title: A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

summary: The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

lead_sponsor: Provention Bio, Inc.

location_country:
Germany
Poland
United Kingdom
Belgium
United States
Czechia
Canada
France

location_facility: Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)

location_facility: UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)

location_facility: University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)

location_facility: MultiCare Health System, Gateway Medical Building (Site 840003)

location_facility: University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)

location_facility: Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)

location_facility: Necker Children's Hospital, 149 Rue de Sevres (Site 250502)

location_facility: Nemours Children's Health, 807 Children's Way

location_facility: BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)

location_facility: St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)

location_facility: Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)

location_facility: Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)

location_facility: CHU La Timone - La Timone Children's Hospital

location_facility: Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)

location_facility: UCL Namur University Hospital Place Louise Godin 15 (Site 056205)

location_facility: University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)

location_facility: UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)

location_facility: Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)

location_facility: Capital Medical Research Associates (Site 840029)

location_facility: Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)

location_facility: UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038)

location_facility: Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)

location_facility: Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)

location_facility: Rady Children's Hospital 3020 Children's Way (Site 840004)

location_facility: AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)

location_facility: University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)

location_facility: Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)

location_facility: Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)

location_facility: University Hospital Brussels (Site 056202)

location_facility: Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)

location_facility: Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)

location_facility: UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)

location_facility: University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)

location_facility: Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)

location_facility: Lenval Hospital, 57 Avenue de la Californie (Site 250508)

location_facility: Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)

location_facility: Baystate Medical Center, 759 Chestnut Street

location_facility: Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)

location_facility: Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)

location_facility: University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)

location_facility: Hospital Augsburg, Stenglinstrasse 2 (Site 276606)

location_facility: Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)

location_facility: Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)

location_facility: Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital

intervention_type: Other


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

acronym: ASPEN

summary: The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Chalmers JD, Usansky H, Rubino CM, Teper A, Fernandez C, Zou J, Mange KC. Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. Clin Pharmacokinet. 2022 Oct;61(10):1457-1469. doi: 10.1007/s40262-022-01147-w. Epub 2022 Jul 25.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: University of Dundee - Discovery Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;discovery.dundee.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ipd_sharing: No

lead_sponsor: Insmed Incorporated

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Canada
Serbia
France
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Belgium
Malaysia
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

acronym: LUNA 3

summary:
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily.

For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up.

For adult participants, the maximum duration of the long-term extension (LTE) period will be 12 months from the date of the last adult participant to enter the LTE.

For pediatric participants, the maximum duration of the LTE period will be 12 months from the date of the last pediatric participant to enter the LTE.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Principia Biopharma, a Sanofi Company

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Canada
France
Hungary
United States
Ukraine
China
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Russian Federation
Israel

location_facility: Qilu Hospital of Shandong University - Investigational Site Number: 15605

location_facility: Erasmus MC_Investigational Site Number 52801

location_facility: Shaanxi Provincial People's Hospital - Investigational Site Number: 15607

location_facility: The Oncology Institute of Hope and Innovation_Investigational Site Number 84031

location_facility: Montefiore Medical Center_Investigational Site Number 84032

location_facility: Kitasato University Hospital - Investigational Site Number: 39207

location_facility: University of Washington Medical Centre Site Number : 84041

location_facility: Hospital do Servidor Publico Estadual de Sao Paulo Site Number : 7607

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital - Investigational Site Number: 39203

location_facility: Uniao Oeste Paranaense de Estudos e Combates ao Cancer Site Number : 7610

location_facility: University Hospitals Cleveland Medical Center Site Number : 84036

location_facility: Hospital Santa Marcelina Site Number : 7611

location_facility: CEMEC Oncologica do Brasil Site Number : 7606

location_facility: The University of Tokyo Hospital - Investigational Site Number: 39208

location_facility: Rush University Medical Center_Investigational Site Number 84029

location_facility: National Hospital Organization Tokyo Medical Center - Investigational Site Number: 39210

location_facility: Second Affiliated Hospital of Kunming Medical University - Investigational Site Number: 15604

location_facility: Children's Hospital Colorado_Investigational Site Number 84025

location_facility: Osaka University Hospital - Investigational Site Number: 39202

location_facility: CHU Sainte-Justine_Investigational site number 12405

location_facility: National Center for Child Health and Development - Investigational Site Number: 39204

location_facility: Hospital De Clinicas De Porto Alegre Site Number : 7605

location_facility: HEMORIO - Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti Site Number : 7609

location_facility: Saitama Medical University Hospital - Investigational Site Number: 39201

location_facility: Massachusetts General Hospital Site Number : 84038

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037

location_facility: Children's Healthcare of Atlanta_Investigational Site Number 84034

location_facility: Wuhan Union Hospital of Tongji Medical College of HUST - Investigational Site Number: 15601

location_facility: Shengjing Hospital of China Medical University - Investigational Site Number: 15603

location_facility: Cleveland Clinic_Investigational Site Number 84026

location_facility: IMMUNOe International Research Centers_Investigational Site Number 84028

location_facility: The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027

location_facility: ASCLEPES Research Centers_Investigational Site Number 84023

location_facility: University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Investigational Site Number: 15602

location_facility: University of Southern California_Investigational Site Number 84024

location_facility: University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035

location_facility: Tokyo Metropolitan Bokutoh Hospital - Investigational Site Number: 39209

location_facility: Local Incorporated Administrative Institution Saitama prefectural hospital organization Saitama prefectural Children's Medical Center - Investigational Site Number: 39206

location_facility: Hospital Sao Rafael Instituto D'Or da Bahia Site Number : 7608

location_facility: Ishikawa Prefectural Central Hospital - Investigational Site Number: 39205

location_facility: UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020


lead_sponsor: Hoffmann-La Roche

summary: This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

location_facility: Cumhuriyet Universitesi Tip Fakultesi; Noroloji Bolumu

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology

location_facility: Michigan Institute for Neurological Disorders

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: N.P. Bechtereva Institute of the Human Brain

location_facility: 5th Cherkasy City Center of Primary Health Care

location_facility: Federal center of brain research and neurotechnologies

location_facility: Regional clinical hospital named after prof. S.V. Ochapovsky

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Szpital Specjalistyczny im. Rydygiera w Krakowie; Oddzial Neurologii i Udarow Mozgu

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Neurologia

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: SI USSRI of Medical and Social Problems of Disabilities of MOHU

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: University of Massachusetts Medical School

location_facility: Texas Institute for Neurological Disorders

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia

location_facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet; Neurology

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: National Center of Social Significant Disease

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: University General Hospital of Larisa; Neurology Clinic

location_facility: Petz Aladar Megyei Oktato Korhaz; Neurologiai Osztaly

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie

location_facility: New Orleans Center for Clinical Research

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

location_facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Washington University School of Medicine

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu

location_facility: Medical Center of Private Execution First Private Clinic

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: Erciyes Universitesi; Pediatric Neurology

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: Hopital Hautepierre - CHU Strasbourg; Service de Neurologie

location_facility: AOU Città della Salute e della Scienza; Neurologia 1

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: Kistarcsai Flor Ferenc Korhaz; Neurology and Stroke Ambulance

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Haseki Training and Research Hospital; Department of Neurology

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Medizinische Hochschule Hannover, Klinik für Neurologie

location_facility: Hospital Eginition; First Department of Neurology

title: A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

source: euctr

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/ourmember/roche/). 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
Poland
Argentina
Brazil
Turkey
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Peru
Italy
United Kingdom
Mexico
Spain
Greece
Bulgaria
Russian Federation


acronym: MESSINA

intervention_type: Biological

lead_sponsor: AstraZeneca

summary: The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.

status: Terminated

title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis

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.

study_completion_date_type: Actual

location_country:
Germany
France
Italy
Poland
United Kingdom
Japan
Netherlands
United States
Spain
Canada
Russian Federation
Israel

status_simplified: Unknown


title: An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT)

acronym: AHEAD-MERIT

summary:
An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1.

This trial has two parts.

Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.

Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.

For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.

lead_sponsor: BioNTech SE

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
United States
Belgium
Italy
United Kingdom
Austria
Mexico
Spain
Sweden

location_facility: Clinica Universidad de Navarra - Madrid (CUN-M)

location_facility: Azienda Sanitaria Universitaria Integrata Friuli Centrale - Presidio ospedaliero di Udine

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: James Lind Centro de Investigación del Cáncer

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

location_facility: Instituto Nacional de Cancer Jose de Alencar Gomes da Silva - INCA

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Mater Salutis Hospital AULSS 9 della Regione Veneto

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: Centro Estatal de Cancerologia de Chihuahua

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Hospital Na Bulovce (Nemocnice na Bulovce)

location_facility: Hospital Universitario "Dr Jose Eleuterio Gonzalez" Centro Universitario contra el Cáncer

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil, E.P.E.

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: University of Miami Miller School of Medicine

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Consultorio del Dr. Joaquín Gabriel Reinoso Toledo

location_facility: Instituto do Cancer do Estado de São Paulo

location_facility: Centro de Atencion e Investigacion Clinica en Oncologia (CAICO)

location_facility: Uniklinikum Salzburg, Univ. Klinik fur Innere Medizin III

location_facility: Charite Universitätsklinikum Berlin - Campus Benjamin Franklin

location_facility: Inonu Universitesi - Turgut Ozal Tip Merkezi

location_facility: Caritas Klinikum Saarbrucken St. Theresia

location_facility: Centro de Estudios y Prevención del Cáncer (CEPREC)

location_facility: Central Hospital of Northern Pest - Military Hospital

location_facility: Klinik für HNO-Heilkunde, Kopf- und Hals-Chirurgie

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre Hospital Santa Rita

location_facility: Centro de Oncología e Investigación Buenos Aires COIBA

location_facility: Fundacao Universidade de Caxias do Sul - Instituto de Pesquisas em Saude IPS-UCS

location_facility: HNO, Kopf-und Halschirurgie Ordensklinikum Linz Barmherzigen Schwestern

location_facility: The University of New Mexico Comprehensive Cancer Center

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: CAIPO Centro para la Atencion Integral del Paciente Oncologico

location_facility: Centro Hospitalar Universitario Lisboa Norte

location_facility: Clinica Universidad de Navarra - Pamplona (CUN-P)

location_facility: Institut Curie, Groupe Hospitalier Paris Saint-Joseph (GHPSJ)

location_facility: Universitaetsmedizin Rostock - Medizinische Klink III (Hamatologie, Onkologie, Palliativmedizin)


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib

summary: This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Germany
Italy
Poland
Israel
Australia
United States
Spain
Bulgaria
France

location_facility: Bologna University Hospital, Institute of Hematology

location_facility: Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii

location_facility: Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: d'Hebron University Hospital in Barcelona

location_facility: Ospedale di Circolo e Fondazione MacchiASST Sette Laghi

location_facility: Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie

location_facility: University Mutiprofile Hospital Alexandrovska


lead_sponsor: Merck Sharp & Dohme LLC

summary: This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.

ReferenceCitation: Kim TW, Taieb J, Gurary EB, Lerman N, Cui K, Yoshino T. Olaparib with or without bevacizumab or bevacizumab and 5-fluorouracil in advanced colorectal cancer: Phase III LYNK-003. Future Oncol. 2021 Dec;17(36):5013-5022. doi: 10.2217/fon-2021-0899. Epub 2021 Nov 15.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

publisher_dissemination: Future Science Ltd

location_facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1128)

location_facility: National Cancer Center Hospital ( Site 0651)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1152)

location_facility: Providence Saint Joseph Medical Center, Disney Family Cancer ( Site 1392)

location_facility: Peninsula Health Frankston Hospital ( Site 0056)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 1383)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0202)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0251)

location_facility: Administradora Country SA - Clinica del Country ( Site 0350)

location_facility: Aichi Cancer Center Hospital ( Site 0658)

location_facility: Washington University in St. Louis ( Site 1384)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0659)

location_facility: Kartal Dr. Lutfi Kirdar Egitim ve Arast Hast ( Site 1211)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0362)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1314)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Princess Margaret Cancer Centre ( Site 0209)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0360)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1127)

location_facility: Hopital Cite de la Sante de Laval ( Site 0203)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 1358)

location_facility: Hospital 12 de Octubre de Madrid ( Site 1150)

location_facility: UC Health Memorial Hospital ( Site 1401)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202)

location_facility: West Cancer Center - East Campus ( Site 1396)

location_facility: Korea University Anam Hospital ( Site 0955)

location_facility: Baskent University Adana Training Hospital ( Site 1205)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 1321)

location_facility: C.H.U. de Strasbourg Hopital de Hautepierre ( Site 0464)

location_facility: National Cancer Center Hospital East ( Site 0650)

location_facility: Hopital Europeen Georges Pompidou ( Site 0452)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0652)

location_facility: Cancercare Rondebosch Oncology ( Site 0904)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0252)

location_facility: Hospital General Universitario de Elche ( Site 1155)

location_facility: Vanderbilt University Medical Center ( Site 1362)

location_facility: Prof. Dr. Cemil Tascioglu Sehir Hastanesi ( Site 1216)

location_facility: Riga East Clinical University Hospital ( Site 1501)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 1432)

location_facility: Royal Brisbane and Women s Hospital ( Site 0054)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1210)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1113)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 1418)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0956)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 0953)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1214)

location_facility: St. Josef und St. Elisabeth Hospital gGmbH-Hematology, oncology and palliative medicine ( Site 0503)

location_facility: Orszagos Onkologiai Intezet ( Site 1431)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0201)

location_facility: Hospital Universitario Central de Asturias ( Site 1153)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1129)

location_facility: Seoul National University Hospital ( Site 0950)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1427)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1429)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0353)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1215)

location_facility: Daugavpils Regional Hospital ( Site 1502)

location_facility: Poudre Valley Health System ( Site 1402)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 1207)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0657)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0655)

location_facility: New England Cancer Specialists ( Site 1422)

location_facility: Severance Hospital Yonsei University Health System ( Site 0951)

location_facility: Providence Portland Medical Center ( Site 1400)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1426)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1319)

location_facility: Nacionalinis Vezio Institutas ( Site 1527)

location_facility: McGill University Health Centre ( Site 0207)

location_facility: University Cancer & Blood Center, LLC ( Site 1381)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203)

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1204)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0455)

location_facility: Oregon Health & Science University ( Site 1411)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 1397)

location_facility: City Clinical Oncology Center ( Site 1114)

location_facility: Cancer Partners of Nebraska ( Site 1353)

location_facility: Dr. Everett Chalmers Regional Hospital ( Site 0204)

location_facility: P. Stradina Clinical University Hospital ( Site 1500)

location_facility: Medical Center Asklepion LLC ( Site 1309)

location_facility: Hacettepe University Faculty of Medicine ( Site 1200)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 1126)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0654)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0900)

location_facility: Allegheny Singer Research Institute ( Site 1364)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1130)

location_facility: James Graham Brown Cancer Center ( Site 1393)

location_facility: University Medical Center New Orleans ( Site 1365)

location_facility: St. Vincent Frontier Cancer Center-Research ( Site 1414)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1304)

status: Completed

title: A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)

location_country:
Germany
Lithuania
Colombia
Hungary
Australia
Japan
Belgium
United States
Korea, Republic of
Latvia
Spain
South Africa
Turkey
Chile
Canada
Ukraine
Russian Federation
France

status_simplified: Completed


acronym: LIBERTY-ABPA AIRED

lead_sponsor: Regeneron Pharmaceuticals

summary:
The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).

The secondary objectives of the study are:

To evaluate the effects of dupilumab on exacerbations in participants with ABPA
To evaluate the effects of dupilumab on ABPA-related exacerbations
To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA
To evaluate the effects of dupilumab on asthma control in participants with ABPA
To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA
To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations
To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels
To evaluate safety and tolerability of dupilumab in participants with ABPA
To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA

ReferenceCitation: Kao CC, Hanania NA, Parulekar AD. The impact of fungal allergic sensitization on asthma. Curr Opin Pulm Med. 2021 Jan;27(1):3-8. doi: 10.1097/MCP.0000000000000740.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Japan
Netherlands
United States
Bulgaria
France


acronym: REEF-IT

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: NHS Greater Glasgow and Clyde - Gartnavel General Hospital

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Republic Clinical Infectious Hospital n.a. AF Agafonov

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

title: A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection

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

location_country:
Germany
United Kingdom
Japan
United States
Spain
Turkey
Taiwan
Canada
Russian Federation
France


title: A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

summary: The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.

design_allocation: Non-Randomized

lead_sponsor: Keros Therapeutics, Inc.

location_country:
Germany
New Zealand
Israel
Australia
United States
Spain
Czechia
France

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of Miami, Sylvester Comprehensive Cancer Center

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: H. Lee Moffitt Cancer Center and Research Center

location_facility: Ballarat Oncology and Haematology Service

location_facility: University of Pittsburgh Medical Health Center

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Hospital Universitario Central de Asturias


title: Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I)

acronym: PersoMed-I

summary: Medulloblastoma is a rare brain malignancy, mainly affecting children. Treatment of this rapidly growing tumor begins with maximal surgical removal plus radiation and chemotherapy. Treatment toxicity is high. Post-pubertal and pediatric medulloblastomas are biologically and prognostically different, which mandates age-adapted treatment strategies. Patients after puberty bear an intermediate to high prognostic risk. This means that a large number of these patients, are faced with death and/or disability (mainly neurocognitive). Therefore, the scientific and medical need is high. One of the genetic subgroups of medulloblastoma, the SHH-subgroup (Sonic HedgeHog- subgroup), is highly overrepresented in medulloblastoma patients after puberty. This subgroup can be treated with a targeted therapy. The investigators will therefore randomize patients and treat SHH-subgroup patients with sonidegib and a reduction of radiotherapy dose in the experimental arm of the trial. The hypothesis that this personalized risk-adapted therapy will improve outcomes in view of increased efficacy and decreased toxicity.

primary_purpose: Health Services Research

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Germany Italy Australia Netherlands Austria Switzerland Spain France

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie

location_facility: Universitaetsklinikum Tuebingen- Crona Kliniken

location_facility: University Frankfurt - Goethe Univ. - University Hospital Frankfurt -Senckenberg Institute of Neurooncology

location_facility: Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie

location_facility: HELIOS Kliniken - HELIOS Klinikum Erfurt GmbH

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: IRCCS - Istituto Neurologico Carlo Besta

location_facility: Klinikum Rechts der isar Der Technische Universitaet Muenchen

location_facility: Universitaetsmedizin Goettingen - Georg-August Universitaet

location_facility: Westmead Hospital - Crown Princess Mary Cancer Center

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

location_facility: Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg

location_facility: Princess Alexandra Hospital - University Of Queensland

location_facility: CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Saint Herblain

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: A.O Landeskrankenhaus - Innsbruck Universitaetsklinik

location_facility: Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi

appel_a_projets: PHRCK

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LEON BERARD

type_etablissement: CLCC

titre: PersoMed-I - EORTC 1634-BTG-Traitement personnalisé, adapté au risque chez des patients pubères porteurs d'un médulloblastome nouvellement diagnostiqué (EORTC-1634-BTG) - Coordination française d'un essai international

discipline_principale: cancer

nom_porteur: TANGUY

prenom_porteur: Ronan


title: A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 Therapy

summary: This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

lead_sponsor: ISA Pharmaceuticals

sponsor_collaborators:
ISA Pharmaceuticals
Regeneron Pharmaceuticals

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

location_facility: Nordwest Hospital GmbH, Clinic of Hematology and Oncology

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: University Hospital Motol, Clinic of Oncology

location_facility: Jean Godinot Institute, Cancer Research Center

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Saint Andre Hospital, Department of Oncology

location_facility: CHU La Timone - La Timone Children's Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Oncology

location_facility: Leon Berard Center, Department of Medical Oncology

location_facility: European Institute of Oncology (IEO), IRCCS, Department of Otolaryngology and Facial Cervix Surgery

location_facility: The University of Texas M. D. Anderson Cancer Center

location_facility: University Hospital Cologne, Department of Otorhinolaryngology (ENT)

location_facility: Institute of Cancer Research and Treatment of Candiolo

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University Hospital Giessen and Marburg GmbH


title: A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

acronym: LOTIS 5

summary: The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.

lead_sponsor: ADC Therapeutics S.A.

location_country:
Italy
Poland
Hungary
Israel
United Kingdom
Netherlands
Mexico
Belgium
Switzerland
United States
China
Spain
Czechia
Canada
France

location_facility: Chongqing University Cancer Hospital - Chongqing Cancer Hospital

location_facility: Centre Hospitalier Regional Universitaire Brest

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke

location_facility: Boca Raton Clinical Research (BRCR) Global Mexico - Guadalajara

location_facility: PanAmerican Clinical Research Mexico - Cuernavaca

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: The First Affiliated Hospital of Zhejiang University School of Medicine

location_facility: UnityPoint Health - Iowa Oncology Research Association (IORA)

location_facility: Zhujiang Hospital of Southern Medical University

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

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

location_facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: Medical College of Wisconsin Cancer Center Clinical Trials Office

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: West China School of Medicine - West China Hospital of Sichuan University

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Kaiser Permanente Interstate Medical Office Central

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST

location_facility: Samson Assuta Ashdod University Hospital

location_facility: University of California San Diego Moores Cancer Center

location_facility: Henan Cancer Hospital - Zhengzhou University

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Elisabeth-TweeSteden Ziekenhuis - Elisabeth

location_facility: Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Boca Raton Clinical Research (BRCR) Global Mexico - Ciudad de México

location_facility: PanAmerican Clinical Research Mexico - Guadalajara

location_facility: Research Institute of the McGill University Health Centre

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Second Affiliated Hospital of Dalian Medical University


lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19).

Secondary Objectives:

Evaluate the 28-day survival rate.
Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity.
Evaluate changes in the National Early Warning Score 2.
Evaluate the duration of predefined symptoms and signs (if applicable).
Evaluate the duration of supplemental oxygen dependency (if applicable).
Evaluate the incidence of new mechanical ventilation use during the study.
Evaluate the duration of new mechanical ventilation use during the Study.
Evaluate the proportion of participants requiring rescue medication during the 28-day period.
Evaluate need for admission into intensive care unit.
Evaluate duration of hospitalization (days).

The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of:

Serious adverse events.
Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia.
Grade greater than or equal to (>=) 2 infusion related reactions.
Grade >=2 hypersensitivity reactions.
Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline).
Major or opportunistic bacterial or fungal infections.

ReferenceCitation: Lescure FX, Honda H, Fowler RA, Lazar JS, Shi G, Wung P, Patel N, Hagino O; Sarilumab COVID-19 Global Study Group. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 May;9(5):522-532. doi: 10.1016/S2213-2600(21)00099-0. Epub 2021 Mar 4.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number 7240001
Investigational Site Number 7240005
Investigational Site Number 1240001
Investigational Site Number 3800006
Investigational Site Number 0760004
Investigational Site Number 0760005
Investigational Site Number 0760002
Investigational Site Number 1520002
Investigational site number 3760003
Investigational Site Number 1520004
Investigational Site Number 1240004
Investigational Site Number 2500002
Investigational Site Number 2760001
Investigational Site Number 3760002
Investigational Site Number 2500005
Investigational Site Number 1520003
Investigational Site Number 1240002
Investigational Site Number 3800005
Investigational Site Number 2500001
Investigational Site Number 6430001
Investigational Site Number 1520001
Investigational Site Number 0760001
Investigational Site Number 6430002
Investigational Site Number 2760004
Investigational Site Number 7240003
Investigational Site Number 0320004
Investigational Site Number 0320001
Investigational Site Number 2500004
Investigational Site Number 3920003
Investigational Site Number 3800002
Investigational Site Number 7240004
Investigational Site Number 3760001
Investigational Site Number 2500007
Investigational Site Number 2760002
Investigational Site Number 2500006
Investigational Site Number 7240002
Investigational Site Number 0760003
Investigational Site Number 0320003
Investigational Site Number 3800001
Investigational Site Number 3800004
Investigational Site Number 3920002
Investigational Site Number 2500003
Investigational Site Number 6430003
Investigational Site Number 3800003
Investigational Site Number 1240005
Investigational Site Number 1240003
Investigational Site Number 3920001

title: An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

location_country:
Germany
Italy
Israel
Argentina
Japan
Brazil
Spain
Chile
Canada
Russian Federation
France


acronym: COVACTA

summary: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

ReferenceCitation: Rosas IO, Brau N, Waters M, Go RC, Malhotra A, Hunter BD, Bhagani S, Skiest D, Savic S, Douglas IS, Garcia-Diaz J, Aziz MS, Cooper N, Youngstein T, Sorbo LD, Zerda DJ, Ustianowski A, Gracian AC, Blyth KG, Carratala J, Francois B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Bauer RN, Cai F, Lee IT, Matharu B, Metcalf L, Wildum S, Graham E, Tsai L, Bao M. Tocilizumab in patients hospitalised with COVID-19 pneumonia: Efficacy, safety, viral clearance, and antibody response from a randomised controlled trial (COVACTA). EClinicalMedicine. 2022 May;47:101409. doi: 10.1016/j.eclinm.2022.101409. Epub 2022 Apr 21.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

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

repository_institution: California Digital Library - eScholarship

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: gold

ReferenceCitation: Tom J, Bao M, Tsai L, Qamra A, Summers D, Carrasco-Triguero M, McBride J, Rosenberger CM, Lin CJF, Stubbings W, Blyth KG, Carratala J, Francois B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Kheradmand F, Rosas IO, Cai F. Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial. Crit Care Med. 2022 Mar 1;50(3):398-409. doi: 10.1097/CCM.0000000000005229.

repositories_concat: PubMed Central;diposit.ub.edu

ReferenceCitation: Rosas IO, Brau N, Waters M, Go RC, Hunter BD, Bhagani S, Skiest D, Aziz MS, Cooper N, Douglas IS, Savic S, Youngstein T, Del Sorbo L, Cubillo Gracian A, De La Zerda DJ, Ustianowski A, Bao M, Dimonaco S, Graham E, Matharu B, Spotswood H, Tsai L, Malhotra A. Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia. N Engl J Med. 2021 Apr 22;384(16):1503-1516. doi: 10.1056/NEJMoa2028700. Epub 2021 Feb 25.

evidence: open (via free article)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of California - eScholarship University of California

publisher_dissemination: Massachusetts Medical Society

location_facility: Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: James J Peters Veterans Administration Medical Center - NAVREF

location_facility: Robert Wood Johnson University Hospital/Rutgers

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Miami Miller School of Medicine

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the clinical study data request platform https://vivli.org.

Further details on Roche's criteria for eligible studies are available here: https://vivli.org.

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
United Kingdom
Denmark
Netherlands
United States
Spain
Canada
France


title: Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

acronym: DYNAKT

summary:
The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up.

As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly E, Buchler M, Ladriere M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Bohmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Dec;3(12):e795-e805. doi: 10.1016/S2589-7500(21)00209-0. Epub 2021 Oct 28.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
Argentina
Brazil
United States
Spain
Croatia
Chile
France

location_facility: Department of Nephrology, Hospital del Mar

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

location_facility: Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

location_facility: Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

location_facility: Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

location_facility: Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb

location_facility: Universidade Federal de São Paulo, Hospital do Rim, Escola Paulista de Medicina

location_facility: Unidad de Trasplante Renopáncreas, Centro de Educación Médica e Investigaciones Clínicas

location_facility: Bretonneau Hospital, Nephrology and Immunology Department

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Renal Transplantation Service

location_facility: Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic

location_facility: Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

acronym: BE HEARD I

summary: The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Germany
Italy
Israel
Norway
Denmark
Australia
Netherlands
Switzerland
Belgium
United States
Spain
Greece
Turkey
Canada
France


acronym: DOR/ISL Open-Label Switch

summary: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

location_facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)

location_facility: Brighton and Sussex University Hospital NHS Trust ( Site 1908)

location_facility: Infectious Clinical Hospital #2 ( Site 1719)

location_facility: University of North Carolina at Chapel Hill ( Site 1042)

location_facility: Toronto General Hospital - University Health Network ( Site 1105)

location_facility: Universitaetsspital Zuerich ( Site 3300)

location_facility: North Manchester General Hospital ( Site 1902)

location_facility: SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)

location_facility: Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)

location_facility: Georgetown University Hospital ( Site 1018)

location_facility: Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 2015)

location_facility: Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 2401)

location_facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)

location_facility: Midway Immunology and Research ( Site 1030)

location_facility: Saint Hope Foundation, Inc. ( Site 1037)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 1305)

location_facility: Triple O Research Institute, P.A. ( Site 1026)

location_facility: Kansas City CARE Health Center ( Site 1008)

location_facility: Hospital Universitario Infanta Leonor ( Site 1601)

location_facility: CHU de Toulouse - Hopital Purpan ( Site 2004)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1606)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 1907)

location_facility: Ospedale Regionale di Lugano Civico ( Site 3305)

location_facility: The Crofoot Research Center, Inc. ( Site 1005)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 1022)

location_facility: Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)

location_facility: Hopitaux Universitaires de Geneve HUG. ( Site 3304)

location_facility: Chatham County Health Department ( Site 1043)

location_facility: Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)

location_facility: Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)

location_facility: North Texas ID Consultants, PA ( Site 1003)

location_facility: Vancouver ID Research and Care Centre Society ( Site 1100)

location_facility: National Hospital Organization Osaka National Hospital ( Site 2402)

location_facility: Melbourne Sexual Health Centre ( Site 2305)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 2403)

location_facility: EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)

location_facility: Centro de Investigacion Clinica UC CICUC ( Site 1303)

location_facility: Hopital Francois Mitterrand ( Site 2019)

location_facility: Hospital Universitario La Paz ( Site 1604)

location_facility: Tokyo Medical University Hospital ( Site 2404)

location_facility: Hospital Clinic i Provincial ( Site 1600)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2406)

location_facility: Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)

location_facility: Southern Alberta HIV Clinic ( Site 1108)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1603)

location_facility: Holdsworth House Medical Practice ( Site 2300)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)

location_facility: Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 2014)

location_facility: Inselspital Universitaetsspital Bern ( Site 3303)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)

location_facility: Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)

location_facility: FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)

title: A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy

location_country:
Italy
Poland
Colombia
New Zealand
United Kingdom
Australia
Japan
Switzerland
United States
Spain
South Africa
Chile
Canada
Russian Federation
France


acronym: PACIFIC-AF

lead_sponsor: Bayer

summary:
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.

ReferenceCitation: Piccini JP, Caso V, Connolly SJ, Fox KAA, Oldgren J, Jones WS, Gorog DA, Durdil V, Viethen T, Neumann C, Mundl H, Patel MR; PACIFIC-AF Investigators. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. Lancet. 2022 Apr 9;399(10333):1383-1390. doi: 10.1016/S0140-6736(22)00456-1. Epub 2022 Apr 3.

oa_host_type: repository

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

unpaywall_oa_status: green

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: P. Stradins Clinical University Hospital

location_facility: Centre Hospitalier Régional - Saint Brieuc

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: University of Semmelweis/ Semmelweis Egyetem

location_facility: Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz

location_facility: Hôpital Cantonal Universitaire de Genève

location_facility: Hospital de la Santa Creu i de Sant Pau | Cardiología

location_facility: Institut universitaire de cardiologie et de pneumologie

title: Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Italy
Hungary
United Kingdom
Japan
Sweden
Netherlands
Austria
Belgium
Switzerland
Latvia
Spain
Czechia
Canada
France


acronym: SELECT

lead_sponsor: Amgen

summary: A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: US Oncology Research Investigational Products Center

location_facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Baylor Charles A Sammons Cancer Center at Dallas

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Rocky Mountain Cancer Centers Denver Midtown

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: University General Hospital of Evros-Alexandroupolis District

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

title: An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)

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

location_country:
Germany
Italy
Denmark
United States
Spain
Greece
Estonia
France


acronym: ADVANCE

lead_sponsor: argenx

summary: This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in patients with primary ITP.

location_facility:
Investigator Site 0390015
Investigator Site 0480016
Investigator Site 0480015
Investigator Site 0340007
Investigator Site 3590002
Investigator Site 0430003
Investigator Site 0010040
Investigator Site 0490010
Investigator site 0810017
Investigator Site 0390010
Investigator Site 0330018
Investigator Site 0480011
Investigator Site 4200008
Investigator Site 0900016
Investigator Site 9950011
Investigator Site 0440008
Investigator Site 0340004
Investigator Site 0900013
Investigator Site 0390017
Investigator Site 0340014
Investigator Site 0430002
Investigator Site 9950007
Investigator Site 0810021
Investigator Site 0900006
Investigator Site 0070012
Investigator Site 0480013
Investigator Site 0320012
Investigator site 0810014
Investigator Site 3800022
Investigator site 3800006
Investigator Site 0010042
Investigator Site 9950008
Investigator Site 0900019
Investigator Site 0320020
Investigator site 0070010
Investigator Site 0340009
Investigator Site 0070007
Investigator Site 0330019
Investigator Site 0340006
Investigator Site 0330008
Investigator Site 0330009
Investigator Site 0440014
Investigator Site 0010041
Investigator Site 0360006
Investigator Site 9950009
Investigator Site 0390014
Investigator site 0480026
Investigator Site 0900003
Investigator Site 0810025
Investigator Site 0320011
Investigator Site 0480014
Investigator Site 0900009
Investigator Site 0330016
Investigator Site 0010045
Investigator Site 0390009
Investigator Site 0810015
Investigator Site 0310007
Investigator Site 0010038
Investigator Site 4200001
Investigator Site 0900010
Investigator Site 0900017
Investigator Site 0390012
Investigator Site 0900015
Investigator Site 0360014
Investigator Site 9950006
Investigator site 0810018
Investigator Site 0340015
Investigator Site 0390011
Investigator site 0810011
Investigator Site 0310005
Investigator Site 0340011
Investigator Site 0390018
Investigator site 0360010
Investigator Site 0490012
Investigator Site 0430004
Investigator site 0340012
Investigator Site 0390019
Investigator Site 0810024
Investigator Site 0480030
Investigator Site 0390021
Investigator Site 0900007
Investigator Site 0900004
Investigator Site 0360004
Investigator Site 0900008
Investigator Site 0330017
Investigator Site 0010034
Investigator Site 0070013
Investigator Site 0010046
Investigator Site 0900018
Investigator Site 0480008
Investigator Site 0340030
Investigator Site 0440010
Investigator Site 0490008
Investigator Site 0340013
Investigator Site 4200006
Investigator site 0310006
Investigator Site 9950012
Investigator Site 0900014
Investigator Site 0480012
Investigator Site 0900002
Investigator Site 0320014
Investigator Site 0070015
Investigator Site 0320015
Investigator Site 0810010
Investigator Site 0440012
Investigator Site 0480010
Investigator Site 0330015
Investigator Site 0390020
Investigator Site 0360015
Investigator site 0810016
Investigator site 0010037
Investigator Site 4200007
Investigator Site 0900005
Investigator site 0320002
Investigator site 0810020
Investigator Site 0810022
Investigator Site 0390016
Investigator Site 0810023
Investigator Site 3590001
Investigator Site 0010049
Investigator site 0070006

title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
Spain
Turkey
Czechia
Ukraine
Bulgaria
Georgia
Russian Federation
France

ipd_sharing: Undecided


title: A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

summary: DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). Two combination therapy cohorts will be opened for enrollment, DF1001 + nivolumab and DF1001 + Nab paclitaxel. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either selected solid tumors, or solid tumors expressing high levels of HER2.

lead_sponsor: Dragonfly Therapeutics

location_country:
Denmark
Netherlands
Belgium
United States
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Stichting Beoordeling Ethiek Biomedisch Onderzoek

location_facility: University of California Irvine Medical Center

location_facility: Domaine Universitaire du Sart Tilman; CHU de Liege

location_facility: Multicare Health System Tacoma General Hospital

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Montefiore Einstein Center for Cancer Care


lead_sponsor: CSL Behring

summary:
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.

Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Universitaetsmedizin der Johannes Gutenberg

location_facility: Royal Free Hospital-Royal Free London NHS Foundation Trust

location_facility: Sanatorio Parque S.A y Consultorios Externos Asociados

location_facility: Centro de Alta Especialidad en Reumatologia

location_facility: Klinika Dermatologii Szpital im. Dzieciątka Jezus

location_facility: Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Louisiana State University Health Sciences Center

location_facility: Hospital Universitari Materno Infantil Vall Dhebron

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Internal Medicine, Nantes University Hospital

location_facility: University of Pennsylvania - Perelman Center

location_facility: University Clinical Centre, Medical University of Gdansk

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie

location_facility: John Hunter Hospital / Autoimmune Resource and Research Centre

location_facility: Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis

location_facility: Lombardi Cancer Center-Georgetown University

location_facility: Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie

location_facility: Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion

location_facility: The University Of Texas Medical School At Houston (Utms)

location_facility: APRILLUS Asistencia e Investigacion Clinica

location_facility: Universita Degli Studi Di Bari Aldo Moro

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP)

location_facility: Centro De Estudios De Investigation Basica Y Clinica S.C

location_facility: Uniwersytecki Szpital Kliniczny W Bialymstoku

location_facility: Centro de Investigacion y Tratamiento Reumatologico S.C.

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

status: Withdrawn

title: A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis

ipd_sharing_description:
CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Switzerland
Mexico
Belgium
United States
Spain
Canada
France


title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program

acronym: BrainStorm

summary:
Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

primary_purpose: Other

lead_sponsor: Jules Bordet Institute

sponsor_collaborators:
Jules Bordet Institute
La Fondation contre le cancer, Belgique
Les Amis de l'Institut Bordet
Bristol-Myers Squibb
Fondation Cancer, Luxembourg

location_country: Luxembourg Belgium France

location_facility: CHU UCL Namur - Site de Sainte-Elisabeth

location_facility: Institut Universitaire du Cancer - Oncopole

location_facility: Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon


acronym: Tuscany 2

lead_sponsor: Telavant, Inc.

summary: This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

sponsor_collaborators:
Telavant, Inc.
Pfizer

location_facility: Allegiance Internal Medicine and Allegiance Research Specialists

location_facility: The University of Chicago Medical Center (clinic address)

location_facility: Gastroenterology Consultants of San Antonio, PA

location_facility: Clinical Hospital named after S.R. Mirotvortsev

location_facility: Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija

location_facility: Bulent Ecevit Universitesi Tip Fakultesi

location_facility: Weill Cornell Medical College- New York Presbyterian Hospital

location_facility: Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"

location_facility: UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"

location_facility: Research Institute of Antimicrobial Chemotherapy

location_facility: Limited Liability Company "Medicinsky Center SibNovoMed"

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion

location_facility: Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent

location_facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

location_facility: Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

location_facility: Clinexpert Tatabanya, Szent Borbala Hospital

location_facility: A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Vanderbilt University Medical Center- Heart Station (ECG)

location_facility: Tokyo Medical And Dental University Hospital

location_facility: Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump

location_facility: M.S. Ramaiah Medical College and Hospitals,

location_facility: Medical Centre Medical Clinic Blagomed LLC

location_facility: Studiengesellschaft BSF UG (haftungsbeschränkt)

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: University Hospitals Leuven/Department of Gastroenterology

location_facility: MeDiNova Northamptonshire Quality Research Site

location_facility: Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC

location_facility: Grant Medical Foundation, Ruby Hall Clinic

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center

location_facility: Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"

location_facility: Endoscopy Facility - Spire Little Aston Hospital

location_facility: "ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD

location_facility: Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez

location_facility: MeDiNova North London Quality Research Site

location_facility: Gastroenterology Associates, PA of Greenville

location_facility: King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

location_facility: The University of Chicago Medical Center

location_facility: Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"

location_facility: Endoscopy Facility - Orpington Endoscopy Centre

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

location_facility: IRCCS "Saverio de Bellis", UOC Gastroenterologia

location_facility: Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"

location_facility: Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Medical Research Center Of Connecticut, LLC

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Medical center of Limited Liability Company "Health Clinic", medical clinical research center

location_facility: Chest X-ray Facility - BMI Bishops Wood Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH

location_facility: Vanderbilt Laboratory Services North One Hundred Oaks

location_facility: Perm Clinical Centre of the Federal Medical-Biological Agency

location_facility: Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"

location_facility: M.S. Ramaiah Medical College and Hospitals

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Vanderbilt GI Endoscopy Lab at One Hundred Oaks

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Gastroenterology Associates of Northern VA

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis

location_country:
Germany
Poland
Australia
Japan
Thailand
Turkey
Serbia
France
Colombia
Slovakia
Hungary
United States
Ukraine
India
Romania
Belgium
Italy
United Kingdom
Mexico
Spain
South Africa
Bulgaria
Russian Federation