title: A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

acronym: SIDEROS

summary: The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

family: Buyse

full_name: Gunnar M Buyse

given: Gunnar M

family: Voit

full_name: Thomas Voit

given: Thomas

family: Schara

full_name: Ulrike Schara

given: Ulrike

family: Straathof

full_name: Chiara S M Straathof

given: Chiara S M

family: D'Angelo

full_name: M Grazia D'Angelo

given: M Grazia

family: Bernert

full_name: Günther Bernert

given: Günther

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Finkel

full_name: Richard S Finkel

given: Richard S

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: McDonald

full_name: Craig M McDonald

given: Craig M

family: Rummey

full_name: Christian Rummey

given: Christian

family: Meier

full_name: Thomas Meier

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: McDonald CM, Meier T, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Spagnolo P, Buyse GM; DELOS Study Group. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2016 Aug;26(8):473-80. doi: 10.1016/j.nmd.2016.05.008. Epub 2016 May 12.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Mayer OH, Spagnolo P, Meier T, McDonald CM; DELOS Study Group. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatr Pulmonol. 2017 Apr;52(4):508-515. doi: 10.1002/ppul.23547. Epub 2016 Aug 29.

lead_sponsor: Santhera Pharmaceuticals

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Germany
France
Bulgaria
Israel
Hungary
Belgium
Ireland
Spain
United States
United Kingdom

location_facility: Centre de Référence Neuromusculaire, CHR Citadelle

location_facility: Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital

location_facility: Semmelweis University 2nd Department of Paediatrics

location_facility: Banner University of Arizona Medical Center

location_facility: Gillette Children's Specialty Healthcare

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital

location_facility: UCL, National Hospital for Neurology and Neurosurgery

location_facility: Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System

location_facility: I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20

location_facility: Servizio di Cardiomiologia e Genetica Medica, AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Reparto Di Neurologia dell'Osperdale Di Padova

location_facility: Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Dipartimento di Clinica Neurologica e Psichiatrica dell'Età Evolutiva della Fondazione IRCCS "C. Mondino" di Pavia

location_facility: John Walton Muscular Dystrophy Research Centre

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin

location_facility: Scientific Coordinator Nemo Sud Clinical Center

location_facility: Institute of Neurology at Schneider Children's Medical Center of Israel

location_facility: Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Universitätsklinikum Heidelberg Zentrum für Kinder- und Jugendmedizin

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Universitätsmedizin Berlin Campus Virchow-Klinikum

location_facility: Great Ormond Street Hospital for Children

location_facility: UC Davis Department of Physical Medicine and Rehabilitation

location_facility: Oxford University hospitals NHS Foundation Trust


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy

summary: Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Albireo

location_country:
Italy
United States
Netherlands
Germany
France
Malaysia
Poland
Israel
Hungary
Belgium
Australia
New Zealand
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: NewYork-Presbyterian Morgan Stanley Children's Hospital

location_facility: Birmingham Women´s and Children´s Hospital

location_facility: UCSF Benioff Children's Hospital San Francisco

location_facility: Istanbul University, Istanbul Medical Faculty

location_facility: University of Michigan Children's Hospital

location_facility: Schneider Children´s Medical Center of Israel

location_facility: Necker University Hospital - Enfants malades

location_facility: Semmelweis Egyetem I.sz Gyermekgyógyászati Klinika

location_facility: University Children´s Hospital Tuebingen

location_facility: Seoul National University Children's Hospital

location_facility: Hacettepe University Ihsan Dogramaci Childrens Hospital

location_facility: University Medical Center Hamburg-Eppendorf UKE

location_facility: Children's Healthcare of Atlanta - Emory University School of Medicine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Other Identifier

title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B

summary:
Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Switzerland
France
Israel
Australia
United States

location_facility: Tasman Oncology Research Pty Ltd ( Site 2403)

location_facility: Calvary Mater Newcastle-Medical Oncology ( Site 2404)

location_facility: Rambam Health Care Campus-Oncology ( Site 2704)

location_facility: Oregon Health & Science University ( Site 2013)

location_facility: Universitaetsspital Zuerich ( Site 2601)

location_facility: Hadassah Ein Karem Jerusalem ( Site 2702)

location_facility: Providence Saint John's Health Center ( Site 2010)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 2107)

location_facility: Istituto Europeo di Oncologia ( Site 2301)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 2377)

location_facility: The Angeles Clinic and Research Institute ( Site 2009)

location_facility: Inova Schar Cancer Institute ( Site 2011)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 2355)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)

location_facility: Melanoma Institute Australia ( Site 2402)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 2008)

location_facility: West Cancer Center - East Campus ( Site 2014)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 2012)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399)


intervention_type: Radiation

location_country:
Guatemala
Malaysia
Romania
Australia
Denmark
Taiwan
Ukraine
France
Japan
Poland
Korea, Republic of
Turkey
Netherlands
Hungary
Puerto Rico
Portugal
United States
United Kingdom
Italy
Czechia
Israel
Spain
Estonia
Latvia

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0209)

location_facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0601)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)

location_facility: Chungnam National University Hospital ( Site 0203)

location_facility: Odense Universitetshospital ( Site 0403)

location_facility: Ospedale Civile di Macerata ( Site 0190)

location_facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)

location_facility: Betsi Cadwaladr University Health Board ( Site 0447)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0442)

location_facility: National Cheng Kung University Hospital ( Site 0208)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)

location_facility: PAN American Center Oncologic ( Site 0280)

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0086)

location_facility: National Taiwan University Hospital ( Site 0210)

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0606)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0097)

location_facility: Institutul Regional de Oncologie Iasi ( Site 0255)

location_facility: Sir Charles Gairdner Hospital ( Site 0223)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0212)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0123)

location_facility: Ukranian Center of TomoTherapy ( Site 0140)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)

location_facility: Netherlands Cancer Institute (NKI) ( Site 0183)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 0445)

location_facility: Nottingham University Hospital NHS Trust ( Site 0250)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)

location_facility: Kyiv City Clinical Oncology Center ( Site 0135)

location_facility: Severance Hospital Yonsei University Health System ( Site 0201)

location_facility: Korea University Anam Hospital ( Site 0205)

location_facility: Ege University Medical Faculty ( Site 0508)

location_facility: Winthrop University Hospital ( Site 0069)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 0604)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)

location_facility: Hirosaki University Hospital ( Site 0602)

location_facility: Froedtert and Medical College of Wisconsin ( Site 0022)

location_facility: BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)

location_facility: Seoul National University Bundang Hospital ( Site 0204)

location_facility: Advance Urology and Laparoscopic Center ( Site 0281)

location_facility: University Malaya Medical Centre ( Site 0236)

location_facility: North Estonia Medical Centre Foundation ( Site 0081)

location_facility: Clinical oncology dispensary of Dnipro ( Site 0133)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)

location_facility: Saint Francis Cancer Center ( Site 0026)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0103)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)

location_facility: Hospital Universiti Sains Malaysia ( Site 0237)

location_facility: Pauls Stradins Clinical University Hospital ( Site 0073)

location_facility: New York Oncology Hematology P.C ( Site 0024)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0136)

location_facility: Baltimore VA Medical Center ( Site 0054)

location_facility: Herlev og Gentofte Hospital. ( Site 0401)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0502)

location_facility: Taipei Veterans General Hospital ( Site 0211)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)

location_facility: New York University Perlmutter Cancer Center ( Site 0001)

location_facility: University of Tsukuba Hospital ( Site 0605)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0099)

location_facility: Nagasaki University Hospital ( Site 0600)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)

location_facility: Bay Pines VA Medical Center ( Site 0055)

location_facility: Monash Health-Monash Medical Centre ( Site 0216)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)

location_facility: Carolina Urologic Research Center ( Site 0002)

location_facility: CNPE "Regional Center of Oncology" ( Site 0134)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)

type: Registry Identifier

source: euctr

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.


title: A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis

acronym: RAISE-XT

summary: The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.

status: Enrolling by invitation

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: Ra Pharmaceuticals

location_country:
Italy
United States
France
Japan
Poland
Norway
Spain
Germany
United Kingdom
Canada

location_facility: Site 126: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Site 204: Centre Hospitalier Régional Universitaire de Lille

location_facility: Site 137: Les Hôpitaux Universitaires de Strasbourg

location_facility: Site 123: Northwell Health Neuroscience Institute

location_facility: Site 153: Toho University Ohashi Medical Center

location_facility: Site 130: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Site 32: University of Kansas Medical Center

location_facility: Site 156: Indiana University Health Neuroscience Center

location_facility: Site 134: Neurology and Sleep Disorders Clinic

location_facility: Site 160: Forbes Norris MDA/ALS Research and Treatment Center

location_facility: Site 28: Wesley Neurology Clinic - North

location_facility: Site 140: Haukeland University Hospital / Health Bergen

location_facility: Site 167: Tokyo Women's Medical University Hospital

location_facility: Site 133: Hospital Universitari Vall d´Hebrón

location_facility: Site 33: Detroit medical Center - University Health Center

location_facility: Site 45: Center for Neurological Disorders

location_facility: Site 31: University of California Irvine

location_facility: Site 168: Hospital de la Santa Creu i Sant Pau

location_facility: Site 135: Augusta University Medical Center

location_facility: Site 188: NorthShore Medical Group - Glenview

location_facility: Site 119: Oxford University Hospitals NHS Foundation Trust

location_facility: Site 47: Mount Sinai Hospital Icahn School of Medicine

location_facility: Site 179: Kagawa University Hospital - Collagen disease/Rheumatic int

location_facility: Site 11: Montreal Neurological Institute and Hospital (McGill University)

location_facility: Site 211: Specjalistyczne Gabinety Sp. z o.o.

location_facility: Site 40: Allegheny Neurological Associates

location_facility: Site 116: Neuromuscular Clinic and Research Center

location_facility: Site 132: Università Cattolica del Sacro Cuore - Campus di Milano

location_facility: Site 163: Tokyo Medical University Hospital

location_facility: Site 195: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Site 128: Medical University of South Carolina

location_facility: Site 138: Hospital Universitario de Basurto

location_facility: Site 19: University of Texas Southwestern

location_facility: Site 164: University of Virginia Health System

location_facility: Site 105: Pitié-Salpêtrière University Hospital

status_simplified: Unknown


ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Hong Kong
Spain
France
Thailand
New Zealand
China
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Piranga

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital; Pharmacy

location_facility: Hopital Brabois Adultes; Service Médecine Interne Hématologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: King College Hospital NHS Foundation Trust

location_facility: Hopital de la Croix-Rousse - Groupement Hospitalier Nord; Pharmacie / Secteur Essais Cliniques

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Asan Medical Center / Clinical Trial Center

location_facility: China Medical University Hospital; Internal Medicine

location_facility: Hospital Universitari Vall dHebron; Oncology

title: A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

summary: This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.


title: A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors

acronym: Bellini

summary: This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

status: Suspended

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29.

family: Kumar

full_name: Shaji K Kumar

given: Shaji K

sequence: first

family: Harrison

full_name: Simon J Harrison

given: Simon J

sequence: additional

family: Cavo

full_name: Michele Cavo

given: Michele

family: de la Rubia

full_name: Javier de la Rubia

given: Javier

family: Popat

full_name: Rakesh Popat

given: Rakesh

family: Gasparetto

full_name: Cristina Gasparetto

given: Cristina

family: Hungria

full_name: Vania Hungria

given: Vania

family: Salwender

full_name: Hans Salwender

given: Hans

family: Suzuki

full_name: Kenshi Suzuki

given: Kenshi

family: Kim

full_name: Inho Kim

given: Inho

family: Punnoose

full_name: Elizabeth A Punnoose

given: Elizabeth A

family: Hong

full_name: Wan-Jen Hong

given: Wan-Jen

family: Freise

full_name: Kevin J Freise

given: Kevin J

family: Yang

full_name: Xiaoqing Yang

given: Xiaoqing

family: Sood

full_name: Anjla Sood

given: Anjla

family: Jalaluddin

full_name: Muhammad Jalaluddin

given: Muhammad

family: Ross

full_name: Jeremy A Ross

given: Jeremy A

family: Ward

full_name: James E Ward

given: James E

family: Maciag

full_name: Paulo C Maciag

given: Paulo C

family: Moreau

full_name: Philippe Moreau

given: Philippe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Oncology

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

location_country:
Italy
Brazil
United States
Germany
France
Japan
Hungary
Australia
Ireland
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: The Queen Elizabeth Hospital /ID# 149104

location_facility: Universidade Federal de Goias /ID# 149290

location_facility: Nagoya City University Hospital /ID# 150943

location_facility: National Hospital Organization Shibukawa Medical Center /ID# 150281

location_facility: Hospital Universitario 12 de Octubre /ID# 148981

location_facility: East Kent Hosp Univ NHS Trust /ID# 149059

location_facility: St Bartholomew's Hospital, Bar /ID# 149050

location_facility: Seoul National University Hospital /ID# 150890

location_facility: Chonnam National University Hospital /ID# 150894

location_facility: JCHO Kyoto Kuramaguchi Medical /ID# 150781

location_facility: Taipei Veterans General Hosp /ID# 154445

location_facility: Somogy Megyei Kaposi Mor Oktat /ID# 152516

location_facility: Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 152518

location_facility: CHRU de Brest - Hopital Morvan /ID# 149299

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 149025

location_facility: Gabrail Cancer Center Research /ID# 149098

location_facility: Gachon University Gil Medical Center /ID# 150893

location_facility: China Medical University Hosp /ID# 154446

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 149301

location_facility: King's College Hospital NHS Foundation Trust /ID# 149045

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 152411

location_facility: Japanese Red Cross Medical Center /ID# 149902

location_facility: The Cancer Institute Hospital Of JFCR /ID# 150780

location_facility: Kobe City Medical Center General Hospital /ID# 150944

location_facility: Samara State Medical Universit /ID# 148952

location_facility: Universitaetsklinikum Dresden /ID# 148948

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 149294

location_facility: National Cancer Center Hospital /ID# 151039

location_facility: National Hospital Organization Disaster Medical Center /ID# 150784

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 149020

location_facility: Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242

location_facility: Royal Prince Alfred Hospital /ID# 149108

location_facility: Japanese Red Cross Osaka Hospital /ID# 150716

location_facility: Univ of Colorado Cancer Center /ID# 149130

location_facility: Seoul National Univ Bundang ho /ID# 150888

location_facility: Duke University Medical Center /ID# 149099

location_facility: Azienda Policlinico Umberto I /ID# 148939

location_facility: National Hospital Organization Mito Medical Center /ID# 151051

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 152517

location_facility: Concord Repatriation & Gen Hos /ID# 149106

location_facility: Nottingham Univ Hospitals NHS /ID# 149047

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 150895

location_facility: Hospital Universitario de la Princesa /ID# 148980

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956

location_facility: The Royal Wolverhampton NHS Tr /ID# 149043

location_facility: Charite Universitaetsmedizin Berlin /ID# 148949

location_facility: Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council /ID# 152414

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 148936

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 148955

location_facility: Hospital Universitario Dr. Peset /ID# 148986

location_facility: University College Hospitals /ID# 149044

location_facility: Royal Brisbane and Women's Hospital /ID# 149105

location_facility: Liga Norte Rigrandese Contra o /ID# 149023


status: Terminated

ipd_sharing_description: Qualified researchers may request access to patient 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. Patient 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: Sanofi

location_country:
Italy
France
Japan
Belgium
Puerto Rico
Russian Federation
Spain
United States
Korea, Republic of
Ukraine

location_facility:
Investigational Site Number 8400012
Investigational Site Number 3800001
Investigational Site Number 4100004
Investigational Site Number 8400003
Investigational Site Number 4100002
Investigational Site Number 8400008
Investigational Site Number 3920003
Investigational Site Number 8040004
Investigational Site Number 6430004
Investigational Site Number 2500002
Investigational Site Number 8400004
Investigational Site Number 3920001
Investigational Site Number 8400001
Investigational Site Number 8400022
Investigational Site Number 4100001
Investigational Site Number 7240003
Investigational Site Number 2500003
Investigational Site Number 6430007
Investigational Site Number 3800004
Investigational Site Number 0560003
Investigational Site Number 3800002
Investigational Site Number 6430003
Investigational Site Number 2500001
Investigational Site Number 8400016
Investigational Site Number 2500004
Investigational Site Number 6430006
Investigational Site Number 8040002
Investigational Site Number 0560001
Investigational Site Number 8400006
Investigational Site Number 8400010
Investigational Site Number 3920002
Investigational Site Number 7240005
Investigational Site Number 8040005
Investigational Site Number 8400017
Investigational Site Number 4100003
Investigational Site Number 7240006
Investigational Site Number 0560002
Investigational Site Number 7240001
Investigational Site Number 8400015
Investigational Site Number 8400011
Investigational Site Number 6430002
Investigational Site Number 8400005
Investigational Site Number 8400014
Investigational Site Number 8040001
Investigational Site Number 7240002
Investigational Site Number 8400018
Investigational Site Number 8400007

study_completion_date_type: Actual

title: Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer

summary:
Primary Objective:

To determine whether amcenestrant given at 2 different doses improves the antiproliferative activity when compared to letrozole

Secondary Objectives:

To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms
To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms
To assess safety in the three treatment arms


title: Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.

acronym: Premium

summary: This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: PregLem SA

location_country:
Italy
Sweden
United Kingdom
Netherlands
Spain
France
Czechia
Lithuania
Poland
Romania
Hungary
Belgium
Portugal
Denmark
Germany
Latvia

location_facility: Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust

location_facility: Elena Doamna Obstetrics and Gynecology Clinical Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie

location_facility: Groupement Hospitalier Universitaire Sud CHU Bicetre

location_facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte

location_facility: Szent Anna Privat Surgery-Szent Anna Magae¡nrendela

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)

location_facility: Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust

location_facility: Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Torino, S. Anna Hospital- City of Health and Science

location_facility: Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw

location_facility: Karolinska Institutet, Karolinska University Hospital Huddinge

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie

location_facility: Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Instituto Palacios, Salud y Medicina de la Mujer

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Endoskopie Und Endometriose-Zentrum Munchen

location_facility: Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust

location_facility: Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert

location_facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika

location_facility: Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

location_facility: University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust

location_facility: Rosemere Cancer Centre - Royal Preston Hospital

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: University ""Magna Graecia"" Of Catanzaro

location_facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing

location_facility: Hospital Universitario de Guadalajara (HUG)

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau


lead_sponsor: Eli Lilly and Company

location_country:
France
Japan
Belgium
Australia
Spain
United States
Korea, Republic of
Taiwan

acronym: EMBER

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Univ of California Irvine College of Medicine

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Peggy and Charles Stephenson Oklahoma Cancer Center

location_facility: University of Rochester School of Medicine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: ICANS_Institut de Cancerologie Strasbourg Europe

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

ipd_sharing: No

title: EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

summary: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.


title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period

acronym: SELECT AXIS 2

summary:
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.

The main objectives of this protocol are:

To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).
To assess the safety and tolerability of upadacitinib in adult participants with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2).
To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and with nr-axSpA who have completed the Double-Blind Period (Study 2).
To evaluate the maintenance of disease control after withdrawal of upadacitinib.

lead_sponsor: AbbVie

location_country:
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Omsk Regional Clinic Hospital /ID# 214464

location_facility: ETYKA-Osrodek Badan Klinicznych /ID# 215572

location_facility: Orenburg State Medical University /ID# 214408

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 214501

location_facility: Nort-Western State Medical University n.a. Mechnikov /ID# 214454

location_facility: Revmatologicky ustav v Praze /ID# 215154

location_facility: Seoul National University Hospital /ID# 214532

location_facility: Barwon Rheumatology Services /ID# 215508

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 215187

location_facility: The Chaim Sheba Medical Center /ID# 215854

location_facility: Diagnostic consultative center 17 Sofia /ID# 214808

location_facility: Gachon University Gil Medical Center /ID# 214534

location_facility: Alliance Biomedical Ural Group /ID# 214457

location_facility: Inland Rheum & Osteo Med Grp /ID# 215807

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186

location_facility: Wayne State University Health Center /ID# 215930

location_facility: The First Affiliated Hospital of Soochow University /ID# 216607

location_facility: Medical centre of CONSILIUM MEDICAL LLC /ID# 216234

location_facility: MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 214784

location_facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055

location_facility: Centre de Recherche Musculo-Squelettique /ID# 215096

location_facility: Hacettepe Universitesi Tip Fak /ID# 214898

location_facility: Scientific Research Institute of Invalid Rehabilitation /ID# 214148

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust /ID# 216226

location_facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181

location_facility: Hospital Universitario La Paz /ID# 216032

location_facility: First Affiliated Hospital of Kunming Medical University /ID# 217945

location_facility: Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust /ID# 214971

location_facility: PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151

location_facility: The First Affiliated Hospital of Shantou University Medical College /ID# 217883

location_facility: Sweet Hope Research Specialty Inc /ID# 215931

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731

location_facility: Centro Medico Privado de Reumatologia /ID# 214559

location_facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184

location_facility: Trinity Universal Research Associates, Inc /ID# 215189

location_facility: MNPE Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrohov /ID# 214147

location_facility: China Medical University Hospital /ID# 214019

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865

location_facility: MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220

location_facility: Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282

location_facility: Universitaetsklinikum Erlangen /ID# 214281

location_facility: MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261

location_facility: Juntendo University Hospital /ID# 214929

location_facility: Oregon Health and Science University /ID# 216446

location_facility: Immanuel Kant Baltic Federal University /ID# 218259

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 214488

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 214965

location_facility: Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895

location_facility: Biopharma Informatic - Park Row /ID# 215907

location_facility: Hyogo College of Medicine College Hospital /Id# 215638

location_facility: NYU Langone Orthopedic Center /ID# 215594

location_facility: Hospital Universitario y Politecnico La Fe /ID# 214966

location_facility: Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212

location_facility: Newport Huntington Medical Group /ID# 216281

location_facility: Tel Aviv Sourasky Medical Center /ID# 216956

location_facility: CPCLIN - Centro de Pesquisas Clínicas /ID# 215175

location_facility: AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354

location_facility: Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418

location_facility: State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 214155

location_facility: Rheumatology and Pulmonary Clinic /ID# 214946

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295

location_facility: Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161

location_facility: Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218

location_facility: Chelyabinsk Regional Clinical Hospital /ID# 214463

location_facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 215303

location_facility: Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159

location_facility: Arth and Osteo Clin Brazo Valley /ID# 215805

location_facility: Multifield Medical Centre of ONMU /ID# 214149

location_facility: Matsuyama Red Cross Hospital /ID# 216021

location_facility: Chung Shan Medical University Hospital /ID# 214018

location_facility: Kyunghee University Hospital at Gangdong /ID# 214296

location_facility: Organizacion Medica de Investigacion (OMI) /ID# 214557

location_facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459

location_facility: The first affiliated hospital of bengbu medical college /ID# 216609

location_facility: CenterPointe Institute of Research /ID# 215793

location_facility: Clinical Pharmacology Study Gr /ID# 215293

location_facility: Medical Center LLC Institute of Rheumatology /ID# 214146

location_facility: St.Luke's International Hospital /ID# 215414

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211

location_facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277

location_facility: Khmelnytskyi Regional Hospital /ID# 214153

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 215113

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 214458

location_facility: Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282

location_facility: MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176

location_facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217

location_facility: Greater Chicago Specialty Physicians /ID# 216213

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967

location_facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208

location_facility: Hokkaido University Hospital /ID# 215221

location_facility: Kaohsiung Veterans General Hos /ID# 214332

location_facility: Innovation Medical Research Center /ID# 216068

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 214205

location_facility: CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 214930

location_facility: Trinity Universal Research Associates - Carrollton /ID# 214948

location_facility: Hospital Universitario Reina Sofia /ID# 214968

location_facility: City Clinical Hospital n.a. O.M. Filatov /ID# 214486

location_facility: Medizinische Hochschule Hannover /ID# 214209

location_facility: Okinawa Prefectural Chubu Hospital /ID# 215575

location_facility: West Texas Clinical Research /ID# 215928

location_facility: PNE City Multifunctional Hospital No.18 /ID# 214154

location_facility: LLC Family Outpatient Clinic № /ID# 214455

location_facility: Huashan Hospital of Fudan University /ID# 216646

location_facility: Hanyang University Seoul Hospital /ID# 214297

location_facility: Kazan State Medical University /ID# 214421

location_facility: CHU Toulouse - Hôtel-Dieu Saint-Jacques /ID# 214780

location_facility: MNI KRC Kyiv Regional Clinical Hospital /ID# 214156

location_facility: Kyiv Railway Clinical Hosp No.2 /ID# 214779

location_facility: Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652

location_facility: EDUMED Educacao em Saude S/S L /ID# 215111

location_facility: Percuro Clinical Research, Ltd /ID# 215302

location_facility: Nagasaki University Hospital /ID# 215947

location_facility: Mugla Sitki Kocman University Medical Faculty /ID# 215358

location_facility: West Suffolk NHS Foundation Trust /ID# 215529

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 215306

location_facility: Universitair Ziekenhuis Leuven /ID# 215006

location_facility: Guangdong Provincial People's Hospital /ID# 216645

location_facility: Peking Union Medical College Hospital /ID# 216545

location_facility: Japanese Red Cross Okayama Hospital /ID# 214732

location_facility: The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612

location_facility: Narodny ustav reumatickych chorob /ID# 214674

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183

location_facility: Far Eastern Memorial Hospital /ID# 215384

location_facility: Nasz Lekarz Przychodnie Medyczne /ID# 214352

location_facility: Ternopil University Hospital /ID# 214705

location_facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556


title: The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

acronym: RADIANCE-HTN

summary: RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

ReferenceCitation: Sanghvi K, Wang Y, Daemen J, Mathur A, Jain A, Dohad S, Sapoval M, Azizi M, Mahfoud F, Lurz P, Sayer J, Levy T, Zagoria R, Loening AM, Coleman L, Craig D, Horesh-Bar M, Kirtane AJ. Renal artery variations in patients with mild-to-moderate hypertension from the RADIANCE-HTN SOLO trial. Cardiovasc Revasc Med. 2021 Sep 30. pii: S1553-8389(21)00670-9. doi: 10.1016/j.carrev.2021.09.008. [Epub ahead of print]

family: Sanghvi

full_name: Kintur Sanghvi

given: Kintur

family: Wang

full_name: Yale Wang

given: Yale

family: Daemen

full_name: Joost Daemen

given: Joost

family: Mathur

full_name: Anthony Mathur

given: Anthony

family: Jain

full_name: Ajay Jain

given: Ajay

family: Dohad

full_name: Suhail Dohad

given: Suhail

family: Sapoval

full_name: Marc Sapoval

given: Marc

family: Azizi

full_name: Michel Azizi

given: Michel

family: Mahfoud

full_name: Felix Mahfoud

given: Felix

family: Lurz

full_name: Philipp Lurz

given: Philipp

family: Sayer

full_name: Jeremy Sayer

given: Jeremy

family: Levy

full_name: Terry Levy

given: Terry

family: Zagoria

full_name: Ronald Zagoria

given: Ronald

family: Loening

full_name: Andreas M. Loening

given: Andreas M.

family: Coleman

full_name: Leslie Coleman

given: Leslie

family: Craig

full_name: David Craig

given: David

family: Horesh-Bar

full_name: Meital Horesh-Bar

given: Meital

family: Kirtane

full_name: Ajay J. Kirtane

given: Ajay J.

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

ReferenceCitation: Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.

ReferenceCitation: Gosse P, Cremer A, Kirtane AJ, Lobo MD, Saxena M, Daemen J, Wang Y, Stegbauer J, Weber MA, Abraham J, Kario K, Bangalore S, Claude L, Liu Y, Azizi M. Ambulatory Blood Pressure Monitoring to Predict Response to Renal Denervation: A Post Hoc Analysis of the RADIANCE-HTN SOLO Study. Hypertension. 2021 Feb;77(2):529-536. doi: 10.1161/HYPERTENSIONAHA.120.16292. Epub 2020 Dec 28.

name: From the Hôpital Saint-André–CHU, Bordeaux, France (P.G., A.C.)

name: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation (A.J.K.)

name: Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, NL, the Netherlands (J.D.)

name: Minneapolis Heart Institute, Abbott Northwestern Hospital, MN (Y.W.)

name: Department of Nephrology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany (J.S.)

name: Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center (M.A.W.)

name: Division of Nephrology and Hypertension, University of Utah, Salt lake city (J.A.)

name: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.)

name: ReCor Medical, Inc, Palo Alto, CA (L.C.)

name: Baim Institute for Clinical Research, Boston, MA (Y.L.)

name: Université de Paris, F-75006 Paris, France (M.A.)

name: AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, F-75015 Paris, France (M.A.)

name: INSERM, CIC1418, F-75015 Paris, France (M.A.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 Mar 17. doi: 10.1161/CIRCULATIONAHA.119.040451. [Epub ahead of print]

name: Université Paris-Descartes, France (M.A., D.F.).

name: AP-HP, Department of Hypertension, Hôpital Européen Georges-Pompidou, Paris, France (M.A., D.F.).

name: INSERM, CIC1418, Paris, France (M.A., D.F.).

name: Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Germany (R.E.S.).

name: Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany (F.M.).

name: Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge (F.M.).

name: Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York (M.A.W.).

name: Erasmus MC, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, The Netherlands (J.D.).

name: Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, United Kingdom (M.D.L., M.S.).

name: Royal Devon and Exeter NHS Foundation Trust, United Kingdom (A.S.P.S.).

name: Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, NV (M.J.B.).

name: Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H Johnson VA Medical Center, Charleston (J.B.).

name: Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (Y.W.).

name: Heart Center Leipzig, University of Leipzig, Germany (P.L.).

name: Cedars-Sinai Heart Institute, Los Angeles, CA (F.R.).

name: The Essex Cardiothoracic Centre, United Kingdom (J.S.).

name: The Brigham and Women’s Hospital, Boston, MA (N.D.L.F.).

name: ReCor Medical, Inc, Palo Alto, CA (N.C.B., H.R.S.).

name: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, NY (A.J.K.).

name: On behalf of the RADIANCE-HTN Investigators

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

title: Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial

ReferenceCitation: Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156.

name: Department of Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham, Alabama, USA

name: Lady Davis Institute of Medical Research, and Department of Medicine, Sir Mortimer B. Davis-Jewish General Hospital, McGill University, Montreal, Quebec, Canada

name: Division of General Medicine, Hypertension Section, Department of Medicine, Springfield, Illinois, USA

title: Resistant Hypertension: An Update

ReferenceCitation: Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23. Erratum in: Lancet. 2018 Sep 8;392(10150):820.

location_country:
United States
Netherlands
France
Poland
Belgium
Germany
United Kingdom

location_facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

location_facility: Imperial College London, Hammersmith Hospital

location_facility: Columbia University / NewYork Presbyterian Hospital

location_facility: The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals

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

location_facility: University Hospitals Cleveland Medical Center

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Renown Institute for Heart& Vascular Health

location_facility: Royal Devon and Exeter Hospital (Wonford)


intervention_type: Procedure

status: Completed

lead_sponsor: Allergan

location_country:
Italy
France
Poland
Thailand
Singapore
Belgium
Russian Federation
Spain
Denmark
United States

location_facility: CHU de Nice - Hopital Pasteur 2 - Service Ophtalmologie

location_facility: Centrum Diagnostykii Mikrochirurgii Oka LENS ul.

location_facility: The Eye Institute for Medicine and Surgery

location_facility: Academician I.P. Pavlov First St. Petersburg state medical university

location_facility: Adjunct Clinic Head University Hospitals Leuven

location_facility: Singapore National Eye Centre - Singapore Eye Research Institute

location_facility: Charlotte Eye Ear Nose and Throat Associates PA

location_facility: GBOU VPO "Omsk state medical University" of Ministry of Health of Russia

location_facility: DCT- Shah Research, LLC dba Discovery Clinical Trials

location_facility: Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital

location_facility: CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie

location_facility: University of Pisa (Azienda Ospedaliero-Universitaria Pisana Cisanello Hospital)

location_facility: Novosibirsk branch of S. Fyodorov Eye Microsurgery Federal State Institution

title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

summary: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.

status_simplified: Completed


title: An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

summary: This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

design_allocation: Non-Randomized

location_country:
Italy
United States
Netherlands
France
Israel
Belgium
Spain
Denmark
Canada
United Kingdom

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

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie

location_facility: Ospedale Policlinico S. Matteo; Phase I Clinical Trial Unit and Experimental Therapy

location_facility: Juravinski Cancer Clinic; Department of Oncology

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

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

location_facility: Washington University; Division of Oncology


lead_sponsor: Guerbet

primary_purpose: Diagnostic

location_country:
Italy
United States
Mexico
France
Poland
Hungary
Belgium
Spain
Germany
Korea, Republic of
Taiwan

acronym: PICTURE

location_facility: South Carolina Clinical & Translational Research (SCTR) Institute

location_facility: University Of Washington - Medical Center

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika

location_facility: University of Missouri Hospital and Clinic

location_facility: ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara

location_facility: CHRU - Hôpital Roger Salengro - Neurologie

location_facility: Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii

location_facility: Axis Heilsa S. de R.L. de C.V. (Althian)

title: Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

summary: the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)


title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

summary: The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Chile
France
Argentina
Spain
Canada

location_facility:
Johns Hopkins University
Hackensack University Medical Center
Washington University
University Of Colorado
Local Institution


title: Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)

summary:
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates.

The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding.

In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand).

In case a participant develops antibodies, treatment will be provided as part of the study.

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

lead_sponsor: Baxalta now part of Shire

location_country:
Finland
Malaysia
Belgium
Denmark
Taiwan
Ukraine
France
Thailand
Norway
Canada
Korea, Republic of
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Austria
Czechia
Spain
Turkey

location_facility: Evelina Children's Hospital - St Thomas' Hospital

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Novant Health Presbyterian Medical Center

location_facility: Texas Tech University Health Sciences Center

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: The University of Hong Kong Queen Mary Hospital

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Oslo Universitetssykehus - Rikshospitalet

intervention_type: Biological


title: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

summary:
This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts:

Cohort using tazemetostat 800 mg BID

Cohort 1 (Closed for enrollment): MRT, RTK, ATRT, and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO]
Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement
Cohort 3 (Closed for enrollment): Other INI1 negative tumors or any solid tumor with an EZH2 gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma
Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)
Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)
Cohort 6 (Opened for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy
Cohort 7 (Closed for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval)

Cohort using tazemetostat 1600 mg QD

• Cohort 8 (Closed for enrollment): Epitheliod sarcoma

Subjects will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is discontinued prior to completing 2 years, subjects will be followed for a maximum duration of 2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks while on study.

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study.

ReferenceCitation: Gounder M, Schöffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, Attia S, Chugh R, Chen TW, Jahan T, Loggers ET, Gupta A, Italiano A, Demetri GD, Ratan R, Davis LE, Mir O, Dileo P, Van Tine BA, Pressey JG, Lingaraj T, Rajarethinam A, Sierra L, Agarwal S, Stacchiotti S. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020 Nov;21(11):1423-1432. doi: 10.1016/S1470-2045(20)30451-4. Epub 2020 Oct 6.

family: Gounder

full_name: Mrinal Gounder

given: Mrinal

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Jones

full_name: Robin L Jones

given: Robin L

family: Agulnik

full_name: Mark Agulnik

given: Mark

family: Cote

full_name: Gregory M Cote

given: Gregory M

family: Villalobos

full_name: Victor M Villalobos

given: Victor M

family: Attia

full_name: Steven Attia

given: Steven

family: Chugh

full_name: Rashmi Chugh

given: Rashmi

family: Chen

full_name: Tom Wei-Wu Chen

given: Tom Wei-Wu

family: Jahan

full_name: Thierry Jahan

given: Thierry

family: Loggers

full_name: Elizabeth T Loggers

given: Elizabeth T

family: Gupta

full_name: Abha Gupta

given: Abha

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Demetri

full_name: George D Demetri

given: George D

family: Ratan

full_name: Ravin Ratan

given: Ravin

family: Davis

full_name: Lara E Davis

given: Lara E

family: Mir

full_name: Olivier Mir

given: Olivier

family: Dileo

full_name: Palma Dileo

given: Palma

family: Van Tine

full_name: Brian A Van Tine

given: Brian A

family: Pressey

full_name: Joseph G Pressey

given: Joseph G

family: Lingaraj

full_name: Trupti Lingaraj

given: Trupti

family: Rajarethinam

full_name: Anand Rajarethinam

given: Anand

family: Sierra

full_name: Laura Sierra

given: Laura

family: Agarwal

full_name: Shefali Agarwal

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

location_facility: Metro South Hospital and Health Service via Princess Alexandra Hospital

location_facility: Massachusetts General Hospital - Cancer Center

location_facility: Institut Jules Bordet Medical Oncology Clinic

location_facility: McGill University Health Centre - Royal Victoria Hospital

location_facility: Instituto Nazionale Tumori - National Cancer Institute Via Giacomo Venezian

location_facility: Cincinnati Children's Hospital Medical Center


title: Pulmonary Hemodynamics During Exercise - Research Network

acronym: PEX-NET

summary: The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

ipd_sharing: Undecided

lead_sponsor: Medical University of Graz

location_country:
Italy
Austria
Brazil
Switzerland
Netherlands
Germany
France
Poland
Australia
Belgium
Spain
Denmark
United States
United Kingdom

location_facility: Thorax Clinic Heidelberg, Centre for Pulmonary Hypertension

location_facility: University Hospital of Zurich, Internal Medicine

location_facility: Sorbonne Universités, Neurophysiologie respiratoire expérimentale et clinique

location_facility: University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine

location_facility: Royal Prince Alfred Hospital, Respiratory Medicine

location_facility: Justus-Liebig-University Giessen, Department of Internal Medicine

location_facility: Centre de Référence de l'Hypertension Pulmonaire, Université ParisSud - Université Paris-Saclay, Hôpital Bicêtre, Assistance Publique Hôpitaux de Paris

location_facility: Free University of Brussels, Faculty of Medicine, Physiology

location_facility: Otwock Medical Center of Postgraduate Education, Department of Pulmonary Circulation and Thromboembolic Diseases

location_facility: Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine

location_facility: University of Cologne, Klinik III fuer Innere Medizin

location_facility: University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA

location_facility: Massachusetts General Hospital, Cardiology Division and Pulmonary Unit

location_facility: Harvard Medical School, Brigham and Women's Hospital

location_facility: University of Rome La Sapienza, Cardiovascular and Respiratory Sciences

location_facility: Imperial College, NHS Healthcare NHS Trust, National Pulmonary Hypertension Service

location_facility: Department of Cardiology, Aarhus University Hospital, Denmark

location_facility: Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA

location_facility: Royal Hallamshire Hospital, Sheffield Pulmonary Vascular Disease Unit

location_facility: University of Arizona, Banner University Medical Center

location_facility: Centre Chirurgical Marie Lannelongue, Thoracic and Vascular Surgery

location_facility: Academic Teaching Hospital of the Julius Maximilian University of Würzburg

intervention_type: Diagnostic Test

lead_sponsor_type: academique


title: The Medtronic CoreValve™ Evolut R™ FORWARD Study

acronym: FORWARD

summary: Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

ReferenceType: result

ReferenceCitation: Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochellière R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.

family: Rodés-Cabau

full_name: Josep Rodés-Cabau

given: Josep

family: Webb

full_name: John G. Webb

given: John G.

family: Cheung

full_name: Anson Cheung

given: Anson

family: Ye

full_name: Jian Ye

given: Jian

family: Dumont

full_name: Eric Dumont

given: Eric

family: Feindel

full_name: Christopher M. Feindel

given: Christopher M.

family: Osten

full_name: Mark Osten

given: Mark

family: Natarajan

full_name: Madhu K. Natarajan

given: Madhu K.

family: Velianou

full_name: James L. Velianou

given: James L.

family: Martucci

full_name: Giuseppe Martucci

given: Giuseppe

family: DeVarennes

full_name: Benoît DeVarennes

given: Benoît

family: Chisholm

full_name: Robert Chisholm

given: Robert

family: Peterson

full_name: Mark D. Peterson

given: Mark D.

family: Lichtenstein

full_name: Samuel V. Lichtenstein

given: Samuel V.

family: Nietlispach

full_name: Fabian Nietlispach

given: Fabian

family: Doyle

full_name: Daniel Doyle

given: Daniel

family: DeLarochellière

full_name: Robert DeLarochellière

family: Teoh

full_name: Kevin Teoh

given: Kevin

family: Chu

full_name: Victor Chu

given: Victor

family: Dancea

full_name: Adrian Dancea

given: Adrian

family: Lachapelle

full_name: Kevin Lachapelle

family: Cheema

full_name: Asim Cheema

given: Asim

family: Latter

full_name: David Latter

given: David

journal_name: Journal of the American College of Cardiology

title: Transcatheter Aortic Valve Implantation for the Treatment of Severe Symptomatic Aortic Stenosis in Patients at Very High or Prohibitive Surgical Risk

ReferenceCitation: Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.

name: From St Thomas’ Hospital, London, UK (M.T.); Städisches Klinikum und Herzklinik, Karlsruhe, Germany (G.S.); Herzzentrum, Leipzig, Germany (T.W.); Hôpital Bichat, Paris, France (D.H.); Jacques Cartier, Massy, France (T.L.); University Heart Center, Hamburg, Germany (H.T.); Uniklinik, Essen, Germany (H.E.); Clinica Montevergine, Mercogliano, Italy (P.R.); Hospital San Raffaele, Milan, Italy (I.M.); Deutsches Herzzentrum, Munich, Germany; Lake Forest, Calif (W.N.A.); and King’s College Hospital,...

title: Thirty-Day Results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry

ReferenceCitation: Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schächinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

name: on behalf of the PARTNER EU Investigator Group

repositories_institution:
Erasmus University, Rotterdam - RePub
PubMed Central - Europe PMC

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

title: Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

title: Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

ReferenceCitation: Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

title: Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery

ReferenceCitation: Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

title: Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

ReferenceCitation: Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27. Review.

title: Current Status of Transcatheter Aortic Valve Replacement

ReferenceCitation: Généreux P, Head SJ, Wood DA, Kodali SK, Williams MR, Paradis JM, Spaziano M, Kappetein AP, Webb JG, Cribier A, Leon MB. Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications. Eur Heart J. 2012 Oct;33(19):2388-98. doi: 10.1093/eurheartj/ehs220. Epub 2012 Jul 31. Review.

ReferenceCitation: Buellesfeld L, Gerckens U, Schuler G, Bonan R, Kovac J, Serruys PW, Labinaz M, den Heijer P, Mullen M, Tymchak W, Windecker S, Mueller R, Grube E. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011 Apr 19;57(16):1650-7. doi: 10.1016/j.jacc.2010.11.044.

title: 2-Year Follow-Up of Patients Undergoing Transcatheter Aortic Valve Implantation Using a Self-Expanding Valve Prosthesis

ReferenceCitation: Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, Violini R, Ramondo A, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, De Carlo M, Napodano M, Fiorina C, De Marco F, Antoniucci D, de Cillis E, Capodanno D, Tamburino C; CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012 Apr;33(8):969-76. doi: 10.1093/eurheartj/ehr491. Epub 2012 Jan 12.

name: on behalf of the CoreValve Italian Registry Investigators

ReferenceCitation: Walther T, Dewey T, Borger MA, Kempfert J, Linke A, Becht R, Falk V, Schuler G, Mohr FW, Mack M. Transapical aortic valve implantation: step by step. Ann Thorac Surg. 2009 Jan;87(1):276-83. doi: 10.1016/j.athoracsur.2008.08.017.

title: Transapical Aortic Valve Implantation: Step by Step

ReferenceCitation: Walther T, Möllmann H, van Linden A, Kempfert J. Transcatheter aortic valve implantation transapical: step by step. Semin Thorac Cardiovasc Surg. 2011 Spring;23(1):55-61. doi: 10.1053/j.semtcvs.2011.05.006.

journal_name: Seminars in Thoracic and Cardiovascular Surgery

title: Transcatheter Aortic Valve Implantation Transapical: Step by Step

ReferenceCitation: Lange R, Bleiziffer S, Piazza N, Mazzitelli D, Hutter A, Tassani-Prell P, Laborde JC, Bauernschmitt R. Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients. Eur J Cardiothorac Surg. 2011 Nov;40(5):1105-13. doi: 10.1016/j.ejcts.2011.03.022. Epub 2011 Apr 22.

journal_name: European Journal of Cardio-Thoracic Surgery

ReferenceCitation: Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.

journal_name: The Journal of Thoracic and Cardiovascular Surgery

title: Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: Occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial

ReferenceCitation: Eggebrecht H, Schmermund A, Voigtländer T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012 May 15;8(1):129-38. doi: 10.4244/EIJV8I1A20. Review.

ReferenceCitation: Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodés-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1637-43. doi: 10.1016/j.amjcard.2012.01.389. Epub 2012 Mar 15.

title: Frequency and Causes of Stroke During or After Transcatheter Aortic Valve Implantation

ReferenceCitation: Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Müller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. doi: 10.1016/j.jacc.2011.11.048.

title: Aortic Regurgitation Index Defines Severity of Peri-Prosthetic Regurgitation and Predicts Outcome in Patients After Transcatheter Aortic Valve Implantation

ReferenceCitation: Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

title: Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement

ReferenceCitation: Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, Soula P, Gabiache Y, Fournial G, Marcheix B, Carrie D, Fajadet J. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention. 2010 Jan;5(6):659-65.

ReferenceCitation: Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Ligthart J, Schultz C, de Jaegere PP, Serruys PW. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. EuroIntervention. 2010 Jan;5(6):673-9.

ReferenceCitation: Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, García-García H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.

ReferenceCitation: Fraccaro C, Buja G, Tarantini G, Gasparetto V, Leoni L, Razzolini R, Corrado D, Bonato R, Basso C, Thiene G, Gerosa G, Isabella G, Iliceto S, Napodano M. Incidence, predictors, and outcome of conduction disorders after transcatheter self-expandable aortic valve implantation. Am J Cardiol. 2011 Mar 1;107(5):747-54. doi: 10.1016/j.amjcard.2010.10.054. Epub 2011 Jan 19.

title: Incidence, Predictors, and Outcome of Conduction Disorders After Transcatheter Self-Expandable Aortic Valve Implantation

ReferenceCitation: van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodés-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58. Review.

title: New conduction abnormalities after TAVI—frequency and causes

ReferenceCitation: Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-Chico JL, Nuis RJ, Kauer F, Schultz C, Serruys PW, de Jaegere PP, Geleijnse ML. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction. Am J Cardiol. 2011 Jan 15;107(2):285-9. doi: 10.1016/j.amjcard.2010.09.015. Epub 2010 Dec 2.

title: Frequency of Conduction Abnormalities After Transcatheter Aortic Valve Implantation With the Medtronic-CoreValve and the Effect on Left Ventricular Ejection Fraction

ReferenceCitation: Sherif MA, Abdel-Wahab M, Stöcker B, Geist V, Richardt D, Tölg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.

title: Anatomic and Procedural Predictors of Paravalvular Aortic Regurgitation After Implantation of the Medtronic CoreValve Bioprosthesis

ReferenceCitation: Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. doi: 10.1002/ccd.23003. Epub 2011 Jul 25.

journal_name: Catheterization and Cardiovascular Interventions

title: Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after corevalve implantation and the impact of postdilatation

ReferenceCitation: Manoharan G, Van Mieghem NM, Windecker S, Bosmans J, Bleiziffer S, Modine T, Linke A, Scholtz W, Chevalier B, Gooley R, Zeng C, Oh JK, Grube E. 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2326-2334. doi: 10.1016/j.jcin.2018.07.032.

ReferenceCitation: Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchétché D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S; FORWARD Study Investigators. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study. J Am Coll Cardiol. 2017 Aug 15;70(7):845-853. doi: 10.1016/j.jacc.2017.06.045.

location_country:
Greece
Belgium
Australia
France
Panama
Poland
Norway
Canada
Colombia
South Africa
Sweden
Saudi Arabia
Netherlands
Hungary
Portugal
Germany
United Kingdom
Italy
Czechia
Israel
Spain

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: London Health Sciences Centre - University Campus

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Herzzentrum Dresden GmbH Universitaetsklinik

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital

location_facility: The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

location_facility: Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum

location_facility: Hospital Universitario Central de Asturias

location_facility: Royal Victoria Hospital - Belfast Health and Social Care Trust

location_facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Centre Hospitalier Universitaire - Hopital Henri Mondor

location_facility: Complejo Hospitalario Dr Arnulfo Arias Madrid

location_facility: Centre Hospitalier Regional Universitaire de Lille


title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.

ReferenceCitation: Sands BE, Peyrin-Biroulet L, Kierkus J, Higgins PDR, Fischer M, Jairath V, Hirai F, D'Haens G, Belin RM, Miller D, Gomez-Valderas E, Naegeli AN, Tuttle JL, Pollack PF, Sandborn WJ. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Gastroenterology. 2021 Nov 5. pii: S0016-5085(21)03725-2. doi: 10.1053/j.gastro.2021.10.050. [Epub ahead of print]

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Kierkus

full_name: Jaroslaw Kierkus

given: Jaroslaw

family: Higgins

full_name: Peter D.R. Higgins

given: Peter D.R.

family: Fischer

full_name: Monika Fischer

given: Monika

family: Jairath

full_name: Vipul Jairath

given: Vipul

family: Hirai

full_name: Fumihito Hirai

given: Fumihito

family: D’Haens

full_name: Geert D’Haens

given: Geert

family: Belin

full_name: Ruth M. Belin

given: Ruth M.

family: Miller

full_name: Debra Miller

given: Debra

family: Gomez-Valderas

full_name: Elisa Gomez-Valderas

given: Elisa

family: Naegeli

full_name: April N. Naegeli

given: April N.

family: Tuttle

full_name: Jay L. Tuttle

given: Jay L.

family: Pollack

full_name: Paul F. Pollack

given: Paul F.

family: Sandborn

full_name: William J. Sandborn

given: William J.

journal_name: Gastroenterology

title: Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients with Crohn’s Disease

ReferenceCitation: Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Sep 18. pii: S1542-3565(20)31289-1. doi: 10.1016/j.cgh.2020.09.028. [Epub ahead of print]

family: Ferrante

full_name: Marc Ferrante

given: Marc

family: Bhandari

full_name: Bal R. Bhandari

given: Bal R.

family: Berliba

full_name: Elina Berliba

given: Elina

family: Hibi

full_name: Toshifumi Hibi

given: Toshifumi

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.

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:
United States
Netherlands
Moldova, Republic of
France
Czechia
Japan
Lithuania
Georgia
Poland
Hungary
Belgium
Australia
Romania
Denmark
Canada
United Kingdom

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.

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.


title: Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A

acronym: PROPEL

summary:
To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)
To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855

primary_purpose: Prevention

ReferenceCitation: Klamroth R, Windyga J, Radulescu V, Collins PW, Stasyshyn O, Ibrahim HM, Engl W, Tangada SD, Savage W, Ewenstein B. Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study. Blood. 2021 Apr 1;137(13):1818-1827. doi: 10.1182/blood.2020005673.

name: Department for Internal Medicine, Vascular Medicine and Haemostaseology, Vivantes Klinikum Friedrichshain, Berlin, Germany;

family: Klamroth

full_name: Robert Klamroth

given: Robert

name: Department of Hemostasis Disorders and Internal Medicine, Institute of Hematology and Transfusion Medicine, Warsaw, Poland;

family: Windyga

full_name: Jerzy Windyga

given: Jerzy

name: Hemophilia Treatment Center, University of Kentucky, Lexington, KY;

family: Radulescu

full_name: Vlad Radulescu

given: Vlad

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

family: Collins

full_name: Peter W. Collins

given: Peter W.

name: Academy of Medical Sciences of Ukraine, Lviv, Ukraine;

family: Stasyshyn

full_name: Oleksandra Stasyshyn

given: Oleksandra

name: Pediatric Department, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia;

family: Ibrahim

full_name: Hishamshah Mohd Ibrahim

given: Hishamshah Mohd

name: Baxalta Innovations GmbH, a Takeda company, Vienna, Austria; and

family: Engl

full_name: Werner Engl

given: Werner

name: Baxalta US Inc, a Takeda company, Cambridge, MA

family: Tangada

full_name: Srilatha D. Tangada

given: Srilatha D.

family: Savage

full_name: William Savage

given: William

family: Ewenstein

full_name: Bruce Ewenstein

given: Bruce

journal_name: Blood

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

license_normalized: no license

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_country:
Malaysia
Romania
Australia
Taiwan
Ukraine
France
Poland
Norway
Sweden
Hong Kong
Switzerland
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Israel
Spain
Turkey

location_facility: Inst. f. Experimentelle Hamatologie u. Transfusionsmedizin

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: MHAT 'Sv. Marina', EAD, Clinic of Clinical Hematology

location_facility: Kyiv CCH #9 Dept of Surgery City SPC of Diagnostics & Treatment of Patients with HP

location_facility: NChSH Okhmatdyt of MoHU Center of Children Oncohematology and Bone Marrow Transplantation

location_facility: Hospital Regional Universitario de Malaga

location_facility: University of Florida College of Medicine

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Arizona Hemophilia & Thrombosis Center, located within The University of Arizona Cancer Center

location_facility: M.V. Sklifosovskyi Poltava RCH Dept of Gematology HSEIU Ukrainian Medical Stomatological Academy

location_facility: Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Klinika Hematologii

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: UOC Ematologia, Azienda ULSS 8 Asolo, Regione Veneto

location_facility: AOU Citta della Salute e della Scienza - Presidio Molinette

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU