title: Multicenter, Non-comparative Extension of Study AC-058B301, to Investigate the Long-term Safety, Tolerability, and Control of Disease of Ponesimod 20 mg in Subjects With Relapsing Multiple Sclerosis

acronym: OPTIMUM-LT

summary: The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.

lead_sponsor: Actelion

location_country:
Finland
Germany
Poland
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Hungary
United States
Latvia
Ukraine
Romania
Italy
United Kingdom
Sweden
Mexico
Spain
Greece
Bulgaria
Georgia
Russian Federation
Israel

location_facility: Public Non-profit Enterprise: Chernihiv City Hospital #4 under Chernihiv City Council

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Municipal health care institution Chernihiv Regional Hospital

location_facility: Federal Scientific Clinical Center of Physico-Chemical Medicine

location_facility: Public Non-Profit Enterprise: Lviv City Clinical Hospital #5

location_facility: O.F. Herbachevskyi Regional Clinical Hospital

location_facility: State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Perm State Medical Academy n.a. E. A. Vagner

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'

location_facility: Spitalul Clinic Judetean de Urgenta 'Pius Brinzeu'

location_facility: Military Medical Academy, Multiprofile Hospital for Active Treatment -Sofia

location_facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Siberian District Medical Center of Federal Medical-Biological Agency

location_facility: Pavlov First Saint Petersburg State Medical University

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

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Hospital Regional Universitario de Malaga

location_facility: Rīgas Austrumu klīniskā universitātes slimnīca

location_facility: Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.

location_facility: Josephson Wallack Munshower Neurology, PC

location_facility: Clinical Research Center sp. z o.o MEDIC-R s.k.

location_facility: State Budgetary Healthcare Institution Kursk Region Kursk Regional Clinical Hospital

location_facility: National Research Center for Radiation Medicine

location_facility: The Research Center of Southern California, LLC

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Limited Liability Company 'Neuro Global'

location_facility: Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb

location_facility: Kharkiv Postgrad Academy, Dept of Neurology #1 At Hosp #7

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy

location_facility: St Ivan Rilski University Multiprofile Hospital For Active Treatment

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

location_facility: Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'

location_facility: Spitalul Universitar de Urgenta Bucuresti

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

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska EAD


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an antidepressant drug in improving depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an antidepressant in participants with MDD.

ReferenceType: derived

ReferenceCitation: Savitz A, Wajs E, Zhang Y, Xu H, Etropolski M, Thase ME, Drevets WC. Efficacy and Safety of Seltorexant as Adjunctive Therapy in Major Depressive Disorder: A Phase 2b, Randomized, Placebo-Controlled, Adaptive Dose-Finding Study. Int J Neuropsychopharmacol. 2021 Dec 8;24(12):965-976. doi: 10.1093/ijnp/pyab050.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

location_facility: CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

location_facility: Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

location_facility: Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia

location_facility: Closed corporation 'Scientific Center of Personalized Psychiatry'

location_facility: Mental Health Center Prof. Dr. Ivan Temkov

location_facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez

location_facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied

location_facility: Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: Synergy Clinical Research Center Of Escondido

location_facility: Medical and Rehabilitation Research Center Phoenix

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: CNCE Odesa regional psychiatric hospital #2 Odesa regional council

location_facility: CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

location_facility: State Psychiatric Hospital - Tzarev Brod

location_facility: Clinical Psychiatry Hospital n.a. N.N. Solodovnikov

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: California Pharmaceutical Research Institute, Inc.

location_facility: St-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: National Center for Global Health and Medicine, Kohnodai hospital

location_facility: Mental Health Center - Veliko Tarnovo EOOD

location_facility: SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: Sverdlov Regional Psychiatric Clinical Hospital

location_facility: Velocity Clinical Research, Hallandale Beach

location_facility: City Psychiatric Hospital of St. Nikolay Chudotvorets

location_facility: Poltava O.F. Maltsev RC Psychiatric Hospital Dept #9 (Ad-P Dept) HSEIU Ukrainian MSA

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

location_facility: Neurologische Praxis Dr. Schoell & Kollegen

location_facility: CNCE'Precarpathian Regional Clinical Mental Health Center Ivano-Frankivsk RC'

location_facility: SHI Arkhangelsk Regional Clinical Psychiatric Hospital

location_facility: CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

status: Completed

title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Adaptive Dose-Finding Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Subjects With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Finland
Japan
United States
Bulgaria
Ukraine
Russian Federation
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III Randomised Controlled Trial of Continuous Beta-lactam Infusion Compared With Intermittent Beta-lactam Dosing in Critically Ill Patients

acronym: BLING III

summary:
The purpose of this study is to find out whether continuous infusion of beta-lactam antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health advantages to patients or if there is no difference.

The investigators will be looking to see whether patients receiving beta-lactams via one administration method or the other have a better chance of recovering from their illness. They will also be looking at long term outcomes such as quality-of-life and healthcare resource use.

Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body.

Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in patients with sepsis and septic shock.

Currently, beta-lactam antibiotics are most commonly given to patients be intermittent infusions, that is, given at regular intervals throughout 24 hours. New research suggests that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic concentrations in the blood remain more consistent and may be more effective at killing bacteria.

However, the benefit to the patient by giving beta-lactams via continuous infusion has not been tested in a high-quality, large clinical trial.

ReferenceCitation: Lipman J, Brett SJ, De Waele JJ, Cotta MO, Davis JS, Finfer S, Glass P, Knowles S, McGuinness S, Myburgh J, Paterson DL, Peake S, Rajbhandari D, Rhodes A, Roberts JA, Shirwadkar C, Starr T, Taylor C, Billot L, Dulhunty JM. A protocol for a phase 3 multicentre randomised controlled trial of continuous versus intermittent beta-lactam antibiotic infusion in critically ill patients with sepsis: BLING III. Crit Care Resusc. 2019 Mar;21(1):63-68.

ipd_sharing: Undecided

ipd_sharing_description: Yet to be decided

lead_sponsor: The George Institute

collaborators: National Health and Medical Research Council, Australia

collaborators: Australian and New Zealand Intensive Care Society Clinical Trials Group

location_country:
New Zealand
United Kingdom
Australia
Sweden
Belgium
Malaysia
France

location_facility: James Cook University Hospital South Tees

location_facility: Northumbria Specialist Emergency Hospital

location_facility: University Hospital Coventry & Warwickshire

location_facility: Basingstoke and North Hampshire Hospital

intervention_type: Other


title: A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

summary: CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Checkpoint Therapeutics, Inc.

sponsor_collaborators:
Checkpoint Therapeutics, Inc.
Novotech (Australia) Pty Limited

location_country:
Poland
New Zealand
Australia
Spain
Thailand
South Africa
Ukraine
Russian Federation
France

status_simplified: Ongoing


title: A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.

acronym: EPITOPE

summary: The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

status: Unknown status

ipd_sharing: No

lead_sponsor: DBV Technologies

location_country:
Germany
Ireland
United Kingdom
Australia
Netherlands
United States
Canada
France

location_facility: The University of North Carolina - Chapell Hill

location_facility: University of California, Rady Children's Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

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

location_facility: University of California School of Medicine

location_facility: Riley Hospital for Children at Indiana University

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

location_facility: Baylor College of Medicine - Texas Children's Hospital

intervention_type: Biological

status_simplified: Unknown


type: Registry Identifier

title: A Phase 1 / 2 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

summary: This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.

status: Active, not recruiting

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Perets R, Bar J, Rasco DW, Ahn MJ, Yoh K, Kim DW, Nagrial A, Satouchi M, Lee DH, Spigel DR, Kotasek D, Gutierrez M, Niu J, Siddiqi S, Li X, Cyrus J, Chackerian A, Chain A, Altura RA, Cho BC. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol. 2021 Mar;32(3):395-403. doi: 10.1016/j.annonc.2020.11.020. Epub 2020 Dec 2.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Yonsei University Medical Library - YUHSpace

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Cho BC, Yoh K, Perets R, Nagrial A, Spigel DR, Gutierrez M, Kim DW, Kotasek D, Rasco D, Niu J, Satouchi M, Ahn MJ, Lee DH, Maurice-Dror C, Siddiqi S, Ren Y, Altura RA, Bar J. Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer. Lung Cancer. 2021 Sep;159:162-170. doi: 10.1016/j.lungcan.2021.07.009. Epub 2021 Jul 18.

oa_host_type: closed

repositories_concat: closed

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Italy
Poland
New Zealand
Israel
Australia
Japan
Sweden
United States
China
Korea, Republic of
Spain
Greece
South Africa
Chile
Canada
France

location_facility: Hospital Clinic i Provincial de Barcelona ( Site 3401)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019)

location_facility: Regional General Hospital of Athens "Laiko" ( Site 3001)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0021)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4801

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 3302)

location_facility: McGill University Health Centre ( Site 1101)

location_facility: Sheba Medical Center - Cancer Center ( Site 0002)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 3907)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 4803)

location_facility: Skanes Universitetssjukhus Lund. ( Site 4601)

location_facility: Tennessee Oncology Nashville ( Site 0004)

location_facility: Inova Schar Cancer Institute ( Site 1001)

location_facility: Chongqing Cancer Hospital-Phase 1 Unite ( Site 5004)

location_facility: Ashford Cancer Centre Research ( Site 0012)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 3403)

location_facility: Sunnybrook Research Institute ( Site 1103)

location_facility: Seoul National University Hospital ( Site 0007)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1102)

location_facility: Hospital Universitario Virgen de la Macarena ( Site 3402)

location_facility: Melanoma Institute Australia ( Site 0017)

location_facility: Hospital General Universitario de Valencia ( Site 3404)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 2704)

location_facility: Canterbury District Health Board ( Site 0023)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 3307)

location_facility: Banner MD Anderson Cancer Center ( Site 0013)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 2701)

location_facility: Cancercare Rondebosch Oncology ( Site 2706)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 3905)

location_facility: National Cancer Center Hospital East ( Site 0014)

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

location_facility: Princess Margaret Cancer Centre ( Site 1104)

location_facility: Fundacion Arturo Lopez Perez ( Site 5601)

location_facility: Cairns and Hinterland Hospital and Health Service ( Site 0020)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 3903)

location_facility: South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

location_facility: Severance Hospital Yonsei University Health System ( Site 0008)

location_facility: Blacktown Hospital. Western Sydney local health district ( Site 0009)

location_facility: Beijing Cancer hospital-Digestive Oncology ( Site 5001)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 3405)

location_facility: Sir Run Run Shaw Hospital-Medical Oncology ( Site 5003)


title: A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

summary: This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

ReferenceCitation: Subbiah V, Wolf J, Konda B, Kang H, Spira A, Weiss J, Takeda M, Ohe Y, Khan S, Ohashi K, Soldatenkova V, Szymczak S, Sullivan L, Wright J, Drilon A. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022 Oct;23(10):1261-1273. doi: 10.1016/S1470-2045(22)00541-1. Epub 2022 Sep 12.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

ReferenceCitation: Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.

ReferenceCitation: Subbiah V, Gainor JF, Oxnard GR, Tan DSW, Owen DH, Cho BC, Loong HH, McCoach CE, Weiss J, Kim YJ, Bazhenova L, Park K, Daga H, Besse B, Gautschi O, Rolfo C, Zhu EY, Kherani JF, Huang X, Kang S, Drilon A. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancers on the LIBRETTO-001 Trial. Clin Cancer Res. 2021 Aug 1;27(15):4160-4167. doi: 10.1158/1078-0432.CCR-21-0800. Epub 2021 Jun 4.

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

repositories_institution: Yonsei University Medical Library - YUHSpace

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardiere C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. doi: 10.1056/NEJMoa2005651.

evidence: open (via free article)

ReferenceCitation: Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, McCoach CE, Gautschi O, Besse B, Cho BC, Peled N, Weiss J, Kim YJ, Ohe Y, Nishio M, Park K, Patel J, Seto T, Sakamoto T, Rosen E, Shah MH, Barlesi F, Cassier PA, Bazhenova L, De Braud F, Garralda E, Velcheti V, Satouchi M, Ohashi K, Pennell NA, Reckamp KL, Dy GK, Wolf J, Solomon B, Falchook G, Ebata K, Nguyen M, Nair B, Zhu EY, Yang L, Huang X, Olek E, Rothenberg SM, Goto K, Subbiah V. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Aug 27;383(9):813-824. doi: 10.1056/NEJMoa2005653.

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

repository_institution: University of California - eScholarship University of California

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Institut du Cancer de Montpellier - Val d'aurelle

location_facility: Seoul National University Bundang Hospital

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: University of Chicago Medicine-Comprehensive Cancer Center

location_facility: Sarah Cannon Research Institute at HealthOne

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

acronym: SERENADE

summary:
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.

The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

location_country:
Germany
Poland
Hungary
Argentina
Denmark
Israel
Brazil
Romania
Austria
Sweden
United Kingdom
United States
Spain
Czechia
Bulgaria
Russian Federation
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Rede D´or Sao Luiz S.A. - Hospital do Coracao do Brasil

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Specialized Hospital for Active Treatment in Cardiology - Pleven

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

location_facility: Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Federal State Budget Scientific Institution

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: University of North Carolina (UNC) - School of Medicine

location_facility: Washington University School of Medicine

location_facility: Maestri E Kormann Consultoria Médico- Científica Ltda

location_facility: Vascular Medicine Institute University Of Pittsburgh

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: State Healthcare Institution, Regional Clinical Cardiology Dispensary

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: Multiprofile Hospital for Active Treatment - National Heart Hospital

location_facility: State Autonomous Healthcare Institution Of Yaroslavl Region

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: Herzzentrum Uniklinik Köln Klinik III für Innere Medizin

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Instituto de Moléstias Cardiovasculares Tatuí

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation


title: Defining Cut-off Values for Widely-used Composite Scores and Patient-reported Outcome Measures in Psoriatic Arthritis Corresponding to Remission and Flare Assessed by the Physician and the Patient

acronym: ReFlaP

summary: The purpose of this study is to define cut-off values of the most widely used composite scores and patient-reported outcomes, for levels corresponding to remission/low disease activity and for changes in levels corresponding to flares, in PsA, when remission/low disease activity and flare are defined from the patient and physician perspective. The ReFlaP (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal, observational study.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Lucasson F, Kiltz U, Kalyoncu U, Leung YY, Palominos P, Canete JD, Scrivo R, Balanescu A, Dernis E, Meisalu S, Ryussen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Richette P, Husni E, Coates LC, de Wit M, Smolen JS, Orbai AM, Gossec L. Disparities in healthcare in psoriatic arthritis: an analysis of 439 patients from 13 countries. RMD Open. 2022 May;8(1):e002031. doi: 10.1136/rmdopen-2021-002031. Erratum In: RMD Open. 2022 May;8(1):

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

publisher_dissemination: British Medical Journal

ReferenceCitation: Coates LC, Robinson DE, Orbai AM, Kiltz U, Leung YY, Palominos P, Canete JD, Scrivo R, Balanescu A, Dernis E, Meisalu S, Ruyssen-Witrand A, Eder L, de Wit M, Smolen JS, Lubrano E, Gossec L. What influences patients' opinion of remission and low disease activity in psoriatic arthritis? Principal component analysis of an international study. Rheumatology (Oxford). 2021 Nov 3;60(11):5292-5299. doi: 10.1093/rheumatology/keab220.

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

repository_normalized: HAL

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

ReferenceCitation: Orbai AM, Perin J, Gorlier C, Coates LC, Kiltz U, Leung YY, Palominos PE, Canete JD, Scrivo R, Balanescu A, Dernis E, Talli S, Ruyssen-Witrand A, Soubrier M, Aydin S, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, Smolen JS, de Wit M, Gossec L. Determinants of Patient-Reported Psoriatic Arthritis Impact of Disease: An Analysis of the Association With Sex in 458 Patients From Fourteen Countries. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1772-1779. doi: 10.1002/acr.24090.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Gorlier C, Orbai AM, Puyraimond-Zemmour D, Coates LC, Kiltz U, Leung YY, Palominos P, Canete JD, Scrivo R, Balanescu A, Dernis E, Talli S, Ruyssen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, de Wit M, Smolen JS, Gossec L. Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries. Ann Rheum Dis. 2019 Feb;78(2):201-208. doi: 10.1136/annrheumdis-2018-214140. Epub 2018 Nov 15.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive)

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_country:
Germany
Italy
United Kingdom
Singapore
Romania
Brazil
Austria
United States
Spain
Turkey
Canada
Estonia
Russian Federation
France

location_facility:
Ruyssen-Witrand
Katy Leung
Balanescu
Kalyoncu
Soubrier
Palominos
Richette
Laure Gossec
Talli
Eder
Husni
Lubrano
Rossana Scrivo
Aydin
Juan Canete
Ana- Maria Orbai
Dernis
Inna Gaydukova
Uta Kiltz
Smolen
Laura Coates
Sibel Aydin

lead_sponsor_type: academique


title: A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

summary:
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.

Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations.

Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

ReferenceCitation: Yuda J, Doki N, Matsuoka H, Yokota T, Tomita A, Takahashi N, Matsumura I, Kubo K, Goto T, Kirito K, Maki A, Aoki M, Allepuz A, Minami Y. Asciminib vs bosutinib in CML patients pretreated with >/=2 tyrosine kinase inhibitors: Results from the Japanese subgroup analysis of ASCEMBL study. Cancer Med. 2023 Feb;12(3):2990-2998. doi: 10.1002/cam4.5212. Epub 2022 Sep 27.

ReferenceCitation: Li YF, Combes FP, Hoch M, Lorenzo S, Sy SKB, Ho YY. Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-Treated Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic and Acute Phases. Clin Pharmacokinet. 2022 Oct;61(10):1393-1403. doi: 10.1007/s40262-022-01148-9. Epub 2022 Jun 28. Erratum In: Clin Pharmacokinet. 2022 Aug 17;:

publisher_dissemination: Springer-Nature

ReferenceCitation: Rea D, Mauro MJ, Boquimpani C, Minami Y, Lomaia E, Voloshin S, Turkina A, Kim DW, Apperley JF, Abdo A, Fogliatto LM, Kim DDH, le Coutre P, Saussele S, Annunziata M, Hughes TP, Chaudhri N, Sasaki K, Chee L, Garcia-Gutierrez V, Cortes JE, Aimone P, Allepuz A, Quenet S, Bedoucha V, Hochhaus A. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021 Nov 25;138(21):2031-2041. doi: 10.1182/blood.2020009984.

oa_colors: green other

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Hungary
Switzerland
United States
Romania
Lebanon
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Saudi Arabia
Spain
Bulgaria
Russian Federation
Israel

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: Indiana Blood and Marrow Institute Regulatory - 2

location_facility: University of Michigan Clinical Trials Office Main Site


lead_sponsor: Bioverativ, a Sanofi company

summary: The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.

sponsor_collaborators:
Bioverativ, a Sanofi company
Swedish Orphan Biovitrum

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Children's & Women's Health Centre of British Columbia

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est)

title: A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

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

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


title: A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

ReferenceCitation: Frances N, Bacac M, Bray-French K, Christen F, Hinton H, Husar E, Quackenbush E, Schafer M, Schick E, Vyver AV, Richter WF. Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab. J Pharm Sci. 2022 Apr;111(4):1208-1218. doi: 10.1016/j.xphs.2021.12.019. Epub 2021 Dec 22.

ReferenceCitation: Broske AE, Korfi K, Belousov A, Wilson S, Ooi CH, Bolen CR, Canamero M, Alcaide EG, James I, Piccione EC, Carlile DJ, Dimier N, Umana P, Bacac M, Weisser M, Dickinson M. Pharmacodynamics and molecular correlates of response to glofitamab in relapsed/refractory non-Hodgkin lymphoma. Blood Adv. 2022 Feb 8;6(3):1025-1037. doi: 10.1182/bloodadvances.2021005954.

evidence: open (via page says license)

ReferenceCitation: Hutchings M, Morschhauser F, Iacoboni G, Carlo-Stella C, Offner FC, Sureda A, Salles G, Martinez-Lopez J, Crump M, Thomas DN, Morcos PN, Ferlini C, Broske AE, Belousov A, Bacac M, Dimier N, Carlile DJ, Lundberg L, Perez-Callejo D, Umana P, Moore T, Weisser M, Dickinson MJ. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J Clin Oncol. 2021 Jun 20;39(18):1959-1970. doi: 10.1200/JCO.20.03175. Epub 2021 Mar 19.

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;archive.ugent.be;diposit.ub.edu

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Italy
Poland
New Zealand
Denmark
Australia
Belgium
United States
Spain
Taiwan
Czechia
Canada
France

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Virginia Commonwealth University Medical Center

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: Hospital Duran i Reynals L'Hospitalet; Hematology Department

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte

location_facility: Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia

location_facility: Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital,

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Hospital del Mar; Servicio de Hematologia


title: A Randomized, Open Label, Multi-center, Comparative Trial, to Assess the Efficacy and Safety of Pritelivir for the Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)

summary: Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).

lead_sponsor: AiCuris Anti-infective Cures AG

sponsor_collaborators:
AiCuris Anti-infective Cures AG
Medpace, Inc.

location_country:
Germany
Italy
Israel
Argentina
United Kingdom
Australia
Switzerland
Mexico
Belgium
United States
Greece
Canada
Georgia
France

location_facility: CHU Limoges - Centre national de reference des Herpes virus

location_facility: Johns Hopkins University School of Medicine

location_facility: Centro de Investigacion Clinica GRAMEL S.C.

location_facility: Yale University School of Medicine - Infectious Diseases

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Melbourne Health - Royal Melbourne Hospital

location_facility: University of Florida (UF) - Division of Infectious Disease

location_facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Alberta Health Services Cross Cancer Institute at the University of Alberta

location_facility: Regional University General Hospital of Heraklion

location_facility: Research Department of Haematology, UCL Cancer Institute

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: David H. Koch Center at Memorial Sloan Kettering Cancer Center

location_facility: Westmead Hospital, Centre for Infectious Disease and Microbiology

location_facility: Department of Medicine J. H. Stroger Hospital of Cook County

location_facility: University of California, Division of Infectious Diseases

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: Midway Immunology and Research Center (MIRC)

location_facility: University Arizona - Department of Medicine Arizona Health Sciences Center

location_facility: Centro de Investigacion Farmaceutica Especializado de Occidente S.C.

location_facility: Multiprofile Clinic Consilium Medulla LTD


lead_sponsor: AbbVie

summary: The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).

ReferenceType: background

ReferenceCitation: Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, Kim I, Stevens DA, Fiedler W, Pagoni M, Samoilova O, Hu Y, Anagnostopoulos A, Bergeron J, Hou JZ, Murthy V, Yamauchi T, McDonald A, Chyla B, Gopalakrishnan S, Jiang Q, Mendes W, Hayslip J, Panayiotidis P. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020 Jun 11;135(24):2137-2145. doi: 10.1182/blood.2020004856.

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

ReferenceCitation: Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Stevens DA, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Anagnostopoulos A, McDonald A, Murthy V, Yamauchi T, Wang J, Chyla B, Sun Y, Jiang Q, Mendes W, Hayslip J, DiNardo CD. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). Blood Cancer J. 2021 Oct 1;11(10):163. doi: 10.1038/s41408-021-00555-8. Erratum In: Blood Cancer J. 2021 Oct 26;11(10):171.

location_facility: Debreceni Egyetem Klinikai Koz /ID# 158178

location_facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 159268

location_facility: Fakult Nem Kralovske Vinohrady /ID# 159248

location_facility: Nanfang Hospital of Southern Medical University /ID# 170147

location_facility: Hospital Universitario y Politecnico La Fe /ID# 161181

location_facility: Universitaetsklinikum Hamburg /ID# 161760

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 160597

location_facility: Almazov North-West Federal Med /ID# 162170

location_facility: Samara State Medical Universit /ID# 164173

location_facility: Pusan National University Hosp /ID# 158725

location_facility: Ruijin Hospital, Shanghai Jiaotong /ID# 167325

location_facility: Seoul National University Hospital /ID# 162253

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 157867

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126

location_facility: Centro de Pesquisas Oncologicas /ID# 163567

location_facility: Hospital Maisonneuve-Rosemont /ID# 159780

location_facility: Dokkyo Medical University Hosp /ID# 159650

location_facility: University of Fukui Hospital /ID# 159770

location_facility: Centre Hospitalier de la Cote /ID# 159697

location_facility: Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127

location_facility: Haukeland University Hospital /ID# 165630

location_facility: National Hospital Organization Mito Medical Center /ID# 162988

location_facility: Hospital do Cancer Mae de Deus /ID# 163416

location_facility: Yaroslavl Regional Clinic Hosp /ID# 162172

location_facility: Tri-Service General Hospital /ID# 161683

location_facility: Casa de Saúde Santa Marcelina /ID# 163413

location_facility: Jiangsu Province People's Hospital /ID# 167511

location_facility: Netcare Pretoria East Hospital /ID# 157373

location_facility: General Hospital of Athens Laiko /ID# 157870

location_facility: Petz Aladar Megyei Oktato Korh /ID# 161739

location_facility: Universitair Ziekenhuis Antwerpen /ID# 159566

location_facility: VA Caribbean Healthcare System /ID# 158999

location_facility: Gen Univ Hosp Alexandroupolis /ID# 157868

location_facility: Qilu Hospital of Shandong Univ /ID# 167507

location_facility: University Gen Hosp of Patra /ID# 157871

location_facility: Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509

location_facility: Nagasaki University Hospital /ID# 160233

location_facility: Instituto Nacional de Cancerol /ID# 159269

location_facility: City Clinical Hospital Botkina /ID# 164086

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991

location_facility: Hospital de Cancer de Barretos /ID# 163568

location_facility: Saint Petersburg State Institu /ID# 162171

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 158724

location_facility: Fujian Medical Univ Union Hosp /ID# 167321

location_facility: Saitama Med Univ Int Med Ctr /ID# 161308

location_facility: Kinki University -Osakasayama Campus /ID# 160777

location_facility: The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324

location_facility: Cliniques Universitaires Saint Luc /ID# 159567

location_facility: Osaka City University Hospital /ID# 159722

location_facility: Yamagata University Hospital /ID# 161223

location_facility: Semmelweis Egyetem I. Belklini /ID# 158180

location_facility: University Hospital of Wales /ID# 162726

location_facility: Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186

location_facility: Juntendo University Hospital /ID# 159781

location_facility: Chungnam National University Hospital /ID# 158726

location_facility: Hopital Sacre Coeur Montreal /ID# 160982

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515

location_facility: Tokyo Metropolitan Komagome Hospital /ID# 160759

location_facility: University of Alberta Hospital /ID# 159646

location_facility: Centro de Invest Clin Chapulte /ID# 162625

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869

location_facility: Kaohsiung Medical University /ID# 161693

location_facility: The First Hosp of Jilin Univ /ID# 167512

location_facility: University Hospital Limerick /ID# 162735

title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

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

location_country:
Germany
Ireland
New Zealand
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Hungary
United States
Belgium
China
Puerto Rico
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation


type: U.S. NIH Grant/Contract

title: MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer

summary:
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.

In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

lead_sponsor: Seagen Inc.

collaborators: Academic and Community Cancer Research United

location_country:
Italy
Belgium
United States
Spain
France

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Case Western Reserve University / University Hospitals Cleveland Medical Center

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute

location_facility: Florida Cancer Specialists - South Region

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Keck Medical Center / University of Southern California

location_facility: University of Iowa Hospitals and Clinics

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Hôpital Franco-Britannique - Fondation Cognacq-Jay

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Florida Cancer Specialists - North Region

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara

location_facility: Providence Regional Medical Center Everett


acronym: Pembrolizumab or placebo in combination with chemoradiation in subjects with locally advanced HNSCC

summary: The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).

ReferenceCitation: Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Figueiredo Lima IP, Pointreau Y, M Hughes BG, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 2020 Jun;16(18):1235-1243. doi: 10.2217/fon-2020-0184. Epub 2020 Jun 3.

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: University of Melbourne - Minerva Access

publisher_dissemination: Future Science Ltd

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)

location_facility: Texas Oncology-Austin Central ( Site 8002)

location_facility: Centro de Investigacion Clinica del Country ( Site 0155)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0357)

location_facility: Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)

location_facility: Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)

location_facility: Institut De Cancerologie De Lorraine ( Site 0758)

location_facility: C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)

location_facility: The Royal Marsden Foundation Trust ( Site 1200)

location_facility: Clinique et Maternite Sainte-Elisabeth ( Site 0653)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0001)

location_facility: Medical Park Izmir Hastanesi ( Site 1109)

location_facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)

location_facility: Noordwest Ziekenhuisgroep NWZ ( Site 1350)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0052)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0156)

location_facility: University of Massachusetts Memorial Medical Center ( Site 0285)

location_facility: Willamette Valley Cancer Institute and Research Center ( Site 8000)

location_facility: Fondazione IRCCS - Policlinico San Matteo ( Site 0960)

location_facility: Hadassah Ein Karem Jerusalem ( Site 0902)

location_facility: Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0011)

location_facility: Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)

location_facility: Chungnam National University Hospital ( Site 0455)

location_facility: Tel Aviv Sourasky Medical Center ( Site 0900)

location_facility: National Cheng Kung University Hospital ( Site 0503)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)

location_facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290)

location_facility: Rush University Medical Center ( Site 0260)

location_facility: Universitares Cancer Center Hamburg - UCCH ( Site 0811)

location_facility: University of California San Francisco ( Site 0274)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1056)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 0400)

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)

location_facility: Erasmus University Medical Center ( Site 1354)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)

location_facility: Oncology Hematology Care, Inc. ( Site 8003)

location_facility: Peter MacCallum Cancer Centre ( Site 0300)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0602)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: University of Rochester - James P. Wilmot Cancer Center ( Site 0255)

location_facility: Princess Alexandra Hospital ( Site 0305)

location_facility: Osaka International Cancer Institute ( Site 0355)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1001)

location_facility: Taipei Veterans General Hospital ( Site 0504)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8004)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1055)

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)

location_facility: Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)

location_facility: Chungbuk National University Hospital ( Site 0454)

location_facility: Princess Margaret Cancer Centre ( Site 0051)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1015)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0256)

location_facility: Hospital Gral Universitario de Valencia ( Site 1050)

location_facility: Medipol Universite Hastanesi ( Site 1104)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0501)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0005)

location_facility: Texas Oncology-Arlington North ( Site 8005)

location_facility: Universitätsklinikum Erlangen ( Site 0801)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 0652)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0272)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1201)

location_facility: Hokkaido University Hospital ( Site 0351)

location_facility: London Health Sciences Centre ( Site 0055)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1101)

location_facility: Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)

location_facility: St. Francis Hospital Cancer Center ( Site 1461)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)

location_facility: Seoul National University Bundang Hospital ( Site 0453)

location_facility: University Hospital Southampton NHS Foundation Trust ( Site 1203)

location_facility: Royal Brisbane and Women s Hospital ( Site 0302)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)

location_facility: Severance Hospital Yonsei University Health System ( Site 0452)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0304)

location_facility: Hospital Clinico San Carlos ( Site 1051)

location_facility: University of Michigan Hospital and Health Systems ( Site 0267)

location_facility: St. Joseph Heritage Healthcare ( Site 0254)

location_facility: University Hospital of North Staffordshire ( Site 1202)

location_facility: Taichung Veterans General Hospital ( Site 0506)

location_facility: Klinikum der Universitaet Munchen ( Site 0810)

location_facility: Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)

location_facility: Medizinische Hochschule Hannover ( Site 0807)

location_facility: Fakultni Nemocnice Hradec Kralove ( Site 0705)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0955)

location_facility: Azienda Ospedaliera San Paolo ( Site 0952)

location_facility: Hiroshima University Hospital ( Site 0352)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1106)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 0502)

location_facility: Centro Regional Integrado de Oncologia ( Site 0002)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)

location_facility: National Cancer Center Hospital East ( Site 0350)

location_facility: Zachodniopomorskie Centrum Onkologii ( Site 1013)

location_facility: Istituto Europeo di Oncologia ( Site 0953)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)

location_facility: McGill University Health Centre ( Site 0061)

location_facility: St. Luke's Cancer Center - Anderson ( Site 0251)

location_facility: University of Virginia Health System ( Site 0261)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0286)

location_facility: Medical Hospital, Tokyo Medical And Dental University ( Site 0356)

title: A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Colombia
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel


acronym: Jewelfish

summary: This is a multi-center, exploratory, non-comparative, and open-label study to investigate the safety, tolerability, PK, and PK/PD relationship of risdiplam in adults, children and infants with Spinal Muscular Atrophy (SMA) previously enrolled in Study BP29420 (Moonfish) with the splicing modifier RO6885247 or previously treated with nusinersen, olesoxime or AVXS-101.

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: Universitätsklinikum Essen; Klinik für Kinderheilkunde I

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique ? L?ESCALE

location_facility: Hopital des Enfants; Unite de Neurologie Pediatrique

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

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

location_facility: UCL Institute of Child Health & Great Ormond Street Hospital for Children

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: Hôpital Necker-Enfants Malades; Service de neuropédiatrie

title: An Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Risdiplam (RO7034067) in Adult and Pediatric Patients With Spinal Muscular Atrophy

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

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


acronym: MORPHO

lead_sponsor: Astellas Pharma Global Development, Inc.

summary: The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

sponsor_collaborators: National Heart, Lung, and Blood Institute (NHLBI)

sponsor_collaborators: Blood and Marrow Transplant Clinical Trials Network

location_facility: University Hospitals of Cleveland Medical Center

location_facility: University of Minnesota School of Medicine

location_facility: University of Wisconsin Hospital and Clinics

title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Denmark
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Canada
France


title: A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease

summary: To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

status: Terminated

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
United Kingdom
United States
Spain
Chile
France


lead_sponsor: Nektar Therapeutics

summary: In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.

ReferenceCitation: Siefker-Radtke AO, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Hurwitz ME, Tannir NM. Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02. Eur Urol. 2022 Oct;82(4):365-373. doi: 10.1016/j.eururo.2022.05.002. Epub 2022 May 25.

ReferenceCitation: Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. J Clin Oncol. 2021 Sep 10;39(26):2914-2925. doi: 10.1200/JCO.21.00675. Epub 2021 Jul 13.

ReferenceCitation: Veatch JR, Singhi N, Jesernig B, Paulson KG, Zalevsky J, Iaccucci E, Tykodi SS, Riddell SR. Mobilization of pre-existing polyclonal T cells specific to neoantigens but not self-antigens during treatment of a patient with melanoma with bempegaldesleukin and nivolumab. J Immunother Cancer. 2020 Dec;8(2):e001591. doi: 10.1136/jitc-2020-001591. Erratum In: J Immunother Cancer. 2021 Feb;9(2):

sponsor_collaborators:
Nektar Therapeutics
Bristol-Myers Squibb

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

location_facility: Institute for Cancer Research and Treatment (IRCC)

location_facility: New York University Langone Medical Center - NYU Cancer Institute

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

location_facility: Washington University School of Medicine in St. Louis

location_facility: Loyola University Medical Center, Chicago

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Indiana University Health Melvin & Bren Simon Cancer Center

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: Assistance Publique Hopitaux de Marseille - Hopital Nord

location_facility: Azienda Ospedaliera Universitaria Senese

title: A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

location_country:
Italy
Poland
United Kingdom
Belgium
United States
Spain
Canada
France


acronym: rVWF IN PROPHYLAXIS

lead_sponsor: Takeda

summary: The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).

ReferenceCitation: Leebeek FWG, Peyvandi F, Escobar M, Tiede A, Castaman G, Wang M, Wynn T, Baptista J, Wang Y, Zhang J, Mellgard B, Ozen G. Recombinant von Willebrand factor prophylaxis in patients with severe von Willebrand disease: phase 3 study results. Blood. 2022 Jul 14;140(2):89-98. doi: 10.1182/blood.2021014810.

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

sponsor_collaborators: Baxalta Innovations GmbH, now part of Shire

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of Florida College of Medicine

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Comprehensive Cancer Center of Wake Forest Unversity

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA

location_facility: Bleeding and Clotting Disorders Institute

title: A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE

primary_purpose: Prevention

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:
Germany
Italy
Netherlands
United States
Spain
Turkey
Canada
Russian Federation
France


title: A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer

summary: The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
Hong Kong
Singapore
Japan
United States
Korea, Republic of
Spain
Taiwan
Russian Federation
France

location_facility: The University Of Texas Md Anderson Cancer Center


title: 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

ReferenceCitation: Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.

location_country:
Germany
Italy
Hungary
United States
Spain
Canada
France


title: Perceval S Valve Clinical Trial for Extended CE Mark

acronym: CAVALIER

summary: The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

ReferenceCitation: Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, Cerutti E, Asch FM, Haverich A; CAVALIER Trial Investigators. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1772-1780.e11. doi: 10.1016/j.jtcvs.2020.12.109. Epub 2021 Jan 13.

lead_sponsor: Corcym S.r.l

location_country:
Germany
Poland
United Kingdom
Netherlands
Austria
Belgium
Switzerland
France

location_facility: RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH

location_facility: Inselspital, Universitätsklinik für Herz- und Gefässchirurgie

location_facility: Academic Medical Center, Division of Cardio-thoracic Surgery

intervention_type: Device


title: A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants With Drug-resistant Epilepsy With Partial-onset Seizures Previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice With or w/o Adjunctive Vagus Nerve Stimulation Therapy

acronym: PuLsE 2

summary: This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

lead_sponsor: Cyberonics, Inc.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Canada
France

location_facility: QE2 Health Sciences Centre Department of Neurology

location_facility: Universitatsklinl Erlangen Zentrum fur Epilepsie

location_facility: Azienda Ospedialiera "Bianchi Melacrino Morelli"

location_facility: Hopital Neurologique Unite d' epileptologie

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Hopital Roger Salengro Service de Neurologie


title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

summary: A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

lead_sponsor: AstraZeneca

location_country:
Poland
United Kingdom
Denmark
Sweden
Bulgaria
Russian Federation
France


title: A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

summary: This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

lead_sponsor: Grifols Therapeutics LLC

location_country: Slovakia Australia Austria Spain Serbia France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Neurology Clinic, Central Military Faculty Hospital

location_facility: Special Hospital for Cerebrovascular Diseases "Sveti Sava"

location_facility: Neurology Clinic Hospital with Policlinic of F.D. Roosevelt

location_facility: Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery

location_facility: I. Neurology Clinic, University Hospital Bratislava

location_facility: Radiology Clinic, University Hospital Martin

location_facility: Heidelberg Repatriation Hospital, Melbourne

location_facility: Clinical Center of Vojvodina, Center for Radiology

location_facility: Neurology Clinic, Faculty Hospital Nitra

location_facility: Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie

location_facility: Clinical Center Kragujevac, Center for Radiology Diagnostic

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Vall d'Hebron, Barcelona

location_facility: Clinical Center Niš, Center of Radiology


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multicentre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 for the Prevention of Migraine

summary: Evaluation of ADX10059 to prevent migraine attacks

lead_sponsor: Addex Pharma S.A.

location_country:
Germany
United Kingdom
Austria
Belgium
France

location_facility:
Hamburg
Liverpool
Frankfurt
Manchester
Sint-Truiden
10
Paris
Liège
Cardiff
28
Bochum
Lille
24
Leipzig
Görlitz
06
Göppingen
Dreseden
Berkshire
Magdeburg
02
Toulouse
Münster
Nice
Itzehoe
05
Wilrijk
Freiburg
Wiesbaden
Berlin Hellersdorf 11


title: A Double Blind, Within Patient, Placebo Controlled Trial to Assess the Efficacy of Juvista (Avotermin) in Conjunction With Scar Revision Surgery for the Improvement of Disfiguring Scars.

acronym: Revise

summary: This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo.

lead_sponsor: Renovo

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
United States
Latvia
Spain
France

location_facility: St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56

location_facility: Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet

location_facility: Hôpital Emile Muller, Service de chirurgie plastique

location_facility: Renovo Clinical Trials Unit, 48 Grafton Street

location_facility: Paula Stradina Clinical University Hospital

location_facility: Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA

location_facility: Queen Victoria Hospital (QVH) NHS Foundation Trust

location_facility: Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7

location_facility: Krankenhaus Barmherzige Brüder Regensburg

location_facility: Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ

location_facility: Chirurgia Plastica, Umberto I Policlinico di Roma

location_facility: Hospital Universitario Nuestra Señora del Perpetuo Socorro

location_facility: Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1

location_facility: Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.

location_facility: Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica

location_facility: Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66

location_facility: Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski

location_facility: Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,

location_facility: Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica

location_facility: Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne

location_facility: Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35

location_facility: Hospital Clinic, Departament o Cirugia plástica

location_facility: Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160

location_facility: Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica


lead_sponsor: Cephalon, Inc.

summary: To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

location_facility:
Teva Investigational Site 15
Teva Investigational Site 32
Teva Investigational Site 27
Teva Investigational Site 9
Teva Investigational Site 20
Teva Investigational Site 2
Teva Investigational Site 5
Teva Investigational Site 8
Teva Investigational Site 11
Teva Investigational Site 21
Teva Investigational Site 1
Teva Investigational Site 30
Teva Investigational Site 29
Teva Investigational Site 33
Teva Investigational Site 23
Teva Investigational Site 16
Teva Investigational Site 34
Teva Investigational Site 25
Teva Investigational Site 26
Teva Investigational Site 4
Teva Investigational Site 14
Teva Investigational Site 3

title: Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Patients With HER2-Positive Breast Cancer

location_country: Germany Italy Austria Belgium Spain France


lead_sponsor: Eisai Inc.

summary: The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.

ReferenceCitation: Wiemer EAC, Wozniak A, Burger H, Smid M, Floris G, Nzokirantevye A, Sciot R, Sleijfer S, Schoffski P. Identification of microRNA biomarkers for response of advanced soft tissue sarcomas to eribulin: Translational results of the EORTC 62052 trial. Eur J Cancer. 2017 Apr;75:33-40. doi: 10.1016/j.ejca.2016.12.018. Epub 2017 Feb 16.

ReferenceCitation: Schoffski P, Ray-Coquard IL, Cioffi A, Bui NB, Bauer S, Hartmann JT, Krarup-Hansen A, Grunwald V, Sciot R, Dumez H, Blay JY, Le Cesne A, Wanders J, Hayward C, Marreaud S, Ouali M, Hohenberger P; European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG). Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011 Oct;12(11):1045-52. doi: 10.1016/S1470-2045(11)70230-3. Epub 2011 Sep 19. Erratum In: Lancet Oncol. 2015 Sep;16(9):e427.

title: Phase II Study of E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

location_country: Germany Poland Denmark Belgium France


title: 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

summary: This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Switzerland
United States
Spain
Canada
France

location_facility: Klinikum der Humboldt Universitat Charite

location_facility: Ciutat Santitaria I Univessitaria de Bellvitge

location_facility: Az. Osp. Di Bologna Polici. S. Orsola - Malpighi

location_facility: Azienda Opedaliera Careggi - Universita degli Studi

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Azienda Ospedaliera di Padova - Universita degli Studi


title: Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44

acronym: PRINCIPLE

summary: The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Daiichi Sankyo, Inc.
The TIMI Study Group

location_country:
United States
Israel
Germany
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.


title: An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome

acronym: FMAS

summary: The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright syndrome (MAS)

ReferenceCitation: Sims EK, Garnett S, Guzman F, Paris F, Sultan C, Eugster EA; Fulvestrant McCune-Albright study group. Fulvestrant treatment of precocious puberty in girls with McCune-Albright syndrome. Int J Pediatr Endocrinol. 2012 Sep 22;2012(1):26. doi: 10.1186/1687-9856-2012-26.

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

location_country:
United States
United Kingdom
France


title: Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access

acronym: RADIANCY

summary: The primary objective of this clinical investigation is to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.

lead_sponsor: Cordis Corporation

collaborators: Qserve NAMSA

sponsor_collaborators:
Cordis Corporation
Qserve
NAMSA

location_country: Italy Switzerland Austria Belgium Spain France

location_facility:
Groupe Hôpital Paris St Joseph
A.Z. Sint-Blasius Hospital-Dendermonde
Hospital Ambroise Pare
Hosp Univ. de Guadalajara
Hanusch Krankenhaus
Klinikum Klagenfurt am Wörtherse
Clinique Rhena
Univ.-Klinik für Innere Medizin II
Clinique Pasteur
Univ Klinikum LKG Graz
Maria Cecilia Hospital
Kantonsspital Winterthur


title: HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

acronym: HighFLO

summary: Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

lead_sponsor: HighLife SAS

location_country:
Germany
Poland
United Kingdom
Australia
Belgium
France

location_facility:
Wesley Hospital
Medical University of Warsaw
Cliniue Pasteur
Centre Hospitalo - Univ de Nantes
Macquarie University Hospital
University Hospital Ulm
UZ Leuven
Brighton and Sussex University Hospital
AZ St. Jan - Brugge
Deutsches Herzzentrum Munchen
Mount Hospital
Medical University of Silesia
CHU de Rennes
CHU Lille


title: SAPIEN 3 Ultra EU Post-Market Observational Study

summary: This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

lead_sponsor: Edwards Lifesciences

location_country:
Finland
Italy
Germany
Portugal
Norway
United Kingdom
Switzerland
Austria
Spain
France

location_facility: Complexo Hospitalario Universitario Coruna

location_facility: Hospital Alvara Cunqueiro, Estrada de Clara Campoamor 341

location_facility: Tampere University Hospital, Teiskontie 35

location_facility: LMU, Klinikum der Universitaet Meunchen - Großhadern

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Hospital Universitario Valdecilla Santander, Av. de Valdecilla 25

location_facility: LKH-Univ. Graz Klinik, Auenbruggerplaz 15

location_facility: Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental , Estrada do Forte do Alto do Duque

location_facility: Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3

location_facility: Institut Hospitalier Jacques Cartier Massy

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitario Clínico San Carlos


title: Limiting AKI Progression In Sepsis (LAPIS): A Phase 4, Multicenter, Randomized Controlled Trial of Biomarker-guided Delivery of Kidney-sparing Care Measures in Sepsis Subjects at Risk of Developing AKI

acronym: LAPIS

summary:
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.

NOTE: Participants are no longer being recruited to this study.

primary_purpose: Diagnostic

ReferenceCitation: Molinari L, Heskia F, Peerapornratana S, Ronco C, Guzzi L, Toback S, Birch R, Beyhaghi H, Kwan T, Kampf JP, Yealy DM, Kellum JA; Sapphire and Protocolized Care for Early Septic Shock (ProCESS) Investigators. Limiting Acute Kidney Injury Progression In Sepsis: Study Protocol and Trial Simulation. Crit Care Med. 2021 Oct 1;49(10):1706-1716. doi: 10.1097/CCM.0000000000005061.

lead_sponsor: BioMérieux

location_country:
United States
Germany
Belgium
France

location_facility: Memorial Sloan Kettering Cancer Center, 1275 York Avenue

location_facility: Hopital Cochin, 27 Rue Du Faubourg Saint Jacques

location_facility: AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10

location_facility: Brigham and Womens Hospital, 75 Francis Street

location_facility: LSU Health Sciences Center, 1541 Kings Highway

location_facility: Universitatsklinikum Munster, Albert-Schweitzer-Campus 1

location_facility: Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque

location_facility: University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110

location_facility: Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20

location_facility: CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel

location_facility: Hôpital Erasme, Soins Intensifs, Route de Lennik 808