acronym: VALOR-CKD

lead_sponsor: Tricida, Inc.

summary: The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

ReferenceCitation: Hultin S, Johnson DW, Badve SV. Recent evidence on the effect of treatment of metabolic acid on the progression of kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):467-473. doi: 10.1097/MNH.0000000000000728.

publisher_dissemination: Wolters Kluwer Health

location_facility:
Investigative Site 1204
Investigative Site 2714
Investigative Site 3108
Investigative Site 3913
Investigative Site 3902
Investigative Site 2202
Investigative Site 6503
Investigative Site 6103
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Investigative Site 3507
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Investigative Site 2603
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Investigative Site 2501
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Investigative Site 4519
Investigative Site 2316
Investigative Site 4307
Investigative Site 2604
Investigative Site 2505
Investigative Site 6507
Investigative Site 6403
Investigative Site 6501
Investigative Site 2208
Investigative Site 4203
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Investigative Site 4709
Investigative Site 2707
Investigative Site 6201
Investigative Site 1208
Investigative Site 4141
Investigative Site 1213
Investigative Site 3209
Investigative Site 4703
Investigative Site 6502
Investigative Site 4123
Investigative Site 4408
Investigative Site 6401
Investigative Site 2710
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Investigative Site 3607
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Investigative Site 2805
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Investigative Site 2718
Investigative Site 1203
Investigative Site 2211
Investigative Site 2703
Investigative Site 6203
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Investigative Site 2306
Investigative Site 4136
Investigative Site 4305
Investigative Site 1210
Investigative Site 2510
Investigative Site 6506
Investigative Site 4506
Investigative Site 5207
Investigative Site 6210
Investigative Site 1211
Investigative Site 4602
Investigative Site 4304
Investigative Site 3815
Investigative Site 6206
Investigative Site 3408
Investigative Site 6202
Investigative Site 2503
Investigative Site 5212
Investigative Site 5203
Investigative Site 5213
Investigative Site 2706
Investigative Site 6208
Investigative Site 1206
Investigative Site 1201
Investigative Site 2412
Investigative Site 3603
Investigative Site 4312
Investigative Site 2704
Investigative Site 4313
Investigative Site 3505
Investigative Site 4516
Investigative Site 4509
Investigative Site 1304
Investigative Site 4712
Investigative Site 4410
Investigative Site 4107
Investigative Site 4310
Investigative Site 4601
Investigative Site 2713
Investigative Site 2721
Investigative Site 2705
Investigative Site 4152
Investigative Site 2304
Investigative Site 1502
Investigative Site 2213
Investigative Site 6105
Investigative Site 4325
Investigative Site 1303
Investigative Site 1412
Investigative Site 6104
Investigative site 2801
Investigative Site 2508
Investigative Site 3911
Investigative Site 2421
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Investigative Site 6511
Investigative Site 3605
Investigative Site 4146
Investigative Site 6101
Investigative Site 4201
Investigative Site 3205
Investigative Site 4320
Investigative Site 4132
Investigative Site 2514
Investigative Site 1302
Investigative Site 4507
Investigative Site 4116
Investigative Site 3716
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Investigative Site 2803
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Investigative Site 4324
Investigative Site 2414
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Investigative Site 4130

title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis

location_country:
Poland
Argentina
Australia
Brazil
Armenia
Chile
Czechia
Canada
Serbia
France
Belarus
Colombia
Portugal
Slovakia
Hungary
Hong Kong
United States
Ukraine
North Macedonia
Romania
Belgium
Malaysia
Italy
Albania
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Georgia
Israel


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

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: background

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, Bunger 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. doi: 10.1583/06-1923.1.

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. No abstract available.

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. doi: 10.1067/mva.2002.123991. No abstract available.

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, Bockler 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, Chakfe 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, Bjorck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwoger 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. No abstract available.

lead_sponsor: IRCCS San Raffaele

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

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

location_facility: Royal Brompton & Harefield NHS Foundation

location_facility: Bristish Hospital XXI / Instituto Cardiovascular de Lisboa

location_facility: Columbia University Irving Medical Center

location_facility: University of Lund, General Hospital, Malmö

location_facility: University School of Medicine Department of Cardiovascular Surgery

lead_sponsor_type: industriel

status_simplified: Ongoing


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_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Grifols Therapeutics LLC

sponsor_collaborators:
Grifols Therapeutics LLC
Instituto Grifols, S.A.

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Milano Hospital Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hépato-Biliaire - Hôpital Universitaire Paul Brousse

location_facility: Ohio State University Wexner Medical Center

location_facility: Royal Free NHS Foundation Trust Hospital

intervention_type: Other


title: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

acronym: EASE SBS 1

summary:
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Zealand Pharma

location_country:
Germany
Poland
United Kingdom
Denmark
Netherlands
Belgium
United States
Canada
France

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Vanderbilt University Medical Center, Nashville

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

location_facility: University of Chicago Children's Hospital

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka

location_facility: Universitätsklinikum Frankfurt - Med. Klinik I

location_facility: University Health Network - Toronto General Hospital

intervention_type: Drug

status_simplified: Completed


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 adults with moderately to severely active psoriatic arthritis (PsA).

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Ostor 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. 2022 Mar;81(3):351-358. doi: 10.1136/annrheumdis-2021-221048. Epub 2021 Nov 23.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: Ghent University - Ghent University Academic Bibliography

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;archive.ugent.be

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ReferenceType: derived

ReferenceCitation: Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Lu W, Wang Z, Soliman AM, Eldred A, Padilla B, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2122-2129. doi: 10.1093/rheumatology/keac605.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: University of Cantabria - UCrea

version: acceptedVersion

publisher_dissemination: Oxford University Press

ReferenceCitation: Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Ostor AJK, Soliman AM, Papp KA, Padilla B, Wang Z, Eldred A, de Vlam K, Kivitz A. Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. RMD Open. 2022 Jun;8(2):e002286. doi: 10.1136/rmdopen-2022-002286.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

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

location_facility: Amarillo Ctr for Clin Research /ID# 208340

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

location_facility: Hospital Italiano de Buenos Aires /ID# 208473

location_facility: Hospital Universitario 12 de Octubre /ID# 207820

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

location_facility: Precision Comprehensive Clinical Research Solutions /ID# 208156

location_facility: Rheumatology and Pulmonary Clinic /ID# 169341

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 208541

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 212582

location_facility: CHRU Tours - Hopital Trousseau /ID# 209343

location_facility: Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658

location_facility: West Broward Rheumatology Associates /ID# 201234

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

location_facility: Winelands Medical Research Centre /ID# 167630

location_facility: North Estonia Medical Centre /ID# 208319

location_facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681

location_facility: Paramount Medical Research Con /ID# 166334

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

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 210956

location_facility: Malopolskie Centrum Kliniczne /ID# 208011

location_facility: West Tennessee Research Institute /ID# 166429

location_facility: Dartmouth-Hitchcock Medical Center /ID# 169443

location_facility: Clinical Pharmacology Study Gr /ID# 166455

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012

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

location_facility: West Texas Clinical Research /ID# 208155

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822

location_facility: Arthritis & Osteo Medical Ctr /ID# 166541

location_facility: Instituto Português De Reumatologia /ID# 208140

location_facility: GCM Medical Group PSC - Hato Rey /ID# 208461

location_facility: Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159

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

location_facility: Centre Rhumatologie de l'Est /ID# 208302

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138

location_facility: Duplicate_Karolinska Univ Sjukhuset /ID# 208174

location_facility: Arthritis Clinical Research Trials /ID# 167611

location_facility: Clinical Research Ctr Reading /ID# 166354

location_facility: Manchester University NHS Foundation Trust /ID# 207923

location_facility: Trinity Universal Research Associates, Inc /ID# 208387

location_facility: Orebro Universitetssjukhuset /ID# 169400

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268

location_facility: Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139

location_facility: East Tallinn Central Hospital /ID# 208317

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

location_facility: Duplicate_Vastmanlands Sjukhus /ID# 168620

location_facility: Universitair Medisch Centrum Groningen /ID# 168450

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

location_facility: Hospital General de Agudos J. M. Ramos Mejia /ID# 169152

location_facility: Rheumatology Clinic of Houston /ID# 166636

location_facility: IRIS Research and Development, LLC /ID# 166351

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

location_facility: Glacier View Research Institute /ID# 169344

location_facility: Rheumatology Research Unit Sunshine Coast /ID# 207191

location_facility: Sweet Hope Research Specialty Inc /ID# 168163

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054

location_facility: Torbay and South Devon Nhs Foundation Trust /Id# 207926

location_facility: Percuro Clinical Research, Ltd /ID# 169530

location_facility: Nashville Arthritis and Rheumatology /ID# 208395

location_facility: Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536

location_facility: Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 168763

location_facility: Rheumatic Disease Center, LLP /ID# 166682

location_facility: Universitair Ziekenhuis Leuven /ID# 208209

location_facility: Centro Medico Privado de Reumatologia /ID# 208342

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

location_facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493

location_facility: Duplicate_Barts Health NHS Trust /ID# 210794

location_facility: Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389

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

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

location_facility: East Bay Rheumatology Medical /ID# 166845


acronym: ADAPT

intervention_type: Biological

lead_sponsor: argenx

summary: A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

ReferenceCitation: Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9. Erratum In: Lancet Neurol. 2021 Aug;20(8):e5.

oa_host_type: repository

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

version: submittedVersion

repositories_concat: irua

unpaywall_oa_status: green

publisher_dissemination: Elsevier

location_facility:
Investigator Site 57
Investigator Site 6
Investigator Site 55
Investigator Site 28
Investigator Site 59
Investigator Site 13
Investigator Site 30
Investigator Site 3
Investigator Site 51
Investigator Site 36
Investigator Site 7
Investigator Site 22
Investigator Site 61
Investigator Site 2
Investigator Site 8
Investigator Site 64
Investigator Site
Investigator Site 45
Investigator Site 34
Investigator Site 52
Investigator Site 56
Investigator Site 10
Investigator Site 58
Investigator Site 33
Investigator Site 15
Investigator Site 53
Investigator Site 65
Investigator Site 38
Investigator Site 44
Investigator Site 24
Investigator Site 63
Investigator Site 49
Investigator Site 16
Investigator Site 47
Investigator Site 5
Investigator Site 18
Investigator Site 39
Investigator Site 23
Investigator Site 46
Investigator Site 60
Investigator Site 27
Investigator Site 35
Investigator Site 14
Investigator Site 29
Investigator Site 25
Investigator Site 11
Investigator Site 32
Investigator Site 54
Investigator Site 26
Investigator Site 50
Investigator Site 41
Investigator Site 37
Investigator Site 62
Investigator Site 17
Investigator Site 48
Investigator Site 43
Investigator Site 40
Investigator Site 19
Investigator Site 21
Investigator Site 31
Investigator Site 66
Investigator Site 9
Investigator Site 20
Investigator Site 42
Investigator Site 4
Investigator Site 12

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

source: euctr

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Japan
Netherlands
Belgium
United States
Czechia
Canada
Georgia
Serbia
Russian Federation
France


title: Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

summary:
The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:

non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
unresectable or metastatic melanoma
hepatocellular carcinoma (HCC)
microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Poland
New Zealand
United Kingdom
Argentina
Brazil
Netherlands
Mexico
United States
Spain
Chile
France

location_facility:
Local Institution - 0017
Local Institution - 0031
Local Institution - 0021
Local Institution - 0003
Local Institution - 0018
Local Institution - 0011
Local Institution - 0009
Local Institution - 0035
Istituto Oncologico Veneto IOV
Local Institution - 0015
Local Institution - 0007
Local Institution - 0040
Local Institution - 0039
Local Institution - 0038
Local Institution - 0024
Local Institution - 0005
Local Institution - 0014
Local Institution - 0012
Local Institution - 0037
Local Institution - 0016
Local Institution - 0020
Winship Cancer Institute.
Local Institution - 0033
Local Institution - 0001
Local Institution - 0022
Local Institution - 0047
Local Institution - 0049
Local Institution - 0025
Local Institution - 0045
Local Institution - 0050
Local Institution - 0026
Local Institution - 0048
Greenville Health System
Local Institution - 0010
Local Institution - 0019
Local Institution - 0046


acronym: U-Accomplish

lead_sponsor: AbbVie

summary: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

ReferenceCitation: Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26. Erratum In: Lancet. 2022 Sep 24;400(10357):996.

oa_host_type: closed

repositories_concat: closed

location_facility: Houma Digestive Health Special /ID# 206176

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 206098

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 209482

location_facility: Klinicki bolnicki centar Rijeka /ID# 208650

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314

location_facility: Froedtert Memorial Lutheran Hospital /ID# 206945

location_facility: Digestive Disease Specialists /ID# 206076

location_facility: General Hospital of Athens Laiko /ID# 208671

location_facility: Duplicate_CHA Bundang Medical Center /ID# 207432

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 206413

location_facility: Hospital Santo Antonio dos Cap /ID# 206145

location_facility: Texas Digestive Disease Consultants /ID# 209805

location_facility: Lenasia Clinical Trial Centre /ID# 214359

location_facility: Percuro Clinical Research, Ltd /ID# 205501

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887

location_facility: Huron Gastroenterology Assoc /ID# 205109

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070

location_facility: Options Health Research, LLC /ID# 206707

location_facility: The First Hospital of Jilin University /ID# 210088

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208494

location_facility: Hamamatsu University Hospital /ID# 206459

location_facility: MediSphere Medical Research Center /ID# 206073

location_facility: Queen Elizabeth University Hos /ID# 205154

location_facility: Digestive Health Partners, P.A /ID# 206842

location_facility: Kazan State Medical University /ID# 208256

location_facility: The First Affiliated Hospital of Nanchang University /ID# 212186

location_facility: Osaka City University Hospital /ID# 206457

location_facility: West Tallinn Central Hospital /ID# 207356

location_facility: Umraniye Training and Res Hosp /ID# 208206

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 206069

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207426

location_facility: Toho University Medical Center Sakura Hospital /ID# 207705

location_facility: West China Hospital, Sichuan University /ID# 205332

location_facility: Kanazawa University Hospital /ID# 206316

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 216622

location_facility: Universitetssykehuset Nord-Norge /ID# 205691

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354

location_facility: Gastro Health & Nutrition - Victoria /ID# 205378

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059

location_facility: University Clinical Hospital Mostar /ID# 208054

location_facility: Inselspital, Universitaetsklinik /ID# 211312

location_facility: Universal Axon Clinical Research /ID# 213462

location_facility: Yamagata University Hospital /ID# 206465

location_facility: Fakultna nemocnica s poliklini /ID# 211372

location_facility: Universitair Ziekenhuis Leuven /ID# 205988

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 217218

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212426

location_facility: Hospital Clinic de Barcelona /ID# 206906

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350

location_facility: St.Luke's International Hospital /ID# 208076

location_facility: Riga East Clinical Univ Hosp /ID# 206828

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117

location_facility: Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082

location_facility: Yonsei University Health System, Severance hospital /ID# 206958

location_facility: Washington Gastroenterology Associates /ID# 206177

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138

location_facility: Hospital Universitario y Politecnico La Fe /ID# 206904

location_facility: University of New Mexico Department of Internal Medicine /ID# 214397

location_facility: The Sixth Affiliated Hosp Sun /ID# 205268

location_facility: Tokai University Hachioji Hospital /ID# 208903

location_facility: Next Innovative Clinical Research - Chicago /ID# 217324

location_facility: Taipei Veterans General Hosp /ID# 207849

location_facility: Hospital Universitario San Vic /ID# 208888

location_facility: Duplicate_Mater Misericordiae /ID# 212687

location_facility: TX Clinical Research Institute /ID# 206718

location_facility: Hospital Britanico de Buenos Aires /ID# 209497

location_facility: Medical centre of CONSILIUM MEDICAL LLC /ID# 217447

location_facility: United Medical Doctors - Murrieta /ID# 205313

location_facility: East Tennessee Research Institute /ID# 206169

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 206717

location_facility: Hospital Privado Univesitario /ID# 206030

location_facility: Hospital Universitario La Paz /ID# 214540

location_facility: Shoyukai Fujita Gastroenterological Hospital /ID# 216493

location_facility: Tokyo Women's Medical University Hospital /ID# 206460

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 206096

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886

location_facility: University of Iowa Hospitals and Clinics /ID# 206167

location_facility: Nagoya City University Hospital /ID# 206058

location_facility: Mautalen Salud e Investigacion /ID# 206033

location_facility: National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710

location_facility: Basingstoke & North Hampshire /ID# 207985

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 206079

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068

location_facility: Showa University Fujigaoka Hospital /ID# 208224

location_facility: Revival Research Institute, LLC /ID# 207282

location_facility: AGA Clinical Research Associates, LLC /ID# 206880

location_facility: Atlanta Gastroenterology Spec /ID# 206173

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 205563

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813

location_facility: Duplicate_Praxis am Bayrischen Platz /ID# 206733

location_facility: Gazi University Med. Faculty /ID# 208040

location_facility: NW State Medical Univ na Mechn /ID# 208258

location_facility: Hospital Universitario Reina Sofia /ID# 204412

location_facility: CB Flock Research Corporation /ID# 206094

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052

location_facility: The Vancouver Clinic, INC. PS /ID# 204973

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 210119

location_facility: Virginia Mason - Seattle Orthapedics /ID# 206070

location_facility: St. Marianna University School of Medicine Hospital /ID# 209451

location_facility: Private Practice Dr MN Rajabally /ID# 205273

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 216940

location_facility: Asahikawa Medical University Hospital /ID# 206404

location_facility: Louisana Research Center, LLC /ID# 206064

location_facility: Mentahaz Maganorvosi Kozpont /ID# 205882

location_facility: Yeungnam University Medical Center /ID# 206959

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 212913

location_facility: National Taiwan University Hospital /ID# 207847

location_facility: Western Connecticut Medical Group /ID# 208290

location_facility: CCA Braga - Hospital de Braga /ID# 206144

location_facility: Gastroenterology Center of CT /ID# 208291

location_facility: Dayton Gastroenterology, Inc. /ID# 205639

location_facility: University Clinical Center Kragujevac /ID# 206410

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 205672

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 206907

location_facility: Duplicate_Universitaetsklinikum Tuebingen /ID# 206737

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 206175

location_facility: Southern Star Research Institute, LLC /ID# 205379

location_facility: Toyohashi Municipal Hospital /ID# 207625

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142

location_facility: University of Michigan Health Systems /ID# 206918

location_facility: St Vincent's Hospital Melbourne /ID# 205758

location_facility: Texas Digestive Disease Consultants /ID# 209948

location_facility: Universitatsklinikum Mannheim /ID# 206811

location_facility: Clinical Center University of Sarajevo /ID# 208058

location_facility: Hospital Clinico Universitario de Salamanca /ID# 205013

location_facility: Hospital Universitario Dr. Negrin /ID# 206905

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992

location_facility: Ctr for Gastrointestinal Healt /ID# 208475

location_facility: University Clinical Center Serbia /ID# 205256

location_facility: Richmond University Medical Center /ID# 213185

location_facility: Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406

location_facility: Faculdade de Medicina do ABC /ID# 206984

location_facility: Bekes Megyei Kozponti Korhaz /ID# 205885

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504

location_facility: Great Lakes Gastroenterology Research LLC /ID# 205631

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848

location_facility: National Hospital Organization Sendai Medical Center /ID# 209528

location_facility: Klinicki bolnicki centar Split /ID# 217027

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 213540

location_facility: Hiroshima University Hospital /ID# 206464

location_facility: Fukuoka University Chikushi Hospital /ID# 214405

location_facility: Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646

location_facility: Atlantic Digestive Health Inst /ID# 208748

location_facility: Duplicate_Tyler Research Institue /ID# 206075

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 206453

location_facility: Kaiser Clinica e Hospital Dia /ID# 206982

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 208460

location_facility: Duplicate_Toronto Digestive Disease Asso /ID# 205498

location_facility: P. Stradins Clinical Univ Hosp /ID# 206827

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 204411

location_facility: Inland Empire Clinical Trials, LLC /ID# 216164

location_facility: Encore Borland-Groover Clinical Research /Id# 208128

location_facility: Healthcare Research Consultant /ID# 206706

location_facility: Vanderbilt University Medical Center /ID# 210405

location_facility: M y F Estudios Clínicos Ltda. /ID# 208035

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208053

location_facility: North Estonia Medical Centre /ID# 207357

location_facility: East Tallinn Central Hospital /ID# 207564

location_facility: Clin Res Inst of Michigan, LLC /ID# 207078

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349

location_facility: Duplicate_Plains Clinical Research Center, LLC /ID# 205111

location_facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939

location_facility: Immanuel Kant Baltic Federal University /ID# 208264

location_facility: Niigata University Medical & Dental Hospital /ID# 218049

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223

location_facility: Barts and the London NHS Trust /ID# 205153

location_facility: Hospital Universitario Ramon y Cajal /ID# 204410

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 211326

location_facility: Yokkaichi Hazu Medical Center /ID# 214348

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208055

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611

location_facility: Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822

location_facility: Citrus Valley Gastroenterology /ID# 205627

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887

location_facility: Shimane University School of Medicine /ID# 208905

location_facility: Sapporo Medical University Hospital /ID# 206314

location_facility: Premier Medical Group - GI Division /ID# 206097

location_facility: InSite Digestive Health Care - Oxnard /ID# 205628

location_facility: Erciyes University Medical Fac /ID# 207506

location_facility: East View Medical Research, LLC /ID# 216933

location_facility: Macquarie University Hospital /ID# 211955

location_facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 207051

location_facility: Medical University of Vienna /ID# 205763

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 206885

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 209532

location_facility: Akershus Universitetssykehus_MAIN /ID# 205293

location_facility: China Medical University Hosp /ID# 207845

location_facility: Huddersfield Royal Infirmary /ID# 217660

location_facility: Wake Forest Baptist Medical Center /ID# 206067

location_facility: University of Mississippi Medical Center /ID# 213116

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 211167

location_facility: The University of Chicago Medical Center /ID# 206172

location_facility: Indianapolis Gastroenterology /ID# 206381

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 205246

location_facility: Republican hospital named after V.A. Baranov /ID# 206507

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 209118

location_facility: Juntendo University Urayasu Hospital /ID# 208784

location_facility: Nature Coast Clinical Research - Inverness /ID# 206087

location_facility: University Clinical Center Tuzla /ID# 208057

location_facility: Advanced Research Institute, Inc /ID# 206077

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 209573

location_facility: Clinical Hosp Center Zvezdara /ID# 205258

location_facility: Japanese Red Cross Osaka Hospital /ID# 209478

location_facility: National University Hospital /ID# 209099

location_facility: Clinical Research Trials of Florida, Inc. /ID# 206068

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265

location_facility: Agaplesion Markus Krankenhaus /ID# 206731

location_facility: Centex Studies, Inc. - Houston /ID# 206168

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507

location_facility: Klaipeda University Hospital /ID# 208790

location_facility: University Clinical Center of Nis /ID# 206411

location_facility: Hometown Urgent Care and Resea /ID# 205630

location_facility: Hospital Nossa Senhora das Graças /ID# 206981

location_facility: Hyogo College of Medicine Hospital /ID# 206455

location_facility: Hospital Garcia de Orta, EPE /ID# 206143

location_facility: Pusan National University Hospital /ID# 206956

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 207061

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267

location_facility: Atrium Health Carolinas Medical Center /ID# 206085

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 207137

location_facility: Moore UC San Diego Cancer Center /ID# 204919

location_facility: Hospital de Clinicas de Porto Alegre /ID# 206985

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 206710

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Belgium
China
Malaysia
Estonia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

ipd_sharing: Yes


title: Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway

summary: This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

status: Enrolling by invitation

ReferenceCitation: Meyer JR, Krentz AD, Berg RL, Richardson JG, Pomeroy J, Hebbring SJ, Haws RM. Kidney failure in Bardet-Biedl syndrome. Clin Genet. 2022 Apr;101(4):429-441. doi: 10.1111/cge.14119.

publisher_dissemination: Wiley

lead_sponsor: Rhythm Pharmaceuticals, Inc.

location_country:
Germany
United Kingdom
Netherlands
United States
Spain
Greece
Canada
France

location_facility: Synexus Clinical Research US, Inc.- Primary Care Associates, PC

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of Florida College of Medicine

location_facility: Synexus Clinical Research US, Inc. - Phoenix Southeast

location_facility: Wellcome Trust-MRC Institute of Metabolic Science

status_simplified: Unknown


type: Other Identifier

title: A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis

summary: The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
France
Poland
Sweden
Netherlands
United States
Spain
Puerto Rico
Israel

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: Washington University School of Medicine

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po

location_facility: Pan American Center for Oncology Trials LLC


lead_sponsor: Amgen

summary: To evaluate long-term safety of denosumab in children/young adults with pediatric osteogenesis imperfecta (OI) who completed the prior study 20130173 (NCT02352753).

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Indiana University - Riley Hospital for Children

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

status: Terminated

title: Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta

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

design_allocation: Non-Randomized

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Belgium
United States
Spain
Czechia
Canada
France


lead_sponsor: Regeneron Pharmaceuticals

summary:
The primary objectives of the study by study part are:

Part A:

To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B.

Part B:

To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.

Part C:

To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.

The secondary objectives of the study are:

To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE
To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_facility:
Regeneron Study Site #1
Regeneron Study Site #2
Regeneron Study Site

title: A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France


acronym: BIANCA

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of the study is to assess the efficacy and safety of tisagenlecleucel in children and adolescents with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). For pediatric patients who have r/r B-NHL, survival rates are dismal, only ~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

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

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

repositories_concat: PubMed Central;ora.ox.ac.uk

location_facility: The Childrens Hospital of Philadelphia Drug Shipment

location_facility: Dana Farber Cancer Institute Dept.of DFCI

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: University of Texas Southwestern Medical Center .

location_facility: Memorial Sloan Kettering Cancer Center MSKCC (8)

title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Subjects With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL)

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Japan
Netherlands
Austria
United States
Spain
Canada
France


acronym: PURSUIT 2

summary: The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.

location_facility: Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Children's Hospital Colorado and University of Colorado

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Emma Children's Hospital Academic Medical Center

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Children's Center for Digestive Health Care

location_facility: Azienda USL di Bologna - Ospedale Maggiore

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Rocky Mountain Pediatric Gastroenterology

location_facility: Universitair Kinderziekenhuis Koningin Fabiola

location_facility: Kyungpook National University Chilgok Hospital

title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

location_country:
France
Italy
Poland
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Israel


acronym: SOLSTICE

intervention_type: Genetic

lead_sponsor: NightstaRx Ltd, a Biogen Company

summary: The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the STAR (NCT03496012) study and BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112 and who have exited an antecedent study.

location_facility: The Northern Alberta Clinical Trials and Research Centre

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Centre Hospitalier National d Ophtalmologie (CHNO) des Quinze-Vingts

location_facility: Universitats Klinikum Tubingen - Institute for Ophthalmic Research

location_facility: Vitreo Retinal Associates PA - The Millennium Center

location_facility: The University of British Columbia - Eye Care Centre

location_facility: University of Wisconsin School of Medicine

title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects With Choroideremia Previously Treated With Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects With X-Linked Retinitis Pigmentosa Previously Treated With Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study

primary_purpose: Other

location_country:
Finland
Germany
United Kingdom
Denmark
Brazil
Netherlands
United States
Canada
France


title: An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis

summary: This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)

ReferenceCitation: Reiter A, Gotlib J, Alvarez-Twose I, Radia DH, Lubke J, Bobbili PJ, Wang A, Norregaard C, Dimitrijevic S, Sullivan E, Louie-Gao M, Schwaab J, Galinsky IA, Perkins C, Sperr WR, Sriskandarajah P, Chin A, Sendhil SR, Duh MS, Valent P, DeAngelo DJ. Efficacy of avapritinib versus best available therapy in the treatment of advanced systemic mastocytosis. Leukemia. 2022 Aug;36(8):2108-2120. doi: 10.1038/s41375-022-01615-z. Epub 2022 Jul 5.

ReferenceCitation: Reiter A, Schwaab J, DeAngelo DJ, Gotlib J, Deininger MW, Pettit KM, Alvarez-Twose I, Vannucchi AM, Panse J, Platzbecker U, Hermine O, Dybedal I, Lin HM, Rylova SN, Ehlert K, Dimitrijevic S, Radia DH. Efficacy and safety of avapritinib in previously treated patients with advanced systemic mastocytosis. Blood Adv. 2022 Nov 8;6(21):5750-5762. doi: 10.1182/bloodadvances.2022007539.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Society of Hematology

ReferenceCitation: Gotlib J, Reiter A, Radia DH, Deininger MW, George TI, Panse J, Vannucchi AM, Platzbecker U, Alvarez-Twose I, Mital A, Hermine O, Dybedal I, Hexner EO, Hicks LK, Span L, Mesa R, Bose P, Pettit KM, Heaney ML, Oh ST, Sen J, Lin HM, Mar BG, DeAngelo DJ. Efficacy and safety of avapritinib in advanced systemic mastocytosis: interim analysis of the phase 2 PATHFINDER trial. Nat Med. 2021 Dec;27(12):2192-2199. doi: 10.1038/s41591-021-01539-8. Epub 2021 Dec 6.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

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

lead_sponsor: Blueprint Medicines Corporation

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Denmark
Netherlands
Austria
United States
Spain
Canada
France

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Klinice Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Beatson West of Scotland Cancer Centre - NHS Greater Glasgow and Clyde

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltranslplantation

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: Universitätsmedizin Mannheim III. Medizinische Klinik

location_facility: Odense University Hospital, Department of Haematology

location_facility: lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo

location_facility: Klinik und Poliklinik für Innere Medizin III, Klinikum rechts der Isar der TU München

location_facility: A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, lnternistische Onkologie, Hämostaseologie

location_facility: Oslo University Hospital-Rikshospitalet, Hematology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie

location_facility: Azienda Ospedaliero-Universitaria Careggi, CRIMM - Centro di Ricerca ed Innovazione per le Malattie Mieloproliferative

location_facility: Centro Ricerche Cliniche di Verona - Azienda Ospedaliera Universitaria Integrata di Verona


acronym: ELARA

summary: This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

ReferenceCitation: Salles G, Schuster SJ, Dreyling M, Fischer L, Kuruvilla J, Patten PEM, von Tresckow B, Smith SM, Jimenez-Ubieto A, Davis KL, Anjos C, Chu J, Zhang J, Lobetti Bodoni C, Thieblemont C, Fowler NH, Dickinson M, Martinez-Lopez J, Wang Y, Link BK. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma. Blood Adv. 2022 Nov 22;6(22):5835-5843. doi: 10.1182/bloodadvances.2022008150.

ReferenceCitation: Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, Ghosh M, Popplewell L, Chavez JC, Bachy E, Kato K, Harigae H, Kersten MJ, Andreadis C, Riedell PA, Ho PJ, Perez-Simon JA, Chen AI, Nastoupil LJ, von Tresckow B, Ferreri AJM, Teshima T, Patten PEM, McGuirk JP, Petzer AL, Offner F, Viardot A, Zinzani PL, Malladi R, Zia A, Awasthi R, Masood A, Anak O, Schuster SJ, Thieblemont C. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022 Feb;28(2):325-332. doi: 10.1038/s41591-021-01622-0. Epub 2021 Dec 17.

repository_institution: King's College London - Research Portal

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)

location_facility: University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2

title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

location_country:
Germany
Italy
Norway
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
United States
Spain
France


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. No abstract available.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Aarhus University Hospital Skejby

location_country:
Finland
United Kingdom
Denmark
Sweden
Spain
Estonia
France

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Cardiovascular Institute, Groupe Hospitalier Mutualiste

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

location_facility: Stockholm South Central Hospital (Södersjukhuset)

location_facility: Hospital Universitari de Tarragona Joan XXIII

intervention_type: Procedure

lead_sponsor_type: academique


title: An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

summary: Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

ReferenceCitation: Glenthoj A, van Beers EJ, Al-Samkari H, Viprakasit V, Kuo KHM, Galacteros F, Chonat S, Porter J, Zagadailov E, Xu R, Oluyadi A, Hawkins P, Gheuens S, Beynon V, Barcellini W; ACTIVATE-T investigators. Mitapivat in adult patients with pyruvate kinase deficiency receiving regular transfusions (ACTIVATE-T): a multicentre, open-label, single-arm, phase 3 trial. Lancet Haematol. 2022 Oct;9(10):e724-e732. doi: 10.1016/S2352-3026(22)00214-9. Epub 2022 Aug 18.

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Ireland
Italy
United Kingdom
Denmark
Netherlands
United States
Thailand
Canada
France

location_facility: Toronto General Hospital, University Health Network

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Department of Paediatrics and Thalassaemia Center, Faculty of Medicine Siriraj Hospital, Mahidol University

location_facility: AOU Policlinico, Università della Campania "Luigi Vanvitelli"

location_facility: St James's Hospital Department of Haematology

location_facility: University of Copenhagen, Herlev Hospital


lead_sponsor: Vertex Pharmaceuticals Incorporated

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).

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(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Hunter Medical Research Institute (HMRI)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Klinika Mukowiscydozy, Oddział Chorób Płuc SZP ZOZ

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

location_facility: Nottingham University Hospital City Campus

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

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


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
Netherlands
France


title: Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock

acronym: DAPT-SHOCK-AMI

summary: Multicenter randomized double blind trial comparing intravenous cangrelor and oral ticagrelor in patients with acute myocardial infarction complicated by initial cardiogenic shock and treated with primary angioplasty.

lead_sponsor: Faculty Hospital Kralovske Vinohrady

sponsor_collaborators:
Faculty Hospital Kralovske Vinohrady
Charles University, Czech Republic

location_country: Germany Poland Slovakia Czechia France

location_facility: Department of Cardiology, University Hospital Brno-Bohunice

location_facility: Département de Cardiologie, Hôpital Bichat Assistance Publique Hôpitaux de Paris

location_facility: Cardiology Department, Regional Hospital

location_facility: Jagiellonianan University, University Hospital Krakow

location_facility: Center of Interventional Neuroradiology and Endovascular Treatment

location_facility: Middle-Slovak Institute of Cardiovascular Diseases

location_facility: Collegium Medicum University Hospital No. 1

location_facility: Department of Cardiology, Regional Hospital,

location_facility: Institute of Clinical and Experimental Medicine

location_facility: Cardiology department, Regional hospital


title: Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive

summary:
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.

The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.

The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD

primary_purpose: Diagnostic

lead_sponsor: Biotronik AG

location_country: Germany Australia Austria Belgium Spain France

location_facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen

intervention_type: Diagnostic Test


title: CHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

summary: This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)

ReferenceCitation: Schilsky ML, Czlonkowska A, Zuin M, Cassiman D, Twardowschy C, Poujois A, Gondim FAA, Denk G, Cury RG, Ott P, Moore J, Ala A, D'Inca R, Couchonnal-Bedoya E, D'Hollander K, Dubois N, Kamlin COF, Weiss KH; CHELATE trial investigators. Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE): a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1092-1102. doi: 10.1016/S2468-1253(22)00270-9. Epub 2022 Sep 30.

lead_sponsor: Orphalan

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Brazil
Belgium
United States
France

location_facility: University of Surrey, Department of Clinical and Experimental Medicine

location_facility: Hospital Nossa Senhora das Graças (HNSG)

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Nucleo de Pesquisa e Desenvolvimento de Medicamentos - Universidade Federal do Ceará - Rodolfo Teófilo

location_facility: KU Leuven, Department of Clinical and Experimental Medicine

location_facility: Centre National de Référence Wilson, Hôpital Lariboisière


title: A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

summary: The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.

lead_sponsor: Incyte Corporation

location_country:
United States
Italy
Austria
France

location_facility: University Health System Inc., Dba the University of Tn Medical Center

location_facility: Washington University School of Medicine

location_facility: AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITï¿½ DI NOVARA

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Weill Medical College of Cornell University

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Regional Universitaire (Chru) de Lille


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.

ReferenceCitation: Sawicki GS, Chilvers M, McNamara J, Naehrlich L, Saunders C, Sermet-Gaudelus I, Wainwright CE, Ahluwalia N, Campbell D, Harris RS, Paz-Diaz H, Shih JL, Davies JC. A Phase 3, open-label, 96-week trial to study the safety, tolerability, and efficacy of tezacaftor/ivacaftor in children >/= 6 years of age homozygous for F508del or heterozygous for F508del and a residual function CFTR variant. J Cyst Fibros. 2022 Jul;21(4):675-683. doi: 10.1016/j.jcf.2022.02.003. Epub 2022 Feb 18.

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

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

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

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

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

location_facility: Medical University of South Carolina (MUSC)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: Children's Hospital & Clinics of Minnesota

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

location_facility: Riley Hospital for Children Indiana University Health

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

location_facility: UBMD Pediatrics/ CF Center of Western New York

location_facility: Children's Hospital of Pittsburgh of UPMC

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

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

location_facility: Nemours/ Alfred I. duPont Hospital for Children

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

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


lead_sponsor: Sarepta Therapeutics, Inc.

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).

location_facility: UF Health: University of Florida Clinical Research Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Cincinnati Children's Hospital Medical Center

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

location_facility: Fakultni nemocnice Brno, Klinika detske neurologie LF MU a FN Brno

location_facility: UOSD Centro Traslazionale di Miologia e Patologie Neurogenerative

location_facility: Schneider Children's Medical Center of Israel

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Alder Hey Children's NHS Foundation Trust

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

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

location_facility: Provningsenhet Barn, Drottning Silvias Och Ungdomssjukhus

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

location_facility: Uniwersyteckie Centrum Kliniczne, Klinica Neurologii Rozwojowej

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: University of Rochester Medical Center - Department of Neurology

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

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


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: The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.

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

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

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

location_facility: Hematology Oncology Association of Rockland Drug Shipment


title: A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors

summary: This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to subjects with advanced solid malignancies who are not candidates for approved or available therapies.

ReferenceCitation: Munck JM, Berdini V, Bevan L, Brothwood JL, Castro J, Courtin A, East C, Ferraldeschi R, Heightman TD, Hindley CJ, Kucia-Tran J, Lyons JF, Martins V, Muench S, Murray CW, Norton D, O'Reilly M, Reader M, Rees DC, Rich SJ, Richardson CJ, Shah AD, Stanczuk L, Thompson NT, Wilsher NE, Woolford AJ, Wallis NG. ASTX029, a Novel Dual-mechanism ERK Inhibitor, Modulates Both the Phosphorylation and Catalytic Activity of ERK. Mol Cancer Ther. 2021 Oct;20(10):1757-1768. doi: 10.1158/1535-7163.MCT-20-0909. Epub 2021 Jul 30.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
United States
Spain
United Kingdom
France

location_facility: Institut Català d'Oncologia Badalona Site#240

location_facility: Hospital Universitari Vall d'Hebrón Servicio de Oncología, Sala coordinación UITM Site#243

location_facility: University of Southern California Norris Comprehensive Cancer Center Site#114

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Site #221

location_facility: University of Michigan Rogel Cancer Center Site #113

location_facility: Columbia University Irving Medical Center - Herbert Irving Pavilion Site#112

location_facility: Providence Portland Medical Center Site #118

location_facility: The University of Texas MD Anderson Cancer Center Site#111

location_facility: University of California Davis Medical Center Site #121

location_facility: California Pacific Medical Center - Sutter Pacific Medical Center Site#117

location_facility: START - South Texas Accelerated Research Therapeutics, LLC Site# 101

location_facility: University of Pennsylvania-Abramson Cancer Center

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Site# 107

location_facility: The Sidney Kimmel Comprehensive Cancer Center Site#106

location_facility: Clinica Universidad de Navarra Madrid Site #242

location_facility: Smilow Cancer Hospital at Yale New Haven Site#105

location_facility: Oregon Health and Science University Site #122

location_facility: Centre Léon Bérard Service d'Oncologie Médicale Site#202

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: The Christie NHS Foundation Trust Site#220

location_facility: City of Hope Comprehensive Cancer Center


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™.

time_perspective: Prospective

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

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United States
Italy
United Kingdom
France

location_facility: University Hospital of North Midlands NHS Trust


lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins.

Secondary Objectives:

To evaluate the efficacy of alirocumab versus placebo on LDL-C levels.
To evaluate the effects of alirocumab versus placebo on other lipid parameters.
To evaluate the safety and tolerability of alirocumab in comparison with placebo.
To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.
To evaluate the development of anti-alirocumab antibodies.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility: Cincinnati Children's Hospital Medical Center-Site Number:8400005

location_facility: Washington University School of Medicine-Site Number:8400006

location_facility: Excel Medical Clinical Trials, LLC-Site Number:8400001

location_facility: Presbyterian Novant Heart & Wellness-Site Number:8400002

title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

location_country:
Finland
Poland
Argentina
Brazil
Turkey
Czechia
Canada
France
Slovenia
Hungary
Denmark
United States
Lebanon
Italy
Norway
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden


title: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

acronym: PRISM

summary: To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.

lead_sponsor: Trevi Therapeutics

location_country:
Germany
Poland
Austria
United States
France

location_facility:
Study Site 308
Study Site 304
Study Site 208
Study Site 132
Study Site 215
Study Site 204
Study Site 316
Study Site 118
Study Site 157
Study Site 314
Study Site 306
Study Site 305
Study Site 219
Study Site 135
Study Site 146
Study Site 106
Study Site 145
Study Site 401
Study Site 209
Study Site 107
Study Site 302
Study Site 312
Study Site 216
Study Site 212
Study Site 103
Study Site 131
Study Site 313
Study Site 108
Study Site 402
Study Site 128
Study Site 214
Study Site 213
Study Site 122
Study Site 142
Study Site 206
Study Site 315
Study Site 221
Study Site 153
Study Site 201
Study Site 301
Study Site 102
Study Site 121
Study Site 137
Study Site 220
Study Site 109
Study Site 159
Study Site 502
Study Site 310
Study Site 303
Study Site 150
Study Site 140
Study Site 151
Study Site 134
Study Site 147
Study Site 222
Study Site 501
Study Site 148
Study Site 138
Study Site 130
Study Site 202
Study Site 144
Study Site 136
Study Site 139
Study Site 205
Study Site 158
Study Site 101
Study Site 120
Study Site 143
Study Site 141
Study Site 309


title: A Randomized, Subject and Investigator Blinded, Placebo Controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne

summary: The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.

location_country:
Germany
Hungary
Netherlands
United States
Czechia
France


title: A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis

summary: A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

lead_sponsor: ZevraDenmark

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac

location_facility: Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

location_facility: Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11

location_facility: Hospital Carlos III - Hospital Universitario La Paz, ALS Unit

location_facility: Montreal Neurological Institute and Hospital

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie

location_facility: UC Irvine Health ALS and Neuromuscular Center

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: Instituti Clinica Scientifici Maugeri - IRCCS

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic

location_facility: University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422

location_facility: University of Kansas Medical Center (KUMC) - Landon Center on Aging


lead_sponsor: BioCryst Pharmaceuticals

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: Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.

ReferenceCitation: Wedner HJ, Aygoren-Pursun 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.

repositories_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Zuraw B, Lumry WR, Johnston DT, Aygoren-Pursun E, Banerji A, Bernstein JA, Christiansen SC, Jacobs JS, Sitz KV, Gower RG, Gagnon R, Wedner HJ, Kinaciyan T, Hakl R, Hanzlikova 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.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

location_facility:
Study center
Study Site
Study Center

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

primary_purpose: Prevention

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


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_facility: Johns Hopkins University School of Medicine

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


title: A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

summary: Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.

lead_sponsor: Amgen

location_country:
Italy
Australia
Japan
United States
Greece
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII


title: COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

summary: The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

ReferenceCitation: Hassan AE, Zaidat OO, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Fifi JT. Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry. Front Neurol. 2022 Aug 9;13:896165. doi: 10.3389/fneur.2022.896165. eCollection 2022.

repository_institution: The University of Texas Rio Grande Valley - ScholarWorks @ UTRGV

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

publisher_dissemination: Frontiers

ReferenceCitation: Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiello T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2022 Mar;53(3):769-778. doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22.

repositories_concat: PubMed Central;scholarworks.utrgv.edu

lead_sponsor: Penumbra Inc.

location_country:
Germany
Poland
United States
Spain
Russian Federation
France

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Foundation Ophthalmic Adolphe De Rothschild

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

intervention_type: Device