title: A Physician-initiated, International, Multi-center, Prospective and Retrospective, Non Randomized, Observational Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique.

acronym: STABILISE

summary: The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery

time_perspective: Other

ReferenceCitation: Fattori R, Cao P, De Rango P, Czerny M, Evangelista A, Nienaber C, Rousseau H, Schepens M. Interdisciplinary expert consensus document on management of type B aortic dissection. J Am Coll Cardiol. 2013 Apr 23;61(16):1661-78. doi: 10.1016/j.jacc.2012.11.072.

ReferenceCitation: Nienaber CA, Kische S, Zeller T, Rehders TC, Schneider H, Lorenzen B, Bünger C, Ince H. Provisional extension to induce complete attachment after stent-graft placement in type B aortic dissection: the PETTICOAT concept. J Endovasc Ther. 2006 Dec;13(6):738-46.

ReferenceCitation: Melissano G, Bertoglio L, Rinaldi E, Civilini E, Tshomba Y, Kahlberg A, Agricola E, Chiesa R. Volume changes in aortic true and false lumen after the "PETTICOAT" procedure for type B aortic dissection. J Vasc Surg. 2012 Mar;55(3):641-51. doi: 10.1016/j.jvs.2011.10.025. Epub 2012 Jan 28.

ReferenceCitation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Teebken O, Lee A, Mossop P, Bharadwaj P; STABLE investigators. Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2012 Mar;55(3):629-640.e2. doi: 10.1016/j.jvs.2011.10.022. Epub 2011 Dec 9.

ReferenceCitation: Melissano G, Bertoglio L, Rinaldi E, Mascia D, Kahlberg A, Loschi D, De Luca M, Monaco F, Chiesa R. Satisfactory short-term outcomes of the STABILISE technique for type B aortic dissection. J Vasc Surg. 2018 Oct;68(4):966-975. doi: 10.1016/j.jvs.2018.01.029. Epub 2018 Mar 30.

ReferenceCitation: Hofferberth SC, Nixon IK, Boston RC, McLachlan CS, Mossop PJ. Stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair: the STABILISE concept. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1240-5. doi: 10.1016/j.jtcvs.2013.03.036. Epub 2013 Apr 17.

ReferenceCitation: Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010 Oct;52(4):1022-33, 1033.e15. doi: 10.1016/j.jvs.2010.07.008.

ReferenceCitation: Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD, Bernhard VM, Harris PL, Kent KC, May J, Veith FJ, Zarins CK. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1061-6. Review.

ReferenceCitation: Dake MD, Thompson M, van Sambeek M, Vermassen F, Morales JP; DEFINE Investigators. DISSECT: a new mnemonic-based approach to the categorization of aortic dissection. Eur J Vasc Endovasc Surg. 2013 Aug;46(2):175-90. doi: 10.1016/j.ejvs.2013.04.029. Epub 2013 May 28.

ReferenceCitation: Riambau V, Böckler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfé N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Björck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwöger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005.

lead_sponsor: IRCCS San Raffaele

location_country:
Italy
Austria
Brazil
Sweden
Netherlands
Spain
Germany
France
Australia
Portugal
Turkey
United States
United Kingdom

location_facility: Royal Brompton & Harefield NHS Foundation

location_facility: University School of Medicine Department of Cardiovascular Surgery

location_facility: London Guy's & St Thomas' NHS Foundation Trust

location_facility: Bristish Hospital XXI / Instituto Cardiovascular de Lisboa

location_facility: University of Lund, General Hospital, Malmö

location_facility: Columbia University Irving Medical Center


title: Effects of Plasma Exchange With Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects With "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality

acronym: APACHE

summary:
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF.

Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period.

The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution.

The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards.

The Follow-up Period for subjects in both groups will be 90 days.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Grifols Therapeutics LLC

location_country:
Italy
Austria
Spain
Germany
France
Belgium
Portugal
Denmark
United States
United Kingdom

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Ohio State University Wexner Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

location_facility: Milano Hospital Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Royal Free NHS Foundation Trust Hospital

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)

summary: The purpose of this study is to evaluate the safety and efficacy of risankizumab in the patients with moderately to severely active psoriatic arthritis (PsA).

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Östör A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Alperovich G, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2021 Nov 23. pii: annrheumdis-2021-221048. doi: 10.1136/annrheumdis-2021-221048. [Epub ahead of print]

family: Östör

full_name: Andrew Östör

given: Andrew

sequence: first

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

sequence: additional

family: Papp

full_name: Kim Papp

given: Kim

family: Asnal

full_name: Cecilia Asnal

given: Cecilia

family: Blanco

full_name: Ricardo Blanco

given: Ricardo

family: Aelion

full_name: Jacob Aelion

given: Jacob

family: Alperovich

full_name: Gabriela Alperovich

given: Gabriela

family: Lu

full_name: Wenjing Lu

given: Wenjing

family: Wang

full_name: Zailong Wang

given: Zailong

family: Soliman

full_name: Ahmed M Soliman

given: Ahmed M

family: Eldred

full_name: Ann Eldred

given: Ann

family: Barcomb

full_name: Lisa Barcomb

given: Lisa

family: Kivitz

full_name: Alan Kivitz

given: Alan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: Yes

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.

lead_sponsor: AbbVie

location_country:
Finland
Greece
Belgium
Australia
Denmark
France
Poland
Argentina
Canada
South Africa
Sweden
Netherlands
Singapore
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Israel
New Zealand
Spain
Estonia

location_facility: Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 209493

location_facility: The Center for Rheumatology & Bone Research /ID# 166448

location_facility: Ospedale Policlinico G. B. Ros /ID# 207264

location_facility: Clinical Research Ctr Reading /ID# 166354

location_facility: Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237

location_facility: Klein & Associates, M.D., P.A. /ID# 166549

location_facility: Malopolskie Centrum Kliniczne /ID# 208011

location_facility: Glacier View Research Institut /ID# 169344

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800

location_facility: Rheumatology Clinic of Houston /ID# 166636

location_facility: Winelands Medical Research Ctr /ID# 167630

location_facility: Paramount Medical Research Con /ID# 166334

location_facility: Rheumatology and Pulmonary cli /ID# 169341

location_facility: Clinical Pharmacology Study Gr /ID# 166455

location_facility: Arthritis & Osteo Medical Ctr /ID# 166541

location_facility: Care Access Research, Huntingt /ID# 207423

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 208139

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 212582

location_facility: Mary Hitchcock Memorial Hospit /ID# 169443

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 206930

location_facility: East Bay Rheumatology Medical /ID# 166845

location_facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208123

location_facility: CIP - Centro Internacional de Pesquisa /ID# 169524

location_facility: Integral Rheumatology & Immunology Specialists /ID# 166351

location_facility: Percuro Clinical Research, Ltd /ID# 169530

location_facility: Hospital Universitario y Politecnico La Fe /ID# 207823

location_facility: Sweet Hope Research Specialty Inc /ID# 168163

location_facility: AOU Ospedali Riuniti di Ancona - G.M. Lancisi, G. Salesi /ID# 207268

location_facility: North Estonian Medical Centre /ID# 208319

location_facility: East Tallinn Central Hospital /ID# 208317

location_facility: Orebro Universitetssjukhuset /ID# 169400

location_facility: Hospital Universitario 12 de Octubre /ID# 207820

location_facility: Universitair Medisch Centrum Groningen /ID# 168450

location_facility: West Texas Clinical Research /ID# 208155

location_facility: Trinity Universal Research Association /ID# 208387

location_facility: Manchester Royal Infirmary, Ma /ID# 207923

location_facility: Hospital Parc Tauli de Sabadell /ID# 207822

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 166707

location_facility: West Tennessee Research Inst /ID# 166429

location_facility: Arthritis Clinical Research Tr /ID# 167611

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 207819

location_facility: Instituto Portugues De Reumatologia /ID# 208140

location_facility: Clayton Medical Associates dba Saint Louis Rheumatology /ID# 166389

location_facility: New England Research Associates, LLC /ID# 166525

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248

location_facility: Arthritis Rheumatic Back Disorder /ID# 166658

location_facility: Hospital General de Agudos Ram /ID# 169152

location_facility: Unidade Local De Saude Do Alto Minho /ID# 208138

location_facility: Amarillo Ctr for Clin Research /ID# 208340

location_facility: CHRU Tours - Hopital Trousseau /ID# 209343

location_facility: Clinical Investigation Specialists - Skokie /ID# 166681

location_facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151

location_facility: Inland Rheum Clin Trials Inc. /ID# 166621

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 211159

location_facility: Centrum Reumatologii Reumatika /ID# 210956

location_facility: Ctr. de Rheum de l'est du QC /ID# 208302

location_facility: The Rheumatic Disease Center /ID# 166682

location_facility: Cent fur Innovative Diagnostik /ID# 209494

location_facility: Centrum Badań Klinicznych Pi-House /ID# 208012

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 208541

location_facility: Hospital Italiano de Buenos Aires /ID# 208473

location_facility: Nashville Arthritis and Rheumatology /ID# 208395

intervention_type: Biological


type: Other Identifier

type: Registry Identifier

title: Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

summary: This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Safety, efficacy and pharmacokinetics of nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previously treated pediatric hemophilia B patients. Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu M-Y, Persson P, Rangarajan S, Santagostino E. Presented 06-Dec-2014 at the American Society of Hematology - 56th Annual Meeting - held in San Francisco, CA, US (poster #1513)

ReferenceType: result

ReferenceCitation: Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu MY, Persson P, Rangarajan S, Santagostino E. Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial. J Thromb Haemost. 2016 Aug;14(8):1521-9. doi: 10.1111/jth.13360. Epub 2016 Jun 22.

name: Division of Haematology/Oncology; Department of Paediatrics and Research Institute; Hospital for Sick Children; University of Toronto; Toronto Ontario Canada

family: Carcao

full_name: M. Carcao

given: M.

family: Zak

full_name: M. Zak

name: Hemophilia Center; National Blood Center; Kuala Lumpur Malaysia

family: Abdul Karim

full_name: F. Abdul Karim

given: F.

family: Hanabusa

full_name: H. Hanabusa

given: H.

name: Hemophilia Treatment Center; Children's Hospital and Clinics of Minnesota; Minneapolis MN USA

family: Kearney

full_name: S. Kearney

given: S.

name: NTUH; Children's and Women's Hospital; Taipei Taiwan

full_name: M.-Y. Lu

family: Persson

full_name: P. Persson

given: P.

name: Haemophilia, Haemostasis & Thrombosis Centre; Hampshire Hospitals NHS Foundation Trust; Basingstoke UK

family: Rangarajan

full_name: S. Rangarajan

name: Angelo Bianchi Bonomi Hemophilia and Thrombosis Center; IRCCS Ca’ Granda Foundation; Maggiore Hospital Policlinico; Milan Italy

family: Santagostino

full_name: E. Santagostino

given: E.

journal_name: Journal of Thrombosis and Haemostasis

evidence: open (via free pdf)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Carcao M, Kearney S, Lu MY, Taki M, Rubens D, Shen C, Santagostino E. Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B. Thromb Haemost. 2020 May;120(5):737-746. doi: 10.1055/s-0040-1709521. Epub 2020 May 5.

name: Division of Haematology/Oncology, Department of Paediatrics and Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

full_name: Manuel Carcao

given: Manuel

name: Center for Bleeding and Clotting Disorders, Children's Hospital of Minnesota, Minneapolis, Minnesota, United States

full_name: Susan Kearney

given: Susan

name: Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan

full_name: Meng Yao Lu

given: Meng Yao

name: Department of Pediatrics, Yokohama City Seibu Hospital, St. Marianna University School of Medicine, Yokohama, Japan

family: Taki

full_name: Masashi Taki

given: Masashi

family: Rubens

full_name: Daniel Rubens

given: Daniel

family: Shen

full_name: Chunduo Shen

given: Chunduo

name: Foundation IRCCS Cá Granda, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Maggiore Hospital Policlinico, Milan, Italy

full_name: Elena Santagostino

given: Elena

journal_name: Thrombosis and Haemostasis

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing_description: According to the Novo Nordiskdisclosure commitment on novonordisk-trials.com

location_country:
Italy
Brazil
Germany
Croatia
France
Japan
Malaysia
United States
United Kingdom
Canada
Taiwan


title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

acronym: OCTAVE

summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

name: Robarts Research Institute Western University London Ontario Canada

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

name: Department of Medicine Division of Gastroenterology Western University London Ontario Canada

family: Khanna

full_name: Reena Khanna

given: Reena

name: Division of Gastroenterology University of California San Diego La Jolla CA USA

family: Sandborn

full_name: William J. Sandborn

given: William J.

name: Department of Gastroenterology University Hospitals Leuven Leuven Belgium

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

name: Department of Internal Medicine III Medical University of Vienna Vienna Austria

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Su

full_name: Chinyu Su

given: Chinyu

family: Salese

full_name: Leonardo Salese

given: Leonardo

family: Fan

full_name: Haiyun Fan

given: Haiyun

family: Paulissen

full_name: Jerome Paulissen

given: Jerome

family: Woodworth

full_name: Deborah A. Woodworth

given: Deborah A.

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

name: Dr. Henry D. Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sinai New York NY USA

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

journal_name: Alimentary Pharmacology & Therapeutics

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

name: Inflammatory Bowel Disease Center Department of Gastroenterology and Hepatology Mayo Clinic Jacksonville FL USA

family: Farraye

full_name: Francis A. Farraye

given: Francis A.

name: Digestive Disease and Surgery Institute Cleveland Clinic Cleveland OH USA

family: Qazi

full_name: Taha Qazi

given: Taha

name: IBD Outpatient Clinics Colorectal Surgery Unit Cajuru University HospitalPontifical Catholic University of Paraná (PUCPR) Curitiba Brazil

family: Kotze

full_name: Paulo G. Kotze

given: Paulo G.

name: Department of Gastroenterology Monash Health Melbourne Vic. Australia

name: School of Clinical Sciences at Monash Health Monash University Melbourne Vic. Australia

family: Moore

full_name: Gregory T. Moore

given: Gregory T.

family: Mundayat

full_name: Rajiv Mundayat

given: Rajiv

family: Lawendy

full_name: Nervin Lawendy

given: Nervin

family: Sharma

full_name: Puza P. Sharma

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

name: University of Chicago Medicine, Inflammatory Bowel Disease Center, 5841 S. Maryland Avenue, MC4076, Chicago, IL 60637, USA

name: Medical University of Vienna, Vienna, Austria

name: Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland

name: IBD Outpatient Clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil

name: Pfizer Switzerland AG, Zürich, Switzerland

name: Zentrum für Gastroenterologie und Hepatologie AG, Zürich, Switzerland

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA

journal_name: Therapeutic Advances in Gastroenterology

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2021 Mar 6. pii: S1542-3565(21)00222-6. doi: 10.1016/j.cgh.2021.02.043. [Epub ahead of print]

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

name: Beijing Linking Truth Technology Co. Ltd  Shanghai China

name: Pfizer Inc  Collegeville Pennsylvania USA

name: Division of Gastroenterology University of California, San Diego  La Jolla California USA

journal_name: Clinical Pharmacology in Drug Development

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

name: Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA

name: Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA

name: Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct 27. pii: S1542-3565(20)31496-8. doi: 10.1016/j.cgh.2020.10.038. [Epub ahead of print]

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

name: Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA

name: Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, California, USA

name: PEC2, EA 7460, University of Bourgogne—Franche Comté and Department of Cardiology, CHU Dijon-Bourgogne, Dijon, France

name: IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

name: Inflammation & Immunology, Pfizer Inc, Collegeville, Pennsylvania, USA

name: Inflammation & Immunology, Pfizer Inc, New York, New York, USA

name: Division of Cardiovascular Medicine, University of California, San Diego, California, USA

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

title: Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib—Implications for Cardiovascular Risk and Patient Management

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panés J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.

name: Icahn School of Medicine at Mount Sinai, New York, New York, USA

name: Pfizer Inc., Collegeville, Pennsylvania, USA

name: Inflammatory Bowel Diseases Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

name: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA

name: Department of Gastroenterology and Hepatology, University of Zürich, Zürich, Switzerland

name: Division of Gastroenterology, Washington University in Saint Louis, Saint Louis, Missouri, USA

name: Pfizer Inc, Collegeville, Pennsylvania, USA

name: Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

name: Division of Gastroenterology; University of California, San Diego; La Jolla California

name: Hospital Clínic de Barcelona; IDIBAPS, CIBERehd; Barcelona Spain

name: Dr. Henry D. Janowitz Division of Gastroenterology; Icahn School of Medicine at Mount Sinai; New York New York

name: Medical University of Vienna; Vienna Austria

name: Division of Gastroenterology; IBD Center; Humanitas University; Rozzano Milan Italy

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

name: Oregon Health & Science University, Portland, Oregon

name: Cedars-Sinai Medical Center, Los Angeles, California

name: Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium

name: Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum in: Intest Res. 2018 Jul;16(3):499-501.

name: IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan.

name: Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.

name: Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.

name: Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

name: Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.

name: Inflammation & Immunology, Pfizer Japan Inc, Tokyo, Japan.

name: Center for Advanced IBD Research and Treatment, Kitasato University, Tokyo, Japan.

publisher: Korean Association for the Study of Intestinal Diseases

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

publisher_group: Korean Association for the Study of Intestinal Diseases

publisher_normalized: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Panés J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum in: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

name: Centre for Immunobiology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK

name: Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

name: The University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panés J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

name: From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I,...

title: Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
Croatia
France
Japan
Poland
Slovakia
Canada
Colombia
South Africa
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Austria
Serbia
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: Baylor College of Medicine (Baylor Medical Center)

location_facility: Bop Clinical School Clinical Trials Unit

location_facility: Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital

location_facility: Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"

location_facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)

location_facility: Cedars Sinai Medical Center - Thalians Bldg

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: National Hospital Organization Sendai Medical Center

location_facility: West Tallinn Central Hospital Internal Diseases Clinic

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Georgia Endoscopy Center (Colonoscopy only)

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: National Hospital Organization Mito Medical Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly

location_facility: ECG Unit of West Tallinn Central Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Huron Gastroenterology Associates / Center for Digestive Care

location_facility: Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Johns Creek Diagnostic Center (X-Ray only)

location_facility: The Private Practice of Simon Lichtiger, MD

location_facility: Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

location_facility: The Hospital of Hyogo College of Medicine

location_facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI

location_facility: Medical Science Research Building 1 - University of Michigan Health Systems

location_facility: State Institution "National L.T. Malaya Therapy Institute of National Academy

location_facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Michigan Clinical Research Unit - Univeristy of Michigan Health System

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

location_facility: Hospital Clínic i provincial de Barcelona

location_facility: General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology

location_facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

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

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III,

location_facility: Hamilton Health Sciences Corporation - McMaster University Medical Centre

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika

location_facility: X-Ray Department of West Tallinn Central Hospital

location_facility: Washington University School of Medicine - Division of Gastroenterology

location_facility: Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)

location_facility: Cambridge University Hospitals Nhs Foundation Trust

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Michigan Heart SJMH (Blood draws and ECGs only)

location_facility: Javorszky Odon Korhaz/Gasztroenterologiai Osztaly

location_facility: SOC Gastroenterologia Centro di Riferimento Oncologico

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: Baylor College of Medicine - Baylor Medical Center (Drug Storage)

location_facility: Federal State Budgetary Military Educational Institution of High Professional Education

location_facility: CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Houston Hospital for Specialized Surgery

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: North Florida Gastroenterology Research, LLC

location_facility: State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia

location_facility: East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: Hertiage Medical Research Clinic- University Of Calgary

location_facility: Kitasato University Kitasato Institute Hospital


title: International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions With Myocardial Ischemia - ISCHEMIA-CTO Trial

acronym: ISCHEMIA-CTO

summary:
Study design

Prospective randomized open labeled multicenter study

Hypotheses

In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events).
In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months.

Inclusion Criteria

CTO in native coronary artery
Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
Age ≥18 yrs.
Able to provide written Informed consent and willing to comply with the specified follow-up contacts
Target artery ≥ 2.5 mm

Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:

Cohort A: Asymptomatic (CCS < 2 and SAQ QoL > 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO

Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO

Cohort C: patients enrolled but not randomized in cohort A or B

Exclusion criteria (for both cohort A and B)

NSTEMI or STEMI within 1 month
Coronary anatomy not suitable for CTO-procedure
Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference
Life expectancy < 2 years
Severe chronic pulmonary disease (FEV1 < 30 % of predicted value)
Contraindication to dual anti-platelet therapy
Pregnancy
eGFR < 30 mL/min/1.73 m2
In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
Severe valvular heart disease

Primary endpoint

Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization*), hospitalization for heart failure or incidence of malignant arrhythmias.

*CCS class ≥ 2 and/or QoL score < 60. Same criteria used as for allocation to Cohort B

Cohort B: SAQ Quality of Life Assessment after 6 months.

Number of patients

1,560 (1200 in cohort A/360 in cohort B

Follow up time

Cohort A: 5 years Cohort B: 6 months

ReferenceCitation: Rinfret S, Sandesara PB. Reducing Ischemia With CTO PCI: Good News, But Questions Remain. JACC Cardiovasc Interv. 2021 Jul 12;14(13):1419-1422. doi: 10.1016/j.jcin.2021.05.028.

family: Rinfret

full_name: Stéphane Rinfret

given: Stéphane

family: Sandesara

full_name: Pratik B. Sandesara

given: Pratik B.

journal_name: JACC: Cardiovascular Interventions

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Reducing Ischemia With CTO PCI

ipd_sharing: Undecided

lead_sponsor: Aarhus University Hospital Skejby

location_country:
Sweden
Finland
France
Norway
Spain
Estonia
Denmark
United Kingdom

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Cardiovascular Institute, Groupe Hospitalier Mutualiste

location_facility: Stockholm South Central Hospital (Södersjukhuset)

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Belfast Health and Social Care Trust, Department of Cardiology

lead_sponsor_type: academique


title: An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

acronym: JOSHUA

summary: This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Netherlands
France
Czechia
Belgium
Spain
Germany
Korea, Republic of

location_facility: University Hospital Na Bulovce; Institut of Radiation Oncology

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

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

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

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

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

location_facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Masaryk Memorial Cancer Institute; Oncological Clinic

intervention_type: Drug

status_simplified: Completed


ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Switzerland
France
Poland
Ireland
Belgium
Australia
Denmark
Germany
United Kingdom

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Klinika Mukowiscydozy, Oddział Chorób Płuc SZP ZOZ

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

location_facility: Nottingham University Hospital City Campus

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hunter Medical Research Institute (HMRI)

source: euctr

title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).


title: An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis

summary:
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after:

14 weeks of treatment with tralokinumab
a single dose of tralokinumab

lead_sponsor: LEO Pharma

location_country:
United States
France
Netherlands


title: ATLAS-PPX: an Open-label, Multinational, Switching Study to Describe the Efficacy and Safety of Fitusiran Prophylaxis in Patients With Hemophilia A and B Previously Receiving Factor or Bypassing Agent Prophylaxis.

acronym: ATLAS-PPX

summary:
Primary Objective:

To characterize the frequency of bleeding episodes while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor or bypassing agent (BPA) prophylaxis

Secondary Objectives:

To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis:
the frequency of spontaneous bleeding episodes
the frequency of joint bleeding episodes
health related quality of life (HRQOL) in patients ≥17 years of age
To characterize the frequency of bleeding episodes during the onset and treatment periods in patients receiving fitusiran
To characterize the safety and tolerability of fitusiran
Annualized weight-adjusted consumption of factor/BPA

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: Genzyme, a Sanofi Company

location_country:
Italy
United States
France
Japan
Malaysia
Israel
Ireland
Australia
China
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility:
Investigational Site Number 4407
Investigational Site Number 3902
Investigational Site Number 9009
Investigational Site Number 8003
Investigational Site Number 9006
Investigational Site Number 3303
Investigational Site Number 8108
Investigational Site Number 8202
Investigational Site Number 9002
Investigational Site Number 0111
Investigational Site Number 9003
Investigational Site Number 9004
Investigational Site Number 4402
Investigational Site Number 8604
Investigational Site Number 3305
Investigational Site Number 8109
Investigational Site Number 6004
Investigational Site Number 0140
Investigational Site Number 1102
Investigational Site Number 8201
Investigational Site Number 8102
Investigational Site Number 0141
Investigational Site Number 4501
Investigational Site Number 6104
Investigational Site Number 4403
Investigational Site Number 8104
Investigational Site Number 5301
Investigational Site Number 4401
Investigational Site Number 8204
Investigational Site Number 1103
Investigational Site Number 9001
Investigational Site Number 9701
Investigational Site Number 6101
Investigational Site Number 8101
Investigational Site Number 8110
Investigational site number 9013
Investigational Site Number 8002
Investigational Site Number 8103
Investigational Site Number 9008
Investigational Site Number 9005
Investigational Site Number 0139
Investigational Site Number 6002
Investigational Site Number 9010
Investigational Site Number 6003


title: An Observational Study to Assess Respiratory Syncytial Virus (RSV)-Associated Illness in Adults With Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)

summary: The primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.

study_type: Observational

time_perspective: Prospective

lead_sponsor: MedImmune LLC

location_country:
Italy
Sweden
Germany
France
Bulgaria
Russian Federation
United States
Czech Republic
Canada


title: Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del)

location_country:
United States
Switzerland
Germany
France
Poland
Ireland
Belgium
Australia
Denmark
Canada
United Kingdom

location_facility: Children's Hospital & Clinics of Minnesota

location_facility: Riley Hospital for Children Indiana University Health

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: Nemours/ Alfred I. duPont Hospital for Children

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: UBMD Pediatrics/ CF Center of Western New York

location_facility: Children's Hospital of The King's Daughters

location_facility: Medical University of South Carolina (MUSC)

title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: This study will evaluate the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in subjects with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.


design_allocation: Non-Randomized

status: Enrolling by invitation

lead_sponsor: Sarepta Therapeutics, Inc.

location_country:
Italy
Sweden
Germany
France
Czechia
Bulgaria
Israel
Poland
Belgium
Spain
United States
United Kingdom

location_facility: UOSD Centro Traslazionale di Miologia e Patologie Neurogenerative

location_facility: Uniwersyteckie Centrum Kliniczne, Klinica Neurologii Rozwojowej

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University Multiprofile Hospital for active treatment Aleksandrovska EAD Clinic of Neurological Diseases

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Rochester Medical Center - Department of Neurology

location_facility: Children's Hopsital of Wisconsin, Corporate Center Suite 540

location_facility: UF Health: University of Florida Clinical Research Center

location_facility: Schneider Children's Medical Center of Israel

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Provningsenhet Barn, Drottning Silvias Och Ungdomssjukhus

location_facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna

location_facility: Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

location_facility: Abigail Wexner Research Institute at Nationwide Children's Hospital

title: Long-term, Open-label Extension Study for Patients With Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen

summary: The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).

status_simplified: Unknown


title: A Phase II, Open-label, Prospective, Single-arm, Study to Assess Ability of Eltrombopag to Induce Sustained Remission in Subjects With ITP Who Are Refractory or Relapsed After First-line Steroids

acronym: TAPER

summary:
This study will assess the ability of eltrombopag to induce sustained treatment-free remission in ITP subjects who relapsed or failed to respond to an initial treatment with steroids.

There is limited, mainly retrospective evidence that earlier use of eltrombopag after ITP diagnosis, will allow a larger proportion of subjects to achieve sustained remission after tapering off drug. Clinically there is a need for a less toxic regimen that will provide responses and sustained remission with a shorter treatment interval. This trial is designed to assess this.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Chile
Brazil
Switzerland
Mexico
France
Japan
Greece
Russian Federation
Spain
Turkey
Oman
United States
United Kingdom

location_facility: Hematology Oncology Association of Rockland Drug Shipment


title: BlueSync Field Evaluation

summary: The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.

ipd_sharing_description: There are not plans to share IPD with other researchers

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
United States
United Kingdom
France

location_facility: University Hospital of North Midlands NHS Trust


ReferenceCitation: Kovács G, Wachtel AE, Basharova EV, Spinelli T, Nicolas P, Kabickova E. Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study. Lancet Oncol. 2016 Mar;17(3):332-344. doi: 10.1016/S1470-2045(15)00520-3. Epub 2016 Jan 19.

family: Kovács

full_name: Gábor Kovács

given: Gábor

family: Wachtel

full_name: Antonio E Wachtel

given: Antonio E

family: Basharova

full_name: Elena V Basharova

given: Elena V

family: Spinelli

full_name: Tulla Spinelli

given: Tulla

family: Nicolas

full_name: Pierre Nicolas

given: Pierre

family: Kabickova

full_name: Edita Kabickova

given: Edita

journal_name: The Lancet Oncology

oa_host_type: repository

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

host_type: repository

repository_institution: Library of the Hungarian Academy of Sciences - Repository of the Academy's Library

version: acceptedVersion

lead_sponsor: Helsinn Healthcare SA

primary_purpose: Prevention

location_country:
Austria
Chile
Peru
Serbia
Germany
France
Bulgaria
Poland
Romania
Hungary
Argentina
Russian Federation
Estonia
United States
Czech Republic
Ukraine

location_facility: Institut Pomnik - The Children Memorial Health Institute, Department of Oncology

location_facility: University Hospital Motol, Department of Paediatric Heamatology and Oncology

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: University Hospital Brno, Children's Medical Centre, Clinic of Pediatric Oncology

location_facility: Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital

location_facility: Sf. Maria - Chidren's Emergency Clinical Hospital

location_facility: CHRU de Lille - Hopital d'Hematologie Pediatrique

location_facility: University Hospital in Ostrava, Clinic of Pediatric

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital

location_facility: Fundeni Clinical Institute, Pediatrics Clinic

location_facility: State Institution: V. K. Husak Institute of Urgent and Reconstructive Surgery

location_facility: Specialised Pediatric Clinic of Clinical Hematology and Oncology Mutiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologica CAA

location_facility: Public Treatment and Prophylaxis Institution: Regional Children's Clinical Hospital

location_facility: Public Healthcare Institution: Regional Children's Clinical Hospital #1

location_facility: Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology

location_facility: Specialised Hospital for Active Treatment of Oncohematological Diseases in Children

location_facility: CHRU de Tours - Centre de Pediatrie Gatien de Clocheville

location_facility: University of Kentucky - Chandler Medical Center

location_facility: Backus Children's Hospital at University Pediatrics

location_facility: "Prof. Dr. Alexandru Trestioreanu" Institute of Oncology, Pediatric Oncology Department

location_facility: Tartu University Hospital, Hematology - Oncology Clinic

location_facility: Hospital Nacional "Prof. Dr. Alejandro Posadas"

location_facility: Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department

location_facility: Clinical Center Nis, Clinic for pediatrics internal diseases, Department for hematology and oncology

location_facility: University of Szeged, Szent-Gyorgyl Albert Clinical Center, Department of Pediatrics

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology, Cluj-Napoca Pediatric Department

location_facility: Semmelweis University, 2nd Department of Pediatrics

title: A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC

summary: The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema

summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

ReferenceCitation: Wedner HJ, Aygören-Pürsün E, Bernstein J, Craig T, Gower R, Jacobs JS, Johnston DT, Lumry WR, Zuraw BL, Best JM, Iocca HA, Murray SC, Desai B, Nagy E, Sheridan WP, Kiani-Alikhan S. Randomized Trial of the Efficacy and Safety of Berotralstat (BCX7353) as an Oral Prophylactic Therapy for Hereditary Angioedema: Results of APeX-2 Through 48 Weeks (Part 2). J Allergy Clin Immunol Pract. 2021 Jun;9(6):2305-2314.e4. doi: 10.1016/j.jaip.2021.03.057. Epub 2021 Apr 15.

family: Wedner

full_name: H. James Wedner

given: H. James

family: Aygören-Pürsün

full_name: Emel Aygören-Pürsün

given: Emel

family: Bernstein

full_name: Jonathan Bernstein

given: Jonathan

family: Craig

full_name: Timothy Craig

given: Timothy

family: Gower

full_name: Richard Gower

given: Richard

family: Jacobs

full_name: Joshua S. Jacobs

given: Joshua S.

family: Johnston

full_name: Douglas T. Johnston

given: Douglas T.

family: Lumry

full_name: William R. Lumry

given: William R.

family: Zuraw

full_name: Bruce L. Zuraw

given: Bruce L.

family: Best

full_name: Jessica M. Best

given: Jessica M.

family: Iocca

full_name: Heather A. Iocca

given: Heather A.

family: Murray

full_name: Sharon C. Murray

given: Sharon C.

family: Desai

full_name: Bhavisha Desai

given: Bhavisha

family: Nagy

full_name: Eniko Nagy

given: Eniko

family: Sheridan

full_name: William P. Sheridan

given: William P.

family: Kiani-Alikhan

full_name: Sorena Kiani-Alikhan

given: Sorena

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

license: cc-by

license_normalized: cc-by

ReferenceCitation: Zuraw B, Lumry WR, Johnston DT, Aygören-Pürsün E, Banerji A, Bernstein JA, Christiansen SC, Jacobs JS, Sitz KV, Gower RG, Gagnon R, Wedner HJ, Kinaciyan T, Hakl R, Hanzlíková J, Anderson JT, McNeil DL, Fritz SB, Yang WH, Tachdjian R, Busse PJ, Craig TJ, Li HH, Farkas H, Best JM, Clemons D, Cornpropst M, Dobo SM, Iocca HA, Kargl D, Nagy E, Murray SC, Collis P, Sheridan WP, Maurer M, Riedl MA. Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial. J Allergy Clin Immunol. 2021 Jul;148(1):164-172.e9. doi: 10.1016/j.jaci.2020.10.015. Epub 2020 Oct 21.

full_name: Bruce Zuraw

given: Bruce

location_country:
Austria
North Macedonia
Germany
France
Czechia
Romania
Hungary
Spain
United States
United Kingdom
Canada


title: A Longitudinal, Exploratory, Natural History Study to Further Characterize and Describe the Signs and Symptoms of Patients With Organic Acidemias

summary: Longitudinal, exploratory, natural history study of patients with MMA due to mut deficiency and PA to characterize the changes in blood disease biomarkers over time and the frequency and severity of clinical events related to their disease.

lead_sponsor: ModernaTX, Inc.

location_country:
United States
United Kingdom
France
Spain

location_facility: Johns Hopkins University School of Medicine

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


title: An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety of Lenvatinib Monotherapy or Lenvatinib Combination Regimen or Comparator Treatment Arm to Cancer Patients in Eisai Sponsored Lenvatinib Trials

summary: This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.

lead_sponsor: Eisai Inc.

location_country:
Italy
Sweden
Netherlands
Spain
Germany
France
Czechia
Poland
Thailand
Romania
Belgium
Australia
China
United States
Korea, Republic of

location_facility: Hospital of The University of Pennsylvania

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Affiliated Hospital of Guilin Medical University

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Cancer Hospital Chinese Academy of Medical Science

location_facility: Institutul National de Endocrinologie "C. I. Parhon"

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach

location_facility: Harbin Medical University Cancer Hospital

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: West China School of Medicine/West China Hospital, Sichuan University


title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients

summary: This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.

lead_sponsor: Bial - Portela C S.A.

location_country: Austria Spain Croatia Czechia Bulgaria France Poland Romania Portugal Germany

location_facility: Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux

location_facility: Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie

location_facility: AIBILI - Centro de Estudos de Biodisponibildade

location_facility: Polyclinic for neurology and psychiatry 'Interneuron

location_facility: General County Hospital Požega, Neurology department

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika

location_facility: Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi

location_facility: Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia

location_facility: Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie

location_facility: Diagnostic & Consultative Center "Sveta Anna" EOOD

location_facility: Klinik für Epileptologie Universität Bonn

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie

location_facility: Universitätsklinik für Neurologie; Christian-Doppler-Klinik

location_facility: Medizinische Universitat Wien Klinik fur Neurologie

location_facility: IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

location_facility: Neurologische Gemeinschaftspraxis am Seelberg

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz


lead_sponsor: Sanofi

location_country:
Italy
United States
Germany
France
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility:
Investigational Site Number 250004
Investigational Site Number 380001
Investigational Site Number 840005
Investigational Site Number 826001
Investigational Site Number 250001
Investigational Site Number 380004
Investigational Site Number 840004
Investigational Site Number 410004
Investigational Site Number 036001
Investigational Site Number 840003
Investigational Site Number 276004
Investigational Site Number 724001
Investigational Site Number 826003
Investigational Site Number 036003
Investigational Site Number 840011
Investigational Site Number 250003
Investigational Site Number 840008
Investigational Site Number 840001
Investigational Site Number 124001
Investigational Site Number 410002
Investigational Site Number 124002
Investigational Site Number 410003
Investigational Site Number 724004
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 036004
Investigational Site Number 124003
Investigational Site Number 036002
Investigational Site Number 826004
Investigational Site Number 840007
Investigational Site Number 276003
Investigational Site Number 724002
Investigational Site Number 826006

title: A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea

summary:
Primary Objective:

Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for :

Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and
Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia.

PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for:

Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and
Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET.

Secondary Objectives:

To evaluate the safety of SAR302503.
To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.
To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts.
To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8.
To evaluate splenic response as measured by spleen volume using MRI or CT.
To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.
To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.
To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life.
To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.


ReferenceCitation: Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017 Aug;4(8):e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

family: Moreira

full_name: Ilídia Moreira

given: Ilídia

family: Kanakasetty

full_name: Govind Babu Kanakasetty

given: Govind Babu

family: Munhoz

full_name: Eduardo Munhoz

given: Eduardo

family: Echeveste

full_name: Maria Asunción Echeveste

given: Maria Asunción

family: Giri

full_name: Pratyush Giri

given: Pratyush

family: Castro

full_name: Nelson Castro

given: Nelson

family: Pereira

full_name: Juliana Pereira

given: Juliana

family: Akria

full_name: Luiza Akria

given: Luiza

family: Alexeev

full_name: Sergey Alexeev

given: Sergey

family: Osmanov

full_name: Eugeniy Osmanov

given: Eugeniy

family: Zhu

full_name: Peijuan Zhu

given: Peijuan

family: Alexandrova

full_name: Siyka Alexandrova

given: Siyka

family: Zubel

full_name: Angela Zubel

given: Angela

family: Harlin

full_name: Olof Harlin

given: Olof

family: Amersdorffer

full_name: Jutta Amersdorffer

given: Jutta

journal_name: The Lancet Haematology

lead_sponsor: Sandoz

location_country:
Peru
Malaysia
Greece
Romania
Australia
Russian Federation
Ukraine
India
France
Japan
Poland
Argentina
Colombia
South Africa
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility:
India
Investigative Site
Investigtive site
Investigator site
Invstigative site
Investigative site

title: A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma

summary: The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.


title: First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study

summary: PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with recombinant human growth hormone (r-hGH).

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Italy
Sweden
United Kingdom
France
Argentina
Spain
Germany
Czech Republic
Canada

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

location_facility: Istituto Giannina Gaslini - Clinica Pediatrica

location_facility: Faculty of Health Sciences, Linkping University

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Karolinska University Hospital Campus Solna

location_facility: Hospital de Niños de la Santisima Trinidad

location_facility: University of Calgary - Alberta Children's Hospital

location_facility: CHU Bordeaux - Hopital pédiatrique Pellegrin

location_facility: Centro di Endocrinologia e Diabetologia Pediatrica

location_facility: University of Cologne Children's Hospital


title: OMEGA: A Prospective, Multicenter Single-Arm Trial to Assess the OMEGA™ Coronary Stent System for the Treatment of a Single De Novo Coronary Artery Lesion

summary: The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.

ReferenceCitation: Wang JC, Carrié D, Masotti M, Erglis A, Mego D, Watkins MW, Underwood P, Allocco DJ, Hamm CW. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent. Cardiovasc Revasc Med. 2015 Mar;16(2):65-9. doi: 10.1016/j.carrev.2014.12.007. Epub 2014 Dec 23.

family: Wang

full_name: John C. Wang

given: John C.

family: Carrié

full_name: Didier Carrié

given: Didier

family: Masotti

full_name: Monica Masotti

given: Monica

family: Erglis

full_name: Andrejs Erglis

given: Andrejs

family: Mego

full_name: David Mego

given: David

family: Watkins

full_name: Matthew W. Watkins

given: Matthew W.

family: Underwood

full_name: Paul Underwood

given: Paul

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Hamm

full_name: Christian W. Hamm

given: Christian W.

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Netherlands
France
Belgium
Spain
Germany
Latvia

location_facility: St. Mary's Duluth Clinic Regional Heart Center

location_facility: Presbyterian University of Pennsylvania Medical Center

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

location_facility: The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

location_facility: Southern Illinois University-Memorial Medical Center

intervention_type: Device


lead_sponsor: Gilead Sciences

location_country:
Italy
United States
France
Poland
Spain
Germany

acronym: PALS

location_facility: Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Nemours Children's Clinic - Jacksonville

location_facility: Azienda Ospedaliero Universitaria - Policlinico di Catania

location_facility: Pediatric Pneunmonology and Cystic Fibrosis Clinic

location_facility: Kinder und Jugendklinik, Abteilung Lungen Bronchialheikunde

location_facility: Azienda Ospedaliera Instituti Ospitalieri di Verona

title: Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways

summary: This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.


title: An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease

summary: The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
United States
Hong Kong
Spain
Germany
France
Israel
Norway
Singapore
Belgium
Egypt
China
New Zealand
Canada
United Kingdom
Korea, Republic of
Taiwan


title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

summary: This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.

ReferenceCitation: Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.

family: Yoshida

full_name: Kenta Yoshida

given: Kenta

family: Moein

full_name: Anita Moein

given: Anita

family: Bittner

full_name: Tobias Bittner

given: Tobias

family: Ostrowitzki

full_name: Susanne Ostrowitzki

given: Susanne

family: Lin

full_name: Helen Lin

given: Helen

family: Honigberg

full_name: Lee Honigberg

given: Lee

family: Jin

full_name: Jin Y. Jin

given: Jin Y.

family: Quartino

full_name: Angelica Quartino

given: Angelica

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer’s disease

ReferenceCitation: Salloway S, Honigberg LA, Cho W, Ward M, Friesenhahn M, Brunstein F, Quartino A, Clayton D, Mortensen D, Bittner T, Ho C, Rabe C, Schauer SP, Wildsmith KR, Fuji RN, Suliman S, Reiman EM, Chen K, Paul R. Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer's disease (BLAZE). Alzheimers Res Ther. 2018 Sep 19;10(1):96. doi: 10.1186/s13195-018-0424-5.

family: Salloway

full_name: Stephen Salloway

given: Stephen

full_name: Lee A. Honigberg

given: Lee A.

family: Cho

full_name: William Cho

given: William

family: Ward

full_name: Michael Ward

given: Michael

family: Friesenhahn

full_name: Michel Friesenhahn

given: Michel

family: Brunstein

full_name: Flavia Brunstein

given: Flavia

family: Clayton

title: Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer’s disease (BLAZE)

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.

location_facility: Memory Enhancement Center of America, Inc.

location_facility: University of California Los Angeles (UCLA)

location_facility: Neuropsychiatric Research; Center of Southwest Florida


ReferenceCitation: Wang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14.

family: Wang

full_name: Erjian Wang

given: Erjian

family: DuBois

full_name: Steven G. DuBois

given: Steven G.

family: Wetmore

full_name: Cynthia Wetmore

given: Cynthia

family: Verschuur

full_name: Arnauld C. Verschuur

given: Arnauld C.

family: Khosravan

full_name: Reza Khosravan

given: Reza

journal_name: European Journal of Drug Metabolism and Pharmacokinetics

oa_colors: green hybrid

ReferenceCitation: Verschuur AC, Bajčiová V, Mascarenhas L, Khosravan R, Lin X, Ingrosso A, Janeway KA. Sunitinib in pediatric patients with advanced gastrointestinal stromal tumor: results from a phase I/II trial. Cancer Chemother Pharmacol. 2019 Jul;84(1):41-50. doi: 10.1007/s00280-019-03814-5. Epub 2019 Apr 20.

family: Bajčiová

full_name: Viera Bajčiová

given: Viera

family: Mascarenhas

full_name: Leo Mascarenhas

given: Leo

full_name: Xun Lin

given: Xun

family: Ingrosso

full_name: Antonella Ingrosso

given: Antonella

family: Janeway

full_name: Katherine A. Janeway

given: Katherine A.

journal_name: Cancer Chemotherapy and Pharmacology

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_facility: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles

title: A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR

summary: Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.


title: A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

lead_sponsor: Jennerex Biotherapeutics

location_country:
United States
Canada
France

location_facility: Ottawa Hospital and Research Institute (OHRI)


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

ReferenceCitation: Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

family: Panés

full_name: Julian Panés

given: Julian

family: Sandborn

full_name: William J Sandborn

given: William J

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Sands

full_name: Bruce E Sands

given: Bruce E

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Higgins

full_name: Peter D R Higgins

given: Peter D R

family: Colombel

full_name: Jean-Frederic Colombel

given: Jean-Frederic

family: Feagan

full_name: Brian G Feagan

given: Brian G

family: Chan

full_name: Gary Chan

given: Gary

family: Moscariello

full_name: Michele Moscariello

given: Michele

full_name: Wenjin Wang

given: Wenjin

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

family: Marren

full_name: Amy Marren

given: Amy

family: Healey

full_name: Paul Healey

given: Paul

family: Maller

full_name: Eric Maller

given: Eric

journal_name: Gut

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Austria
United States
South Africa
Netherlands
Germany
Croatia
Bulgaria
France
Greece
Israel
Japan
Hungary
Australia
Spain
Canada
Czech Republic
Korea, Republic of
Ukraine

location_facility: Advanced Clinical Research Institute - Phase 1, LLC

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: University Hospitals Chagrin Highlands Health Center

location_facility: Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium

location_facility: Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: London Health Sciences Centre - University Hospital

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly

location_facility: Digestive Diseases Institute, Shaare Zedek Medical Center

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: Office of Drs. Ranjith Andrew Singh and Jamie D. Papp

location_facility: Medical Research Center of Connecticut, LLC

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"

location_facility: Gasteroenterology Consultants of Clearwater

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Charlotte Gastroenterology and Hepatology, PLLC

location_facility: Medical Diagnostic Imaging (MDI) X-ray and MRI only

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly

location_facility: Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"

location_facility: University Hospitals Case Medical Center

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: Suncoast Endoscopy Center (Colonoscopy Only)

location_facility: Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course

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

location_facility: University Hospitals Westlake Medical Center

location_facility: Shands Hospital at the University of Florida

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft

location_facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.

location_facility: Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I

location_facility: Heartland Medical Research, Inc (Administrative Only)

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Clinical Research Institute of Michigan LLC

location_facility: Endoscopy Center of the Rockies - Longmont

location_facility: University of Kentucky Chandler Medical Center

location_facility: Severance Hospital, Yeonsei University Health System

location_facility: State Institution "Institute of Gastroenterology of AMS of Ukraine"

location_facility: North Florida Gastroenterology Research, LLC


ReferenceCitation: Steinhorn RH, Fineman J, Kusic-Pajic A, Cornelisse P, Gehin M, Nowbakht P, Pierce CM, Beghetti M; FUTURE-4 study investigators. Bosentan as Adjunctive Therapy for Persistent Pulmonary Hypertension of the Newborn: Results of the Randomized Multicenter Placebo-Controlled Exploratory Trial. J Pediatr. 2016 Oct;177:90-96.e3. doi: 10.1016/j.jpeds.2016.06.078. Epub 2016 Aug 5.

family: Steinhorn

full_name: Robin H. Steinhorn

given: Robin H.

family: Fineman

full_name: Jeffrey Fineman

given: Jeffrey

family: Kusic-Pajic

full_name: Andjela Kusic-Pajic

given: Andjela

family: Cornelisse

full_name: Peter Cornelisse

given: Peter

family: Gehin

full_name: Martine Gehin

given: Martine

family: Nowbakht

full_name: Pegah Nowbakht

given: Pegah

family: Pierce

full_name: Christine M. Pierce

given: Christine M.

family: Beghetti

full_name: Maurice Beghetti

given: Maurice

journal_name: The Journal of Pediatrics

status: Terminated

lead_sponsor: Actelion

location_country:
Switzerland
United Kingdom
Germany
France
Poland
Singapore
Belgium
Australia
Russian Federation
United States
Czech Republic
Korea, Republic of

acronym: FUTURE 4

location_facility: Fakultní nemocnice v Motole Novorozenecké oddělení - Site 2001

location_facility: LURIE CHILDREN'S HOSPITAL OF CHICAGO - Site 6021

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust - Site 1703

location_facility: Great Ormond Street Hospital, Paediatric and Neonatal Intensive Care Unit - Site 1700

location_facility: Liverpool Women's NHS Foundation Trust - Site 1702

location_facility: Uniwersytet Medyczny im. K. Marcinkowskiego w Poznaniu - Site 2103

location_facility: Hôpital Trousseau - Service de réanimation néonatale et pédiatrique - Site 1804

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre - Service de réanimation néonatale - Site 1802

location_facility: KK Women's and Children's Hospital - Site 5401

location_facility: Advocate Lutheran General Div. of Neonatal & Development Medicine - Site 6010

location_facility: Všeobecná fakultní nemocnice Klinika dětského a dorostového lékařství - Site 2002

location_facility: Kantonsspital Luzern, Kinderspital Kinder-Intensivmedizin / Pädiatrie / Neonatologie - Site 1902

location_facility: Klinikum der Universität zu Köln Klinik und Poliklinik für Kinder-und Jugendmedizin, Dep. Neonatologie u. Pädiatrische Intensivmedizin - Site 1203

location_facility: Advocate Hope Children's Hospital - Site 6009

location_facility: Medical University of South Carolina, Pediatric Cardiology - Site 6019

location_facility: Szpital Kliniczny im. ks. Anny Mazowieckiej - Site 2101

location_facility: Instytut Centrum Zdrowia Matki Polki - Site 2106

location_facility: Federal State Budgetary Institution "Scientific Center for obstetrics, gynecology and perinatology named after V.I. Kulakov" Ministry of Healthcare of the Russian Federation - Site 2501

location_facility: Division of Neonatology, Mater Mothers' Hospital, Mater Health Services, Brisbane Ltd. - Site 3003

location_facility: Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Neonatologie - Site 1201

location_facility: Centre Hospitalier Universitaire Vaudois Départment Médico-Chirurgical de Pédiatrie / Service de Néonatologie - Site 1901

location_facility: The Royal Children's Hospital, Department of Neonatology - Site 3001

title: Multicenter, Double-blind, Placebo-controlled, Randomized, Prospective Study of Bosentan as Adjunctive Therapy to Inhaled Nitric Oxide in the Management of Persistent Pulmonary Hypertension of the Newborn (PPHN)

summary: The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.