title: A Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)

summary: A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

lead_sponsor: Pliant Therapeutics, Inc.

location_country:
Germany
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Canada
France

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: London Health Sciences Centre-University Hospital

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Centre Hépato-Biliaire - Hôpital Paul-Brousse

location_facility: Massachusetts General Hospital Gastroenterology Liver Center

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: King's College Hospital NHS Foundation Trust, Denmark Hill

location_facility: University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine

location_facility: VCU Health Clinical Research Services Unit

location_facility: Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme

location_facility: Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital

location_facility: University of California, Davis Medical Center

location_facility: Indiana University Health University Hospital

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: Liverpool Hospital: Department of Gastroenterology and Hepatology

location_facility: Universitätsmedizin Mainz, I. Med. Klinik

location_facility: Saint Antoine Hospital/ Hepatology Department

location_facility: Schiff Center of Liver Diseases/University of Miami

location_facility: California Pacific Medical Center Research Institute

location_facility: John Radcliffe Hospital/Oxford University Hospital

location_facility: Medical University of Vienna Div. of Gastroenterology and Hepatology

location_facility: Baylor College of Medicine - Advanced Liver Therapies


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

status: Active, not recruiting

title: A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Japan
Brazil
Netherlands
United States
Korea, Republic of
Spain
Thailand
Greece
Malaysia
Taiwan
Czechia
Canada
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

summary: This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

ipd_sharing: No

lead_sponsor: Jazz Pharmaceuticals

sponsor_collaborators:
Jazz Pharmaceuticals
BeiGene, Ltd.

location_country:
Italy
United Kingdom
United States
China
Korea, Republic of
Spain
Chile
Canada
France

location_facility: The Oncology Institute of Hope and Innovation

location_facility: University of Texas Southwestern Medical Center - Hospital

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest

location_facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

location_facility: The First Hospital Of Lanzhou University

location_facility: Affiliated Zhongshan Hospital of Fudan University

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: The Third Affiliated Hospital of the Chinese PLA

location_facility: University College London Hospitals (UCLH)

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Washington University School of Medicine

location_facility: Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Winship Cancer Institute, Emory University

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital Universitari Parc Tauli de Sabadell


title: Phase IIb, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

summary:
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life.

The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Bone Therapeutics S.A

sponsor_collaborators:
Bone Therapeutics S.A
ICON plc

location_country: Germany Poland Hungary Belgium Spain Czechia France

intervention_type: Other


title: Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study

summary:
The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:

PV antral isolation alone (PVAI)
PV antral isolation plus ablation of drivers (PVAI+drivers)
PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

lead_sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

location_country: Australia Austria Belgium Canada France

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Royal Adelaide Hospital and Cardiovascular Centre

intervention_type: Procedure

lead_sponsor_type: academique


lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.

sponsor_collaborators:
GlaxoSmithKline
Merck Sharp & Dohme LLC

status: Terminated

title: A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

study_completion_date_type: Actual

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Korea, Republic of
Spain
Russian Federation
Sweden

ipd_sharing: Yes

status_simplified: Unknown


title: GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)

summary: This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].

design_allocation: Non-Randomized

primary_purpose: Screening

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

lead_sponsor: Pfizer

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

location_facility: Nucleotron/ Doral Imaging Institute, CIRA DBA

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Cardiology Associates of North Mississippi, LLC

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital

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

location_facility: Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare

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

location_facility: St George's Hospital, St George's University Hospitals NHS Foundation Trust

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

location_facility: U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Centre Hospitalier Saint-Joseph Saint-Luc

location_facility: Spectrum Health Medical Group Cardiovascular Medicine

location_facility: Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Hospital Universitari i Politècnic La Fe

intervention_type: Diagnostic Test


title: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)

summary: A study to evaluate posoleucel (ALVR105); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

ReferenceType: background

ReferenceCitation: Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.

lead_sponsor: AlloVir

location_country:
Italy
United Kingdom
Sweden
United States
Korea, Republic of
Spain
France

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Seoul St. Mary's Hospital, The Catholic University of Korea

location_facility: Queen Elizabeth University Hospital - Glasgow

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Great Ormond Street Hospital for Children

location_facility: The University of Texas Southwestern Medical Center

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Ohio State University Medical Center (OSUMC)

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

location_facility: Froedtert Hospital and the Medical College of Wisconsin

intervention_type: Biological


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

summary: A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.

lead_sponsor: Alector Inc.

location_country:
Germany
Italy
Portugal
United Kingdom
Argentina
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Greece
Turkey
Canada
France

location_facility: Johns Hopkins University School of Medicine

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: Indiana University Health Neuroscience Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Sunnybrook Research Institute - University of Toronto

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara

location_facility: Houston Methodist Institute for Academic Medicine

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Azienda Unita Sanita Locale (ASL) di Reggio Emilia - IRCCS

location_facility: Karolinska Universitetssjukhuset Huddinge - PPDS

location_facility: University of Kansas Alzheimer's Disease Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

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

location_facility: University Of Cincinnati Gardner Neuroscience institute

location_facility: Eginitio University General Hospital of Athens - 1st University Neurology Clinic

location_facility: University of North Carolina at Chapel Hill

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: University General Hospital of Alexandroupolis - Department of Neurology

location_facility: Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Irving Institute for Clinical and Translational Research

location_facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli


acronym: RUXCOVID

lead_sponsor: Novartis Pharmaceuticals

summary: This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.

ReferenceType: derived

ReferenceCitation: Han MK, Antila M, Ficker JH, Gordeev I, Guerreros A, Bernus AL, Roquilly A, Sifuentes-Osornio J, Tabak F, Teijeiro R, Bandelli L, Bonagura DS, Shu X, Felser JM, Knorr B, Cao W, Langmuir P, Lehmann T, Levine M, Savic S. Ruxolitinib in addition to standard of care for the treatment of patients admitted to hospital with COVID-19 (RUXCOVID): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Rheumatol. 2022 May;4(5):e351-e361. doi: 10.1016/S2665-9913(22)00044-3. Epub 2022 Mar 29.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

version: acceptedVersion

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

sponsor_collaborators:
Novartis Pharmaceuticals
Incyte Corporation

status: Completed

title: Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)

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

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

location_country:
Germany
Colombia
United Kingdom
Argentina
Brazil
Mexico
United States
Spain
Turkey
Peru
Russian Federation
France

status_simplified: Completed


title: SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

summary: This protocol provides access to eculizumab treatment for participants with severe COVID-19.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Burwick RM, Dellapiana G, Newman RA, Smithson SD, Naqvi M, Williams J 3rd, Wong MS, Bautista M, Gaden A, Kazani SD, Dunn DA, Ma MH, Mitter S, Monteleone JPR, Ortiz SR, Ghandehari S, Merin N, Zakowski MI, Karumanchi SA. Complement blockade with eculizumab for treatment of severe Coronavirus Disease 2019 in pregnancy: A case series. Am J Reprod Immunol. 2022 Aug;88(2):e13559. doi: 10.1111/aji.13559. Epub 2022 May 12.

oa_colors: green hybrid

evidence: open (via crossref license)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

location_country:
United States
France

location_facility: The Ohio State University Wexner Medical Center


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).

location_facility: Justus-Liebig-Universität Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Great Ormond Street Hospital for Sick Children

location_facility: Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin

location_facility: Erasmus Medical Center / Sophia Children's Hospital

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Charite Paediatric Pulmonology Department

location_facility: Hadassah University Hospital Mount Scopus

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

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

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

title: A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

location_country:
Germany
Israel
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Spain
Canada
France


lead_sponsor: Celgene

summary:
This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.

The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts:

Cohort A: SCLC in ICI naïve subjects
Cohort B: SCLC in ICI progressor subjects
Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1.

In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility.

In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.

location_facility:
Local Institution - 106
Local Institution - 105
Local Institution - 351
Local Institution - 110
Local Institution - 154
Local Institution - 453
Local Institution - 359
Local Institution - 352
Local Institution - 354
Local Institution - 102
Local Institution - 109
Local Institution - 301
Local Institution - 306
Local Institution - 251
Local Institution - 358
Local Institution - 454
Local Institution - 151
Local Institution - 305
Local Institution - 255
Local Institution - 362
Local Institution - 451
Local Institution - 104
Local Institution - 303
Local Institution - 356
Local Institution - 353
Local Institution - 152
Local Institution - 153
Local Institution - 355
Local Institution - 304
Local Institution - 111
Local Institution - 156
Local Institution - 254
Local Institution - 452
Local Institution - 357
Local Institution - 360
Local Institution - 107
Local Institution - 361

title: A Phase 2, Multicenter, Open-label, Multi-cohort Study to Assess Safety and Efficacy of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

location_country:
Italy
Poland
United Kingdom
United States
Spain
France


lead_sponsor: Hoffmann-La Roche

summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: McGill University Health Centre - Glen Site

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological

location_facility: National Taiwan University Hospital; Obstetrics & Gynecology

location_facility: Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin?

location_facility: Mackay Memorial Hospital; Obstetrics & Gynaecology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Chelyabisnk regional clinical center for oncology and nuclear medicine

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences

location_facility: Taichung Veterans General Hospital; Obstetrics and Gynecology

location_facility: Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology

location_facility: Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

title: A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

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:
Italy
Poland
United Kingdom
Australia
Brazil
Costa Rica
Mexico
United States
Korea, Republic of
Spain
Thailand
Panama
Taiwan
Peru
Canada
Russian Federation
France


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

ReferenceCitation: Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, Spinner CD, Galli M, Ahn MY, Nahass RG, Chen YS, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wei X, Gaggar A, Brainard DM, Towner WJ, Munoz J, Mullane KM, Marty FM, Tashima KT, Diaz G, Subramanian A; GS-US-540-5773 Investigators. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19. N Engl J Med. 2020 Nov 5;383(19):1827-1837. doi: 10.1056/NEJMoa2015301. Epub 2020 May 27.

ReferenceCitation: Jacobson KB, Rao M, Bonilla H, Subramanian A, Hack I, Madrigal M, Singh U, Jagannathan P, Grant P. Patients With Uncomplicated Coronavirus Disease 2019 (COVID-19) Have Long-Term Persistent Symptoms and Functional Impairment Similar to Patients with Severe COVID-19: A Cautionary Tale During a Global Pandemic. Clin Infect Dis. 2021 Aug 2;73(3):e826-e829. doi: 10.1093/cid/ciab103.

evidence: open (via free article)

publisher_dissemination: Oxford University Press

ReferenceCitation: Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, Wang S, Walunas TL, Swaminathan S, Slim J, Chin B, De Wit S, Ali SM, Soriano Viladomiu A, Robinson P, Gottlieb RL, Tsang TYO, Lee IH, Hu H, Haubrich RH, Chokkalingam AP, Lin L, Zhong L, Bekele BN, Mera-Giler R, Phulpin C, Edgar H, Gallant J, Diaz-Cuervo H, Smith LE, Osinusi AO, Brainard DM, Bernardino JI; GS-US-540-5773 and GS-US-540-5807 Investigators. Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care. Clin Infect Dis. 2021 Dec 6;73(11):e4166-e4174. doi: 10.1093/cid/ciaa1041.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repositories_concat: PubMed Central;dipot.ulb.ac.be

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: SCL Health St. Joseph Hospital, 200 Exempla Circle.

location_facility: Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

location_facility: Dipartimento di Malattie Infettive, Malattie Infettive I- Malattie Infettive III, AssT Fatebenefratelli Sacco Ospedale Luigi Sacco

location_facility: UOC Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: Ospedale Guglielmo da Saliceto AUSL di Piacenza

location_facility: Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

location_facility: UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territor

location_facility: Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

location_facility: The Liver Institute of Methodist Dallas Medical Center

location_facility: Brigham & Women's Hospital and Harvard Medical School

location_facility: James J. Peters Veterans Administration Medical Center

location_facility: Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

location_facility: UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

location_facility: Icahn School of Medicine at Mount Sinai, 440 West 114th St.

location_facility: Providence Regional Medical Center Everett

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: UOC Malattie Infettive I, Fondazione IRCCS Policlinio San Matteo

location_facility: University Hospitals Cleveland Medical Center

location_facility: CHU de Montpellier-Hopital Gui de Chauliac

location_facility: Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

location_facility: Icahn School of Medicine at Mount Sinai, 350 East 17th Street

location_facility: National Centre for Infectious Diseases, Tan Tock Seng Hospital

location_facility: Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue

location_facility: Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

location_facility: SCL Health St. Joseph Hospital, 1375 East 19th Ave

location_facility: Manchester University NHS Foundation Trust

location_facility: Kaiser Permanente Oakland Medical Center, 2500 Merced St

location_facility: Hospital of the University of Pennsylvania, 51 N. 31st Street

location_facility: Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)

location_facility: Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

location_facility: Robert Wood Johnson University Hospital Somerset

location_facility: Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: The University of Michigan Hospitals and Health Systems

location_facility: California Pacific Medical Center-Infectious Disease Associates Medical Group

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

location_facility: Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

location_facility: Amsterdam University Medical Centre - Location AMC

location_facility: Hospital Regional Universitario de Málaga

location_facility: Sutter Medical Center Sacramento, One Medical Plaza

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

location_facility: Providence St Patrick Hospital and International Heart Institute of MT Foundation

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Mission Hospital Regional Medical Center

location_facility: Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

location_facility: Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: Prisma Health Richland Hospital, 701 Grove Road

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: UOC Malattie Infettive, ASST Papa Giovanni XXIII

location_facility: Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

location_facility: North Shore University Hospital, 270-05 76th Ave

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 5201 Harry Hines Blvd.

location_facility: Baylor University Medical Center, 1400 8th Ave

location_facility: Klinikum rechts der Isar der TU Munchen, Klinik und Poliklinik Innere Medizin 2

location_facility: Universitatsklinikum Dusseldorf, Klinik fur Gastroenterologie, Hepatologie und Infektiologie

location_facility: UOC Medicina Di Laboratorio, Azienda Ospedaliera di Padova

location_facility: Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

location_facility: Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

location_facility: Hospital of the University of Pennsylvania

location_facility: Baylor University Medical Center, 2401 S. 31st St.

location_facility: Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe COVID-19

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

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


summary: The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.

ReferenceType: result

ReferenceCitation: Spinner CD, Gottlieb RL, Criner GJ, Arribas Lopez JR, Cattelan AM, Soriano Viladomiu A, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LYA, Roestenberg M, Tsang OTY, Bernasconi E, Le Turnier P, Chang SC, SenGupta D, Hyland RH, Osinusi AO, Cao H, Blair C, Wang H, Gaggar A, Brainard DM, McPhail MJ, Bhagani S, Ahn MY, Sanyal AJ, Huhn G, Marty FM; GS-US-540-5774 Investigators. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020 Sep 15;324(11):1048-1057. doi: 10.1001/jama.2020.16349.

oa_host_type: repository

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

repository_institution: Leiden University - Leiden Repository

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

ReferenceCitation: Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.

location_facility: SCL Health St. Joseph Hospital, 200 Exempla Circle.

location_facility: Klinik für Hämatologie, Onkologie, Immunologie

location_facility: Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

location_facility: Ospedale Guglielmo da Saliceto AUSL di Piacenza

location_facility: UOC Malattie Infettive, IRCCS Ospedale San Raffaele

location_facility: Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

location_facility: UOC Malattie Infettive ad Alta Intensita di Cure, Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territor

location_facility: Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

location_facility: The Liver Institute of Methodist Dallas Medical Center

location_facility: Brigham & Women's Hospital and Harvard Medical School

location_facility: James J. Peters Veterans Administration Medical Center

location_facility: Klinikum St. Georg gGmbH Klinik fur Infektiologie, Tropenmedizin, Nephrologie und Rheumatologie

location_facility: Kaiser Permanente Los Angeles Medical Center,27300 Iris Avenue

location_facility: UO Malattie Infettive, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Weill Cornell Medical College/NYU Presbyterian Hospital

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: UOC Malattie Infettive e Tropicali, Azienda Ospedaliera di Padova

location_facility: Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

location_facility: Icahn School of Medicine at Mount Sinai, 440 West 114th St.

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University Hospitals Cleveland Medical Center

location_facility: CHU de Montpellier-Hopital Gui de Chauliac

location_facility: Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik Infektiologie Pneumologie

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

location_facility: Icahn School of Medicine at Mount Sinai, 350 East 17th Street

location_facility: National Centre for Infectious Diseases, Tan Tock Seng Hospital

location_facility: Kaiser Sunnyside Medical Center, 2875 NW Stucki Ave

location_facility: SCL Health St. Joseph Hospital, 1375 East 19th Ave

location_facility: Manchester University NHS Foundation Trust

location_facility: Kaiser Permanente Oakland Medical Center, 2500 Merced St

location_facility: Hospital of the University of Pennsylvania, 51 N. 31st Street

location_facility: Robert-Bosch-Krankenhaus (RBK), Klinik Schillerhohe (KSH) und Dr. Margarete Fischer-Bosch-Institut fur klinische Pharmakologie (IKP)

location_facility: Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

location_facility: Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: The University of Michigan Hospitals and Health Systems

location_facility: California Pacific Medical Center-Infectious Disease Associates Medical Group

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

location_facility: Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

location_facility: Amsterdam University Medical Centre - Location AMC

location_facility: Hospital Regional Universitario de Málaga

location_facility: Sutter Medical Center Sacramento, One Medical Plaza

location_facility: UT Southwestern Medical Center Amelia Court, HIV Research Clinic, 6201 Harry Hines Blvd

location_facility: NHS Lothian, Royal lnfirmary of Edinburgh

location_facility: Malattie Infettive I, Fondazione IRCCS Policlinico San Matteo

location_facility: Providence St Patrick Hospital and International Heart Institute of MT Foundation

location_facility: Mission Hospital Regional Medical Center

location_facility: Icahn School of Medicine at Mount Sinai, 1000 10th Avenue

location_facility: Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

location_facility: Prisma Health Richland Hospital, 701 Grove Road

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: UOC Malattie Infettive, ASST Papa Giovanni XXIII

location_facility: Kaiser Permanente Los Angeles Medical Center,13651 Willard Street

location_facility: Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center

location_facility: Columbia University Irving Medical Center

title: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment


acronym: DREAMM 7

summary: This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

title: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Czechia
Canada
France
United States
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

ipd_sharing_description: There is no plan to share data

lead_sponsor: Incyte Corporation

location_country:
Australia
Japan
Belgium
United States
France

location_facility: Institut de Cancerologie de L Ouest - Site Paul Papin

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Institut Jules Bordet Clinical Trials Conduct Unit


title: A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours

summary: A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.

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

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Australia
Brazil
United Kingdom
Austria
United States
Korea, Republic of
Spain
Canada
Ukraine
Russian Federation
France


title: Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

acronym: CATALYST

summary:
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
Lithuania
Poland
United Kingdom
Hong Kong
Denmark
Australia
Japan
Netherlands
Switzerland
United States
Spain
Czechia
Canada
France

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: AdventHealth Florida Cardiology - Altamonte Springs

location_facility: CHI Health Creighton University Medical Center-Bergan Mercy

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: New York Presbyterian Hospital/Cornell University

location_facility: Cardiovascular Research Institute of Kansas

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier

location_facility: Tokyo Medical and Dental University Hospital of Medicine

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: AdventHealth Florida Cardiology - Lake Mary

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: St. Cloud Hospital - Central MN Heart Clinic

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Northside Hospital (CardioVascular Group Lawrenceville)

location_facility: Cardioangiologisches Centrum am Bethanien Krankenhaus

location_facility: University of California at San Diego (UCSD) Medical Center

location_facility: Baylor All Saints Medical Center at Fort Worth

location_facility: The University of Hong Kong (Queen Mary Hospital)

location_facility: Kansas City Cardiac Arrhythmia Research Foundation

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

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

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: AdventHealth Florida Cardiology - Oviedo

intervention_type: Device


acronym: Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IV

lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone:

In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and
In participants with a tumor that has a PD-L1 CPS ≥ 20.

ReferenceCitation: McIntosh JA, Liu Z, Andresen BM, Marzijarani NS, Moore JC, Marshall NM, Borra-Garske M, Obligacion JV, Fier PS, Peng F, Forstater JH, Winston MS, An C, Chang W, Lim J, Huffman MA, Miller SP, Tsay FR, Altman MD, Lesburg CA, Steinhuebel D, Trotter BW, Cumming JN, Northrup A, Bu X, Mann BF, Biba M, Hiraga K, Murphy GS, Kolev JN, Makarewicz A, Pan W, Farasat I, Bade RS, Stone K, Duan D, Alvizo O, Adpressa D, Guetschow E, Hoyt E, Regalado EL, Castro S, Rivera N, Smith JP, Wang F, Crespo A, Verma D, Axnanda S, Dance ZEX, Devine PN, Tschaen D, Canada KA, Bulger PG, Sherry BD, Truppo MD, Ruck RT, Campeau LC, Bennett DJ, Humphrey GR, Campos KR, Maddess ML. A kinase-cGAS cascade to synthesize a therapeutic STING activator. Nature. 2022 Mar;603(7901):439-444. doi: 10.1038/s41586-022-04422-9. Epub 2022 Mar 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0014)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0085)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0115)

location_facility: Hospital de Caridade de Ijui ( Site 0061)

location_facility: Haukeland Universitetssykehus, Klinisk forskningspost voksne ( Site 0086)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0031)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0064)

location_facility: Calvary Central Districts Hospital ( Site 0042)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0114)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0049)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0078)

location_facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 0051)

location_facility: University of California at San Francisco ( Site 0006)

location_facility: Hospital Clinico de Barcelona ( Site 0116)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 0032)

location_facility: Monash Health-Monash Medical Centre ( Site 0041)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0058)

location_facility: Centro Regional Integrado de Oncologia ( Site 0062)

title: A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination With IV Pembrolizumab vs IV Pembrolizumab Monotherapy

location_country:
Israel
Norway
United Kingdom
Australia
Brazil
Austria
United States
Korea, Republic of
Spain
France


summary:
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment.

This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).

title: A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301

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

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Croatia
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
United States
India
Romania
Tunisia
Lebanon
Belgium
Malaysia
Peru
Oman
Estonia
Puerto Rico
Philippines
Italy
Guatemala
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics & Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients w/ Advanced Solid Malignancies

summary:
This is a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that have select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal growth factor receptor (EGFR/ErbB1). The main goals of this study are to:

Find the recommended dose of BDTX-189 that can be given safely to participants
Learn more about the side effects of BDTX-189
Learn what the body does to BDTX-189 after it has been taken (pharmacokinetics or PK)
Determine the antitumor activity of BDTX-189 in participants with select allosteric ErbB gene mutations

ReferenceCitation: Erika Paige Hamilton, Manish R. Patel, Jordi Rodon, David S. Hong, Alison M. Schram, Pasi A. Janne, Patricia LoRusso, Jasgit C. Sachdev, Sai Hong Ou, Elizabeth A Buck, Matthew O'Connor, Nigel Waters, Karsten Witt, Carl Cook. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. J Clin Oncol 38: 2020 (suppl; abstr TPS3665)

lead_sponsor: Black Diamond Therapeutics, Inc.

location_country:
United States
Denmark
Spain
France


summary:
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

Hypotheses include:

Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

oa_host_type: publisher

evidence: open (via page says license)

publisher_dissemination: Future Science Ltd

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Aichi Cancer Center Hospital ( Site 1113)

location_facility: Yokohama City University Hospital ( Site 1104)

location_facility: ASL Liguria 2 - Ospedale San Paolo ( Site 2401)

location_facility: Washington University School of Medicine ( Site 0060)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0703)

location_facility: The Third Affiliated Hospital of Harbin Medical University ( Site 3302)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1103)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)

location_facility: University of Kansas Cancer Center ( Site 0033)

location_facility: Seoul National University Bundang Hospital ( Site 1205)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)

location_facility: Christie NHS Foundation Trust ( Site 2903)

location_facility: Universitaetsklinikum Regensburg ( Site 2100)

location_facility: West China Hospital of Sichuan University ( Site 3308)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0704)

location_facility: Peking Union Medical College Hospital ( Site 3304)

location_facility: Universitaetsklinikum Koeln ( Site 2111)

location_facility: Medipol Universite Hastanesi ( Site 2800)

location_facility: Hospital Universitario La Paz ( Site 2706)

location_facility: University of Louisville, James Graham Brown Cancer Center ( Site 0045)

location_facility: Universitaetsklinikum Frankfurt ( Site 2107)

location_facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)

location_facility: Fundacao Sao Francisco Xavier ( Site 0409)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)

location_facility: California Cancer Associates for Research & Excellence ( Site 0059)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 2507)

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

location_facility: California Cancer Associates for Research & Excellence ( Site 0025)

location_facility: National Cancer Center Hospital East ( Site 1100)

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2206)

location_facility: University of Colorado Cancer Center ( Site 0023)

location_facility: Princess Margaret Cancer Centre ( Site 0200)

location_facility: Hospital Universitario 12 de Octubre ( Site 2702)

location_facility: National Cancer Center Hospital ( Site 1102)

location_facility: University of North Carolina- Chapel Hill ( Site 0056)

location_facility: Tianjin Medical University Cancer Hospital ( Site 3312)

location_facility: National Cheng Kung University Hospital ( Site 1603)

location_facility: Universitaetsklinikum Tuebingen ( Site 2108)

location_facility: Fujian Provincial Cancer Hospital ( Site 3326)

location_facility: Wuhan Union hospital Cancer Center ( Site 3307)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)

location_facility: Christus Muguerza Clinica Vidriera ( Site 0607)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 1111)

location_facility: University of Connecticut Health Center ( Site 0020)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: National Taiwan University Hospital ( Site 1600)

location_facility: IEO Istituto Europeo di Oncologia ( Site 2406)

location_facility: Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)

location_facility: Altay Regional Oncology Dispensary ( Site 2611)

location_facility: Medical Park Izmir Hospital ( Site 2807)

location_facility: Providence Portland Medical Center ( Site 0048)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)

location_facility: Georgia Cancer Center at Augusta University ( Site 0013)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)

location_facility: Dana Farber Cancer Institute ( Site 0019)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 2805)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)

location_facility: St. Vincent Frontier Cancer Center ( Site 0008)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)

location_facility: Inova Schar Cancer Institute ( Site 0009)

location_facility: Taunton and Somerset Hospital ( Site 2900)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)

location_facility: Xiangya Hospital of Central South University ( Site 3305)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)

location_facility: Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)

location_facility: University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0603)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)

location_facility: Orszagos Onkologiai Intezet ( Site 2202)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)

location_facility: Taipei Veterans General Hospital ( Site 1601)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 2703)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2910)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1101)

location_facility: McGill University Health Centre ( Site 0206)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)

location_facility: SUNY Upstate Medical University ( Site 0051)

location_facility: Keimyung University Dongsan Hospital ( Site 1203)

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0028)

location_facility: ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site

location_facility: Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)

location_facility: Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)

location_facility: Hiroshima University Hospital ( Site 1109)

location_facility: Fudan University Shanghai Cancer Center ( Site 3324)

location_facility: Chonnam National University Hwasun Hospital ( Site 1202)

location_facility: Universitätsklinikum Leipzig-Department for ENT ( Site 2106)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2801)

title: A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).

type: Registry Identifier

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Canada
France
Hungary
United States
China
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


acronym: Heads UP

lead_sponsor: AbbVie

summary:
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377

location_facility: California Allergy and Asthma Medical Group /ID# 218635

location_facility: Wellington Regional Hospital /ID# 218689

location_facility: Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 214634

location_facility: Hospital Universitario Dr. Negrin /ID# 214256

location_facility: Fakultni nemocnice Hradec Kralove /ID# 214176

location_facility: Taipei Municipal Wan Fang Hospital /ID# 218918

location_facility: Hospital Universitario de Bellvitge /ID# 214257

location_facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385

location_facility: First OC Dermatology Research Inc /ID# 218619

location_facility: Michigan Center for Research Company /ID# 218577

location_facility: Florida International Rsrch cr /ID# 218663

location_facility: The Royal Free London NHS Foundation Trust /ID# 213560

location_facility: Clinical Research Trials of Florida, Inc. /ID# 218438

location_facility: Universitaetsklinikum Frankfurt /ID# 214223

location_facility: Hospital Universitario Arnau Vilanova /ID# 214254

location_facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218441

location_facility: Royalderm Agnieszka Nawrocka /ID# 214302

location_facility: CHU Toulouse - Hopital Larrey /ID# 218958

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 218724

location_facility: Klinicki bolnicki centar Zagreb /ID# 218375

location_facility: Oregon Medical Res Center PC /ID# 218440

location_facility: NHS Greater Glasgow and Clyde /ID# 213561

location_facility: Medical Dermatology Associates of Chicago /ID# 218551

location_facility: Beacon Clinical Research, LLC /ID# 218636

location_facility: Dermoklinika Centrum Medyczne s.c. /ID# 214300

location_facility: The Chaim Sheba Medical Center /ID# 218522

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225

location_facility: Kyiv City Clinical Skin and Venereal Hospital /ID# 218382

location_facility: National University Hospital /ID# 219093

location_facility: Clinical Research Solutions, LLC /ID# 218447

location_facility: Chung Shan Medical University Hospital /ID# 218919

location_facility: Medizinische Hochschule Hannover /ID# 214226

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 214093

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095

location_facility: Keski-pohjanmaa Central Hospital /ID# 214630

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 214096

location_facility: University Hospitals Sussex NHS Foundation Trust /ID# 213562

location_facility: Hospital Pakar Sultanah Fatimah /ID# 218877

location_facility: Dermatology Research Institute Inc. /ID# 218728

location_facility: Universitaetsklinikum Muenster /ID# 214222

location_facility: Oregon Medical Research Center /ID# 218578

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 218725

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214984

location_facility: Nemocnice Jihlava, prispevkova organizace /ID# 214178

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 218959

location_facility: Dermatology Research Associates /ID# 218637

location_facility: China Medical University Hospital /ID# 218409

location_facility: Oulun yliopistollinen sairaala /ID# 214628

location_facility: Universitair Medisch Centrum Groningen /ID# 218775

location_facility: Miami Dermatology and Laser Institute /ID# 218664

location_facility: University Hospitals Case Medical Center /ID# 218574

location_facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376

location_facility: Holdsworth House Medical Practice /ID# 218755

location_facility: Universitair Medisch Centrum Utrecht /ID# 218771

location_facility: Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548

location_facility: ClinicMed Daniluk, Nowak Sp.k. /ID# 214299

location_facility: Medical University of South Carolina /ID# 221072

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 214255

location_facility: Hospital Universitario y Politecnico La Fe /ID# 214252

location_facility: National Taiwan University Hospital /ID# 218917

location_facility: University of Arkansas for Medical Sciences /ID# 221021

location_facility: Dr. Wei Jing Loo Medicine Prof /ID# 218722

location_facility: Clinical Research Partners, LLC /ID# 218480

location_facility: AP-HM - Hopital de la Timone /ID# 218957

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 214301

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221

location_facility: St Vincent's University Hospital /ID# 213558

title: A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

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

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Croatia
Czechia
Canada
France
Hungary
United States
Ukraine
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Spain
Taiwan
Israel


title: A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)

acronym: CIPHER

summary: The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

primary_purpose: Diagnostic

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
United States
Spain
Ukraine
France

location_facility: The Houston Methodist Research Institute

location_facility: Europejskie Centrum Zdrowia Otwock Sp. z o.o

location_facility: University Of Colorado Cardiac And Vascular Center

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

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

location_facility: National Waiting Times Centre Board Golden Jubilee National Hospital

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin I

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'


acronym: NATRON

summary:
This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur.

Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.

title: A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24 Week Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Italy
Poland
Israel
Denmark
Japan
Netherlands
Austria
Belgium
Switzerland
United States
France


title: VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis

acronym: VOYAGE

summary: The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.

lead_sponsor: Viking Therapeutics, Inc.

location_country:
Mexico
Belgium
United States
Puerto Rico
France

location_facility:
Viking Clinical Site 610
Viking Clinical Site 208
Viking Clinical Site 137
Viking Clinical Site 421
Viking Clinical Site 312
Viking Clinical Site 161
Viking Clinical Site 121
Viking Clinical Site 301
Viking Clinical Site 214
Viking Clinical Site 158
Viking Clinical Site 211
Viking Clinical Site 205
Viking Clinical Site 217
Viking Clinical Site 220
Viking Clinical Site 502
Viking Clinical Site 112
Viking Clinical Site 117
Viking Clinical Site 145
Viking Clinical Site 209
Viking Clinical Site 134
Viking Clinical Site 219
Viking Clinical Site 148
Viking Clinical Site 110
Viking Clinical Site 109
Viking Clinical Site 115
Viking Clinical Site 314
Viking Clinical Site 226
Viking Clinical Site 128
Viking Clinical Site 153
Viking Clinical Site 503
Viking Clinical Site 304
Viking Clinical Site 130
Viking Clinical Site 146
Viking Clinical Site 120
Viking Clinical Site 131
Viking Clinical Site 125
Viking Clinical Site 227
Viking Clinical Site 102
Viking Clinical Site 307
Viking Clinical Site 147
Viking Clinical Site 612
Viking Clinical Site 223
Viking Clinical Site 156
Viking Clinical Site 310
Viking Clinical Site 142
Viking Clinical Site 213
Viking Clinical Site 126
Viking Clinical Site 101
Viking Clinical Site 107
Viking Clinical Site 422
Viking Clinical Site 103
Viking Clinical Site 224
Viking Clinical Site 216
Viking Clinical Site 317
Viking Clinical Site 105
Viking Clinical Site 302
Viking Clinical Site 150
Viking Clinical Site 166
Viking Clinical Site 215
Viking Clinical Site 607
Viking Clinical Site 143
Viking Clinical Site 401
Viking Clinical Site 133
Viking Clinical Site 127
Viking Clinical Site 159
Viking Clinical Site 116
Viking Clinical Site 118
Viking Clinical Site 311
Viking Clinical Site 152
Viking Clinical Site 201
Viking Clinical Site 160
Viking Clinical Site 111
Viking Clinical Site 144
Viking Clinical Site 611
Viking Clinical Site 113
Viking Clinical Site 603
Viking Clinical Site 221
Viking Clinical Site 218
Viking Clinical Site 106


title: A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

acronym: BANFF

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

lead_sponsor: Genentech, Inc.

location_country:
Belgium
United States
Spain
Puerto Rico
France

location_facility: UC San Diego Airway Research and Clinical Trials Center

location_facility: Texas Digetive Disease Consultants - Austin

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Consorci Hospital General Universitari de València

location_facility: Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)

location_facility: Hôpital d'Enfants, Service d?onco-hématologie pédiatrique

location_facility: Pinnacle Clinical Research - San Antonio

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Duke Medical Center; Gen Clinic Research Ctr

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica

location_facility: National Research Institute - Panorama City

location_facility: Hunter Holmes McGuire V.A. Medical Center

location_facility: Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department


title: Safety Study of Oral Edaravone Administered in Subjects With ALS

summary: The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

ipd_sharing: Undecided

lead_sponsor: Mitsubishi Tanabe Pharma America Inc.

location_country:
Germany
Italy
Japan
United States
Canada
France

location_facility: CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

location_facility: Shiga University of Medical Science Hospital

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

location_facility: University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: National Hospital Organization Iou National Hospital

location_facility: University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location

location_facility: Montreal Neurological Institute and Hospital

location_facility: Houston Methodist Neurological Institute

location_facility: Heritage Medical Research Clinic - University Of Calgary

location_facility: National Hospital Organization Toneyama Medical Center

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: National Hospital Organization Utano Hospital

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: National Hospital Organization Kumamoto Saishun Medical Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

location_facility: Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

location_facility: University of Michigan - ALS Center of Excellence

location_facility: National Hospital Organization Chiba-East-Hospital

location_facility: Niigata University Medical And Dental Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique


lead_sponsor: NuCana plc

summary:
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care
The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

ReferenceCitation: McNamara MG, Goyal L, Doherty M, Springfeld C, Cosgrove D, Sjoquist KM, Park JO, Verdaguer H, Braconi C, Ross PJ, Gramont A, Zalcberg JR, Palmer DH, Valle JW, Knox JJ. NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121). Future Oncol. 2020 Jun;16(16):1069-1081. doi: 10.2217/fon-2020-0247. Epub 2020 May 6.

repository_institution: The University of Glasgow - Enlighten: Publications

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Northwest Cancer Specialists, P.C.-Vancouver

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

location_facility: SI "Shalimov's National Institute of Surgery and Transplantation" of NAMSU

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Rocky Mountain Cancer Centers, LLP- Aurora

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

location_facility: Baskent University Adana Application and Research Center

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: Corporal Michael J. Crescenz VA Medical Center

location_facility: Centro Ricerche Cliniche di Verona S.r.l

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: The Research Foundation for The State University of New York

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Communal Institution Odesa Regional Clinical Hospital

location_facility: University of Rochester Medical Center - Strong Memorial Hospital

location_facility: Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: CHA Bundang Medical Center, CHA University

location_facility: State Budget Institution of Healthcare "Leningrad Regional Clinical Oncology Dispensary"

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
United States
Korea, Republic of
Spain
Turkey
Taiwan
Czechia
Canada
Ukraine
Russian Federation
France


title: Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

summary: This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

lead_sponsor: Cellectis S.A.

location_country:
United States
France

location_facility: Hôpital Robert Debré - Service d'hémato-immunologie

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: University of Colorado - Aurora Cancer Center

location_facility: Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie

location_facility: Weill Medical College of Cornell University

location_facility: Sarah Cannon - Colorado Blood Cancer Institute

location_facility: Sarah Cannon - St. David's South Austin Medical Center

location_facility: Sarah Cannon - Texas Transplant Institute at Methodist Hospital


lead_sponsor: Eli Lilly and Company

summary: This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

sponsor_collaborators:
Eli Lilly and Company
Dermira, Inc.

location_facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

location_facility: Smite Aija - Practice in Dermatology Venereology

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: California Dermatology & Clinical Research Institute

location_facility: Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-ME

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: JSC "Center for Diagnosis and Treatment of Allergic Diseases"

location_facility: Soon Chun Hyang University Seoul Hospital

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Sant Joan de Deu Serveis En Salut Mental

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Lithuania
Poland
Australia
United States
Korea, Republic of
Latvia
Spain
Canada
Estonia
France


acronym: M-PLACE

lead_sponsor: HI-Bio

summary: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: The Ohio State University Wexner Medical Center

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Miami Division of Nephrology & Hypertension

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Hospital General Universitario de Valencia

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Kidney Care and Transplant Services of New England, PC

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Hallym University Kangdong Sacred Heart Hospital

title: A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)

ipd_sharing_description: Data supporting this study are not publicly available due to the ongoing nature of the clinical development program. Datasets may be available upon reasonable request 18 months after the final clinical study report has been completed and, as appropriate, once the regulatory review of the indication or drug has completed, whichever is later.

location_country:
Italy
Poland
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
France


title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease

summary: This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.

lead_sponsor: Amicus Therapeutics

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Bosnia and Herzegovina
Canada
France
Slovenia
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Sweden

location_facility: University of Florida Clinical Research Center

location_facility: University of Cincinnati Gardner Neuroscience Institute

location_facility: Royal Free Hospital NHS Foundation Trust

location_facility: UOC di Neurologia e Malattie Neuromuscolari

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Washington University School of Medicine

location_facility: Lysosomal and Rare Disorders Research and Treatment Center, Inc.

location_facility: University of Arkansas for Medical Sciences

location_facility: UPMC Montefiore Clinical and Translational Research Center