B, Scott CR, Weinreb N. Transformation in pretreatment manifestations of Gaucher disease type 1 during two decades of alglucerase/imiglucerase enzyme replacement therapy in the International Collaborative Gaucher Group (ICGG) Gaucher Registry. Am J Hematol. 2017 Sep;92(9):929-939. doi: 10.1002/ajh.24801. Epub 2017 Jul 7.

ReferenceCitation: Weinreb NJ, Goldblatt J, Villalobos J, Charrow J, Cole JA, Kerstenetzky M, vom Dahl S, Hollak C. Long-term clinical outcomes in type 1 Gaucher disease following 10 years of imiglucerase treatment. J Inherit Metab Dis. 2013 May;36(3):543-53. doi: 10.1007/s10545-012-9528-4. Epub 2012 Sep 14. Erratum in: J Inherit Metab Dis. 2014 Jan;37(1):147.

ReferenceType: derived

ReferenceCitation: Weinreb NJ, Camelo JS Jr, Charrow J, McClain MR, Mistry P, Belmatoug N; International Collaborative Gaucher Group (ICGG) Gaucher Registry (NCT00358943) investigators. Gaucher disease type 1 patients from the ICGG Gaucher Registry sustain initial clinical improvements during twenty years of imiglucerase treatment. Mol Genet Metab. 2021 Feb;132(2):100-111. doi: 10.1016/j.ymgme.2020.12.295. Epub 2021 Jan 8.

family: Weinreb

full_name: Neal J. Weinreb

given: Neal J.

sequence: first

family: Camelo

full_name: José Simon Camelo

given: José Simon

sequence: additional

suffix: Jr

family: Charrow

full_name: Joel Charrow

given: Joel

family: McClain

full_name: Monica R. McClain

given: Monica R.

family: Mistry

full_name: Pramod Mistry

given: Pramod

family: Belmatoug

full_name: Nadia Belmatoug

given: Nadia

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Molecular Genetics and Metabolism

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Weinreb NJ, Kaplan P. The history and accomplishments of the ICGG Gaucher registry. Am J Hematol. 2015 Jul;90 Suppl 1:S2-5. doi: 10.1002/ajh.24054.

name: University Research Foundation for Lysosomal Storage Disorders; Coral Springs, Florida, USA

name: Department of Pediatrics; Children's Hospital of Philadelphia; Philadelphia, Pennsylvania, USA

family: Kaplan

full_name: Paige Kaplan

given: Paige

journal_name: American Journal of Hematology

evidence: open (via free pdf)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Buyers RP, Collin-Histed T. Foreword. Am J Hematol. 2015 Jul;90 Suppl 1:S1. doi: 10.1002/ajh.24053.

name: National Gaucher Foundation; Harpers Ferry West Virginia, USA

family: Buyers

full_name: Rhonda P. Buyers

given: Rhonda P.

name: European Gaucher Alliance; Dursley Gloucestershire Gl11 4ND, UK

family: Collin-Histed

full_name: Tanya Collin-Histed

given: Tanya

bso_classification: Humanities

title: Foreword

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Peru
Jordan
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
Pakistan
Croatia
France
Japan
Lithuania
Kuwait
Poland
Slovakia
Argentina
Thailand
Indonesia
Canada
Korea, Republic of
South Africa
Sweden
United Arab Emirates
Saudi Arabia
Switzerland
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Lebanon
Dominican Republic
Czechia
Israel
Egypt
Spain
Turkey

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lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia

summary: The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098. Erratum in: Eur J Heart Fail. 2010 Jul;12(7):765. Pouler, A C [corrected to Pouleur, A C].

ReferenceCitation: Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.

ReferenceCitation: Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.

family: Abraityte

full_name: Aurelija Abraityte

given: Aurelija

family: Aukrust

full_name: Pål Aukrust

given: Pål

family: Kou

full_name: Lei Kou

given: Lei

family: Anand

full_name: Inder S. Anand

given: Inder S.

family: Young

full_name: James Young

given: James

family: Mcmurray

full_name: John J. V. Mcmurray

given: John J. V.

family: van Veldhuisen

full_name: Dirk J. van Veldhuisen

given: Dirk J.

family: Gullestad

full_name: Lars Gullestad

given: Lars

family: Ueland

full_name: Thor Ueland

given: Thor

journal_name: Clinical Research in Cardiology

oa_host_type: repository

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

host_type: repository

repository_institution: The Arctic University of Norway - Munin Open Research Archive

version: submittedVersion

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: van der Meer P, Grote Beverborg N, Pfeffer MA, Olson K, Anand IS, Westenbrink BD, McMurray JJV, Swedberg K, Young JB, Solomon SD, van Veldhuisen DJ. Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations. Circ Heart Fail. 2018 Feb;11(2):e004431. doi: 10.1161/CIRCHEARTFAILURE.117.004431.

name: From the Department of Cardiology, University Medical Center Groningen, University of Groningen, the Netherlands (P.v.d.M., N.G.B., B.D.W., D.J.v.V.); Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (M.A.P., S.D.S.), Amgen, Thousand Oaks, CA (K.O.); Department of Medicine, University of Minnesota Medical School and VA Medical Center, Minneapolis (I.S.A.); BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.); Department of Medicine, Sahlgrenska...

family: van der Meer

full_name: Peter van der Meer

given: Peter

family: Grote Beverborg

full_name: Niels Grote Beverborg

given: Niels

family: Pfeffer

full_name: Marc A. Pfeffer

given: Marc A.

family: Olson

full_name: Kurt Olson

given: Kurt

family: Westenbrink

full_name: B. Daan Westenbrink

given: B. Daan

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Swedberg

full_name: Karl Swedberg

given: Karl

full_name: James B. Young

given: James B.

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
India
France
Poland
Lithuania
Slovakia
Norway
Argentina
Canada
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Estonia
Latvia


title: A Multicenter, Double-Blind, Randomized, Active Comparator, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

summary: Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

lead_sponsor: Solvay Pharmaceuticals

location_country:
Netherlands
France
Poland
Hungary
Denmark
Germany
Czech Republic
Ukraine

location_facility:
Site 411
Site 303
Site 408
Site 606
Site 019
Site 110
Site 403
Site 109
Site 205
Site 309
Site 302
Site 114
Site 102
Site 702
Site 503
Site 609
Site 106
Site 010
Site 104
Site 409
Site 404
Site 016
Site 504
Site 410
Site 314
Site 013
Site 014
Site 107
Site 710
Site 108
Site 306
Site 317
Site 318
Site 709
Site 607
Site 012
Site 308
Site 509
Site 111
Site 006
Site 608
Site 605
Site 412
Site 319
Site 502
Site 320
Site 113
Site 506
Site 703
Site 315
Site 401
Site 501
Site 610
Site 112
Site 002
Site 512
Site 603
Site 705
Site 407
Site 312
Site 004
Site 402
Site 305
Site 101
Site 715
Site 105
Site 103
Site 115
Site 008
Site 713
Site 321
Site 005
Site 001
Site 007
Site 714
Site 009
Site 018
Site 310
Site 508
Site 201
Site 307
Site 203
Site 017
Site 511
Site 704
Site 311
Site 505
Site 701
Site 711
Site 301
Site 003
Site 313
Site 406
Site 604
Site 514
Site 602
Site 706
Site 513
Site 304
Site 405
Site 316
Site 413
Site 712
Site 011
Site 015
Site 510
Site 708
Site 601
Site 507
Site 707

intervention_type: Drug

status_simplified: Completed


title: A 54-week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Donepezil on Cognition and Overall Clinical Response in APOE ε4-stratified Subjects With Mild to Moderate Alzheimer's Disease.

summary:
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with the currently approved AD medication, Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects their response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Austria
United States
Brazil
Chile
India
Switzerland
Mexico
Spain
Germany
France
Czechia
Greece
Japan
Poland
Hungary
Argentina
Portugal
Canada

intervention_type: Other


title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity

summary: Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

ReferenceCitation: Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jägel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P, Nolan D, Hughes S, Hughes A, Ryan S, Fitch N, Thorborn D, Benbow A; PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008 Feb 7;358(6):568-79. doi: 10.1056/NEJMoa0706135.

family: Mallal

full_name: Simon Mallal

given: Simon

family: Phillips

full_name: Elizabeth Phillips

given: Elizabeth

family: Carosi

full_name: Giampiero Carosi

given: Giampiero

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Workman

full_name: Cassy Workman

given: Cassy

family: Tomažič

full_name: Janez Tomažič

given: Janez

family: Jägel-Guedes

full_name: Eva Jägel-Guedes

given: Eva

family: Rugina

full_name: Sorin Rugina

given: Sorin

family: Kozyrev

full_name: Oleg Kozyrev

given: Oleg

family: Cid

full_name: Juan Flores Cid

given: Juan Flores

family: Hay

full_name: Phillip Hay

given: Phillip

family: Nolan

full_name: David Nolan

given: David

family: Hughes

full_name: Sara Hughes

given: Sara

full_name: Arlene Hughes

given: Arlene

family: Ryan

full_name: Susanna Ryan

given: Susanna

family: Fitch

full_name: Nicholas Fitch

given: Nicholas

family: Thorborn

full_name: Daren Thorborn

given: Daren

family: Benbow

full_name: Alastair Benbow

given: Alastair

journal_name: New England Journal of Medicine

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

repository_institution: Murdoch University - Murdoch Research Repository

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: HLA-B*5701 Screening for Hypersensitivity to Abacavir

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
United Kingdom
France
Poland
Israel
Slovenia
Norway
Ireland
Australia
Belgium
Romania
Portugal
Russian Federation
Germany
Latvia


title: A Case-Control Toxicogenomics Study to Identify Unique Genetic Polymorphisms in Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

summary: Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.

time_perspective: Retrospective

lead_sponsor: Boehringer Ingelheim

location_country:
United States
Netherlands
Germany
France
Thailand
Argentina
Australia
Spain
Canada
United Kingdom
Taiwan

location_facility: 1100.1452.34011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.3310A Hôpital Bichat Claude Bernard

location_facility: 1100.1452.4910 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.3303A Hôpital de la Pité Salpêtrière

location_facility: 1100.1452.3310B Hôpital Bichat Claude Bernard

location_facility: 1100.1452.61005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.31002 Onze Lieve Vrouwen Gasthuis

location_facility: 1100.1452.01011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.66001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4916 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34010 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4931 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.3314A Hôpital Européen Georges Pompidou

location_facility: 1100.1452.66003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.31001 Academisch Medisch Centrum

location_facility: 1100.1452.01003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01016 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4903 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88606 China Medical University Hospital

location_facility: 1100.1452.01015 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88605 Chung-Ho Memorial Hospital, Kaohsiung Medical University

location_facility: 1100.1452.66002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.99999 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4902 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34009 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88601 National Taiwan University Hospital

location_facility: 1100.1452.44006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4933 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44008 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4904 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.54004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.61008 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01504 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01012 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.88602 Kaohsiung Veterans General Hospital

location_facility: 1100.1452.4912 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01013 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.34005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44009 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.54003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01502 Toronto General Hospital

location_facility: 1100.1452.4918 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.9907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.01006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.44001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1452.4932 Boehringer Ingelheim Investigational Site


title: An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.

summary: This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Zhou L, Meng F, Yin O, Wang J, Wang Y, Wei Y, Hu P, Shen Z. Nilotinib for imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis: a single- and multiple-dose, open-label pharmacokinetic study in Chinese patients. Clin Ther. 2009 Jul;31(7):1568-75. doi: 10.1016/j.clinthera.2009.07.016.

family: Zhou

full_name: Li Zhou

given: Li

family: Meng

full_name: Fanyi Meng

given: Fanyi

family: Yin

full_name: Ophelia Yin

given: Ophelia

family: Wang

full_name: Jianxiang Wang

given: Jianxiang

full_name: Ying Wang

given: Ying

family: Wei

full_name: Yongqiang Wei

given: Yongqiang

family: Hu

full_name: Pei Hu

given: Pei

family: Shen

full_name: Zhixiang Shen

given: Zhixiang

journal_name: Clinical Therapeutics

title: Nilotinib for imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis: A single- and multiple-dose, open-label pharmacokinetic study in Chinese patients

lead_sponsor: Novartis Pharmaceuticals

location_country:
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
France
Poland
Thailand
Slovakia
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Spain
Turkey

location_facility: Georgetown University Medical Center-Lombardi Cancer Center

location_facility: University of New Mexico Health Sciences Center

location_facility: University of South Alabama Cancer Research Institute

location_facility: Osler Medical Inc./Osler Clinical Research

status_simplified: Unknown


title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

summary:
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

ReferenceType: result

ReferenceCitation: Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum in: Lancet. 2010 Oct 2;376(9747):1146.

family: Calverley

full_name: Peter MA Calverley

given: Peter MA

family: Rabe

full_name: Klaus F Rabe

given: Klaus F

family: Goehring

full_name: Udo-Michael Goehring

given: Udo-Michael

family: Kristiansen

full_name: Søren Kristiansen

given: Søren

family: Fabbri

full_name: Leonardo M Fabbri

given: Leonardo M

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

journal_name: The Lancet

ReferenceCitation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

name: Takeda Pharmaceuticals International GmbH; Glattpark-Opfikon (Zürich) Switzerland

family: Facius

full_name: Axel Facius

given: Axel

name: Pharsight Consulting Services; Pharsight, a Certara Company; Mountain View CA USA

family: Krause

full_name: Andreas Krause

given: Andreas

family: Claret

full_name: Laurent Claret

given: Laurent

family: Bruno

full_name: Rene Bruno

given: Rene

family: Lahu

full_name: Gezim Lahu

given: Gezim

journal_name: The Journal of Clinical Pharmacology

ReferenceCitation: Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.

family: Hanania

full_name: Nicola A. Hanania

given: Nicola A.

full_name: Peter M.A. Calverley

given: Peter M.A.

family: Dransfield

full_name: Mark T. Dransfield

given: Mark T.

family: Karpel

full_name: Jill P. Karpel

given: Jill P.

family: Brose

full_name: Manja Brose

given: Manja

family: Zhu

full_name: Haiyuan Zhu

given: Haiyuan

family: Rowe

ReferenceCitation: Wedzicha JA, Rabe KF, Martinez FJ, Bredenbröker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.

title: Efficacy of Roflumilast in the COPD Frequent Exacerbator Phenotype

ReferenceCitation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201. Review.

location_country:
Austria
Brazil
Germany
France
Romania
Hungary
Australia
Russian Federation
New Zealand
United States
United Kingdom

location_facility: Altana Pharma/Nycomed Investigational Site


type: EudraCT Number

title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

acronym: RE-COVER I

summary: The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER®, RE-COVER™ II, and RE-MEDY™. Vasc Med. 2016 Dec;21(6):506-514. Epub 2016 Nov 1.

ReferenceCitation: Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

name: From the Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, C.K.); Department of Hematology, Karolinska University Hospital, Stockholm, Sweden (S.S.); Thrombosis Research Institute and University College London, London, UK (A.K.K.); Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.Z.G.); Medical Division 2, Municipal Hospital Friedrichstadt, Dresden, Germany (S. Schellong); Department of Medicine,...

family: Schulman

full_name: Sam Schulman

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family: Kakkar

full_name: Ajay K. Kakkar

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family: Goldhaber

full_name: Samuel Z. Goldhaber

given: Samuel Z.

family: Schellong

full_name: Sebastian Schellong

given: Sebastian

family: Eriksson

full_name: Henry Eriksson

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family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Christiansen

full_name: Anita Vedel Christiansen

given: Anita Vedel

family: Friedman

full_name: Jeffrey Friedman

given: Jeffrey

family: Le Maulf

full_name: Florence Le Maulf

given: Florence

family: Peter

full_name: Nuala Peter

given: Nuala

family: Kearon

full_name: Clive Kearon

given: Clive

journal_name: Circulation

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Treatment of Acute Venous Thromboembolism With Dabigatran or Warfarin and Pooled Analysis

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

name: From the Coagulation Unit, Hematology Center, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden (A.M., S.S.); the Department of Medicine, Soonchunhyang University Gumi’s Hospital, North Kyungsang Province, South Korea (H.-G-H.); McMaster University, Population Health Research Institute, Hamilton, ON, Canada (S.J.C., J.W.E., S.Y.); Lankenau Medical Center, Thomas Jefferson Medical College, Wynnewood, PA (M.D.E.); Uppsala Clinical Research Center and Department of Medical...

family: Majeed

full_name: Ammar Majeed

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family: Hwang

full_name: Hun-Gyu Hwang

given: Hun-Gyu

family: Connolly

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family: Eikelboom

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family: Ezekowitz

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given: Michael D.

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Fraessdorf

full_name: Mandy Fraessdorf

given: Mandy

family: Yusuf

title: Management and Outcomes of Major Bleeding During Treatment With Dabigatran or Warfarin

ReferenceCitation: Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

title: Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism

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title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

acronym: PACIFIC

summary: A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.

status: Active, not recruiting

ReferenceCitation: Ouwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. Curr Ther Res Clin Exp. 2021 Aug 12;95:100640. doi: 10.1016/j.curtheres.2021.100640. eCollection 2021.

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repository_normalized: PubMed Central

title: Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non–Small Cell Lung Cancer from the PACIFIC Study

ReferenceCitation: Socinski MA, Özgüroğlu M, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Gray JE, Park K, Vincent M, Mann H, Newton M, Dennis PA, Antonia SJ. Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (PACIFIC). Clin Lung Cancer. 2021 Nov;22(6):549-561. doi: 10.1016/j.cllc.2021.05.009. Epub 2021 Jun 12.

family: Socinski

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given: Mark A.

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

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family: Villegas

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given: Augusto

family: Daniel

full_name: Davey Daniel

given: Davey

family: Vicente

full_name: David Vicente

given: David

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full_name: Shuji Murakami

given: Shuji

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full_name: Jhanelle E. Gray

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family: Park

full_name: Keunchil Park

given: Keunchil

family: Vincent

full_name: Mark Vincent

given: Mark

title: Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non–Small–Cell Lung Cancer (PACIFIC)

ReferenceCitation: Garassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, Özgüroğlu M, Daniel D, Vicente D, Murakami S, Langer C, Senan S, Spigel D, Rydén A, Zhang Y, O'Brien C, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab by PD-L1 expression and prior chemoradiotherapy-related variables in unresectable stage III non-small-cell lung cancer. Future Oncol. 2021 Apr;17(10):1165-1184. doi: 10.2217/fon-2020-1102. Epub 2021 Feb 15.

name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, 20133, Italy

name: Hospital Universitario 12 de Octubre, CiberOnc, Universidad Complutense & CNIO, Madrid, 28041, Spain

name: Westmead Hospital & the University of Sydney, Sydney, NSW, 2145, Australia

name: The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK

name: Virginia Cancer Specialists Research Institute, Fairfax, VA, & US Oncology Research, The Woodlands, TX 22031, USA

name: Institut Gustave Roussy, Department of Medical Oncology, Thoracic Group, Villejuif, 94805, France

name: Istanbul University – Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, 34320, Turkey

name: Sarah Cannon Research Institute/Tennessee Oncology, Chattanooga, TN 37203, USA

name: Hospital Universitario Virgen Macarena, Seville, 41009, Spain

name: Kanagawa Cancer Center, Yokohama, 241-8515, Japan

name: Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA 19104, USA

name: Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, 1081, The Netherlands

name: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN 3720231, USA

name: AstraZeneca, Gaithersburg, MD 20878, USA

name: H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA

ReferenceCitation: Mehra R, Yong C, Seal B, van Keep M, Raad A, Zhang Y. Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective. J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb.

name: 1University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, Maryland;

name: 2AstraZeneca Pharmaceuticals LP, Gaithersburg, Maryland;

name: 3BresMed Netherlands, Utrecht, The Netherlands; and

name: 4BresMed Health Solutions, Sheffield, United Kingdom.

journal_name: Journal of the National Comprehensive Cancer Network

ReferenceCitation: Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Özgüroğlu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

title: Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial

ReferenceCitation: Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Özgüroğlu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26.

ReferenceCitation: Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Özgüroğlu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21.

ReferenceCitation: Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Özgüroğlu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC—Update from PACIFIC

ReferenceCitation: Hui R, Özgüroğlu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Rydén A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7.

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

name: From the H. Lee Moffitt Cancer Center and Research Institute, Tampa (S.J.A., A.C., J.E.G.), Cancer Specialists of North Florida, Jacksonville (A.V.), Florida Cancer Specialists, Fleming Island (A.V.), and Florida Hospital Cancer Institute, Orlando (T.M.) — all in Florida; Tennessee Oncology, Chattanooga (D.D.), and Sarah Cannon Research Institute, Nashville (D.D., D.R.S.) — both in Tennessee; Hospital Universitario Virgen Macarena, Seville (D.V.), and Hospital Universitario 12 de Octubre, CiberOnc,...

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

name: From the H. Lee Moffitt Cancer Center and Research Institute, Tampa (S.J.A., A.C., J.E.G.), Cancer Specialists of North Florida, Jacksonville (A.V.), and Florida Hospital Cancer Institute, Orlando (T.M.) — all in Florida; Tennessee Oncology, Chattanooga, and Sarah Cannon Research Institute, Nashville — both in Tennessee (D.D.); Hospital Universitario Virgen Macarena, Seville (D.V.), and Hospital Universitario 12 de Octubre, Centro de Investigación Biomédica en Red de Cáncer, Universidad Complutense and...

repository_institution: Queensland University of Technology - QUT ePrints

repository_institution: University of Liège - Open Repository and Bibliography

title: Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Peru
Greece
Belgium
Australia
Taiwan
France
Japan
Poland
Slovakia
Thailand
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Vietnam
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain
Turkey


title: ADVATE/ ADYNOVI Hemophilia A Outcome Database

acronym: AHEAD

summary: The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
France
Poland
Norway
Canada
Slovenia
Colombia
Sweden
Switzerland
Bulgaria
Hungary
Portugal
China
United Kingdom
Italy
Austria
Brazil
Czechia
Spain

location_facility: Institute of Hematology, Blood Disease Hospital, PUMC&CAMS

location_facility: Fundación Oftalmológica de Santander FOSCAL

location_facility: Faculdade de Medicina da Universidade de São Paulo

location_facility: Clinics of FSBEI High Education Samara SMU of MoH of Russia

location_facility: Beijing Children's Hospital Affiliated to Capital University of Medical Sciences

location_facility: Centro Hospitalar Lisboa Norte Hospital de Sta. Maria

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology

location_facility: Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital

location_facility: Università degli studi di Roma "La Sapienza"

location_facility: Hôpital de la Mère et de l'Enfant - CHU de LIMOGES

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Stollery Children's Hospital, University of Alberta

location_facility: CHU de Reims Hôpital Maison Blanche - CRTH

location_facility: Hospital Universitari Vall d'Hebron (HUVH)

location_facility: East Kent Hospitals University Foundation Trust, Kent & Canterbury Hospital

location_facility: Rikshospitalet, Oslo University Hospital

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Federal State Budget Institution "Hematology Research Center" of Ministry of Healthcare of Russian Federation

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centro Hospitalar e Universitade de Coimbra

location_facility: Fakultní nemocnice Ostrava, Krevní centrum

location_facility: Nanfang Hospital Affiliated to Nanfang Medical University

location_facility: Azienda Ospedaliera di Padova Clinica Medica II

location_facility: General Hospital of Thessaloniki "Ippokratio"

location_facility: The Affiliated Hospital of Medical College, Qingdao University

location_facility: State Budget Healthcare Institution of Saint-Petersburg "City polyclinic #37"

location_facility: Hospital Teresa Herrera-Materno Infantil

location_facility: Szpital Uniwersytecki nr 1 im. dr Andrzeja Jurasza

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Azienda Ospedaliera Policlinico Consorziale Di Bari

location_facility: Kliniska studier i Sverige - Forum Söder

location_facility: Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: SBHI Chelyabinsk Regional Children's Clinical Hospital

location_facility: Centre Régional de Traitement de l'Hémophilie et des Maladies hémorragiques. CHU de Rennes - Hôpital Pontchaillou

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: FMH Kinder und Jugendmedizin, im Wabern-Zentrum

location_facility: SBHI of the Republic of Kareliya Republican Hospital n.a. V.A. Baranov

location_facility: Azienda Ospedaliera Universitaria Vittorio Emanuele, Ferrarotto, S. Bambino

location_facility: Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde

location_facility: Azienda Ospedaliera Universitaria Federico II

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

location_facility: Fakultní nemocnice Ostrava, Oddělení dětské hematologie a hematoonkologie

location_facility: South Metropolitan Health Service trading as Fiona Stanley Hospital

location_facility: Landes Frauen und Kinderklinik Linz (LFKK Linz)

intervention_type: Biological


title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

summary: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

ReferenceCitation: Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.

family: Lugogo

full_name: Njira L. Lugogo

given: Njira L.

family: Kreindler

full_name: James L. Kreindler

given: James L.

family: Martin

full_name: Ubaldo J. Martin

given: Ubaldo J.

family: Cook

full_name: Bill Cook

given: Bill

family: Hirsch

full_name: Ian Hirsch

given: Ian

family: Trudo

full_name: Frank J. Trudo

given: Frank J.

journal_name: Annals of Allergy, Asthma & Immunology

ReferenceCitation: Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.

family: Jackson

full_name: David J. Jackson

given: David J.

family: Humbert

full_name: Marc Humbert

given: Marc

family: Newbold

full_name: Paul Newbold

given: Paul

family: Garcia Gil

full_name: Esther Garcia Gil

given: Esther

journal_name: Advances in Therapy

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.

family: Chipps

full_name: Bradley E. Chipps

given: Bradley E.

ReferenceCitation: Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

ReferenceCitation: Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4). pii: 1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.

ReferenceCitation: DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.

name: From the Division of Allergy and Immunology, Department of Internal Medicine, George Washington University School of Medicine and Health Sciences, George Washington University Medical Faculty Associates, Washington, D.C.

name: Translational Medicine, MedImmune LLC, Gaithersburg, Maryl

name: Department of Statistics, AstraZeneca, Gaithersburg, Maryland

name: Department of Medical Affairs, AstraZeneca, Wilmington, Delaware

ReferenceCitation: Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.

ReferenceCitation: Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkström V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β(2)-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.

title: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial

location_country:
Italy
Brazil
Peru
South Africa
United Kingdom
Mexico
Vietnam
France
Bulgaria
Poland
Australia
Russian Federation
Spain
Turkey
United States
Czech Republic
Korea, Republic of