title: CRYptogenic STroke And underLying AF Trial

acronym: CRYSTAL-AF

summary: The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.

primary_purpose: Diagnostic

ReferenceCitation: Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617. doi: 10.1161/01.STR.0000199147.30016.74.

ReferenceCitation: Sinha AM, Diener HC, Morillo CA, Sanna T, Bernstein RA, Di Lazzaro V, Passman R, Beckers F, Brachmann J. Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale. Am Heart J. 2010 Jul;160(1):36-41.e1. doi: 10.1016/j.ahj.2010.03.032.

ReferenceCitation: Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2022 Mar;65(2):101540. doi: 10.1016/j.rehab.2021.101540. Epub 2021 Nov 13.

ReferenceCitation: Witte KK, Tsivgoulis G, Reynolds MR, Tsintzos SI, Eggington S, Ismyrloglou E, Lyon J, Huynh M, Egea M, de Brouwer B, Ziegler PD, Franco N, Joglekar R, Rosemas SC, Liu S, Thijs V. Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation. BMC Cardiovasc Disord. 2021 Mar 31;21(1):160. doi: 10.1186/s12872-021-01967-x.

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories_concat: PubMed Central;Research Square;University of Melbourne - Minerva Access

ReferenceCitation: Verma N, Ziegler PD, Liu S, Passman RS. Incidence of atrial fibrillation among patients with an embolic stroke of undetermined source: Insights from insertable cardiac monitors. Int J Stroke. 2019 Feb;14(2):146-153. doi: 10.1177/1747493018798554. Epub 2018 Sep 10.

publisher_dissemination: SAGE Publications

ReferenceCitation: Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.

ReferenceCitation: Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11.

publisher_dissemination: S. Karger AG

ReferenceCitation: Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Finland
Germany
Italy
Slovakia
Denmark
Sweden
Netherlands
Austria
Belgium
United States
Spain
Greece
Canada
France

location_facility: Clinique Parly II - Centre Hospitalier de Versailles

location_facility: Brussels Heart Center (St. Lean - St. Pierre)

location_facility: Mid America Heart Institute / St. Lukes Hospital

location_facility: Central Bucks Specialists / Doylestown Hospital

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Neurology clinic, Turku University Central Hospital

location_facility: Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald

location_facility: South Denver Cardiology / Swedish Medical Center

location_facility: University of Texas - Southwestern Medical Center

location_facility: Cliniques Universitaires UCL Mont-Godinne

location_facility: Greenville Hospital System Cardiology/Cardiovascular Research

location_facility: Hamilton Health Sciences / Hamilton General Hospital


intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).

ReferenceType: derived

ReferenceCitation: San-Miguel J, Blade J, Shpilberg O, Grosicki S, Maloisel F, Min CK, Polo Zarzuela M, Robak T, Prasad SV, Tee Goh Y, Laubach J, Spencer A, Mateos MV, Palumbo A, Puchalski T, Reddy M, Uhlar C, Qin X, van de Velde H, Xie H, Orlowski RZ. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014 Jun 26;123(26):4136-42. doi: 10.1182/blood-2013-12-546374. Epub 2014 May 15. Erratum In: Blood. 2014 Aug 14;124(7):1201.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

status: Completed

title: A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
France
Poland
India
Singapore
Romania
Australia
United States
Korea, Republic of
Spain
Russian Federation
Israel

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


acronym: STRIVE

lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.

ReferenceType: background

ReferenceCitation: Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Drevinek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordonez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185.

ReferenceCitation: Flume PA, Wainwright CE, Elizabeth Tullis D, Rodriguez S, Niknian M, Higgins M, Davies JC, Wagener JS. Recovery of lung function following a pulmonary exacerbation in patients with cystic fibrosis and the G551D-CFTR mutation treated with ivacaftor. J Cyst Fibros. 2018 Jan;17(1):83-88. doi: 10.1016/j.jcf.2017.06.002. Epub 2017 Jun 24.

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Imperial College London - Spiral

version: submittedVersion

publisher_dissemination: Elsevier

ReferenceCitation: Solem CT, Vera-Llonch M, Liu S, Botteman M, Castiglione B. Impact of pulmonary exacerbations and lung function on generic health-related quality of life in patients with cystic fibrosis. Health Qual Life Outcomes. 2016 Apr 21;14:63. doi: 10.1186/s12955-016-0465-z.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Quittner A, Suthoff E, Rendas-Baum R, Bayliss MS, Sermet-Gaudelus I, Castiglione B, Vera-Llonch M. Effect of ivacaftor treatment in patients with cystic fibrosis and the G551D-CFTR mutation: patient-reported outcomes in the STRIVE randomized, controlled trial. Health Qual Life Outcomes. 2015 Jul 2;13:93. doi: 10.1186/s12955-015-0293-6.

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis Foundation

location_facility: Mukoviszidose-Zentrum am Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Kinder- und Jugendmedizin

location_facility: Pediatric & Pulmonary Division, Rainbow Babies/Case Western

location_facility: Cystic Fibrosis Research Office, Stanford University

location_facility: National Jewish Medical and Research Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Adult Pulmonary/ CF, University of Nebraska Medical Center

location_facility: Division of Pulmonary and CCM, University of Washington

location_facility: Kinder- und Jugendklinik Universitätsklinikum Erlangen

location_facility: Women and Children's Hospital of Buffalo

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: University of North Carolina at Chapel Hill

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Klinikum der LMU München, Dr. von Haunersches Kinderspital (CHA)

location_facility: Pulmonary, Allergy & Critical Care Medicine, University of Minnesota

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation

location_country:
Germany
Ireland
United Kingdom
Australia
United States
Canada
Czech Republic
France


acronym: PETIT

lead_sponsor: GlaxoSmithKline

summary: Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board.

ReferenceCitation: Grainger JD, Blanchette VS, Grotzinger KM, Roy A, Bussel JB. Health-related quality of life in children with chronic immune thrombocytopenia treated with eltrombopag in the PETIT study. Br J Haematol. 2019 Apr;185(1):102-106. doi: 10.1111/bjh.15732. Epub 2018 Dec 27.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Wire MB, Li X, Zhang J, Sallas W, Aslanis V, Ouatas T. Modeling and Simulation Support Eltrombopag Dosing in Pediatric Patients With Immune Thrombocytopenia. Clin Pharmacol Ther. 2018 Dec;104(6):1199-1207. doi: 10.1002/cpt.1066. Epub 2018 Apr 17.

oa_host_type: closed

ReferenceCitation: Bussel JB, de Miguel PG, Despotovic JM, Grainger JD, Sevilla J, Blanchette VS, Krishnamurti L, Connor P, David M, Boayue KB, Matthews DC, Lambert MP, Marcello LM, Iyengar M, Chan GW, Chagin KD, Theodore D, Bailey CK, Bakshi KK. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015 Aug;2(8):e315-25. doi: 10.1016/S2352-3026(15)00114-3. Epub 2015 Jul 28. Erratum In: Lancet Haematol. 2015 Oct;2(10):e407.

title: A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP.

location_country:
United Kingdom
Netherlands
United States
Spain
Canada
France


title: A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™ System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis With Neurogenic Intermittent Claudication

acronym: NICE

summary: The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Germany
Italy
Poland
United Kingdom
Singapore
Australia
Sweden
Belgium
Iceland
France

location_facility: Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie

location_facility: Azienda Ospedaliera Sant'Andrea - Neurochirurgia

location_facility: Neurochirurgische Klinik - Campus Benjamin Franklin

location_facility: Klinikum rechts der Isar der TU München - Neurochirurgie

location_facility: Ospedale di Circolo - Ortopedia e Traumatologia

location_facility: Landspitali - National hospital of Iceland

location_facility: CHU de Nice Hôpital Pasteur - Neurochirurgie

location_facility: Szpital Kliniczny Dziecatka Jezus - Orthopaedics

location_facility: Hôpital Roger Salengro - Clinique de Neurochirurgie

location_facility: Woodend Hospital - Department of Orthopaedics

location_facility: Singapore General Hospital - Orthopaedic Surgery

location_facility: Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie

intervention_type: Procedure


title: A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

acronym: MUSIC

summary:
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).

The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

ReferenceCitation: Raghu G, Million-Rousseau R, Morganti A, Perchenet L, Behr J; MUSIC Study Group. Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial. Eur Respir J. 2013 Dec;42(6):1622-32. doi: 10.1183/09031936.00104612. Epub 2013 May 16.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

publisher_dissemination: European Respiratory Society

lead_sponsor: Actelion

location_country:
Germany
Italy
Slovenia
Israel
Australia
Sweden
United States
Spain
South Africa
Turkey
Canada
France

location_facility: Hôpital Cardiologique et Pneumologique Louis Pradel

location_facility: University of Alberta - Health Sciences Center

location_facility: Centre for Chest Diseases, Milpark Hospital

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: University of California - San Francisco

location_facility: Temple University Hospital - Lung Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: National Jewish Medical & Research Center

location_facility: Università degli Studi di Torino Clinica di Malattie dell'Apparato Respiratorio

location_facility: CHRU - Hopital Calmette Clinique des Maladies Respiratoires

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: Karolinska Universitetssjukhuset Lung Allergi kliniken

location_facility: Stanford University Medical Center - Chest Clinic


title: TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment-experienced HIV-1 Infected Subjects

summary: The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.

lead_sponsor: Janssen R&D Ireland

location_country:
Argentina
United States
Thailand
South Africa
France


title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

summary:
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

ReferenceCitation: Richter MJ, Schermuly R, Seeger W, Rao Y, Ghofrani HA, Gall H. Relevance of angiopoietin-2 and soluble P-selectin levels in patients with pulmonary arterial hypertension receiving combination therapy with oral treprostinil: a FREEDOM-C2 biomarker substudy. Pulm Circ. 2016 Dec;6(4):516-523. doi: 10.1086/688671.

ReferenceCitation: Tapson VF, Jing ZC, Xu KF, Pan L, Feldman J, Kiely DG, Kotlyar E, McSwain CS, Laliberte K, Arneson C, Rubin LJ; FREEDOM-C2 Study Team. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013 Sep;144(3):952-958. doi: 10.1378/chest.12-2875.

lead_sponsor: United Therapeutics

location_country:
Germany
Italy
Portugal
Israel
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Columbia University Presbyterian Medical Center

location_facility: Pulmonary Critical Care Medicine, Brigham and Women's Hospital

location_facility: The University of Texas Health Science Center at Houston

location_facility: Vancouver Coastal Health Respiratory Clinic

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of California, San Francisco-Fresno

location_facility: University Hospitals Case Medical Center

location_facility: University of Colorado Health Science Center

location_facility: Mary M Parkes Center for Asthma, Allergy and Pulmonary Care

location_facility: Pulmonology Department Rambam Medical Center


type: Registry Identifier

title: Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

summary: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Cerhan JH, Anderson SK, Butts AM, Porter AB, Jaeckle K, Galanis E, Brown PD. Examiner accuracy in cognitive testing in multisite brain-tumor clinical trials: an analysis from the Alliance for Clinical Trials in Oncology. Neurooncol Pract. 2019 Jul;6(4):283-288. doi: 10.1093/nop/npy048. Epub 2018 Nov 24.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

ReferenceCitation: Drappatz J, Lieberman F. Chemotherapy of Oligodendrogliomas. Prog Neurol Surg. 2018;31:152-161. doi: 10.1159/000467376. Epub 2018 Jan 25.

lead_sponsor: Alliance for Clinical Trials in Oncology

collaborators: European Organisation for Research and Treatment Center (EORTC)

sponsor_collaborators: Alliance for Clinical Trials in Oncology

location_country:
Netherlands
Austria
Belgium
United States
Canada
France

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: UCHealth University of Colorado Hospital

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: University of Kentucky/Markey Cancer Center

location_facility: Southeast Nebraska Cancer Center - 68th Street Place

location_facility: Maine Medical Center- Scarborough Campus

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: Saint Alphonsus Cancer Care Center-Caldwell

location_facility: Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Memorial Regional Cancer Center Day Road

location_facility: Norton Hospital Pavilion and Medical Campus

location_facility: Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

location_facility: New York-Presbyterian/Brooklyn Methodist Hospital

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: University of Washington Medical Center - Montlake

location_facility: University of Kansas Hospital-Indian Creek Campus

location_facility: University of Kansas Cancer Center - Lee's Summit

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Regional West Medical Center Cancer Center

location_facility: University of Kansas Cancer Center-Overland Park

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: Radiation Oncology Centers of Nevada Southeast

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: Coborn Cancer Center at Saint Cloud Hospital

location_facility: Walter Reed National Military Medical Center

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: Smilow Cancer Hospital Care Center-Trumbull

location_facility: University of Alabama at Birmingham Cancer Center

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: Minnesota Oncology Hematology PA-Woodbury

location_facility: Kootenai Clinic Cancer Services - Post Falls

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: Western Illinois Cancer Treatment Center

location_facility: University Health Network-Princess Margaret Hospital

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Florida Health Science Center - Gainesville

location_facility: University of Kansas Hospital-Westwood Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Odette Cancer Centre- Sunnybrook Health Sciences Centre

location_facility: MU Health - University Hospital/Ellis Fischel Cancer Center

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: Cleveland Clinic Wooster Family Health and Surgery Center

location_facility: Minnesota Oncology Hematology PA-Maplewood

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Washington University School of Medicine

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Ottawa Hospital and Cancer Center-General Campus

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: Skagit Regional Health Cancer Care Center

location_facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: University of Kansas Cancer Center at North Kansas City Hospital

location_facility: UC Irvine Health/Chao Family Comprehensive Cancer Center

location_facility: State University of New York Upstate Medical University

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Anchorage Associates in Radiation Medicine

location_facility: Norton Brownsboro Hospital and Medical Campus

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: University of Kansas Cancer Center - North

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: Saint Alphonsus Cancer Care Center-Nampa

location_facility: Radiation Oncology Centers of Nevada Central

location_facility: Maastro Clinic-Maastricht Radiation Oncology

location_facility: Cancer Care Specialists of Illinois - Decatur

status_simplified: Ongoing


title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

summary: The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

ReferenceCitation: Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France

location_facility: University Of Colorado Denver & Hospital

location_facility: Alabama Liver & Digestive Specialists (Alds)


acronym: ENGAGE

summary: The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Bockler D, Fitridge R, Wolf Y, Hayes P, Silveira PG, Numan F, Riambau V; ENGAGE Investigators. Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled. J Cardiovasc Surg (Torino). 2010 Aug;51(4):481-91.

ReferenceCitation: Stokmans RA, Teijink JA, Forbes TL, Bockler D, Peeters PJ, Riambau V, Hayes PD, van Sambeek MR. Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):369-75. doi: 10.1016/j.ejvs.2012.07.005. Epub 2012 Jul 24.

ReferenceCitation: Stokmans RA, Teijink JA, Cuypers PW, Riambau V, van Sambeek MR. No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry. Eur J Vasc Endovasc Surg. 2012 Jun;43(6):667-73. doi: 10.1016/j.ejvs.2012.02.034. Epub 2012 Mar 21.

ReferenceCitation: Dubois L, Novick TV, Harris JR, Derose G, Forbes TL. Outcomes after endovascular abdominal aortic aneurysm repair are equivalent between genders despite anatomic differences in women. J Vasc Surg. 2013 Feb;57(2):382-389.e1. doi: 10.1016/j.jvs.2012.09.075. Epub 2012 Dec 21.

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

ReferenceCitation: Pol RA, Zeebregts CJ, van Sterkenburg SM, Reijnen MM; ENGAGE Investigators. Thirty-day outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians based on the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). J Vasc Surg. 2012 Jul;56(1):27-35. doi: 10.1016/j.jvs.2011.12.080. Epub 2012 Mar 28.

ReferenceCitation: Tang T, Sadat U, Walsh S, Hayes PD; ENGAGE Investigators. Comparison of the endurant bifurcated endograft vs. aortouni-iliac stent-grafting in patients with abdominal aortic aneurysms: experience from the ENGAGE registry. J Endovasc Ther. 2013 Apr;20(2):172-81. doi: 10.1583/1545-1550-20.2.172.

publisher_dissemination: International Society of Endovascular Specialists

ReferenceCitation: Pol RA, Zeebregts CJ, van Sterkenburg SM, Ferreira LM, Goktay Y, Reijnen MM; Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) Investigators. Outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians. J Vasc Surg. 2014 Aug;60(2):308-17. doi: 10.1016/j.jvs.2014.02.009. Epub 2014 Mar 20.

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

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

ReferenceCitation: Kiguchi MM, Forbes TL, Teijink JA, Pliagas GA, Ellozy SH, Bockler D, Makaroun MS. Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair. J Vasc Surg. 2014 Dec;60(6):1452-9. doi: 10.1016/j.jvs.2014.08.063. Epub 2014 Oct 3. Erratum In: J Vasc Surg. 2015 Jan;61(1):285. Boeckler, Dittmar [Corrected to Bockler, Dittmar].

ReferenceCitation: Faure EM, Becquemin JP, Cochennec F; ENGAGE collaborators. Predictive factors for limb occlusions after endovascular aneurysm repair. J Vasc Surg. 2015 May;61(5):1138-45.e2. doi: 10.1016/j.jvs.2014.11.084. Epub 2015 Feb 2.

ReferenceCitation: Dijkstra ML, Zeebregts CJ, Verhagen HJM, Teijink JAW, Power AH, Bockler D, Peeters P, Riambau V, Becquemin JP, Reijnen MMPJ; ENGAGE investigators. Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data. J Vasc Surg. 2020 Mar;71(3):780-789. doi: 10.1016/j.jvs.2019.04.486. Epub 2019 Aug 20.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Twente - University of Twente Research Information

ReferenceCitation: Dijkstra ML, van Sterkenburg SM, Lardenoye JW, Zeebregts CJ, Reijnen MM; ENGAGE Investigators. One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft: Comparison of the ASA Classification and SVS/AAVS Medical Comorbidity Grading System for the Prediction of Mortality and Adverse Events. J Endovasc Ther. 2016 Aug;23(4):574-82. doi: 10.1177/1526602816648455. Epub 2016 May 10.

ReferenceCitation: Broos PP, Stokmans RA, van Sterkenburg SM, Torsello G, Vermassen F, Cuypers PW, van Sambeek MR, Teijink JA. Performance of the Endurant stent graft in challenging anatomy. J Vasc Surg. 2015 Aug;62(2):312-8. doi: 10.1016/j.jvs.2015.03.024. Epub 2015 May 1.

ipd_sharing_description: Only multi center data will be available

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Thailand
Turkey
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hong Kong
Switzerland
Belgium
China
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Uruguay
Greece
South Africa
Israel

location_facility: Hôpitaux Universitaires - Hôpital Henri Mondor

location_facility: Istanbul Universitesi - Istanbul Tip Fakultesi Hastanesi

location_facility: JMLS Medical Services PTY, trading as Perth Institute of Vascular Research

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Euromedica - Kyanous Stavros General Hospital

location_facility: Yonsei University health System -Severence Hospital

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: IKEM - Institutu Klinicke a Experimentalni Mediciny

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

location_facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

location_facility: Life Healthcare - Life St Georges Hospital

location_facility: Life Healthcare - Life Kingsbury Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitari Clínic de Barcelona

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: St George's University Hospitals - NHS Trust

location_facility: Complejo Hospitalario Universitario Granada Hospital Campus de la Salud

location_facility: West China Hospital of Sichuan University

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Vilnius University Hospital Santaros Klinikos


lead_sponsor: Seagen Inc.

summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

ReferenceCitation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.

ReferenceCitation: Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3. Erratum In: Blood. 2018 Jul 26;132(4):458-459.

sponsor_collaborators:
Seagen Inc.
Millennium Pharmaceuticals, Inc.

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Baylor Sammons Cancer Center / Texas Oncology

location_facility: MD Anderson Cancer Center / University of Texas

title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

location_country:
United Kingdom
Belgium
United States
Canada
France


lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

ReferenceCitation: Emslie GJ, Wells TG, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. Acute and longer-term safety results from a pooled analysis of duloxetine studies for the treatment of children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2015 May;25(4):293-305. doi: 10.1089/cap.2014.0076.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):180-9. doi: 10.1089/cap.2013.0146. Epub 2014 May 9.

ReferenceCitation: Bliznak L, Berg R, Hage A, Dittmann RW. High rate of non-eligibility: methodological factors impacting on recruitment for a multicentre, double-blind study of paediatric patients with major depressive disorder. Pharmacopsychiatry. 2013 Jan;46(1):23-8. doi: 10.1055/s-0032-1314806. Epub 2012 Jun 14.

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

title: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder

location_country:
Germany
Slovakia
United States
South Africa
Ukraine
Russian Federation
France


title: Acute Respiratory Infections Global Outpatient Study

acronym: ARGOS

summary: The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.

primary_purpose: Other

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Poland
United Kingdom
Japan
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Canada
France

location_facility: Fiel Family and Sports Medicine Clinical Research Advantage

location_facility: NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: CCT Research at South Ogden Family Medicine

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Innovative Research of West Florida, Incorporated

location_facility: PharmaDUX Clinical Medical Research, LLC

location_facility: Urgent Care Clinical Trials at AFC Urgent Care

location_facility: NZOZ Leczniczo-Rehabilitacyjny Ośrodek Medycyny Rodzinnej

intervention_type: Diagnostic Test


lead_sponsor: Ionis Pharmaceuticals, Inc.

summary: The purpose of this study is to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

title: A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients With Hereditary Angioedema (HAE)

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Turkey
Bulgaria
Canada
France

ipd_sharing: No


title: Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors

summary:
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use.

Participants will have to inject the study medicine every day under the skin with a pen-injector.

The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.

design_allocation: Non-Randomized

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

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Japan
Bosnia and Herzegovina
Thailand
Turkey
Canada
France
Lithuania
United States
North Macedonia
India
Romania
Malaysia
Estonia
Italy
Norway
United Kingdom
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden


title: An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

summary: The purpose of this study is to evaluate the effect of olezarsen (formerly known as AKCEA-APOCIII-LRx) on the percent change in fasting triglycerides (TG) from baseline.

status: Active, not recruiting

location_country:
Italy
Portugal
Slovakia
Norway
United Kingdom
Sweden
Netherlands
United States
Spain
Canada
France

location_facility: Dra Margarida Falcao Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz

location_facility: Institute de Recherches Cliniques de Montreal

location_facility: Azienda Ospedaliero Universitaria Policlinico Umberto I

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: Academisch Medisch Centrum Goederenontvangst Apotheek t.a.v. Kenniscentrum

location_facility: Diabetes/Lipid Management & Research Center

location_facility: Clinique des Maladies Lipidiques de Quebec Inc.

location_facility: University of Kansas Medical Center (KUMC)

location_facility: Groupement Hospitalier Est- Pharmacie Secteur Essais Clinique


title: Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

acronym: OASIS

summary: The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

lead_sponsor: F2G Biotech GmbH

sponsor_collaborators:
F2G Biotech GmbH
Iqvia Pty Ltd

location_country:
Israel
Singapore
Australia
Brazil
Netherlands
Belgium
United States
Spain
Thailand
Turkey
Taiwan
Canada
France

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital da Universidade Federal de Santa Maria CEP/UFSM

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: University of California Davis Health System

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS

location_facility: UCSF Helen Diller Medical Center at Parnassus Heights

location_facility: Washington University School of Medicine

location_facility: Hamilton Health Sciences - Juravinski Site


title: A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

acronym: MTAP

summary:
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.

The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.

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

lead_sponsor: Amgen

location_country:
Germany
United Kingdom
Hong Kong
Australia
Japan
Switzerland
Austria
Belgium
United States
Taiwan
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: University of Hong Kong, Queen Mary Hospital

location_facility: Community Health Network MD Anderson Cancer Center - North

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc


title: An Open-label, First-in-human, Dose-escalation/Expansion Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Adult and Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

summary: This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.

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

lead_sponsor: Sanofi

location_country:
United States
Australia
Netherlands
France

location_facility: Montefiore Medical Center-Site Number:8400012

location_facility: Oregon Health and Science University-Site Number:8400011

location_facility: Weill Cornell Medical College-Site Number:8400003

location_facility: MD Anderson Cancer Center-Site Number:8400001

location_facility: Beth Israel Deaconess Medical Center-Site Number:8400004


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

acronym: PATHWAY

summary: The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility:
Investigative Site JP010
Investigative Site JP009
Investigative Site IT001
Investigative Site FR001
Investigative Site NL001
Investigative Site BE002
Investigative Site US005
Investigative Site IT002
Investigative Site JP004
Investigative Site PL004
Investigative Site CA001
Investigative Site DE001
Investigative Site FR002
Investigative Site US010
Investigative Site FR003
Investigative Site GB005
Investigative Site DE002
Investigative Site ES001
Investigative Site IT006
Investigative Site US009
Investigative Site US007
Investigative Site JP005
Investigative Site ES004
Investigative Site JP003
Investigative Site US001
Investigative Site ES005
Investigative Site PL003
Investigative Site PL001
Investigative Site IL001
Investigative Site IT003
Investigative Site GB004
Investigative Site GB006
Investigative Site IL002
Investigative Site JP007
Investigative Site AT002
Investigative Site US006
Investigative Site US002
Investigative Site US003
Investigative Site JP002
Investigative Site ES002
Investigative Site BE001
Investigative Site US012
Investigative Site ES006
Investigative Site JP006
Investigative Site ES003
Investigative Site IT005
Investigative Site IT004
Investigative Site PL005
Investigative Site US004
Investigative Site PL006
Investigative Site JP008
Investigative Site PL002
Investigative Site GB002
Investigative Site JP001
Investigative Site GB003
Investigative Site AT001


acronym: AFFINITY

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

location_facility: Smolensk regional hospital on Smolensk railway station

location_facility: Unity Health-White County Medical Center

location_facility: Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'

location_facility: GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

location_facility: Atlanta Research Center for Rheumatology

location_facility: Trinity Universal Research Associates, LLC

location_facility: ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

location_facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Municipal Institution Regional hospital-center of emergency care and disasters medicine

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Ryazan Regional Clinical Dermatovenerological Dispensary

location_facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

location_facility: Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

location_facility: Rostov Regional Clinical Dermatovenerological Dispensary

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

location_facility: WroMedica I.Bielicka, A.Strzałkowska s.c.

location_facility: Republican Clinical Hospital - G.G. Kuvatov

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

location_facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

title: A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Italy
Poland
Hungary
Denmark
Sweden
United States
Spain
Ukraine
Russian Federation
France


title: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

acronym: MOTION

summary:
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option.

The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Germany
Italy
Poland
Norway
Hong Kong
United Kingdom
Australia
Netherlands
Switzerland
United States
Spain
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: University Hospital Essen (Universitätsklinikum Essen)

location_facility: Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy


title: A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

acronym: MAJIC

summary: A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

ReferenceCitation: Ryan CE, Davids MS, Hermann R, Shahkarami M, Biondo J, Abhyankar S, Alhasani H, Sharman JP, Mato AR, Roeker LE. MAJIC: a phase III trial of acalabrutinib + venetoclax versus venetoclax + obinutuzumab in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Future Oncol. 2022 Oct;18(33):3689-3699. doi: 10.2217/fon-2022-0456. Epub 2022 Sep 14. Erratum In: Future Oncol. 2023 Jan;19(3):271.

evidence: open (via page says license)

publisher_dissemination: Future Science Ltd

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

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

lead_sponsor: AstraZeneca

location_country:
Poland
Hungary
Australia
United States
Spain
Czechia
France


title: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

summary: The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

status: Enrolling by invitation

lead_sponsor: Kite, A Gilead Company

location_country:
Germany
Israel
Australia
Netherlands
United States
Canada
France

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: The University of Kansas Cancer Center Westwood

location_facility: Amsterdam Universitair Medische Centra (UMC)

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Princess Margaret Cancer Center - University Health Network

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: University of California, San Francisco Medical Center

location_facility: University of Chicago Medical Center Clinical Laboratories

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin

location_facility: LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III

intervention_type: Biological

status_simplified: Unknown


title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

summary:
HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF).

Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase.

During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors:

Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no
Forced vital capacity (FVC) % predicted at Baseline: ≥70% or <70%

Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.

ipd_sharing: Undecided

lead_sponsor: Horizon Therapeutics Ireland DAC

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Chile
Canada
France
United States
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan

location_facility: Centro Respiratorio Integral LTDA. (CENRESIN)

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Presidio Ospedaliero GB Morgagni L Pierantoni

location_facility: Instituto De Enfermedades Respiratorias E Investigacion Medica

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: University of Cape Town Lung Institute (UCTLI)

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Oaxaca Site management Organization (OSMO)

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Clinical Trials Center of Middle Tennessee

location_facility: Metroplex Pulmonary and Sleep Medicine Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Stony Brook Medicine Advanced Specialty Care

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

location_facility: Seoul National University Bundang Hospital

location_facility: China Medical University Hospital - PPDS

location_facility: University General Hospital of Heraklion

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: National Hospital Organization Ibarakihigashi National Hospital

location_facility: Hospital Universitario Dr. Jose Eleuterio González


title: AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

summary: This is a randomized investigator and patient blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

lead_sponsor: BeiGene

location_country:
Australia
Austria
United States
China
Korea, Republic of
Spain
France

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Peninsula & South Eastern Hematology and Oncology Group

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Huashan hospital affiliated to Fudan University

location_facility: First Affiliated Hospital, School of Medicine, Shihezi University

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Hopital Charles Nicolle - Centre Hospitalier Universitaire de Rouen

location_facility: University of Iowa Hospitals and Clinics

location_facility: First Affiliated Hospital of Zhengzhou University

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Hospital Universitario Central de Asturias

location_facility: Olivia Newton-John Cancer Wellness & Research Centre

location_facility: Xin Qiao Hospital Affiliated to The Army Medical University

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


title: A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies

summary: Study consists of two main parts to explore BGB-16673 recommended dosing, a Part 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a part 2 (dose expansion cohorts)

location_country:
Italy
Moldova, Republic of
Australia
Sweden
United States
Spain
Canada
Georgia
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Weill Cornell Medical College Newyork Presbyterian Hospital

location_facility: University of California San Diego (Ucsd) Moores Cancer Center

location_facility: The Institute of Oncology, Arensia Exploratory Medicine

location_facility: University of Alabama At Birmingham Hospital

location_facility: Memorial Sloan Kettering Cancer Center Mskcc

location_facility: Policlinico Sorsola Malpighi, Aou Di Bologna

location_facility: Niguarda Cancer Center Division of Hematology

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Hospital Clinico Universitario de Valencia


title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

summary: The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Brazil
United States
Spain
Turkey
Chile
Taiwan
Canada
Ukraine
Russian Federation
France

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)

location_facility: Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)

location_facility: Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)

location_facility: Ege University Medicine of Faculty ( Site 0565)

location_facility: City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)

location_facility: National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (

location_facility: centre hospitalier lyon sud-Service Hématologie ( Site 0300)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0014)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0262)

location_facility: Dokuz Eylül Üniversitesi-Hematology ( Site 0563)

location_facility: Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)

location_facility: Universitätsklinikum Marburg ( Site 0333)

location_facility: Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)

location_facility: Ankara University Hospital Cebeci ( Site 0561)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0593)

location_facility: University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021

location_facility: Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)

location_facility: Instituto Nacional del Cancer ( Site 0626)

location_facility: Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)

location_facility: University of Chicago Medical Center ( Site 0005)

location_facility: Instituto do Câncer e Transplante de Curitiba ( Site 0611)

location_facility: Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)

location_facility: Sheba Medical Center-Hemato Oncology ( Site 0524)

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)

location_facility: Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)

location_facility: Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)

location_facility: Rigshospitalet-Hematology - CTU ( Site 0361)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0023)

location_facility: Universitätsklinikum Leipzig ( Site 0328)

location_facility: Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (

location_facility: McGill University Health Centre ( Site 0037)

location_facility: Clinica Universidad de Navarra ( Site 0444)

location_facility: Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (

location_facility: Hospital Universitario de Salamanca-Hematology ( Site 0441)

location_facility: Ospedale San Raffaele-Unità Linfomi ( Site 0382)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)

location_facility: Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0547)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

location_facility: Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)

location_facility: Universitaetsklinikum Essen ( Site 0327)

location_facility: Soroka Medical Center-Hematology Department ( Site 0523)

location_facility: Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0016)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)

location_facility: Medical Oncology Associates, PS ( Site 0001)

location_facility: Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)


title: A Phase 2a Study of TPN-101 in Patients With Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated With Hexanucleotide Repeat Expansion in the C9orf72 Gene (C9ORF72 ALS/FTD)

summary: This is a Phase 2a study to assess the the safety and tolerability of TPN-101 in patients with Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated with Hexanucleotide Repeat Expansion in the C9orf72 gene (C9ORF72 ALS/FTD).

lead_sponsor: Transposon Therapeutics, Inc.

location_country:
Germany
Belgium
United States
Spain
France

location_facility: VIB-KU Leuven Center for Brain & Disease Research

location_facility: UCSF Neurosciences Clinical Research Unit (NCRU)

location_facility: The University of North Carolina at Chapel Hill, Department of Neurology

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: Massachusetts General Hospital (MGH) - Amyotrophic Lateral Sclerosis (ALS) Multidisciplinary Clinic

location_facility: Groupe Hospitalier Pitie-Salpetriere - La Federation de Maladies du Systeme Nerveux

location_facility: University of California Irvine - ALS & Neuromuscular Center

location_facility: Columbia University Medical Center - The Neurological Institute of New York

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)


title: BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

summary: The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Italy
Israel
United Kingdom
Switzerland
Belgium
United States
Canada
France


title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)

summary: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.

primary_purpose: Prevention

lead_sponsor: Pi-cardia

location_country:
Germany
France
United Kingdom
United States
Israel

location_facility: CHU de Bordeaux (Bordeaux University Hospital)

location_facility: Baylor Scott & White, The Heart Hospital Plano

location_facility: Smidt Heart Institute Cedars-Sinai Medical

location_facility: Carolinas Medical Center / Atrium Health

location_facility: Kaiser Permanente - San Francisco Medical Center

intervention_type: Device


title: An Open-label, Multi-center, ph II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With SOC Anti-cancer Therapy for the 2L Treatment of Metastatic Colorectal Cancer (mCRC)

summary:
The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC.

This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Israel
Hong Kong
Singapore
Australia
Japan
Switzerland
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France

location_facility: Sarah Cannon Research Institute DeptofSarahCannonRes.Inst. (2)

location_facility: The Angeles Clinic and Research Institute .


summary: This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

location_facility: Children's Hospital of Orange County ( Site 0047)

location_facility: University Malaya Medical Centre-Department of Paediatrics ( Site 0480)

location_facility: Hospital Universitary General de Catalunya-Pediatrics ( Site 0737)

location_facility: Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0201)

location_facility: Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0383)

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

location_facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 0305)

location_facility: Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet-PIC ( Site 0384)

location_facility: University of Kentucky HealthCare - Turfland ( Site 0044)

location_facility: Southampton General Hospital ( Site 0826)

location_facility: Chulalongkorn University-Pediatrics ( Site 0777)

location_facility: Fundación Hospitalaria San Vicente de Paúl ( Site 0233)

location_facility: Children's Hospital Aglaia Kyriakou-2nd Department of Pediatrics NKUA ( Site 0854)

location_facility: Sabah Women and Children Hospital ( Site 0478)

location_facility: Hospital Universitario Central de Asturias ( Site 0740)

location_facility: The John Radcliffe Hospital-Paediatrics Infectious Diseases ( Site 0827)

location_facility: Semmelweis University-Szülészeti és Nőgyógyászati Klinika PIC ( Site 0381)

location_facility: UPR Medical Sciences Campus-Pediatrics ( Site 0626)

location_facility: Clínica Universitaria Bolivariana ( Site 0227)

location_facility: Maebashi Red Cross Hospital ( Site 0451)

location_facility: MRC Unit on Child And Adolescent Health-Department of Paediatrics and child Health ( Site 0710)

location_facility: Hospital Raja Perempuan Zainab II-Department of Pediatric ( Site 0477)

location_facility: Hospital Germans Trias i Pujol ( Site 0738)

location_facility: Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030)

location_facility: The University of North Carolina at Chapel Hill ( Site 0035)

location_facility: Mater Misericordiae Limited-Neonatalogy ( Site 0102)

location_facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 0304)

location_facility: KK Women's and Children's Hospital-Department of Neonatology ( Site 0877)

location_facility: MultiCare Health System-Baker Center ( Site 0036)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 0752)

location_facility: Tribe Clinical Research, LLC ( Site 0002)

location_facility: Instituto Nacional de Pediatria ( Site 0506)

location_facility: Azienda Ospedaliero Universitaria di Parma-UO Clinica Pediatrica ( Site 0433)

location_facility: Queen Elizabeth University Hospital ( Site 0842)

location_facility: M Health Fairview University of Minnesota Masonic Children's Hospital, West Bank-Peds Research ( Sit

location_facility: Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0778)

location_facility: Ospedale Pediatrico Bambino Gesù IRCCS-UOC Broncopneumologia ( Site 0427)

location_facility: Evelina London Children's Hospital ( Site 0829)

location_facility: Japan Community Healthcare Organization Kyushu Hospital ( Site 0454)

location_facility: Ankara Bilkent Şehir Hastanesi. ( Site 0807)

location_facility: Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 0577)

location_facility: DHR Health Institute for Research and Development ( Site 0029)

location_facility: Nihon University Itabashi Hospital ( Site 0453)

location_facility: Shizuoka Saiseikai General Hospital ( Site 0456)

location_facility: Our Lady of the Lake Children's Hospital ( Site 0031)

location_facility: Universitaetsklinikum Heidelberg-Zentrum für Kinder-und Jugendmedizin ( Site 0366)

location_facility: National Center for Child Health and Development ( Site 0455)

location_facility: Hospital Universitario La Paz ( Site 0726)

location_facility: Rutgers University-Pediatric Clinical Research Center ( Site 0007)

location_facility: Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 07

location_facility: Ibaraki Children's Hospital ( Site 0458)

location_facility: Hospital Universitario HM Monteprincipe-pediatric ( Site 0743)

location_facility: FVR, Turun rokotetutkimusklinikka ( Site 0302)

location_facility: FVR, Oulun rokotetutkimusklinikka ( Site 0303)

location_facility: National Taiwan University Hospital ( Site 0751)

location_facility: Hospital Roberto del Río-Infectología Pediátrica ( Site 0205)

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0432)

location_facility: Driscoll Children's Hospital ( Site 0025)

location_facility: Clínica Alemana de Santiago-Neonatology department ( Site 0207)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Children's National Medical Center ( Site 0020)

location_facility: Capital and Coast District Health Board-Clinical Trials Unit ( Site 0527)

location_facility: Universitätsklinikum Leipzig-Neonatology ( Site 0354)

location_facility: Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi

location_facility: Kinder und Jugendaerztliche Gemeinschaftspraxis Bedikian & Bouikidis ( Site 0359)

location_facility: Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0376)

location_facility: Miller Children's & Women's Hospital Long Beach ( Site 0001)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0426)

location_facility: Ankara University Hospital Cebeci ( Site 0801)

location_facility: Orlando Health - Arnold Palmer Hospital-Orlando Health-Arnold Palmer Hospital Pulmonary and Sleep M

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL-3rd Department of Pediatrics ( Site 0855)

location_facility: HOSPITAL DOCENTE MADRE-NIÑO SAN BARTOLOME-NEUMOLOGIA PEDIATRICA ( Site 0576)

location_facility: Azienda Ospedaliera di Padova-Department of Women and Child Health ( Site 0428)

location_facility: Oaxaca Site Management Organization ( Site 0504)

location_facility: Universitätsklinikum Schleswig-Holstein-Pediatrics ( Site 0361)

location_facility: Fukuoka Children's Hospital ( Site 0452)

location_facility: Canadian Center for Vaccinology ( Site 0179)

location_facility: Fakultni nemocnice Ostrava-Oddeleni neonatologie ( Site 0252)

location_facility: Hippokration University Hopsital-3rd Pediatric Department ( Site 0851)

location_facility: Children's Hospital Colorado ( Site 0011)

location_facility: Nemours Children's Health, Lake Nona Medical City ( Site 0032)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0731)

location_facility: Songklanagarind hospital-Department of Pediatrics ( Site 0776)

location_facility: Multicare Rockwood Main Clinic-Rockwood Pediatrics ( Site 0004)

location_facility: University Hospital-Pediatrics ( Site 0019)

location_facility: Morehouse School Of Medicine ( Site 0049)

location_facility: NYU Langone Hospital - Long Island-Pediatrics ( Site 0028)

location_facility: Bacs-Kiskun Megyei Korhaz-Pediatrics ( Site 0380)

location_facility: Medizinische Hochschule Hannover ( Site 0364)

location_facility: Telethon Kids Institute-Vaccine Trials Group ( Site 0101)

location_facility: Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 0502)

location_facility: Taichung Veterans General Hospital ( Site 0754)

location_facility: MeVac - Meilahti Vaccine Research Center ( Site 0306)

location_facility: Family Clinical Research Unit (Fam-Cru)-Pediatric ( Site 0703)

location_facility: Dr. von Haunersches Kinderspital ( Site 0358)

location_facility: Centre Hospitalier de Versailles André Mignot-NEONATOLOGY ( Site 0331)

location_facility: Universitaetsklinikum Freiburg ( Site 0365)

location_facility: Alder Hey Children's Hospital-Paediatric Respiratory Medicine ( Site 0843)

location_facility: Whipps Cross University Hospital ( Site 0846)

location_facility: Barts Health NHS Trust-Children's Clinical Research Facility ( Site 0844)

location_facility: Intermountain - Primary Children's Hospital ( Site 0026)

location_facility: The Children's Hospital of San Antonio ( Site 0038)

location_facility: Bordeaux University Hospital - Pellegrin-Pediatrics ( Site 0332)

location_facility: Oslo Universitetssykehus Ullevål ( Site 0551)

location_facility: University of South Florida-Department of Pediatrics ( Site 0045)

location_facility: Erciyes University Medical Faculty-pediatric infection ( Site 0804)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0378)

location_facility: Institute for the Care of Mother and Child ( Site 0251)

location_facility: Tulane University School of Medicine ( Site 0010)

location_facility: Hospital Tunku Azizah-Paediatric ( Site 0481)

location_facility: Morales Vargas Centro de Investigacion ( Site 0509)

location_facility: Chris Hani Baragwanath Academic Hospital ( Site 0701)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0739)

location_facility: FVR, Tampereen rokotetutkimusklinikka ( Site 0301)

location_facility: Alberta Children's Hospital-Department of Pediatrics ( Site 0180)

location_facility: University of Rochester Medical Center ( Site 0017)

location_facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0230)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház-Újszülött Intenzív Osztály ( Si

location_facility: Mackay Memorial Hospital-Pediatrics ( Site 0753)

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C. ( Site 0508)

title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

location_country:
Finland
Germany
New Zealand
Australia
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
Hong Kong
United States
Malaysia
Peru
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Mexico
Spain
Greece
South Africa
Taiwan


lead_sponsor: Pfizer

summary: This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

location_facility: Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera

location_facility: Rush University Medical Center Investigator Pharmacy

location_facility: Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell

location_facility: DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitel

location_facility: Ahmadu Bello University Teaching Hospital

location_facility: UCSF Benioff Children's Hospital, Oakland

location_facility: Barau Dikko Teaching Hospital/Kaduna State University

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

location_facility: Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy

location_facility: Sociedad de Oncologia y hematologia del Cesar S.A.S.

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU)

location_facility: Cairo University Paediatric Hospital - abou el Reesh University Hospital

location_facility: University of South Alabama Strada Patient Care Center

location_facility: DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria

location_facility: U.O.C. Farmacia Istituto Oncologico Veneto

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Comite de Etica em Pesquisa - CEP do Hospital Alemao Oswaldo Cruz/ SP

location_facility: Kenya Medical Research Institute- Center for Respiratory Disease Research

location_facility: Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO

location_facility: University of Illinois Hospital and Health Sciences System(UI Health)

location_facility: USF Clinical Investigational Research Pharmacy

location_facility: Hemocentro de Belo Horizonte - Fundacao Hemominas

location_facility: McGovern Medical School/Health Science Center Houston

location_facility: UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria

location_facility: Organizacion Clinica Bonnadona Prevenir S.A.S.

location_facility: UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"

location_facility: DUMC Investigational Drug Services Pharmacy

location_facility: American University of Beirut Medical Center

location_facility: Dana-Farber Cancer Institute IDS Pharmacy

location_facility: University of South Alabama Children's and Women's Hospital

location_facility: Al Kasr Al Ainy Cairo University Hospital

location_facility: Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A

location_facility: USF Health South Tampa Center for Advanced Healthcare

location_facility: Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Farmacia Azienda Ospedale Universita Padova

location_facility: University of Michigan Hospitals - Michigan Medicine

location_facility: Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital

location_facility: S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro Azienda

location_facility: UT Physicians Comprehensive Sickle Cell Clinic

location_facility: Children's Healthcare of Atlanta - Egleston

location_facility: Sickle-Cell Office, Directorate of Child Health, Komfo Anokye Teaching Hospital

location_facility: Hospital das Clinicas da Universidade Federal de Minas Gerais

location_facility: KEMRI/CRDR, Siaya, KEMRI Clinical Research Annex

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

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo-HCFMUSP

location_facility: Hospital Pharmacy Services- Investigational Drug Services

location_facility: University Teaching Hospital- Children's Hospital

location_facility: Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi

location_facility: University of Illinois Clinical Research Center (CRC)

location_facility: Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica

location_facility: Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES)

location_facility: Children's Healthcare of Atlanta - Scottish Rite

location_facility: USF Health Carol & Frank Morsani Center for Advanced Healthcare

location_facility: John S. Curran, MD.,Children's Health Center

title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

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

location_country:
Germany
Italy
Colombia
United Kingdom
Nigeria
Brazil
Tanzania
Lebanon
United States
Saudi Arabia
Turkey
Zambia
Oman
Kenya
Ghana
Egypt
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept, Phase IIA Study of MP1032 Plus Standard of Care vs Standard of Care in the Treatment of Hospitalized Participants With Moderate to Severe COVID-19

summary: The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe coronavirus disease 2019 (COVID-19).

lead_sponsor: MetrioPharm AG

sponsor_collaborators:
MetrioPharm AG
Syneos Health, LLC

location_country:
Italy
Hungary
Romania
United States
Spain
Bulgaria
France

location_facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva"

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Hospital Clinic de Barcelona Hospital Clinic i Provincial

location_facility: Hospital Ramon y Cajal, Edificio Central

location_facility: Hospital Universitario Marqués de Valdecilla/IDIVAL


title: A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors.

summary: This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.

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

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Moldova, Republic of
Japan
Netherlands
United States
China
Spain
Turkey
Canada
Georgia
France


title: A 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label Extension

acronym: NEOS

summary: Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Canada
Serbia
France
Portugal
Slovakia
United States
Latvia
India
Romania
Belgium
Estonia
Italy
Guatemala
Austria
Mexico
Spain
Taiwan
Russian Federation
Israel


title: A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET)

acronym: KOMET

summary: A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

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

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

sponsor_collaborators:
AstraZeneca
Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Brazil
Japan
United States
China
Spain
Canada
Russian Federation
France