title: A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

summary: This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

ReferenceCitation: Kaminsky DA, Grosset DG, Kegler-Ebo DM, Cangiamilla S, Klingler M, Zhao P, Oh C. Natural history of lung function over one year in patients with Parkinson's disease. Respir Med. 2021 Jun;182:106396. doi: 10.1016/j.rmed.2021.106396. Epub 2021 Apr 16.

family: Kaminsky

full_name: David A. Kaminsky

given: David A.

family: Grosset

full_name: Donald G. Grosset

given: Donald G.

family: Kegler-Ebo

full_name: Deena M. Kegler-Ebo

given: Deena M.

family: Cangiamilla

full_name: Salvador Cangiamilla

given: Salvador

family: Klingler

full_name: Michael Klingler

given: Michael

family: Zhao

full_name: Ping Zhao

given: Ping

family: Oh

full_name: Charles Oh

given: Charles

journal_name: Respiratory Medicine

lead_sponsor: Acorda Therapeutics

location_country:
Austria
Serbia
Netherlands
Germany
France
Czechia
Poland
Israel
Romania
Hungary
Belgium
Spain
United States
United Kingdom

location_facility:
Acorda Site #7116
Acorda Site #7002
Acorda Site #7114
Acorda Site #7122
Acorda Site #7083
Acorda Site #7086
Acorda Site # 7142
Acorda Site #7121
Acorda Site #7131
Acorda Site #7130
Acorda Site #7062
Acorda Site #7050
Acorda Site #7150
Acorda Site #7025
Acorda Site #7094
Acorda Site #7084
Acorda Site #7103
Acorda Site #7115
Acorda Site #7135
Acorda Site #7139
Acorda Site #7046
Acorda Site #7081
Acorda Site #7092
Acorda Site #7036
Acorda Site #7012
Acorda Site #7133
Acorda Site #7034
Acorda Site #7048
Acorda Site #7119
Acorda Site #7049
Acorda Site #7051
Acorda Site #7123
Acorda Site #7102
Acorda Site #7043
Acorda Site #7042
Acorda Site #7031
Acorda Site #7088
Acorda Site #7061
Acorda Site #7111
Acorda Site #7120
Acorda Site #7032
Acorda Site #7087
Acorda Site #7023
Acorda Site #7045
Acorda Site #7118
Acorda Site #7022
Acorda Site #7085
Acorda Site #7145
Acorda Site #7004
Acorda Site #7003
Acorda Site #7091
Acorda Site #7047
Acorda Site #7140
Acorda Site #7035
Acorda Site #7037
Acorda Site #7033
Acorda Site #7041
Acorda Site #7134
Acorda Site #7044
Acorda Site #7137
Acorda Site #7053
Acorda Site #7021
Acorda Site #7064
Acorda Site #7138
Acorda Site #7013
Acorda Site #7063
Acorda Site #7082
Acorda Site #7101
Acorda Site #7141
Acorda Site #7112
Acorda Site #7113
Acorda Site #7093
Acorda Site #7095
Acorda Site #7024
Acorda Site #7148
Acorda Site #7011


ReferenceType: derived

ReferenceCitation: Kimata A, Nogami A, Yamasaki H, Ohigashi T, Gosho M, Igarashi M, Sekiguchi Y, Ieda M, Calkins H, Aonuma K. Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials. J Cardiol. 2021 Jun;77(6):652-659. doi: 10.1016/j.jjcc.2020.12.010. Epub 2021 Jan 25.

family: Kimata

full_name: Akira Kimata

given: Akira

sequence: first

family: Nogami

full_name: Akihiko Nogami

given: Akihiko

sequence: additional

family: Yamasaki

full_name: Hiro Yamasaki

given: Hiro

family: Ohigashi

full_name: Tomohiro Ohigashi

given: Tomohiro

family: Gosho

full_name: Masahiko Gosho

given: Masahiko

family: Igarashi

full_name: Miyako Igarashi

given: Miyako

family: Sekiguchi

full_name: Yukio Sekiguchi

given: Yukio

family: Ieda

full_name: Masaki Ieda

given: Masaki

family: Calkins

full_name: Hugh Calkins

given: Hugh

family: Aonuma

full_name: Kazutaka Aonuma

given: Kazutaka

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Cardiology

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: Hohnloser SH, Calkins H, Willems S, Verma A, Schilling R, Okumura K, Nordaby M, Kleine E, Biss B, Gerstenfeld EP; RE-CIRCUIT® investigators. Regional differences in patient characteristics and outcomes during uninterrupted anticoagulation with dabigatran versus warfarin in catheter ablation of atrial fibrillation: the RE-CIRCUIT study. J Interv Card Electrophysiol. 2019 Aug;55(2):145-152. doi: 10.1007/s10840-019-00518-x. Epub 2019 Feb 13.

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

family: Willems

full_name: Stephan Willems

given: Stephan

family: Verma

full_name: Atul Verma

given: Atul

family: Schilling

full_name: Richard Schilling

given: Richard

family: Okumura

full_name: Ken Okumura

given: Ken

family: Nordaby

full_name: Matias Nordaby

given: Matias

family: Kleine

full_name: Eva Kleine

given: Eva

family: Biss

full_name: Branislav Biss

given: Branislav

family: Gerstenfeld

full_name: Edward P. Gerstenfeld

given: Edward P.

journal_name: Journal of Interventional Cardiac Electrophysiology

ReferenceCitation: Calkins H, Willems S, Gerstenfeld EP, Verma A, Schilling R, Hohnloser SH, Okumura K, Serota H, Nordaby M, Guiver K, Biss B, Brouwer MA, Grimaldi M; RE-CIRCUIT Investigators. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017 Apr 27;376(17):1627-1636. doi: 10.1056/NEJMoa1701005. Epub 2017 Mar 19.

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

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

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Mission Cardiovascular Research Institute

location_facility: Mercy Medical Group, a service of Dignity Health Medical Foundation

location_facility: CLI Nouvelles Cliniques Nantaises,Cardio,Nantes Cedex 2

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Yaroslavl Regional Clin. Hospital, Dept. Endocrinology

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: University of Tennessee Methodist Physicians

location_facility: Instit.of Surgery na Vishnevskiy,Treatm.of comp.arrhythm.dep

location_facility: Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia

location_facility: University of Utah Health Sciences Center

location_facility: Antwerpen - HOSP ZNA Middelheim - Pneumo

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

location_facility: University at Buffalo, The State University of New York

location_facility: St Luke's Health Baylor College of Medicine Med Center

location_facility: Golden Jubilee National Hospital, Clydebank

location_facility: Penn State Milton S. Hershey Medical Center

title: Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)

summary:
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.

Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.

It is not intended to assess confirmatory hypothesis, this is an exploratory study.


title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Taylor-Cousar JL, Munck A, McKone EF, van der Ent CK, Moeller A, Simard C, Wang LT, Ingenito EP, McKee C, Lu Y, Lekstrom-Himes J, Elborn JS. Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del. N Engl J Med. 2017 Nov 23;377(21):2013-2023. doi: 10.1056/NEJMoa1709846. Epub 2017 Nov 3.

family: Taylor-Cousar

full_name: Jennifer L. Taylor-Cousar

given: Jennifer L.

family: Munck

full_name: Anne Munck

given: Anne

family: McKone

full_name: Edward F. McKone

given: Edward F.

family: van der Ent

full_name: Cornelis K. van der Ent

given: Cornelis K.

family: Moeller

full_name: Alexander Moeller

given: Alexander

family: Simard

full_name: Christopher Simard

given: Christopher

family: Wang

full_name: Linda T. Wang

given: Linda T.

family: Ingenito

full_name: Edward P. Ingenito

family: McKee

full_name: Charlotte McKee

given: Charlotte

family: Lu

full_name: Yimeng Lu

given: Yimeng

family: Lekstrom-Himes

full_name: Julie Lekstrom-Himes

given: Julie

family: Elborn

full_name: J. Stuart Elborn

given: J. Stuart

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

license_normalized: no license

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

host_type: repository

repository_institution: Queen's University Belfast - Research Portal

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Tezacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Italy
Sweden
Switzerland
Netherlands
Germany
France
Ireland
Spain
Denmark
United States
United Kingdom
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease

summary: The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

ReferenceCitation: Frölich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

family: Frölich

full_name: Lutz Frölich

given: Lutz

family: Wunderlich

full_name: Glen Wunderlich

given: Glen

family: Thamer

full_name: Claus Thamer

given: Claus

family: Roehrle

full_name: Michael Roehrle

given: Michael

family: Garcia

full_name: Miguel Garcia

given: Miguel

suffix: Jr

family: Dubois

full_name: Bruno Dubois

given: Bruno

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer’s disease

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Poland
Belgium
Portugal
Canada
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: Private Practice for Psychiatry and Neurology

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center

location_facility: Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Institut universitaire de geriatrie Sherbrooke

location_facility: Neurologie und Psychiatrie / Psychotherapie

location_facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Psychiatry And Alzheimer's Care of Rochester, PLLC

location_facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: West Devon (Tavistock) CMHT & Memory Clinic (EDI)

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Non-Public Outpatient Clinic Neuromed M. i M. Nastaj

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH


title: A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab

acronym: STORM

summary: This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

design_allocation: Non-Randomized

ReferenceCitation: Tremblay G, Daniele P, Breeze J, Li L, Shah J, Shacham S, Kauffman M, Engelhardt M, Chari A, Nooka A, Vogl D, Gavriatopoulou M, Dimopoulos MA, Richardson P, Biran N, Siegel D, Vlummens P, Doyen C, Facon T, Mohty M, Meuleman N, Levy M, Costa L, Hoffman JE, Delforge M, Kaminetzky D, Weisel K, Raab M, Dingli D, Tuchman S, Laurent F, Vij R, Schiller G, Moreau P, Richter J, Schreder M, Podar K, Parker T, Cornell RF, Lionel K, Choquet S, Sundar J. Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study. BMC Cancer. 2021 Sep 6;21(1):993. doi: 10.1186/s12885-021-08453-9.

family: Tremblay

full_name: Gabriel Tremblay

given: Gabriel

family: Daniele

full_name: Patrick Daniele

given: Patrick

family: Breeze

full_name: Janis Breeze

given: Janis

family: Li

full_name: Lingling Li

given: Lingling

family: Shah

full_name: Jatin Shah

given: Jatin

family: Shacham

full_name: Sharon Shacham

given: Sharon

family: Kauffman

full_name: Michael Kauffman

family: Engelhardt

full_name: Monika Engelhardt

given: Monika

family: Chari

full_name: Ajaj Chari

given: Ajaj

family: Nooka

full_name: Ajay Nooka

given: Ajay

family: Vogl

full_name: Dan Vogl

given: Dan

family: Gavriatopoulou

full_name: Maria Gavriatopoulou

given: Maria

family: Dimopoulos

full_name: Meletios-Athanasios Dimopoulos

given: Meletios-Athanasios

family: Richardson

full_name: Paul Richardson

given: Paul

family: Biran

full_name: Noa Biran

given: Noa

family: Siegel

full_name: David Siegel

given: David

family: Vlummens

full_name: Philip Vlummens

given: Philip

family: Doyen

full_name: Chantal Doyen

given: Chantal

family: Facon

full_name: Thierry Facon

given: Thierry

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

family: Meuleman

full_name: Nathalie Meuleman

given: Nathalie

family: Levy

full_name: Moshe Levy

given: Moshe

family: Costa

full_name: Luciano Costa

given: Luciano

ReferenceCitation: Chari A, Florendo E, Mancia IS, Cho H, Madduri D, Parekh S, Richter J, Dhadwal A, Thomas J, Jiang G, Lagana A, Bhalla S, Jagannath S. Optimal Supportive Care With Selinexor Improves Outcomes in Patients With Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Jul 18. pii: S2152-2650(21)00286-X. doi: 10.1016/j.clml.2021.07.014. [Epub ahead of print]

ReferenceCitation: Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, Dingli D, Cole C, Lonial S, Dimopoulos M, Stewart AK, Richter J, Vij R, Tuchman S, Raab MS, Weisel KC, Delforge M, Cornell RF, Kaminetzky D, Hoffman JE, Costa LJ, Parker TL, Levy M, Schreder M, Meuleman N, Frenzel L, Mohty M, Choquet S, Schiller G, Comenzo RL, Engelhardt M, Illmer T, Vlummens P, Doyen C, Facon T, Karlin L, Perrot A, Podar K, Kauffman MG, Shacham S, Li L, Tang S, Picklesimer C, Saint-Martin JR, Crochiere M, Chang H, Parekh S, Landesman Y, Shah J, Richardson PG, Jagannath S. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med. 2019 Aug 22;381(8):727-738. doi: 10.1056/NEJMoa1903455.

name: From the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai (A.C., S.P., S.J.), and New York University Langone Medical Center (D.K.) — both in New York; the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia (D.T.V.); the School of Medicine, National and Kapodistrian University of Athens, Athens (M.G., M. Dimopoulos); the Winship Cancer Institute, Emory University, Atlanta (A.K.N., S.L.); Massachusetts General Hospital Cancer Center (A.J.Y.), Tufts...

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

title: Oral Selinexor–Dexamethasone for Triple-Class Refractory Multiple Myeloma

ReferenceCitation: Vogl DT, Dingli D, Cornell RF, Huff CA, Jagannath S, Bhutani D, Zonder J, Baz R, Nooka A, Richter J, Cole C, Vij R, Jakubowiak A, Abonour R, Schiller G, Parker TL, Costa LJ, Kaminetzky D, Hoffman JE, Yee AJ, Chari A, Siegel D, Fonseca R, Van Wier S, Ahmann G, Lopez I, Kauffman M, Shacham S, Saint-Martin JR, Picklesimer CD, Choe-Juliak C, Stewart AK. Selective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 20;36(9):859-866. doi: 10.1200/JCO.2017.75.5207. Epub 2018 Jan 30.

name: Dan T. Vogl, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; David Dingli, Mayo Clinic, Rochester, MN; Robert Frank Cornell, Vanderbilt University Medical Center, Nashville, TN; Carol Ann Huff, Johns Hopkins University, Baltimore, MD; Sundar Jagannath, Tisch Cancer Institute, Mount Sinai School of Medicine; David Kaminetzky, New York University Langone Medical Center; Ajai Chari, Icahn School of Medicine at Mount Sanai, New York, NY; Divaya Bhutani and...

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Austria
Germany
France
Greece
Belgium
United States

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Universitätsklinikum Heidelberg Medizinische Klinik V

location_facility: Emory University / Winship Cancer Institute

location_facility: University Hospital Freiburg, Department of Internal Medicine I

location_facility: La Pitie-Salpetriere University Hospital, Department of Clinical Hematology

location_facility: Hopital Saint-Antoine, Service d´Hematologie Clinique et Therapie Cellulaire

location_facility: Vanderbilt University Ingram Cancer Center

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: University of Florida Health Cancer Center- Shands Cancer Center Hospital

location_facility: Jonnsson Comprehensive Cancer Center / University of Los Angeles

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: University Hospital Krems, Department of Internal Medicine II

location_facility: University hospital of Tuebingen, Internal Medicine II

location_facility: Hackensack University Medical Center / John Therurer Cancer Center

location_facility: Medical University Vienna, Department of Internal Medicine I

location_facility: Universitätsklinikum des Saarlandes Klinik für Innere Medizin I

location_facility: Med. Klinik und Poliklinik II Universitätsklinikum

location_facility: South Lyon Hospital Center, Department of Clinical Hematology

location_facility: Claude Huriez Hospital, Department of Blood Diseases

location_facility: National & Kapodistrain University of Athens School of Medicine, Alexandra Hospital

location_facility: H. Lee Moffitt Cancer Center Research Institute


title: The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure

acronym: REDUCE FMR

summary: The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.

ReferenceType: background

ReferenceCitation: Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tübler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

ReferenceCitation: Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

ReferenceCitation: Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 2009 Aug 15;104(4):565-70. doi: 10.1016/j.amjcard.2009.04.021. Epub 2009 May 29.

ReferenceCitation: Witte KK, Lipiecki J, Siminiak T, Meredith IT, Malkin CJ, Goldberg SL, Stark MA, von Bardeleben RS, Cremer PC, Jaber WA, Celermajer DS, Kaye DM, Sievert H. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.

family: Witte

full_name: Klaus K. Witte

given: Klaus K.

family: Lipiecki

full_name: Janusz Lipiecki

given: Janusz

family: Siminiak

full_name: Tomasz Siminiak

given: Tomasz

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Malkin

full_name: Christopher J. Malkin

given: Christopher J.

family: Goldberg

full_name: Steven L. Goldberg

given: Steven L.

family: Stark

full_name: Matthew A. Stark

given: Matthew A.

family: von Bardeleben

full_name: Ralph Stephan von Bardeleben

given: Ralph Stephan

family: Cremer

full_name: Paul C. Cremer

given: Paul C.

family: Jaber

full_name: Wael A. Jaber

given: Wael A.

family: Celermajer

full_name: David S. Celermajer

given: David S.

family: Kaye

full_name: David M. Kaye

given: David M.

family: Sievert

full_name: Horst Sievert

given: Horst

bso_classification: Physical sciences, Astronomy

journal_name: JACC: Heart Failure

title: The REDUCE FMR Trial

ipd_sharing: No

lead_sponsor: Cardiac Dimensions Pty Ltd

location_country:
Netherlands
France
Czechia
Poland
Australia
New Zealand
Germany
United Kingdom

location_facility: Institut klinické a experimentální medicíny (IKEM)

location_facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid

intervention_type: Device


title: A Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of Orfadin Treatment in Hypertyrosinemia Type 1 (HT-1) Patients in Standard Care

acronym: OPAL

summary: The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

study_type: Observational

time_perspective: Other

ipd_sharing: Undecided

ipd_sharing_description: Discussions ongoing with regards to data sharing/registry.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Italy
Austria
Sweden
Netherlands
Spain
Finland
France
Czechia
Poland
Norway
Hungary
Belgium
Ireland
Portugal
Denmark
Germany
United Kingdom

location_facility: Swedish Oprhan Biovitrum Investigational Site

location_facility: Swedish Orphan Biovitrum Investigational Site


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

acronym: RAINFALL

summary: The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1. Erratum in: Lancet Oncol. 2019 May;20(5):e242.

family: Fuchs

full_name: Charles S Fuchs

given: Charles S

family: Shitara

full_name: Kohei Shitara

given: Kohei

family: Di Bartolomeo

full_name: Maria Di Bartolomeo

given: Maria

family: Lonardi

full_name: Sara Lonardi

given: Sara

family: Al-Batran

full_name: Salah-Eddin Al-Batran

given: Salah-Eddin

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Ilson

full_name: David H Ilson

given: David H

family: Alsina

full_name: Maria Alsina

family: Chau

full_name: Ian Chau

given: Ian

family: Lacy

full_name: Jill Lacy

given: Jill

family: Ducreux

full_name: Michel Ducreux

given: Michel

family: Mendez

full_name: Guillermo Ariel Mendez

given: Guillermo Ariel

family: Alavez

full_name: Alejandro Molina Alavez

given: Alejandro Molina

family: Takahari

full_name: Daisuke Takahari

given: Daisuke

family: Mansoor

full_name: Wasat Mansoor

given: Wasat

family: Enzinger

full_name: Peter C Enzinger

given: Peter C

family: Gorbounova

full_name: Vera Gorbounova

given: Vera

family: Wainberg

full_name: Zev A Wainberg

given: Zev A

family: Hegewisch-Becker

full_name: Susanna Hegewisch-Becker

given: Susanna

family: Ferry

full_name: David Ferry

given: David

family: Lin

full_name: Ji Lin

given: Ji

family: Carlesi

full_name: Roberto Carlesi

given: Roberto

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

location_country:
Italy
United States
Mexico
Netherlands
Germany
Spain
Finland
France
Czechia
Japan
Israel
Poland
Hungary
Belgium
Argentina
Puerto Rico
Russian Federation
Denmark
Canada
United Kingdom

location_facility: University of Colorado School of Medicine

location_facility: Florida Cancer Specialists and Research Institute

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

location_facility: Central Coast Medical Oncology Corporation

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.


title: A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

acronym: REPAIR

summary: The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

ReferenceCitation: Vonk Noordegraaf A, Channick R, Cottreel E, Kiely DG, Marcus JT, Martin N, Moiseeva O, Peacock A, Swift AJ, Tawakol A, Torbicki A, Rosenkranz S, Galiè N. The REPAIR Study: Effects of Macitentan on RV Structure and Function in Pulmonary Arterial Hypertension. JACC Cardiovasc Imaging. 2021 Nov 6. pii: S1936-878X(21)00635-5. doi: 10.1016/j.jcmg.2021.07.027. [Epub ahead of print]

family: Vonk Noordegraaf

full_name: Anton Vonk Noordegraaf

given: Anton

family: Channick

full_name: Richard Channick

given: Richard

family: Cottreel

full_name: Emmanuelle Cottreel

given: Emmanuelle

family: Kiely

full_name: David G. Kiely

given: David G.

family: Marcus

full_name: J. Tim Marcus

given: J. Tim

family: Martin

full_name: Nicolas Martin

given: Nicolas

family: Moiseeva

full_name: Olga Moiseeva

given: Olga

family: Peacock

full_name: Andrew Peacock

given: Andrew

family: Swift

full_name: Andrew J. Swift

given: Andrew J.

family: Tawakol

full_name: Ahmed Tawakol

given: Ahmed

family: Torbicki

full_name: Adam Torbicki

given: Adam

family: Rosenkranz

full_name: Stephan Rosenkranz

given: Stephan

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

journal_name: JACC: Cardiovascular Imaging

title: The REPAIR Study

lead_sponsor: Actelion

location_country:
Italy
United States
Hong Kong
Netherlands
France
Malaysia
Israel
Singapore
Australia
Russian Federation
Germany
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz Centrum für Thrombose und Hämostase

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: "CHRU de Lille - Hôpital Albert Calmette "

location_facility: Almazov Federal North-West Medical Research Centre of Department of Health

location_facility: Pulmonology institute, Soroka Medical Center

location_facility: Washington University School of Medicine

location_facility: "Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital"

location_facility: Medizinische Klinik und Poliklinik II Universitätsklinik Bonn

location_facility: National University Hospital - The Heart Institute - Cardiac Department

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Fondazione IRCCS Policlinico San Matteo Ambulatorio Scompenso Cardiaco e Trapianti

location_facility: Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin

location_facility: University of Texas Southwestern Medical


title: A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

acronym: UC

summary: The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).

ReferenceCitation: Danese S, Neurath MF, Kopoń A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D. Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2526-2534.e9. doi: 10.1016/j.cgh.2019.12.032. Epub 2020 Jan 8.

family: Danese

full_name: Silvio Danese

given: Silvio

family: Neurath

full_name: Markus F. Neurath

given: Markus F.

family: Kopoń

full_name: Adam Kopoń

family: Zakko

full_name: Salam F. Zakko

given: Salam F.

family: Simmons

full_name: Timothy C. Simmons

given: Timothy C.

family: Fogel

full_name: Ronald Fogel

given: Ronald

family: Siegel

full_name: Corey A. Siegel

given: Corey A.

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Zhan

full_name: Xiaojiang Zhan

given: Xiaojiang

family: Usiskin

full_name: Keith Usiskin

given: Keith

family: Chitkara

full_name: Denesh Chitkara

given: Denesh

journal_name: Clinical Gastroenterology and Hepatology

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
United States
Netherlands
Germany
France
Czechia
Bulgaria
Poland
Hungary
Australia
Russian Federation
New Zealand
Canada
Ukraine

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

location_facility: Consultants for Clinical Research of South Florida

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Multiprofile Hospital for Active Treatment Kaspela

location_facility: Osrodek Badan Klinicznych CLINSANTE S.C.

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Private Enterprise Private Manufacture Company Acinus

location_facility: Vinnytsia Regional Clinical Hospital n a M I Pyrohov

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Digestive Research Center/ Gastroenterology Consultants of San Antonio

location_facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD

location_facility: Lviv Emergency Clinical Hospital, Therapeutics Department No. 1

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre

location_facility: Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University

location_facility: Digestive Health Specialists of The Southeast

location_facility: Connecticut Clinical Research Foundation

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie

location_facility: Russian Medical Military Academy na SMKirov

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

location_facility: Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED


title: A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer

summary: This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

ReferenceCitation: Eiger D, Brandão M, de Azambuja E. Lessons learned at SABCS 2019 and to-dos from immunotherapy in breast cancer. ESMO Open. 2020 Mar;5(2). pii: e000688. doi: 10.1136/esmoopen-2020-000688.

family: Eiger

full_name: Daniel Eiger

given: Daniel

family: Brandão

full_name: Mariana Brandão

given: Mariana

family: de Azambuja

full_name: Evandro de Azambuja

given: Evandro

currency_apc_doaj: EUR

journal_name: ESMO Open

license: cc-by-nc

license_normalized: cc-by-nc

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

ReferenceCitation: Eiger D, Franzoi MA, Pondé N, Brandão M, de Angelis C, Schmitt Nogueira M, de Hemptinne Q, de Azambuja E. Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials. ESMO Open. 2020 Feb;5(1). pii: e000659. doi: 10.1136/esmoopen-2019-000659.

family: Franzoi

full_name: Maria Alice Franzoi

given: Maria Alice

family: Pondé

full_name: Noam Pondé

given: Noam

family: de Angelis

full_name: Claudia de Angelis

given: Claudia

family: Schmitt Nogueira

full_name: Melanie Schmitt Nogueira

given: Melanie

family: de Hemptinne

full_name: Quentin de Hemptinne

given: Quentin

ReferenceCitation: Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Peña L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E. Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8.

location_country:
Peru
Guatemala
Australia
Belgium
France
Panama
Poland
El Salvador
Korea, Republic of
Chile
Switzerland
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

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

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

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Centre Jean Perrin; Division De Recherche Clinique

location_facility: Yonsei University Severance Hospital; Medical Oncology

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

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

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

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Hospital Nacional Cayetano Heredia; Hematology - Oncology

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

location_facility: Hopital Saint Louis; Service Onco Thoracique

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

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

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

location_facility: National Cancer Center; Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

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

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie

location_facility: Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

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

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Frimley Park Hospital; Breast Resaerch Team

location_facility: Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Royal Bournemouth General Hospital; Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Clinico Universitario; Oncologia

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie

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

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

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

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Ospedale Per Acuti Mater Salutis Di Legnago

location_facility: Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

location_facility: Centro Clinico Champalimaud; Oncologia Medica

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

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

location_facility: Instituto Universitario Dexeus; Servicio de Oncología

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

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon


intervention_type: Biological

ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Bioverativ, a Sanofi company

location_country:
Italy
Brazil
United States
Sweden
Netherlands
Germany
France
Poland
Ireland
Australia
New Zealand
Spain
Canada
United Kingdom

source: euctr

title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

summary: The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.


title: A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial

acronym: EBBINGHAUS

summary: This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

primary_purpose: Other

ReferenceCitation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16.

ReferenceCitation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

name: Institute of Cardiovascular Science; University College London; London UK

name: Department of Cardiology, Division Heart and Lungs; UMC Utrecht; Utrecht Netherlands

family: Schmidt

full_name: Amand F Schmidt

given: Amand F

name: Department of Clinical Pharmacology and Therapeutics; University College London Hospital; London UK

family: Carter

full_name: John-Paul L Carter

given: John-Paul L

name: Department of Non-communicable Disease Epidemiology; London School of Hygiene & Tropical Medicine; London UK

family: Pearce

full_name: Lucy S Pearce

given: Lucy S

name: The Department of Medicine (Cardiology) and the Department of Preventive Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wilkins

full_name: John T Wilkins

given: John T

name: Medicines Discovery Catapult; Alderly Edge UK

family: Overington

full_name: John P Overington

given: John P

family: Hingorani

full_name: Aroon D Hingorani

given: Aroon D

name: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); VA Boston Healthcare System; Boston Massachusetts USA

family: Casas

full_name: JP Casas

given: JP

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_country:
Finland
Malaysia
Greece
Belgium
Australia
Russian Federation
Denmark
France
Japan
Lithuania
Poland
Slovakia
Norway
Canada
Turkey
South Africa
Sweden
Hong Kong
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Czechia
New Zealand
Spain
Estonia
Latvia


title: Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children

summary: The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process [LP]).

primary_purpose: Prevention

ReferenceCitation: Claeys C, Drame M, García-Sicilia J, Zaman K, Carmona A, Tran PM, Miranda M, Martinón-Torres F, Thollot F, Horn M, Schwarz TF, Behre U, Merino JM, Sadowska-Krawczenko I, Szymański H, Schu P, Neumeier E, Li P, Jain VK, Innis BL. Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults. BMC Infect Dis. 2018 Apr 18;18(1):186. doi: 10.1186/s12879-018-3079-8.

family: Claeys

full_name: Carine Claeys

given: Carine

family: Drame

full_name: Mamadou Drame

given: Mamadou

family: García-Sicilia

full_name: José García-Sicilia

given: José

family: Zaman

full_name: Khalequ Zaman

given: Khalequ

family: Carmona

full_name: Alfonso Carmona

given: Alfonso

family: Tran

full_name: Phu My Tran

given: Phu My

family: Miranda

full_name: Mariano Miranda

given: Mariano

family: Martinón-Torres

full_name: Federico Martinón-Torres

given: Federico

family: Thollot

full_name: Franck Thollot

given: Franck

family: Horn

full_name: Michael Horn

given: Michael

family: Schwarz

full_name: Tino F. Schwarz

given: Tino F.

family: Behre

full_name: Ulrich Behre

given: Ulrich

family: Merino

full_name: José M. Merino

given: José M.

family: Sadowska-Krawczenko

full_name: Iwona Sadowska-Krawczenko

given: Iwona

family: Szymański

full_name: Henryk Szymański

given: Henryk

family: Schu

full_name: Peter Schu

given: Peter

family: Neumeier

full_name: Elisabeth Neumeier

given: Elisabeth

family: Li

full_name: Ping Li

given: Ping

family: Jain

full_name: Varsha K. Jain

given: Varsha K.

family: Innis

full_name: Bruce L. Innis

given: Bruce L.

journal_name: BMC Infectious Diseases

location_country:
United States
France
Czechia
Poland
Bangladesh
Spain
Germany


ReferenceCitation: Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Dû K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588.

lead_sponsor: Hoffmann-La Roche

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

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Primary Healthcare Associates SC - Harvey

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

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: University of Illinois at Chicago College of Medicine

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

location_facility: West Virginia Uni Med. Center - Robert Byrd Health Science

location_facility: Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Universitätsklinikum Köln; Klinik I für Innere Medizin

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: University of Pennsylvania; School of Medicine

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

location_facility: UCLA School of Medicine; Hematology/Oncology

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Royal Marsden Nhs Trust; Consultant Cancer Physician

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: University College London, Department of Haematology

title: A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma

summary: This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.


title: A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1.

Secondary Objectives:

To characterize the overall safety profile of SAR408701.
To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
To identify the recommended phase 2 dose (RP2D) of SAR408701.
To assess the potential immunogenicity of SAR408701.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country:
France
Korea, Republic of
Spain
United States
Canada

location_facility:
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 250001
Investigational Site Number 410004
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 250006
Investigational Site Number 724006
Investigational Site Number 250003
Investigational Site Number 840105
Investigational Site Number 840001
Investigational Site Number 124001
Investigational Site Number 840006
Investigational Site Number 410002
Investigational Site Number 410003
Investigational Site Number 724004
Investigational Site Number 840002
Investigational Site Number 410001
Investigational Site Number 724003
Investigational Site Number 250007
Investigational Site Number 724007
Investigational Site Number 410005
Investigational Site Number 724002

status_simplified: Ongoing


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes (PIONEER)

acronym: PIONEER

summary: The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.

status: Terminated

lead_sponsor: NephroGenex, Inc.

location_country:
United States
Hong Kong
France
Bulgaria
Poland
Israel
Hungary
Australia
Puerto Rico
Spain
Germany
Mauritius

location_facility:
CSG Investigational Site (#701)
CSG Investigational Site (#706)
CSG Investigational Site (#160)
CSG Investigative Site (#204)
CSG Investigational Site (#800)
CSG Investigational Site (#159)
CSG Investigational Site (#707)
CSG Investigational Site (#147)
CSG Investigational Site (#205)
CSG Investigational Site (#142)
CSG Investigational Site (#602)
CSG Investigational Site (#700)
CSG Investigational Site (# 850)
CSG Investigational Site (# 756)
CSG Investigational Site (#757)
CSG Investigational Site (#134)
CSG Investigational Site (#502)
CSG Investigational Site (#805)
CSG Investigational Site (#108)
CSG Investigational Site (#155)
CSG Investigational Site (#752)
CSG Investigational Site (#754)
CSG Investigational Site (#145)
CSG Investigational Site (#135)
CSG Investigational Site (#300)
CSG Investigational Site (#806)
CSG Investigational Site (#157)
CSG Investigational Site (#504)
CSG Investigational Site (#604)
CSG Investigational Site (#312)
CSG Investigational Site (#123)
CSG Investigational Site (#653)
CSG Investigational Site (#751)
CSG Investigational Site (#112)
CSG Investigational Site (#208)
CSG Investigational Site (#106)
CSG Investigational Site (#117)
CSG Investigational Site (#119)
CSG Investigational Site (#500)
CSG Investigational Site (#308)
CSG Investigational Site (#301)
CSG Investigative Site (#702)
CSG Investigational Site (#162)
CSG Investigational Site (#304)
CSG Investigational Site (#402)
CSG Investigational Site (#133)
CSG Investigational Site (#600)
CSG Investigational Site (#803)
CSG Investigational Site (#200)
CSG Investigational Site (#124)
CSG Investigational Site (#801)
CSG Investigational Site (#151)
CSG Investigational Site (#128)
CSG Investigational Site (#120)
CSG Investigational Site (#127)
CSG Investigational Site (#118)
CSG Investigational Site (#708)
CSG Investigational Site (#154)
CSG Investigational Site (#510)
CSG Investigational Site (#122)
CSG Investigational Site (#303)
CSG Investigational Site (#206)
CSG Investigational Site (#115)
CSG Investigational Site (#207)
CSG Investigational Site (#513)
CSG Investigational Site (#137)
CSG Investigational Site (#503)
CSG Investigational Site (#102)
CSG Investigational Site (#110)
CSG Investigational Site (#114)
CSG Investigational Site (#209)
CSG Investigational Site (#158)
CSG Investigational Site (# 607)
CSG Investigational Site (#101)
CSG Investigational Site (#103)
CSG Investigational Site (#400)
CSG Investigational Site (#136)
CSG Investigational Site (#152)
CSG Investigational Site (#709)
CSG Investigational Site (#121)
CSG Investigational Site (#505)
CSG Investigational Site (#313)
CSG Investigational Site (#501)
CSG Investigational Site (#153)
CSG Investigational Site (#401)
CSG Investigational Site (#651)
CSG Investigational Site (#309)
CSG Investigational Site (#315)
CSG Investigational Site (#601)
CSG Investigational Site (#143)
CSG Investigational Site (#508)
CSG Investigational Site (#307)
CSG Investigational Site (#201)
CSG Investigational Site (#302)
CSG Investigational Site (#305)
CSG Investigational Site (#150)
CSG Investigational Site (#802)
CSG Investigational Site (#148)
CSG Investigational Site (#506)
CSG Investigational Site (#507)
CSG Investigational Site (#655)
CSG Investigational Site (#107)
CSG Investigational Site (#603)
CSG Investigational Site (#311)
CSG Investigational Site (#310)
CSG Investigational Site (#509)
CSG Investigational Site (#804)
CSG Investigational Site (#149)
CSG Investigational Site (#129)
CSG Investigational Site (#131)
CSG Investigational Site (#113)
CSG Investigational Site (# 755)
CSG Investigational Site (#306)
CSG Investigational Site (#109)
CSG Investigational Site (#141)
CSG Investigational Site (#606)
CSG Investigational Site (#657)
CSG Investigational Site (# 750)
CSG Investigational Site (#139)
CSG Investigational Site (#656)
CSG Investigational Site (#514)
CSG Investigational Site (#146)
CSG Investigational Site (#314)
CSG Investigational Site (#111)
CSG Investigational Site (#104)
CSG Investigational Site (#132)
CSG Investigational Site (#202)
CSG Investigational Site (#156)
CSG Investigational Site (#703)
CSG Investigational Site (#116)
CSG Investigational Site (#105)
CSG Investigational Site (#605)
CSG Investigational Site (#144)
CSG Investigational Site (#652)
CSG Investigational Site (#125)
CSG Investigational Site (#753)
CSG Investigational Site (#130)

status_simplified: Unknown


ipd_sharing_description: Information available on the Grünenthal Web Site (see URL below for details)

lead_sponsor: Grünenthal GmbH

location_country:
Italy
Chile
Spain
France
Bulgaria
Hungary
Belgium
Portugal
Germany
United Kingdom

title: An Open-label Trial, Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment, to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR, Followed by an Open-label Extension

summary: Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.


title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia

summary: The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

ReferenceCitation: Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

name: Women’s Health Research Program, University of Cincinnati College of Medicine, Cincinnati, OH, USA;

family: Arnold

full_name: Lesley M. Arnold

given: Lesley M.

name: Daiichi Sankyo Inc., Basking Ridge, NJ, USA;

family: Whitaker

full_name: Susan Whitaker

given: Susan

family: Hsu

full_name: Ching Hsu

given: Ching

family: Jacobs

full_name: David Jacobs

given: David

name: Global Clinical Development, Daiichi Sankyo Development, Gerrards Cross, United Kingdom

family: Merante

full_name: Domenico Merante

given: Domenico

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Sweden
Serbia
Netherlands
Germany
Finland
France
Czechia
Norway
Denmark
United States
Canada


ReferenceCitation: Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. Review.

intervention_type: Dietary Supplement

location_country:
Italy
United States
Spain
France
Czechia
Greece
Lithuania
Poland
Slovakia
Hungary
Belgium
Russian Federation
New Zealand
Portugal
Germany
Ukraine

title: A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

summary: The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.


title: Study MEA117106: Mepolizumab vs. Placebo as add-on Treatment for Frequently Exacerbating COPD Patients

summary:
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection.

In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy.

Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

ReferenceCitation: Pavord ID, Chapman KR, Bafadhel M, Sciurba FC, Bradford ES, Schweiker Harris S, Mayer B, Rubin DB, Yancey SW, Paggiaro P. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770. doi: 10.2147/COPD.S294333. eCollection 2021.

family: Pavord

full_name: Ian Pavord

given: Ian

family: Chapman

full_name: Kenneth Chapman

given: Kenneth

family: Bafadhel

full_name: Mona Bafadhel

given: Mona

family: Sciurba

full_name: Frank C Sciurba

given: Frank C

family: Bradford

full_name: Eric S Bradford

given: Eric S

family: Schweiker Harris

full_name: Stephanie Schweiker Harris

given: Stephanie

family: Mayer

full_name: Bhabita Mayer

given: Bhabita

family: Rubin

full_name: David B Rubin

given: David B

family: Yancey

full_name: Steven W Yancey

given: Steven W

family: Paggiaro

full_name: Pierluigi Paggiaro

given: Pierluigi

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

ReferenceCitation: Condreay LD, Gao C, Bradford E, Yancey SW, Ghosh S. No genetic associations with mepolizumab efficacy in COPD with peripheral blood eosinophilia. Respir Med. 2019 Aug;155:26-28. doi: 10.1016/j.rmed.2019.07.004. Epub 2019 Jul 5.

family: Condreay

full_name: Lynn D. Condreay

given: Lynn D.

family: Gao

full_name: Chuan Gao

given: Chuan

full_name: Eric Bradford

given: Eric

full_name: Steven W. Yancey

given: Steven W.

family: Ghosh

full_name: Soumitra Ghosh

given: Soumitra

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Pavord ID, Chanez P, Criner GJ, Kerstjens HAM, Korn S, Lugogo N, Martinot JB, Sagara H, Albers FC, Bradford ES, Harris SS, Mayer B, Rubin DB, Yancey SW, Sciurba FC. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

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

location_country:
Italy
United States
Peru
Sweden
Mexico
France
Czechia
Greece
Poland
Norway
Belgium
Australia
Russian Federation
Spain
Estonia
Canada


ReferenceCitation: Harrison CN, Vannucchi AM, Platzbecker U, Cervantes F, Gupta V, Lavie D, Passamonti F, Winton EF, Dong H, Kawashima J, Maltzman JD, Kiladjian JJ, Verstovsek S. Momelotinib versus best available therapy in patients with myelofibrosis previously treated with ruxolitinib (SIMPLIFY 2): a randomised, open-label, phase 3 trial. Lancet Haematol. 2018 Feb;5(2):e73-e81. doi: 10.1016/S2352-3026(17)30237-5. Epub 2017 Dec 20.

family: Harrison

full_name: Claire N Harrison

given: Claire N

family: Vannucchi

full_name: Alessandro M Vannucchi

given: Alessandro M

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

family: Cervantes

full_name: Francisco Cervantes

given: Francisco

family: Gupta

full_name: Vikas Gupta

given: Vikas

family: Lavie

full_name: David Lavie

given: David

family: Passamonti

full_name: Francesco Passamonti

given: Francesco

family: Winton

full_name: Elliott F Winton

given: Elliott F

family: Dong

full_name: Hua Dong

given: Hua

family: Kawashima

full_name: Jun Kawashima

given: Jun

family: Maltzman

full_name: Julia D Maltzman

given: Julia D

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

family: Verstovsek

full_name: Srdan Verstovsek

given: Srdan

journal_name: The Lancet Haematology

lead_sponsor: Sierra Oncology, Inc.

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

acronym: Simplify 2

title: A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib

summary:
This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).

Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival follow-up visits are not required.


title: PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.

ReferenceCitation: Lehmann S, Bykov VJ, Ali D, Andrén O, Cherif H, Tidefelt U, Uggla B, Yachnin J, Juliusson G, Moshfegh A, Paul C, Wiman KG, Andersson PO. Targeting p53 in vivo: a first-in-human study with p53-targeting compound APR-246 in refractory hematologic malignancies and prostate cancer. J Clin Oncol. 2012 Oct 10;30(29):3633-9. doi: 10.1200/JCO.2011.40.7783. Epub 2012 Sep 10.

ReferenceCitation: Deneberg S, Cherif H, Lazarevic V, Andersson PO, von Euler M, Juliusson G, Lehmann S. An open-label phase I dose-finding study of APR-246 in hematological malignancies. Blood Cancer J. 2016 Jul 15;6(7):e447. doi: 10.1038/bcj.2016.60.

lead_sponsor: Aprea Therapeutics

location_country:
United States
Sweden
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility: Medische oncologie, Universitair Ziekenhuis Gent

location_facility: Massey Cancer Center, Virginia Commonwealth University

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Edinburgh Cancer Research Centre, The University of Edinburgh

location_facility: Institut Català d'Oncologia, Hospital Germans Trias i Pujol

location_facility: UPMC Hillman Cancer Center, Magee-Womens Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Clatterbridge Cancer Center NHS Foundation Trust

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Bristol Haematology & Oncology Centre, University Hospitals Bristol

location_facility: Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Imperial College London, Hammersmith Hospital Campus

location_facility: University of Texas Southwestern Medical Center

location_facility: Parkland, UT Southwestern Medical Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Clinico Universitario de Valencia


title: A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis

acronym: ASPIRE-PCa

summary: The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.

time_perspective: Prospective

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Peru
Australia
Oman
Taiwan
Spain
France
Thailand
Argentina
Indonesia
Canada
Korea, Republic of
Colombia
Saudi Arabia
Netherlands
Philippines
Singapore
Algeria
Germany
United Kingdom
Italy
Brazil
Austria
Lebanon
Mexico
Israel
Egypt
New Zealand


ReferenceCitation: Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z.

family: Klein

full_name: Gregory Klein

given: Gregory

family: Delmar

full_name: Paul Delmar

given: Paul

family: Voyle

full_name: Nicola Voyle

given: Nicola

family: Rehal

full_name: Sunita Rehal

given: Sunita

family: Hofmann

full_name: Carsten Hofmann

given: Carsten

family: Abi-Saab

full_name: Danielle Abi-Saab

given: Danielle

family: Andjelkovic

full_name: Mirjana Andjelkovic

given: Mirjana

family: Ristic

full_name: Smiljana Ristic

given: Smiljana

family: Wang

full_name: Guoqiao Wang

given: Guoqiao

family: Bateman

full_name: Randall Bateman

given: Randall

family: Kerchner

full_name: Geoffrey A. Kerchner

given: Geoffrey A.

family: Baudler

full_name: Monika Baudler

given: Monika

family: Fontoura

full_name: Paulo Fontoura

given: Paulo

family: Doody

full_name: Rachelle Doody

given: Rachelle

title: Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer’s disease: a PET substudy interim analysis

location_country:
Finland
Belgium
Australia
Russian Federation
Denmark
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Spain
Turkey

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Inha University Hospital; Neurology Department

location_facility: Fukuoka University Hospital; Neurology and Health Care

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

location_facility: University of Utah, Center for Alzheimer's Care Imaging & Research

location_facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

location_facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: MBAL St. Marina; First Neurology Department

location_facility: Alzheimer's Research and Treatment Center

location_facility: Shizuoka City Shimizu Hospital; Neurology

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Australian Alzheimer's Research Foundation

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Ewha Womans University Mokdong Hospital; Dept of Neurology

location_facility: Erasmus Mc - Locatie Centrum; Dept of Neurology

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Jewish General Hospital / McGill University

location_facility: Semmelweis University; Department of Neurology

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

location_facility: CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Seoul National University Bundang Hospital; Neurology Department

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

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Charing Cross Hospital; Dept of Neurosciences

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Royal Adelaide Hospital; Memory Trials Centre

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

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

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Territory Neurology and Research Institute

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Hopital la Grave; Gerontopole - Centre de Recherche Clinique

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: Dokuz Eylul University Medicine Faculty; Noroloji Departmani

location_facility: Shonan Kamakura General Hospital; Neurology

location_facility: Juntendo University Urayasu Hospital; Neurology

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: National Hospital Organization Chiba-east Hospital; Neurology

location_facility: Universitäres Zentrum für Altersmedizin und Rehabilitation

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

summary:
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).

A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.


ReferenceType: result

ReferenceCitation: Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nolè F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6. Erratum in: Lancet Oncol. 2019 Oct;20(10):e559.

family: Smith

full_name: Matthew Smith

given: Matthew

family: Parker

full_name: Chris Parker

given: Chris

family: Saad

full_name: Fred Saad

given: Fred

family: Miller

full_name: Kurt Miller

given: Kurt

family: Tombal

full_name: Bertrand Tombal

given: Bertrand

family: Ng

full_name: Quan Sing Ng

given: Quan Sing

family: Boegemann

full_name: Martin Boegemann

given: Martin

family: Matveev

full_name: Vsevolod Matveev

given: Vsevolod

family: Piulats

full_name: Josep Maria Piulats

given: Josep Maria

family: Zucca

full_name: Luis Eduardo Zucca

given: Luis Eduardo

family: Karyakin

full_name: Oleg Karyakin

given: Oleg

family: Kimura

full_name: Go Kimura

given: Go

family: Matsubara

full_name: Nobuaki Matsubara

given: Nobuaki

family: Nahas

full_name: William Carlos Nahas

given: William Carlos

family: Nolè

full_name: Franco Nolè

given: Franco

family: Rosenbaum

full_name: Eli Rosenbaum

given: Eli

family: Heidenreich

full_name: Axel Heidenreich

given: Axel

family: Kakehi

full_name: Yoshiyuki Kakehi

given: Yoshiyuki

family: Zhang

full_name: Amily Zhang

given: Amily

family: Krissel

full_name: Heiko Krissel

given: Heiko

family: Teufel

full_name: Michael Teufel

given: Michael

family: Shen

full_name: Junwu Shen

given: Junwu

family: Wagner

full_name: Volker Wagner

given: Volker

family: Higano

full_name: Celestia Higano

given: Celestia

ReferenceCitation: Shore N, Higano CS, George DJ, Sternberg CN, Saad F, Tombal B, Miller K, Kalinovsky J, Jiao X, Tangirala K, Sartor O. Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):680-688. doi: 10.1038/s41391-020-0236-0. Epub 2020 May 13.

ReferenceCitation: Matsubara N, Kimura G, Uemura H, Uemura H, Nakamura M, Nagamori S, Mizokami A, Kikukawa H, Hosono M, Kinuya S, Krissel H, Siegel J, Kakehi Y. A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study. Int J Clin Oncol. 2020 Apr;25(4):720-731. doi: 10.1007/s10147-019-01589-6. Epub 2019 Dec 10.

journal_name: International Journal of Clinical Oncology

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Italy
United States
Brazil
Sweden
Netherlands
Germany
Finland
France
Japan
Poland
Israel
Norway
Singapore
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom

title: A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)

summary: To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.