title: An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), biomarker effects, and efficacy of BIIB067 administered to participants with ALS and a confirmed SOD1 mutation.

ReferenceCitation: Miller TM, Cudkowicz ME, Genge A, Shaw PJ, Sobue G, Bucelli RC, Chiò A, Van Damme P, Ludolph AC, Glass JD, Andrews JA, Babu S, Benatar M, McDermott CJ, Cochrane T, Chary S, Chew S, Zhu H, Wu F, Nestorov I, Graham D, Sun P, McNeill M, Fanning L, Ferguson TA, Fradette S; VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110. doi: 10.1056/NEJMoa2204705.

lead_sponsor: Biogen

location_country:
United Kingdom
Italy
New Zealand
Canada
United States
France
Belgium
Japan
Germany


ipd_sharing: No

status: Completed

primary_purpose: Treatment

acronym: DIVERGENCE 1

intervention_type: Drug

title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

study_completion_date_type: Actual

lead_sponsor: Gilead Sciences

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Rivière P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.

enrollment_type: Actual

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Ukraine
Hungary
United States
France
Belgium
Germany
Czechia

location_facility: Indiana University Health University Hospital

location_facility: CHU de Toulouse -Hopital Rangueil (Main Office)

location_facility: Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University

location_facility: Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Hospital Universitario Gran Canaria Dr. Negrin

location_facility: Bugát Pál Kórház, Gasztroenterológiai osztály

location_facility: Medical University of Innsbruck, Department of Internal Medicine I

location_facility: Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1

location_facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

location_facility: University of South Florida South Tampa campus

location_facility: Royal Devon and Exeter Hospital, Department of Gastroenterology

location_facility: Azienda Ospedaliero - Universitaria Mater Domini

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Center for lnterventional Endoscopy- Florida Hospital

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

location_facility: Gastroenterology Research of San Antonio

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology

summary: The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

lead_sponsor_type: industriel

status_simplified: Completed


type: Registry Identifier

title: A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

acronym: ARROW

summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceCitation: Subbiah V, Cassier PA, Siena S, Garralda E, Paz-Ares L, Garrido P, Nadal E, Vuky J, Lopes G, Kalemkerian GP, Bowles DW, Seetharam M, Chang J, Zhang H, Green J, Zalutskaya A, Schuler M, Fan Y, Curigliano G. Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial. Nat Med. 2022 Aug;28(8):1640-1645. doi: 10.1038/s41591-022-01931-y. Epub 2022 Aug 12.

ReferenceCitation: Popat S, Liu SV, Scheuer N, Hsu GG, Lockhart A, Ramagopalan SV, Griesinger F, Subbiah V. Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer. Nat Commun. 2022 Jun 17;13(1):3500. doi: 10.1038/s41467-022-30908-1.

ReferenceCitation: Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. doi: 10.1016/S2213-8587(21)00120-0. Epub 2021 Jun 9. Erratum in: Lancet Diabetes Endocrinol. 2021 Oct;9(10):e4.

ReferenceCitation: Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS, Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021 Jul;22(7):959-969. doi: 10.1016/S1470-2045(21)00247-3. Epub 2021 Jun 9. Erratum in: Lancet Oncol. 2021 Aug;22(8):e347.

lead_sponsor: Hoffmann-La Roche

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Netherlands
Korea, Republic of
United States
France
China
Singapore
Germany

location_facility: University of Colorado Anschutz Medical Campus

location_facility: IEO; Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative

location_facility: First Affiliated Hospital of Gannan Medical University

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

location_facility: Washington University School of Medicine in St. Louis

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

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

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The affiliated Cancer Hospital, School of Medicine, UESTC

location_facility: Severance Hospital, Yonsei University Health System; Oncology

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Sylvester Comprehensive Cancer Center; University of Miami School of Medicine

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

location_facility: Tianjin Medical University Cancer Institute & Hospital

status_simplified: Ongoing


title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

acronym: FINCH 4

summary: The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

ReferenceCitation: Combe B, Besuyen R, Gómez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2022 Oct 7. doi: 10.1007/s40744-022-00494-1. [Epub ahead of print]

lead_sponsor: Galapagos NV

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Israel
Mexico
Malaysia
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France
Chile

location_facility: Municipal Institution City Hospital #7, Department of Therapy

location_facility: Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Carolina Rheumatology & Neurology Assoc., PC

location_facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"

location_facility: Department of Medicine & Theraputics, The Chinese University of Hong Kong

location_facility: M. Vladimirsky Moscow Regional Research Clinical Institute

location_facility: "MHAT Lyulin" EAD, Department of Rheumatology

location_facility: Warrington and Halton Hospitals Nhs Foundation Trust

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Yoshida orthopaedic and rheumatology Clinic

location_facility: Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz

location_facility: Revmatologicka ambulance, Nuselska Poliklinika

location_facility: MHAT "Sveta Petka" AD, Department of Internal Diseases

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

location_facility: Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach

location_facility: Umass Memorial Medical Center- Memorial Campus

location_facility: Centre for Rheumatic Disease, Hermes Doctor House

location_facility: Municipal Institution "City Hospital #1", Department of Therapy

location_facility: Shri Nidaan Hospital and Hope Fertility Centre

location_facility: University of Florida College of Medicine, Jacksonville - Rheumatology Research

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital

location_facility: Santokba Durlabhji Memorial Hospital Cum Medical Research Institute

location_facility: Onganizacion Medica de Investigacion S.A (OMI)

location_facility: Rheumatology Associates of North Alabama, PC

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

location_facility: Chanre Rheumatology and Immunology Centre and Research

location_facility: Synexus Polska Sp. z.o.o. Oddzial w Porznaniu

location_facility: Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie

location_facility: Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh

location_facility: Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski

location_facility: Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine

location_facility: Centro De Investigación Clínica De Morelia, Sc

location_facility: Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology

location_facility: Kyiv City Clinical Hospital #6, Department of Therapy

location_facility: SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach

location_facility: Investigacion y Biomedicina de Chihuahua, S.C.

location_facility: Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1

location_facility: Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"

location_facility: Department of Medicine, Queen Mary Hospital

location_facility: Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City

location_facility: Suretech Hospital and Research Centre Pvt Ltd

location_facility: Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: The Center For Rheumatology And Bone Research

location_facility: Military Medical Academy, Clinic of Rheumatology

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology

location_facility: Municipal Clinical Hospital No. 15 named after O.M. Filatov

location_facility: C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia

location_facility: Keck Medicine of USC- Division of Rheumatology

location_facility: State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital

location_facility: Institute For Treatment And Rehabilitation Niska Banja

location_facility: FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy

location_facility: Twoja Przychodnia -Centrum Medyzcne Nowa Sol

location_facility: Hospital HM Nuestra Senora de la Esperanza

location_facility: Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine

location_facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department

location_facility: Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology

location_facility: Trinity Universal Research Associates, Inc

location_facility: Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"

location_facility: Centro Peninsular De Investigacion Clinica S.C.P.

location_facility: Rajavithi Hospital, Rheumatology and Allergy Unit

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Chennai Meenakshi Multispeciality Hospital Ltd

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.

location_facility: Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council

location_facility: Investigaciones Reumatologicas Y Osteologicas (IRO) SRL

location_facility: Medical College Baroda and Sir Sayajirao General Hospital

location_facility: State Healthcare Institution, Regional Clinical Hospital

location_facility: Chonbuk National University Medical School

location_facility: Articularis Healthcare Group d/b/a Low Country Rheumatology

location_facility: Articularis Healthcare Inc., dba Columbia Arthritis Center, PA

location_facility: PA Regional Center For Arthritis And Osteoporosis Research

location_facility: Department of Rheumatology, KG Medical University

location_facility: Weill Cornell Physicians At Brooklyn Heights

location_facility: Articularis Healthcare Group d/b/a ACME Research

location_facility: Chung-Ang University Hospital Institutional Review Board

location_facility: Nizhny Novgorod City Clinical Hospital #5

location_facility: HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR

location_facility: Spitalul Clinic Judetean de Urgenta Tirgu Mures

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: Medical Corporation Kojyokai Hirose Clinic

location_facility: Rajiv Gandhi Institute of Medical Sciences and Government General Hospital

location_facility: Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.

location_facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2

location_facility: Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie

location_facility: Hôpital Lapeyronie, Service d'Immuno-Rhumatologic

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly

location_facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy

location_facility: Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej

location_facility: Daegu Catholic University Medical Center

location_facility: Clinical Trial Unit, CCHDB, Wellington Hospital

location_facility: Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: University of California San Diego (UCSD) - Perlman Ambulatory Clinic

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy

location_facility: City Clinical Hospital #1, Department of Rheumatology

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Hospital Regional Universitario de Malaga

location_facility: Arthrocare, Arthritis Care & Research PC

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"

location_facility: Stanford University Hospitals and Clinics (Immunology & Rheumatology)

location_facility: Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso

location_facility: LLC Polyclinic of Private Security Personnel

location_facility: The Oklahoma Center For Arthritis Therapy & Research, Inc.

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Centre De Recherche Musculo Squelettique

location_facility: Chi Mei Hospital, Chi Mei Medical Center

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: City Clinical Hospital #4 of Department of Healthcare of Moscow City


title: Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

summary: The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

ipd_sharing: Undecided

lead_sponsor: Abbott Medical Devices

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

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: Main Line Health Center/Lankenau Hospital

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: CHI St. Luke's Health Baylor College of Medicine

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

intervention_type: Device


type: Other Identifier

type: U.S. NIH Grant/Contract

title: International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

summary: This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Children's Oncology Group

location_country:
Hong Kong
Saudi Arabia
Italy
Austria
Australia
Netherlands
Canada
Finland
New Zealand
Switzerland
Sweden
Puerto Rico
United States
Chile
France
Israel
Belgium
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Children's Healthcare of Atlanta - Egleston

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: Children's Hospital and Medical Center of Omaha

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Methodist Children's Hospital of South Texas

location_facility: Memorial Health University Medical Center

location_facility: Southern Illinois University School of Medicine

location_facility: State University of New York Upstate Medical University

location_facility: Walter Reed National Military Medical Center

location_facility: University of Minnesota/Masonic Cancer Center

location_facility: UMass Memorial Medical Center - University Campus

location_facility: University of Kentucky/Markey Cancer Center

location_facility: BI-LO Charities Children's Cancer Center

location_facility: University of Iowa/Holden Comprehensive Cancer Center

location_facility: The Children's Hospital at TriStar Centennial

location_facility: Ascension Saint Vincent Indianapolis Hospital

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

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

location_facility: Schneider Children's Medical Center of Israel

location_facility: University Medical Center of Southern Nevada

location_facility: Dell Children's Medical Center of Central Texas

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Helen DeVos Children's Hospital at Spectrum Health

location_facility: Children's Hospitals and Clinics of Minnesota - Minneapolis

location_facility: Novant Health Presbyterian Medical Center

location_facility: Michigan State University Clinical Center

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

location_facility: Sanford USD Medical Center - Sioux Falls

location_facility: University of Oklahoma Health Sciences Center

location_facility: Saint Christopher's Hospital for Children

location_facility: ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

location_facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

location_facility: The Montreal Children's Hospital of the MUHC

location_facility: Montefiore Medical Center - Moses Campus

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: University of Vermont and State Agricultural College

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: The Steven and Alexandra Cohen Children's Medical Center of New York

location_facility: Hospital Roberto del Rio-Universidad de Chile

location_facility: University of Mississippi Medical Center

location_facility: Children's Hospital Medical Center of Akron

location_facility: Princess Máxima Center for Pediatric Oncology

location_facility: McMaster Children's Hospital at Hamilton Health Sciences

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: King Faisal Specialist Hospital and Research Centre

location_facility: Lucile Packard Children's Hospital Stanford University

location_facility: University Medical Center chleswig- Campus Kiel

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM

location_facility: Golisano Children's Hospital of Southwest Florida

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa

location_facility: Saint Vincent Hospital Cancer Center Green Bay

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital

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

location_facility: Mary Bridge Children's Hospital and Health Center

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Miller Children's and Women's Hospital Long Beach

location_facility: Texas Tech University Health Sciences Center-Amarillo

location_facility: Banner University Medical Center - Tucson

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Kapiolani Medical Center for Women and Children

intervention_type: Biological


ipd_sharing: Yes

title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

lead_sponsor: Shire

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

location_country:
Poland
Spain
Italy
Austria
Australia
Estonia
Canada
Hungary
Puerto Rico
United States
France
Israel
South Africa

location_facility: Centro Dotal de Investigaciones de Servicios de Salud

location_facility: Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

location_facility: Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH

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

location_facility: East Tallinn Central Hospital Eye Clinic

location_facility: Emanuelli Research & Development Center, LLC

location_facility: University of the Sunshine Coast Clinical Trials Centre

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS

location_facility: The Ottawa Hospital - General Campus, University of Ottawa Eye Institute

location_facility: Cornea and Cataract Consultants of Arizona

location_facility: Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)

location_facility: University of Waterloo School of Optometry and Vision Science

location_facility: Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC

location_facility: Advanced Laser Vision & Surgical Institute

location_facility: Vienna Institute for Research in Ocular Surgery

summary: The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.


status: Terminated

primary_purpose: Prevention

acronym: HATCY

title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy

lead_sponsor: Kiadis Pharma

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

location_facility: University Hospital Frankfurt, Goethe University

location_facility: Servicio de Hematología Hospital, Universitari I politècnic La Fe

location_facility: Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Ludwig-Maximilians-University Hospital of Munich-Grosshadern

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Faculdade de Medicina da Universidade de Lisboa

location_facility: University Hospital Barcelona Vall d' Hebron

location_facility: Hadassah Medical Center & Hadassah Hospital Ein Karem

location_facility: Sourasky Medical Center & Tel Aviv University

summary: The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.

status_simplified: Unknown


acronym: alleviate 1

title: Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Klamroth R, Feistritzer C, Friedrich U, Lentz SR, Reichwald K, Zak M, Chowdary P. Pharmacokinetics, immunogenicity, safety, and preliminary efficacy of subcutaneous turoctocog alfa pegol in previously treated patients with severe hemophilia A (alleviate 1). J Thromb Haemost. 2020 Feb;18(2):341-351. doi: 10.1111/jth.14660. Epub 2019 Nov 15.

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

location_country:
Serbia
Austria
United States
France
Japan
Germany

summary: The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.


title: Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

summary:
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)

This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Polyganics BV

location_country:
Spain
Italy
United Kingdom
Sweden
United States
France
Germany

location_facility: Veterans affairs Medical Center Portland

location_facility: University Hospital Lund - Department of Hand Surgery

location_facility: Virginia Commonwealth University Medical Center

location_facility: Stanford Medical Center Hand and Upper Limb Center

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)


title: PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial

summary:
One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP).

Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV.

Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.

ReferenceCitation: Kiss T, Wittenstein J, Becker C, Birr K, Cinnella G, Cohen E, El Tahan MR, Falcão LF, Gregoretti C, Granell M, Hachenberg T, Hollmann MW, Jankovic R, Karzai W, Krassler J, Loop T, Licker MJ, Marczin N, Mills GH, Murrell MT, Neskovic V, Nisnevitch-Savarese Z, Pelosi P, Rossaint R, Schultz MJ, Serpa Neto A, Severgnini P, Szegedi L, Vegh T, Voyagis G, Zhong J, Gama de Abreu M, Senturk M; PROTHOR investigators; Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA). Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):213. doi: 10.1186/s13063-019-3208-8. Erratum in: Trials. 2019 May 8;20(1):259.

lead_sponsor: Technische Universität Dresden

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Japan
Czechia
Albania
Slovenia
Austria
Turkey
Egypt
Brazil
Switzerland
Hungary
China
Germany
Taiwan
Greece
France
Chile
Netherlands

location_facility: University School of Medicine Campus Bio-Medico of Rome

location_facility: Institutul de Pneumoftiziologie Bucharest

location_facility: University Hospital of Dijon - François Mitterrand

location_facility: Celal Bayar University Medical Faculty, Dept of Anesthesiology

location_facility: University of Debrecen, Department of anesthesiology and Intensive Care

location_facility: Hospital General Universitario de Valencia

location_facility: Department of Anesthesiology and Intensive Care, Dresden University of Technology

location_facility: Clinical Center Nis, Clinic for anesthesia and intensive therapy

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital

location_facility: Anhui Provincial Hospital, First Aff. Hospital, University of Science and Technology of China

location_facility: NIHS Sheffield Clinical Research Facility

location_facility: Clinics Hospital from the Botucatu Medical School, University of Sao Paulo State

location_facility: Fudan University, Shanghai Cancer Center

location_facility: Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital

location_facility: Radboud University Medical Centre Nijmegen

location_facility: Hospital Clínic. Universitat de Barcelona

intervention_type: Procedure

lead_sponsor_type: academique


title: An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

acronym: RELAY-1 Extend

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

location_country:
Romania
Serbia
Spain
Italy
Austria
Estonia
Georgia
Latvia
United Kingdom
France
Belgium
Bulgaria
Slovakia
Czechia

location_facility:
Research Site 2
Research Site 1
Research Site


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

location_country:
Romania
Serbia
Spain
Italy
Austria
Georgia
Latvia
United Kingdom
France
Belgium
Netherlands
Bulgaria
Slovakia
Czechia

location_facility:
Research Site
Reasearch Site

summary: The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.


title: Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

acronym: ASPIRE-SSI

summary: ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.

lead_sponsor: UMC Utrecht

location_country:
Romania
Serbia
Spain
Italy
United Kingdom
Estonia
France
Belgium
Netherlands
Czechia

location_facility: Prof. C.C. Iliescu Cardiovascular Diseases Institute

location_facility: Institute for Orthopedic Surgery Banjica

location_facility: Derby Teaching Hospitals NHS Foundation Trust

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Carol Davila University of Medicine and Pharmacy Bucharest

location_facility: Brighton & Sussex University Hospital NHS Trust

location_facility: Hospital Universitario Central de Asturias

location_facility: Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent

location_facility: York Teaching Hospitals NHS Foundation Trust

location_facility: The Pennine Acute Hospitals NHS Trust Manchester

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona

location_facility: Centre Hospitalier Universitaire de Limoges


title: A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB

summary: This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

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.

lead_sponsor: Pfizer

location_country:
Poland
United Kingdom
Russian Federation
Canada
Hungary
United States
France
Germany
Moldova, Republic of

location_facility: Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Frauenklinik des Universitaetsklinikums Erlangen

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: UCLA Hematology/Oncology - Santa Clarita

location_facility: FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

location_facility: (IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center


title: Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant

acronym: MOVES-PD

summary:
Primary Objectives:

Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants.
Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants.

Secondary Objectives:

Part 1:

To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation.
To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation.

Part 2:

To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo.
To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.

ReferenceCitation: Peterschmitt MJ, Saiki H, Hatano T, Gasser T, Isaacson SH, Gaemers SJM, Minini P, Saubadu S, Sharma J, Walbillic S, Alcalay RN, Cutter G, Hattori N, Höglinger GU, Marek K, Schapira AHV, Scherzer CR, Simuni T, Giladi N, Sardi SP, Fischer TZ; MOVES-PD Investigators. Safety, Pharmacokinetics, and Pharmacodynamics of Oral Venglustat in Patients with Parkinson's Disease and a GBA Mutation: Results from Part 1 of the Randomized, Double-Blinded, Placebo-Controlled MOVES-PD Trial. J Parkinsons Dis. 2022;12(2):557-570. doi: 10.3233/JPD-212714.

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: Genzyme, a Sanofi Company

location_country:
Taiwan
Portugal
Spain
Greece
Austria
Italy
United Kingdom
Canada
Sweden
United States
France
Israel
Norway
Singapore
Japan
Germany

location_facility:
Investigational Site Number :3800006
Investigational Site Number :3760001
Investigational Site Number :8400009
Investigational Site Number :8400014
Investigational Site Number :3800001
Investigational Site Number :8400010
Investigational Site Number :8400004
Investigational Site Number :8400012
Investigational Site Number :3920005
Investigational Site Number :2760002
Investigational Site Number :3800003
Investigational Site Number :8400001
Investigational Site Number :7020001
Investigational Site Number :7240002
Investigational Site Number :3920003
Investigational Site Number :3760003
Investigational Site Number :0400001
Investigational Site Number :7020002
Investigational Site Number :8400002
Investigational Site Number :8400006
Investigational Site Number :3760002
Investigational Site Number :8400018
Investigational Site Number :8400017
Investigational Site Number :3000002
Investigational Site Number :8260001
Investigational Site Number :2760001
Investigational Site Number :8400016
Investigational Site Number :8400015
Investigational Site Number :1240001
Investigational Site Number :6200003
Investigational Site Number :8400011
Investigational Site Number :5780001
Investigational Site Number :1580001
Investigational Site Number :3800004
Investigational Site Number :3920001
Investigational Site Number :3800002
Investigational Site Number :7240001
Investigational Site Number :6200002
Investigational Site Number :1240002
Investigational Site Number :3920004
Investigational Site Number :8400019
Investigational Site Number :8400005
Investigational Site Number :1240003
Investigational Site Number :3920002
Investigational Site Number :2500001
Investigational Site Number :8400013
Investigational Site Number :8400008
Investigational Site Number :8260002
Investigational Site Number :3760004
Investigational Site Number :8400021
Investigational Site Number :8400020
Investigational Site Number :7520001


acronym: ODYSSEY KIDS

title: An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase

lead_sponsor: Sanofi

ReferenceCitation: Daniels S, Caprio S, Chaudhari U, Manvelian G, Baccara-Dinet MT, Brunet A, Scemama M, Loizeau V, Bruckert E. PCSK9 inhibition with alirocumab in pediatric patients with heterozygous familial hypercholesterolemia: The ODYSSEY KIDS study. J Clin Lipidol. 2020 May - Jun;14(3):322-330.e5. doi: 10.1016/j.jacl.2020.03.001. Epub 2020 Mar 28. Erratum in: J Clin Lipidol. 2020 Sep - Oct;14(5):741.

location_country:
Spain
Russian Federation
Canada
Sweden
United States
France
South Africa
Norway
Netherlands
Czechia

location_facility:
Investigational Site Number 6430001
Investigational Site Number 2030003
Investigational Site Number 5280001
Investigational Site Number 2500001
Investigational Site Number 7520001
Investigational Site Number 8400005
Investigational Site Number 2030002
Investigational Site Number 5780001
Investigational Site Number 6430004
Investigational Site Number 7100001
Investigational Site Number 7240001
Investigational Site Number 2030001
Investigational Site Number 1240001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 7240004

summary:
Primary Objective:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.

Secondary Objective:

To evaluate the safety and tolerability of alirocumab.
To evaluate the pharmacokinetics profile of alirocumab.
To evaluate the effects of alirocumab on other lipid parameters.


acronym: FINCH 2

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

publications_result: Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.

ReferenceType: result

ReferenceCitation: Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055. Erratum in: JAMA. 2020 Feb 4;323(5):480.

ReferenceCitation: Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7.

ReferenceCitation: Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, de Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2022 Jan 5;32(1):59-67. doi: 10.1080/14397595.2020.1859675.

location_country:
Poland
Spain
United Kingdom
Australia
Mexico
Argentina
Switzerland
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

summary: The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.


title: Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis

summary: This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

location_country:
Brazil
New Zealand
United States
France
Sweden


title: A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer

summary: The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.

ReferenceCitation: Bhagwat SV, McMillen WT, Cai S, Zhao B, Whitesell M, Shen W, Kindler L, Flack RS, Wu W, Anderson B, Zhai Y, Yuan XJ, Pogue M, Van Horn RD, Rao X, McCann D, Dropsey AJ, Manro J, Walgren J, Yuen E, Rodriguez MJ, Plowman GD, Tiu RV, Joseph S, Peng SB. ERK Inhibitor LY3214996 Targets ERK Pathway-Driven Cancers: A Therapeutic Approach Toward Precision Medicine. Mol Cancer Ther. 2020 Feb;19(2):325-336. doi: 10.1158/1535-7163.MCT-19-0183. Epub 2019 Nov 19.

lead_sponsor: Eli Lilly and Company

location_country:
Japan
Australia
United States
France

location_facility: University of Texas MD Anderson Cancer Center


title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

summary: The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

primary_purpose: Other

ipd_sharing_description: Not yet determined

lead_sponsor: University of Virginia

location_country:
Netherlands
United States
Italy
France

location_facility: University of Virginia Center for Diabetes Technology

location_facility: Barbara Davis Center, University of Colorado

location_facility: Harvard University (Joslin Diabetes Center)


title: A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

acronym: TAURUS

summary:
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.

In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.

lead_sponsor: Bayer

location_country:
Taiwan
Belgium
Luxembourg
Slovenia
Greece
Italy
Netherlands
Spain
Canada
United States
France
Colombia
Germany

location_facility: University of Florida Health Cancer Center

location_facility: University of Colorado Hemophilia and Thrombosis Center

location_facility: Washington University Center for Bleeding and Blood Clotting Disorders

location_facility: Intermountain Hemophilia & Thrombosis Center

location_facility: Wake Forest University School of Medicine

location_facility: Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin

location_facility: East Carolina University - Brody School of Medicine

location_facility: Children's Hospital at OU Medical Center

location_facility: Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center

location_facility: Children's Rehabilitation Services/ University of South Alabama

location_facility: Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville


acronym: VIOLET

title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema (DME)

ReferenceCitation: Garweg JG, Štefanickova J, Hoyng C, Niesen T, Schmelter T, Leal S, Sivaprasad S; VIOLET Investigators. Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial. Adv Ther. 2022 Jun;39(6):2701-2716. doi: 10.1007/s12325-022-02119-z. Epub 2022 Apr 12.

location_country:
Poland
Portugal
Spain
Italy
Austria
United Kingdom
Canada
Lithuania
Switzerland
Hungary
France
Germany
Slovakia
Czechia

summary: To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)


title: PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)

acronym: PRODIGY

summary:
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort.

The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8.

ReferenceCitation: Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.

ReferenceCitation: Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. Epub 2004 May 28. Review.

ReferenceCitation: Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.

ReferenceCitation: Kor JJ, Sprung J, Khanna AK, Weingarten TN. Continuous Monitoring Detected Respiratory Depressive Episodes in Proximity to Adverse Respiratory Events During the PRODIGY Trial. J Patient Saf. 2022 Apr 8. doi: 10.1097/PTS.0000000000001003. Online ahead of print.

ReferenceCitation: Sim MA, Seet E, Khanna AK, Weingarten TN, Liew L, Law LS, Liu KE, Di Piazza F, Ti LK; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Association Between Race and Opioid-Induced Respiratory Depression: An International Post Hoc Analysis of the Prediction of Opioid-induced Respiratory Depression In Patients Monitored by Capnography Trial. Anesth Analg. 2022 Nov 1;135(5):1097-1105. doi: 10.1213/ANE.0000000000006006. Epub 2022 Mar 29.

ReferenceCitation: Khanna AK, Jungquist CR, Buhre W, Soto R, Di Piazza F, Saager L; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Modeling the Cost Savings of Continuous Pulse Oximetry and Capnography Monitoring of United States General Care Floor Patients Receiving Opioids Based on the PRODIGY Trial. Adv Ther. 2021 Jul;38(7):3745-3759. doi: 10.1007/s12325-021-01779-7. Epub 2021 May 24.

ReferenceCitation: Khanna AK, Saager L, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Ti LK, Soto R, Jiang W, Buhre W. Opioid-induced respiratory depression increases hospital costs and length of stay in patients recovering on the general care floor. BMC Anesthesiol. 2021 Mar 20;21(1):88. doi: 10.1186/s12871-021-01307-8.

ReferenceCitation: Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.

ReferenceCitation: Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.

ReferenceCitation: Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF. Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18. Review.

lead_sponsor: Medtronic - MITG

location_country:
Spain
Netherlands
United States
France
Singapore
Japan
Germany

location_facility: Hospital Clínico Universitario de Valencia

location_facility: The Jikei University School of Medicine Hospital

location_facility: The Ohio State University Wexner Medical Center

location_facility: Providence Regional Medical Center Everett


title: A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Hong Kong
Spain
Italy
Finland
Switzerland
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Washington University School of Medicine

summary: The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.


title: Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

summary: Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.

status: Unknown status

lead_sponsor: Hybrigenics Corporation

location_country:
United States
France

location_facility: Georgia Cancer Center-Augusta University

location_facility: University of Texas; M D Anderson Cancer Center

location_facility: Duke Cancer Institute, Duke Univ Medical Center


title: A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta

acronym: BALANCE

summary: This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample. No more than 50% of the patients will be female.

lead_sponsor: Protalix

location_country:
Slovenia
Italy
Spain
United Kingdom
Finland
Switzerland
Hungary
United States
France
Norway
Netherlands
Czechia

location_facility: Institute of Metabolic Disease, Baylor Healthcare

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Eccles Primary Children's Outpatient Services Building

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Klinik und Poliklinik für Innere Medizin UniversitätsSpital Zürich

location_facility: University of Iowa Hosptials and Clinics

location_facility: Renal Disease Research Institute, LLC - Dallas

location_facility: Institute of Metabolism and Systems Research

location_facility: Haukeland University Hospital Klinisk Forskningspost


title: Helicobacter Pylori Genome Project (HpGP)

summary:
Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems, including stomach cancer. Researchers want to look at samples of the bacteria. These H. pylori strains will be taken from chronically infected people. They want to identify the genetic and epigenetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get stomach cancer. This could lead to the cancer being detected earlier. It could also mean less people get stomach cancer.

Objectives:

To study genetic variations of H. pylori strains based on samples from chronically infected people. To identify the features of strains that might lead to severe stomach problems or stomach cancer.

Eligibility:

People ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer

Design:

Participants will be screened by the doctor who does their procedure and a study nurse.

Participants who have endoscopy will have ~6 biopsies removed. These are tissue samples. They are about the size of a grain of rice. Participants will allow the study team to access reports from their stomach exam.

Participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. They will allow the study team to access reports of their surgery. They will also allow them to access the microscope slides of their stomach.

time_perspective: Cross-Sectional

ReferenceCitation: Correa P, Haenszel W, Cuello C, Tannenbaum S, Archer M. A model for gastric cancer epidemiology. Lancet. 1975 Jul 12;2(7924):58-60.

ReferenceCitation: Tomb JF, White O, Kerlavage AR, Clayton RA, Sutton GG, Fleischmann RD, Ketchum KA, Klenk HP, Gill S, Dougherty BA, Nelson K, Quackenbush J, Zhou L, Kirkness EF, Peterson S, Loftus B, Richardson D, Dodson R, Khalak HG, Glodek A, McKenney K, Fitzegerald LM, Lee N, Adams MD, Hickey EK, Berg DE, Gocayne JD, Utterback TR, Peterson JD, Kelley JM, Cotton MD, Weidman JM, Fujii C, Bowman C, Watthey L, Wallin E, Hayes WS, Borodovsky M, Karp PD, Smith HO, Fraser CM, Venter JC. The complete genome sequence of the gastric pathogen Helicobacter pylori. Nature. 1997 Aug 7;388(6642):539-47. Erratum in: Nature 1997 Sep 25;389(6649):412.

ReferenceCitation: Krebes J, Morgan RD, Bunk B, Spröer C, Luong K, Parusel R, Anton BP, König C, Josenhans C, Overmann J, Roberts RJ, Korlach J, Suerbaum S. The complex methylome of the human gastric pathogen Helicobacter pylori. Nucleic Acids Res. 2014 Feb;42(4):2415-32. doi: 10.1093/nar/gkt1201. Epub 2013 Dec 2.

lead_sponsor: National Cancer Institute (NCI)

location_country:
Spain
Italy
Honduras
Lithuania
Kazakhstan
United States
Costa Rica
Peru
Belgium
Iceland
Japan
South Africa
Poland
Portugal
Congo, The Democratic Republic of the
Russian Federation
Sudan
Argentina
Kyrgyzstan
Indonesia
Nepal
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Cameroon
Kenya
Brazil
Myanmar
Canada
Bangladesh
Switzerland
Guatemala
Germany
Bulgaria
Ghana
Taiwan
Jordan
Dominican Republic
Greece
Iran, Islamic Republic of
Latvia
Nigeria
Vietnam
Algeria
France
Chile
Korea, Republic of
Colombia

location_facility: Instituto Nacional de Saúde Dr. Ricardo Jorge

location_facility: Institut d'Investigació Biomédica de Bellvitge (Idibell)

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Lithuanian University of Health Sciences

location_facility: Jordan University of Science and Technology

location_facility: University of Jos / University Teaching Hospital

location_facility: Evangelismos Hospital and Hellenic Pasteur Institute

location_facility: Sudan University of Science and Technology

location_facility: Seoul National University Bundang Hospital

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Centers for Disease Control and Prevention

location_facility: Instituto Nacional de Enfermedades Neoplasicas


title: A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy

summary: The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).

location_country:
United Kingdom
Italy
Spain
United States
France

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.

intervention_type: Radiation


acronym: SKYPP

title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Argentina
Canada
Finland
United States
Chile
France
Mexico
Germany
Czechia

location_facility:
Investigational Site Number :3800052
Investigational Site Number :6430001
Investigational Site Number :2760061
Investigational Site Number :4840061
Investigational Site Number :1240112
Investigational Site Number :8400415
Investigational Site Number :2030041
Investigational Site Number :6430063
Investigational Site Number :8400418
Investigational Site Number :7240052
Investigational Site Number :1520016
Investigational Site Number :3800051
Investigational Site Number :0320004
Investigational Site Number :4840060
Investigational Site Number :2760064
Investigational Site Number :3800053
Investigational Site Number :0320060
Investigational Site Number :2460040
Investigational Site Number :6160074
Investigational Site Number :8400416
Investigational Site Number :6160073
Investigational Site Number :7240050
Investigational Site Number :7240051
Investigational Site Number :2500040
Investigational Site Number :6430062
Investigational Site Number :8260031
Investigational Site Number :8400417
Investigational Site Number :5280020
Investigational Site Number :8260033
Investigational Site Number :1240110
Investigational Site Number :6160072
Investigational Site Number :7240053
Investigational Site Number :6160070
Investigational Site Number :2760062
Investigational Site Number :6160071

summary:
Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population

Secondary Objective:

To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.


title: Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects

acronym: OSCAR

summary:
This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Participants with each half-face randomized to one of the two following treatments:

Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).
Vehicle gel

The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.

ReferenceCitation: Dréno B, Bissonnette R, Gagné-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.

ReferenceCitation: Dréno B, Bissonnette R, Gagné-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.

lead_sponsor: Galderma R&D

location_country: Canada France


intervention_type: Other

title: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies

lead_sponsor: Gamida Cell ltd

ReferenceCitation: Horwitz ME, Stiff PJ, Cutler C, Brunstein C, Hanna R, Maziarz RT, Rezvani AR, Karris NA, McGuirk J, Valcarcel D, Schiller GJ, Lindemans CA, Hwang WYK, Koh LP, Keating A, Khaled Y, Hamerschlak N, Frankfurt O, Peled T, Segalovich I, Blackwell B, Wease S, Freedman LS, Galamidi-Cohen E, Sanz G. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440. doi: 10.1182/blood.2021011719.

ReferenceCitation: Del Pozo Martín Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31.

location_country:
Brazil
Portugal
Spain
Italy
United Kingdom
United States
Israel
France
Singapore
Netherlands

location_facility: Manchester University NHS Foundation Trust

location_facility: The University of Maryland Medicine Center

location_facility: Prinses Maxima Centrum voor Kinderoncologie B.V.

location_facility: Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Hospital Universitario y Politécnico La Fe (pediatric)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA

location_facility: Hospital Universitari Vall d'Hebron pediatrics

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

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Loyola University, Cardinal Bernardin Cancer Center

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

location_facility: Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil

summary: This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.


acronym: ACH

title: A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children With Achondroplasia

lead_sponsor: BioMarin Pharmaceutical

ReferenceCitation: Savarirayan R, Irving M, Bacino CA, Bostwick B, Charrow J, Cormier-Daire V, Le Quan Sang KH, Dickson P, Harmatz P, Phillips J, Owen N, Cherukuri A, Jayaram K, Jeha GS, Larimore K, Chan ML, Huntsman Labed A, Day J, Hoover-Fong J. C-Type Natriuretic Peptide Analogue Therapy in Children with Achondroplasia. N Engl J Med. 2019 Jul 4;381(1):25-35. doi: 10.1056/NEJMoa1813446. Epub 2019 Jun 18.

location_country:
Australia
United States
United Kingdom
France

location_facility: Johns Hopkins McKusick - Institute of Genetic Medicine

location_facility: Children's Hospital & Research Center Oakland

location_facility: Guys & St. Thomas NHS Foundation Trust Evelina Hospital

location_facility: Ann and Robert H. Lurie Childrens Hospital of Chicago

summary: This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.


title: A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Müller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nüesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2.

location_country:
Poland
Portugal
Serbia
Spain
United Kingdom
Russian Federation
Australia
New Zealand
Guatemala
Hungary
Korea, Republic of
France
Israel
China
Panama
Belgium
Germany

summary: This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.


title: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

summary: A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

ReferenceCitation: Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.

ReferenceCitation: Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. Epub 2016 Sep 6.

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: Acerta Pharma BV

location_country:
Spain
United Kingdom
United States
France
Israel
Belgium


title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

lead_sponsor: Incyte Corporation

ReferenceCitation: Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.

location_country:
United States
France
Belgium

location_facility: University of Rochester, Wilmot Cancer Center

location_facility: University of North Carolina at Chapel Hill

location_facility: HÔPITAL SAINT-LOUIS, Service Hématologie Adultes

location_facility: Sarah Cannon Research Institute at Health One

location_facility: MultiCare Institute for Research and Innovation

location_facility: Institut Jules Bordet, Clinical Trial Conduct Unit

location_facility: Hematology - Oncology Associates of Treasure Coast

summary:
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.

Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.


title: A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

summary: The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

ReferenceCitation: Goldman JW, Piha-Paul SA, Curti B, Pedersen KS, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Kirby G, McGlinchey K, Hammond SA, Streicher K, Townsley DM, Chae YK, Voortman J, Marabelle A, Powderly J. Safety and Tolerability of MEDI0562, an OX40 Agonist mAb, in Combination with Durvalumab or Tremelimumab in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Sep 1;28(17):3709-3719. doi: 10.1158/1078-0432.CCR-21-3016.

lead_sponsor: MedImmune LLC

location_country:
Netherlands
United States
France


title: A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis

summary: The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

ReferenceCitation: Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.

lead_sponsor: NGM Biopharmaceuticals, Inc

location_country:
Netherlands
United States
United Kingdom
France

location_facility:
NGM Clinical Study Site 503
NGM Clinical Study Site 118
NGM Clinical Study Site 105
NGM Clinical Study Site 119
NGM Clinical Study Site 111
NGM Clinical Study Site 113
NGM Clinical Study Site 401
NGM Clinical Study Site 117
NGM Clinical Study Site 121
NGM Clinical Study Site 116
NGM Clinical Study Site 127
NGM Clinical Study Site 107
NGM Clinical Study Site 126
NGM Clinical Study Site 406
NGM Clinical Study Site 103
NGM Clinical Study Site 402
NGM Clinical Study Site 405
NGM Clinical Study Site 301
NGM Clinical Study Site 122
NGM Clinical Study Site 404
NGM Clinical Study Site 124
NGM Clinical Study Site 109
NGM Clinical Study Site 112
NGM Clinical Study Site 407
NGM Clinical Study Site 502
NGM Clinical Study Site 108
NGM Clinical Study Site 106
NGM Clinical Study Site 114
NGM Clinical Study Site 505
NGM Clinical Study Site 104
NGM Clinical Study Site 125
NGM Clinical Study Site 501
NGM Clinical Study Site 110
NGM Clinical Study Site 120
NGM Clinical Study Site 504
NGM Clinical Study Site 101
NGM Clinical Study Site 102
NGM Clinical Study Site 115


status: Enrolling by invitation

intervention_type: Genetic

title: Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

lead_sponsor: bluebird bio

location_country:
Brazil
United Kingdom
Australia
Netherlands
Argentina
United States
France
Germany

location_facility: Lucile Packard Children's Hospital - Stanford

location_facility: Boston Children's Hospital/Massachusetts General Hospital

location_facility: Hospital das Clínicas da Universidade de São Paulo

summary:
This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in a parent clinical study.

After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

summary: Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study 1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization was stratified by age group (< 6 years, ≥6 to 18 years) to achieve balance across treatment arms, with the target of 25% of subjects in each age group. All subjects were titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects continued treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled in a follow-on study. Subjects were followed for post-study safety monitoring.

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.

ReferenceCitation: Sullivan J, Specchio N, Devinsky O, Auvin S, Perry MS, Strzelczyk A, Gil-Nagel A, Dai D, Galer BS, Gammaitoni AR. Fenfluramine significantly reduces day-to-day seizure burden by increasing number of seizure-free days and time between seizures in patients with Dravet syndrome: A time-to-event analysis. Epilepsia. 2022 Jan;63(1):130-138. doi: 10.1111/epi.17106. Epub 2021 Oct 22.

ReferenceCitation: Lagae L, Sullivan J, Knupp K, Laux L, Polster T, Nikanorova M, Devinsky O, Cross JH, Guerrini R, Talwar D, Miller I, Farfel G, Galer BS, Gammaitoni A, Mistry A, Morrison G, Lock M, Agarwal A, Lai WW, Ceulemans B; FAiRE DS Study Group. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2019 Dec 21;394(10216):2243-2254. doi: 10.1016/S0140-6736(19)32500-0. Epub 2019 Dec 17.

ReferenceCitation: Sullivan J, Perry MS, Wheless JW, Galer B, Gammaitoni A. Fenfluramine responder analyses and numbers needed to treat: Translating epilepsy trial data into clinical practice. Eur J Paediatr Neurol. 2021 Mar;31:10-14. doi: 10.1016/j.ejpn.2021.01.005. Epub 2021 Jan 22.

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Belgium
Japan
Germany

location_facility: Ospedal Policlinico Giambattista Rossi diBorga Roma

location_facility: Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital

location_facility: National Epilepsy Center Shizuoka Institute

location_facility: Clinica Universitaria de Navarra Fase 4. Segunda planta, Consulta de Pediatria

location_facility: MultiCare Institute for Research & Innovation

location_facility: Institute of Neurosciences Queens Elizabeth University Hospital

location_facility: U.O. Neurologia Dipartimento di Neuroscienze Ospedale Pediatrico Bambino Gesù, IRCS

location_facility: Schoen Klinik Vogtareuth Neuropaediatrie und Neurologische Rehabilitation, Epilepsiezentrum fuer Kinder und Jugendlische,Tagesklinik fuer Neuropaediatrie

location_facility: Miami Children's Hospital Brain Institute

location_facility: Istituto Pediatrico Giannina Gaslini Dipartimento di Neurologia

location_facility: Hospital Ruber Internacional Primera Planta Servicio de Neurologia

location_facility: Krankenhaus Mara Epilepsie-Zentrum Bethel

location_facility: Great Ormonnd Street Hospital for Children NHS Foundation Trust

location_facility: Klinik für Neuropädiatrie Universitätsklinikum Schleswig Holstein Campus Kiel

location_facility: Universitaetsklinik fuer Kinder- und Jugendmedizin Abteilung III

location_facility: British Columbia Children's Hospital BCCH

location_facility: Tokyo Women's Medical University Hospital

location_facility: Kleinwachau Saechsisches Epilepsiezentrum Radeberggemeinnuetzige GmbH

location_facility: Epilepsiezentrum / Neuropädiatrie Hedwig-von-Rittberg-Zentrum Für Kinder und Jugendliche

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Universitaetsklinikum Jena Klinik fuer Kinder- und Jugendmedizin Neuropaediatrie

location_facility: The Children's Hospital Westmead Dept. of Neurology and Neurosurgery


acronym: CIRCLE

title: A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)

lead_sponsor: ThromboGenics

location_country:
Spain
Italy
United Kingdom
Hungary
United States
France
Israel
Germany
Czechia

summary: The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).


title: A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

acronym: FOCUS

summary: This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

lead_sponsor: Delcath Systems Inc.

location_country:
Spain
Italy
Austria
United Kingdom
Switzerland
United States
France
Belgium
Germany

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: University of Tennessee Health Science Center

location_facility: Charité Unversitätsmedizin Berlin Comprehensive Cancer Center

location_facility: University Hospital Southampton NHS Trust

location_facility: Ohio State University James Cancer Center

intervention_type: Combination Product


title: Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)

summary: Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

ReferenceCitation: Parkes MD, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Halloran PF. An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms. J Heart Lung Transplant. 2019 Jun;38(6):636-646. doi: 10.1016/j.healun.2019.01.1318. Epub 2019 Feb 6.

ReferenceCitation: Loupy A, Duong Van Huyen JP, Hidalgo L, Reeve J, Racapé M, Aubert O, Venner JM, Falmuski K, Bories MC, Beuscart T, Guillemain R, François A, Pattier S, Toquet C, Gay A, Rouvier P, Varnous S, Leprince P, Empana JP, Lefaucheur C, Bruneval P, Jouven X, Halloran PF. Gene Expression Profiling for the Identification and Classification of Antibody-Mediated Heart Rejection. Circulation. 2017 Mar 7;135(10):917-935. doi: 10.1161/CIRCULATIONAHA.116.022907. Epub 2017 Feb 1.

ReferenceCitation: Halloran PF, Potena L, Van Huyen JD, Bruneval P, Leone O, Kim DH, Jouven X, Reeve J, Loupy A. Building a tissue-based molecular diagnostic system in heart transplant rejection: The heart Molecular Microscope Diagnostic (MMDx) System. J Heart Lung Transplant. 2017 Nov;36(11):1192-1200. doi: 10.1016/j.healun.2017.05.029. Epub 2017 May 29.

ReferenceCitation: Halloran PF, Reeve J, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Jouven X, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Parkes MD. Exploring the cardiac response to injury in heart transplant biopsies. JCI Insight. 2018 Oct 18;3(20). pii: 123674. doi: 10.1172/jci.insight.123674.

ReferenceCitation: Madill-Thomsen KS, Reeve J, Aliabadi-Zuckermann A, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Goekler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Halloran PF. Assessing the Relationship Between Molecular Rejection and Parenchymal Injury in Heart Transplant Biopsies. Transplantation. 2022 Nov 1;106(11):2205-2216. doi: 10.1097/TP.0000000000004231. Epub 2022 Oct 21.

ReferenceCitation: Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A. Many heart transplant biopsies currently diagnosed as no rejection have mild molecular antibody-mediated rejection-related changes. J Heart Lung Transplant. 2022 Mar;41(3):334-344. doi: 10.1016/j.healun.2021.08.004. Epub 2021 Aug 26.

ReferenceCitation: Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17.

lead_sponsor: University of Alberta

location_country:
Spain
Italy
Austria
Australia
Canada
United States
France

location_facility: Alberta Transplant Applied Genomics Center, University of Alberta

location_facility: Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

location_facility: Cardiovascular Medicine, University of Utah Health

location_facility: Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades

location_facility: Department of Cardiac Surgery, Medical University of Vienna

location_facility: Virginia Commonwealth University, Division of Cardiology

location_facility: Division of Cardiology, University of Alberta

location_facility: Heart Failure and Heart Transplant Unit, University of Bologna