title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma

acronym: VESTIGE

summary:
Primary Objective:

o To assess the effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging

Secondary Objective:

To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
To evaluate safety of dupilumab

lead_sponsor: Sanofi

location_country:
Denmark
Taiwan
Portugal
Saudi Arabia
Italy
Spain
United Kingdom
Canada
Ukraine
United States
France
Romania
Sweden
Bulgaria

location_facility: ~Spartanburg Medical Research-Site Number:8400004

location_facility: University of Kansas School of Medicine-Site Number:8400008

location_facility: Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program-Site Number:8400009

location_facility: Velocity Clinical Research, Medford-Site Number:8400014

location_facility: The Lung Research Center-Site Number:8400010

location_facility: VitaLink Research - Spartanburg-Site Number:8400011

location_facility: University of Michigan-Site Number:8400002

location_facility: American Health Research-Site Number:8400005

location_facility: Allianz Research Institute-Site Number:8400020


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.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Alector Inc.

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

location_facility: University of North Carolina at Chapel Hill

location_facility: Johns Hopkins University School of Medicine

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University Of Cincinnati Gardner Neuroscience institute

location_facility: Karolinska Universitetssjukhuset Huddinge - PPDS

location_facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

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

location_facility: University of Kansas Alzheimer's Disease Center

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

location_facility: Houston Methodist Institute for Academic Medicine

location_facility: University General Hospital of Alexandroupolis - Department of Neurology

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

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

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Froedtert and The Medical College of Wisconsin

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

location_facility: Sunnybrook Research Institute - University of Toronto

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

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

location_facility: Indiana University Health Neuroscience Center

location_facility: Irving Institute for Clinical and Translational Research

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)

summary: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in subjects with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: FibroGen

location_country:
Spain
Italy
Austria
Australia
United Kingdom
Canada
Switzerland
United States
France
China
Israel
Belgium
Netherlands
Czechia

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Klinika dÄ>tské neurologie, Neuromuskulární centrum

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Children's Specialty Group - Medical Center Office

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

location_facility: Fakultní Nemocnice Brno - Dětská Nemocnice

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: West China Second University Hospital, Sichuan University

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: Carolinas HealthCare System Neurosciences Institute-Neurology - Charlotte

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

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

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of California Los Angeles Medical Center


ipd_sharing: Yes

status: Terminated

intervention_type: Biological

title: A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

study_completion_date_type: Actual

lead_sponsor: Alexion Pharmaceuticals

source: euctr

ReferenceType: background

ReferenceCitation: WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.

ReferenceType: result

ReferenceCitation: McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7.

ReferenceCitation: Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z.

ReferenceType: derived

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

ReferenceCitation: Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15). pii: 140711. doi: 10.1172/jci.insight.140711. Review.

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

location_country:
United Kingdom
Spain
United States
France
Japan

location_facility: Washington University School of Medicine

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Medical Hospital, Tokyo Medical and Dental University

summary: This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.

status_simplified: Unknown


status: Completed

acronym: Coronavirus

intervention_type: Other

title: A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

lead_sponsor: Karyopharm Therapeutics Inc

type: EudraCT Number

location_country:
Spain
United Kingdom
Austria
United States
Israel
France

location_facility: Miami Cancer Institute at Baptist Health

location_facility: Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases

location_facility: Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca

location_facility: Levine Cancer Institute-Atrium Health University City

location_facility: MultiCare Institute for Research & Innovation (Puget Sound)

summary: The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.

status_simplified: Completed


title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

summary: This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.

lead_sponsor: PellePharm, Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Utah, Midvalley Dermatology

location_facility: Columbia University Irving Medical Center


type: Other Identifier

title: A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)

acronym: Expedition

summary: The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.

status: Enrolling by invitation

design_allocation: Non-Randomized

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:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Japan
Czechia
Poland
Austria
Russian Federation
Puerto Rico
India
Israel
Slovakia
Canada
Hungary
Germany
Taiwan
Korea, Republic of
France


title: Screening/Observational Protocol to Determine Patient Eligibility for Inclusion in AAV Gene Therapy Clinical Trials (ECLIPSE)

acronym: ECLIPSE

summary: Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.

study_type: Observational

time_perspective: Other

ipd_sharing: No

lead_sponsor: Freeline Therapeutics

location_country:
United Kingdom
Ireland
Austria
Australia
Italy
Canada
Netherlands
United States
France
Turkey
South Africa
Germany

location_facility: Indiana Hemophilia and Thrombosis Center

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

location_facility: Samsun Ondokuz Mayis University Medical Faculty

location_facility: Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: University of Cape Town Clinical Research Center

location_facility: Newcastle Hemophilia Comprehensive Care Centre

location_facility: University Hospitals Cleveland Medical Center

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Citta della Salute e della Scienza di Torino - Ospedale le Molinette

location_facility: Lombardi Comprehensive Cancer Center at Georgetown University

location_facility: Universitaetsklinikum des Saarlandes und Medizinische Fakultaet der Universitaet des Saarlandes


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

summary: The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Argentina
Canada
Switzerland
Korea, Republic of
United States
France
Israel
Puerto Rico
Belgium
Japan
Germany

location_facility: Research Foundation of SUNY - University of Buffalo

location_facility: Tulane University School of Medicine-Gastroenterology and Hepatology

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo

location_facility: Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel-Allgemeine Innere Medizin I

location_facility: Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II

location_facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)-UC San Diego NAFLD Research Cent

location_facility: NYU Langone Health-Department of Medicine

location_facility: A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic

location_facility: University Diabetes & Endocrine Consultants


title: Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL 2

summary: This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with Achondroplasia (ACH) who previously participated in the PROPEL study (Protocol QBGJ398-001) for at least 6 months. The study includes dose escalation with extended treatment, and dose expansion. The study also includes a PK Substudy to fully characterize the pharmacokinetics of infigratinib in children with ACH.

ReferenceCitation: Savarirayan R, De Bergua JM, Arundel P, McDevitt H, Cormier-Daire V, Saraff V, Skae M, Delgado B, Leiva-Gea A, Santos-Simarro F, Salles JP, Nicolino M, Rossi M, Kannu P, Bober MB, Phillips J 3rd, Saal H, Harmatz P, Burren C, Gotway G, Cho T, Muslimova E, Weng R, Rogoff D, Hoover-Fong J, Irving M. Infigratinib in children with achondroplasia: the PROPEL and PROPEL 2 studies. Ther Adv Musculoskelet Dis. 2022 Mar 21;14:1759720X221084848. doi: 10.1177/1759720X221084848. eCollection 2022.

lead_sponsor: QED Therapeutics, Inc.

location_country:
Spain
United Kingdom
Australia
Canada
United States
France

location_facility: Manchester University Children's Hospital

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Nemours Alfred I. Dupont Hospital for Children

location_facility: Hospital Universitario Virgen de la Victoria


acronym: TRANSCEND FL

title: A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

lead_sponsor: Celgene

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Sweden
United States
France
Japan
Germany

location_facility: Providence Cancer Center/Earle A. Chiles Res. Inst.

location_facility: Massachusetts General Hospital - Dana-Farber Cancer Institute

location_facility: Novant Health Presbyterian Medical Center

location_facility: University of Pennsylvania - Perelman Center for Advanced Medicine

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

summary:
This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.


title: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies

summary: This is a phase 1, 2-part, global, multicenter, open-label, PK, safety and tolerability study of oral tazemetostat in subjects with either advanced solid tumors, or hematological malignancies and normal hepatic function or moderate, or severe hepatic impairment.

lead_sponsor: Epizyme, Inc.

location_country:
Poland
United States
France
Belgium
Slovakia

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Oncology Consultants - Texas Medical Center


title: A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

summary: The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment.

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.

lead_sponsor: Eli Lilly and Company

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

location_facility: The Regents of the University of California - Los Angeles (UCLA Pediatrics)

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)

summary: The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Poland
Serbia
Spain
Italy
Australia
Ukraine
Hungary
United States
France
Germany

location_facility:
Elk Grove Village, Illinois
Muenchen
Katowice
Kragujevac
Memphis, Tennessee
Szeged
Tatabanya
Siemianowice Slaskie
Pamplona
Gera
Toulouse Cedex 9
Belgrade
Houston, Texas
Syracuse, New York
Coral Springs, Florida
Bochum
Gyor,
Round Rock, Texas
Milano
Rome
Winter Park, Florida
Cincinnati, Ohio
Albany, New York
San Sebastián
West Bloomfield, Michigan
Kiev
Nantes CEDEX 1
Cracow
Lviv
Dnipro
Móstoles, Madrid
Berlin
Maitland, Florida
Zaporozhya
Cleveland, Ohio
Barcelona
Ocala, Florida
Krakow
Belgrade, Serbia
Port Charlotte, Florida
Clayton VIC
Fresno, California
Vinnitsa
Rozzano Milano
Strasbourg
Torino
München
Sydney, New South Wales
Richmond, Virginia
Saint Louis, Missouri
Pecs
Kirkland, Washington
Budapest
Cassino
Belgrade,
Kogarah, New South Wales


title: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Czechia
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Sweden
Brazil
Canada
Guatemala
Hungary
China
Germany
Taiwan
Greece
Ireland
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)

location_facility: Harbin Medical University Cancer Hospital ( Site 1013)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 1132)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)

location_facility: Osaka International Cancer Institute ( Site 1161)

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

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0227)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0913)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 0630)

location_facility: Zhejiang Provincial People's Hospital ( Site 1021)

location_facility: Centro Medico Monte Carmelo ( Site 0289)

location_facility: Istituto Europeo di Oncologia ( Site 0536)

location_facility: University of Kentucky Markey Cancer Center ( Site 0015)

location_facility: McGill University Health Centre ( Site 0105)

location_facility: Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)

location_facility: Karolinska Universitetssjukhuset ( Site 0784)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0017)

location_facility: Klinikum der Universitaet in Muenchen ( Site 0446)

location_facility: Hokkaido University Hospital ( Site 1163)

location_facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)

location_facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)

location_facility: Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)

location_facility: I.U. Cerrahpasa Medical Faculty ( Site 0755)

location_facility: Medizinische Universität Wien ( Site 0567)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0816)

location_facility: Legacy Good Samaritan Medical Center ( Site 0013)

location_facility: Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)

location_facility: Peter MacCallum Cancer Centre ( Site 0971)

location_facility: Instituto Nacional Do Cancer II ( Site 0173)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 8002)

location_facility: Xiangya Hospital Central-South University ( Site 1009)

location_facility: HonorHealth Research Institute - Biltmore ( Site 8009)

location_facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)

location_facility: Keimyung University Dongsan Medical Center ( Site 1066)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)

location_facility: Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)

location_facility: Centre Hospitalier Lyon Sud ( Site 0413)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0442)

location_facility: Hospital Universitari Vall d Hebron ( Site 0634)

location_facility: Iwate Medical University Hospital ( Site 1165)

location_facility: Minnesota Oncology Hematology, PA ( Site 8007)

location_facility: Medizinische Universitat Graz ( Site 0569)

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)

location_facility: Universitaetsklinik Leipzig ( Site 0456)

location_facility: Virginia Commonwealth University ( Site 0024)

location_facility: National Cancer Center Hospital East ( Site 1159)

location_facility: Orszagos Onkologiai Intezet ( Site 0846)

location_facility: Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)

location_facility: University of Colorado Health Sciences Center and Hospital ( Site 0028)

location_facility: Saitama Medical University International Medical Center ( Site 1168)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0292)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0228)

location_facility: Policlinico Universitario Gemelli ( Site 0538)

location_facility: Royal Brisbane and Women s Hospital ( Site 0972)

location_facility: National Cancer Center Hospital ( Site 1172)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)

location_facility: Euromedica General Clinic of Thessaloniki ( Site 0474)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0231)

location_facility: Anhui Provincial Cancer Hospital ( Site 1007)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)

location_facility: Princess Margaret Cancer Centre ( Site 0102)

location_facility: C.I.U. Hopital Ambroise Pare ( Site 0353)

location_facility: University of North Carolina at Chapel Hill ( Site 0025)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 1162)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0170)

location_facility: Hoag Memorial Hospital Presbyterian ( Site 0038)

location_facility: Complejo Hospitalario de Jaen ( Site 0632)

location_facility: Texas Oncology-Fort Worth Cancer Center ( Site 8001)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0194)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)

location_facility: Texas Oncology-Austin Central ( Site 8006)

location_facility: Hospital Nacional Daniel Alcides Carrion ( Site 0293)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)

location_facility: UZA University Hospital Antwerp ( Site 0351)

location_facility: Texas Oncology-The Woodlands ( Site 8003)

location_facility: St John of God Subiaco Hospital ( Site 0969)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)

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

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)

location_facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)

location_facility: Our Lady of the Lake Regional Medical Center. ( Site 0031)

location_facility: Aichi Cancer Center Hospital ( Site 1155)

location_facility: Monash Health-Monash Medical Centre ( Site 0970)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0600)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)

location_facility: The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 0754)

location_facility: University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)

location_facility: Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)

location_facility: Ramathibodi Hospital, Mahidol University ( Site 1131)

location_facility: Peking Union Medical College Hospital ( Site 1001)

location_facility: General Hospital of Patras. St Andrews ( Site 0473)

location_facility: Hospital de Clínicas de Ribeirão Preto ( Site 0171)

location_facility: Hospital das Clinicas da UFMG ( Site 0172)

location_facility: Medizinische Universitat Innsbruck ( Site 0566)

location_facility: IRCCS Ospedale San Raffaele ( Site 0539)

location_facility: Fondazione Giovanni Pascale Di Napoli ( Site 0544)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 1167)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1133)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 1025)

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

location_facility: Istituto di Candiolo - IRCCS ( Site 0546)

location_facility: Fakultni Nemocnice Brno Bohunice ( Site 0912)

location_facility: Sanford Gynecology Oncology ( Site 0003)

location_facility: Universitaetsklinikum Freiburg ( Site 0454)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0845)

location_facility: Sanford Bismarck Medical Center ( Site 0046)

location_facility: Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 1097)

location_facility: National Taiwan University Hospital ( Site 1095)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0026)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0023)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)

location_facility: Istituto Nazionale Tumori Regina Elena ( Site 0540)

location_facility: University of the Ryukyus Hospital ( Site 1156)

summary:
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.

Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma

summary:
The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.

The secondary objectives of the study are:

To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma
To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

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

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Poland
Spain
United States
France
Germany

location_facility: IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)

location_facility: University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine

location_facility: IKF Pneumologie GmbH & Co. KG - Institut fuer klinische Forschung Pneumologie Frankfurt (Clinical Research Centre Respiratory Medicine) to IKF Pneumologie Frankfurt GmbH & Co KG.

location_facility: Lekarze Specjalisci - J. Malolepszy i Partnerzy

location_facility: Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)

location_facility: The University of Texas Medical School at Houston

location_facility: Centrum Medycyny Oddechowej, Mroz Spolka Jawna


title: A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

summary: An open-label, Phase 1 study of HPN217 to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

lead_sponsor: Harpoon Therapeutics

location_country:
Germany
United States
Spain
France

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Josep Carreras Leukaemia Research Institute

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: The Centre Hospitalier Universitaire de Lille

location_facility: Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

location_facility: University of Rochester James P Wilmot Cancer Institute

location_facility: University of Washington - Seattle Cancer Center Alliance


acronym: HAVEN 6

title: A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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:
Poland
Spain
United Kingdom
Netherlands
Canada
United States
France
South Africa
Belgium
Germany

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Great Ormond street Hospital for Children NHS Foundation Trust; Haemophilia Centre

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Cardiff and Vale NHS Trust; Arthur Bloom Haemophilia Centre

location_facility: University of Michigan, C.S. Mott Children's Hospital

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Klinikum der Universität München, Campus Innenstadt; Hämostaseologische Ambulanz/Hämophiliezentrum

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hemophilia of Georgia Center for Bleeding & Clotting Disorders

summary: This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).


status: Suspended

title: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma

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

location_facility: Seattle Children's Hospital Research Foundation

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Golisano Children's Hospital of Southwest Florida

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

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

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

summary: This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.


title: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor

location_facility: Children's Healthcare of Atlanta, Inc. at Egleston

summary: This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.


title: A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50%

summary: The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Hong Kong
Spain
Greece
Italy
Australia
Netherlands
Canada
Thailand
France
India
Malaysia
Belgium
Japan
Germany
Czechia


title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5

summary: B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

ReferenceCitation: Hosoya H, Sidana S. Antibody-Based Treatment Approaches in Multiple Myeloma. Curr Hematol Malig Rep. 2021 Apr;16(2):183-191. doi: 10.1007/s11899-021-00624-6. Epub 2021 Mar 17. Review.

ReferenceCitation: Nooka AK, Weisel K, van de Donk NW, Routledge D, Otero PR, Song K, Quach H, Callander N, Minnema MC, Trudel S, Jackson NA, Ahlers CM, Im E, Cheng S, Smith L, Hareth N, Ferron-Brady G, Brouch M, Montes de Oca R, Paul S, Holkova B, Gupta I, Kremer BE, Richardson P. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021 Jun;17(16):1987-2003. doi: 10.2217/fon-2020-1269. Epub 2021 Mar 8.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Greece
Russian Federation
Australia
Netherlands
Canada
Sweden
Korea, Republic of
United States
France
Mexico
Norway
Germany


title: A Dose-optimization, Exploratory Phase Ib/II Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143, When Given in Combination With the Anti-PD-1 Antibody Nivolumab in Patients With Specific Solid Tumors Who Have Progressed During or Immediately After Anti-PD-1/PD-L1 Treatment

summary:
Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments.

Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer [SCLC]; Cohort 2: squamous cell carcinoma of the head and neck [SCCHN]; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer [EOC], endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD).

lead_sponsor: Debiopharm International SA

location_country:
United States
Spain
France

location_facility: Methodist Hospital, Houston Methodist Cancer Center

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole


title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in Preceding Studies With LOU064

summary: This study is an open-label, single arm, multicenter, long-term safety and tolerability extension study for CSU patients who completed CLOU064A2201 or other preceding studies with LOU064

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:
Denmark
Poland
Spain
United Kingdom
Russian Federation
Argentina
Canada
Hungary
United States
France
Turkey
Belgium
Japan
Slovakia
Czechia


title: A Prospective and Retrospective Cohort Study to Refine and Expand the Knowledge on Patients With Chronic Forms of Acid Sphingomyelinase Deficiency (ASMD)

summary:
Primary Objective:

To describe the clinical features and their severity at the time of diagnosis and their evolution over time in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD
To describe Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) at enrollment and their evolution over time; disease severity at the time of diagnosis and its evolution over time

Secondary Objectives:

To describe abnormal values in laboratory parameters and all values of specific clinical and imaging assessments at the time of diagnosis and their evolution over time
To study the use and applicability towards validation of a newly developed ASMD disease severity scoring system
To study the use and applicability towards validation of a newly developed ASMD PRO tool
To describe ASMD-related disease burden among patients with ASMD, caregivers, and healthcare resource utilization
To describe the association between patient demographics (eg, age, gender, race, Ashkenazi ancestry) and genotype with selected clinical features in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD

primary_purpose: Other

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

lead_sponsor: Sanofi

location_country:
Brazil
Portugal
Romania
Italy
Spain
Argentina
United States
Chile
France
Turkey
Belgium
Germany
Czechia

location_facility:
Investigational Site Number :6200001
Investigational Site Number :7920003
Investigational Site Number :2760002
Investigational Site Number :7920005
Investigational Site Number :2500003
Investigational Site Number :8400001
Investigational Site Number :7240005
Investigational Site Number :380001
Investigational Site Number :8400002
Investigational Site Number :2030001
Investigational Site Number :0320002
Investigational Site Number :2500002
Investigational Site Number :0760002
Investigational Site Number :7920001
Investigational Site Number :380002
Investigational Site Number :6420001
Investigational Site Number :0560001
Investigational Site Number :7240001
Investigational Site Number :6200002
Investigational Site Number :2760005
Investigational Site Number :0760001
Investigational Site Number :0760006
Investigational Site Number :152001
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :2500001
Investigational Site Number :152002
Investigational Site Number :0320001

intervention_type: Procedure


title: An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

acronym: WAVE

summary: The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

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.

location_country:
Serbia
Spain
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
India
Israel
Turkey
Malaysia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands


title: A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

summary: This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1 and Cohort 2) or MRCLS (Cohort 1) .

ReferenceCitation: Sanderson JP, Crowley DJ, Wiedermann GE, Quinn LL, Crossland KL, Tunbridge HM, Cornforth TV, Barnes CS, Ahmed T, Howe K, Saini M, Abbott RJ, Anderson VE, Tavano B, Maroto M, Gerry AB. Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy. Oncoimmunology. 2019 Nov 24;9(1):1682381. doi: 10.1080/2162402X.2019.1682381. eCollection 2020.

lead_sponsor: Adaptimmune

location_country:
United Kingdom
Spain
Canada
United States
France

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Medical College of WI Froedtert Hospital

location_facility: Start Madrid-FJD, Fundación Jimѐnez Díaz

intervention_type: Genetic


title: Prospective Clinical Assessment Study in Children With Achondroplasia: The PROPEL Trial

summary: This is a long-term, multi-center, observational study in children 2.5 to 10 years with achondroplasia (ACH). The objective is to evaluate growth, ACH-related medical complications and treatments of study participants. No study medication will be administered.

time_perspective: Prospective

location_country:
Spain
United Kingdom
Australia
Canada
United States
France

location_facility: Manchester University Children's Hospital

location_facility: Nemours Alfred I. Dupont Hospital for Children

location_facility: Hospital Universitario Virgen de la Victoria


title: Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)

lead_sponsor: Boehringer Ingelheim

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Poland
Taiwan
United Kingdom
Russian Federation
Australia
Netherlands
Canada
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

location_facility: York Dermatology Clinic and Research Centre

location_facility: Tokyo Dental College Ichikawa General Hospital

location_facility: Total Skin and Beauty Dermatology Center, PC

location_facility: Veszprem County Csolnoky Ferenc Hospital

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Markusovszky University Teaching Hospital

location_facility: Shirasaki Dermatology and Neurology Clinic

location_facility: Dermatovenereological Dispensary #10, St. Petersburg

location_facility: Shiga University of Medical Science Hospital

location_facility: The Psoriasis Treatment Center of Central New Jersey

location_facility: Seoul National University Bundang Hospital

location_facility: The Guenther Dermatology Research Centre

location_facility: SimcoDerm Medical and Surgical Dermatology Centre

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

summary:
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.

Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.


title: APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

summary: The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
United Kingdom
Italy
United States
Belgium
Japan
Czechia
Hong Kong
Portugal
Australia
Argentina
Mexico
Sweden
Brazil
Bulgaria
Denmark
Taiwan
New Zealand
Korea, Republic of
France
Chile
Netherlands


acronym: A treatment study in patients with WHIM Syndrome.

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Mavorixafor in Patients With WHIM Syndrome With Open-Label Extension

lead_sponsor: X4 Pharmaceuticals

location_country:
Denmark
Spain
Italy
Austria
Australia
Russian Federation
Hungary
Korea, Republic of
United States
France
Israel
Turkey
Netherlands

location_facility: CHU Paris Est, Hôpital d'Enfants Armand-Trousseau

location_facility: Università degli Studi di Brescia, Scienze Cliniche e Sperimentali

location_facility: University of California San Diego Health/Rady Children's Hospital

location_facility: Emma Children's Hospital Academic Medical Center (AMC)

location_facility: CHU de Lyon, Institut d'Hematologie et d'Oncologie Pediatrique

location_facility: Medical University of Vienna - Medizinische Universität Wien

location_facility: Seoul National University Hospital, Children's Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

location_facility: University of Debrecen, Affiliated Department of Infectology

location_facility: Academician I.P. Pavlov First Saint Petersburg State Medical University

summary: This study has a double-blind, Randomized Placebo-Controlled Period and an Open-Label Period. The primary objective of the Randomized Placebo-Controlled Period is to demonstrate the efficacy of mavorixafor in participants with WHIM syndrome as assessed by increasing levels of circulating neutrophils compared with placebo, and relative to a clinically meaningful threshold. The primary objective of the Open-Label Period is to evaluate the safety and tolerability of mavorixafor in participants with WHIM syndrome. Participants are allowed to continue treatment in the Open-Label Period, if regionally applicable, until mavorixafor becomes commercially available, or until the study is terminated by the Sponsor.


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.

summary: The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

lead_sponsor: ObsEva SA

location_country:
Poland
Spain
Austria
Ukraine
Hungary
United States
France
Romania
Bulgaria
Czechia

location_facility: University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133

location_facility: Multi-Specialty Research Associates, Inc./ ID # 625

location_facility: Medical center of LLC "Medical Center "Verum"/ ID # 503

location_facility: Chattanooga Medical Research LLC/ ID# 602

location_facility: Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509

location_facility: Multiprofile Hospital for Active Treatment St. Sofia/ ID # 137

location_facility: Gynekologicko - Porodnicka Ambulance/ ID # 162

location_facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505

location_facility: Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354

location_facility: Spitalul Clinic "Nicolae Malaxa"/ ID # 352

location_facility: Next Innovative Clinical Research/ ID # 617

location_facility: Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251

location_facility: Kyiv City Clinical Hospital #9/ ID # 501

location_facility: Clinical Medical Research sp. Z o. O/ ID # 406

location_facility: City clinical maternity hospital №1/ ID # 502

location_facility: Universal Axon - Homestead, LLC/ ID # 620

location_facility: Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506

location_facility: Institute of Pediatrics Obstetrics and Gynecology/ ID # 508

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410

location_facility: Group Practice for Specialized Medical Assistance in GINART/ ID # 132

location_facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404

location_facility: CHRU Strasbourg - Hopital Hautepierre/ ID # 205

location_facility: Kyiv City Maternity Hospital #6/ ID # 504

location_facility: Obstetrics & Gynecology Associates, Inc./ ID# 606

location_facility: Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510

location_facility: Women's & Family Care, LLC dba GTC Research/ ID # 608

location_facility: Ternopil' Communal City Hospital #2/ ID # 511

location_facility: MUDr Jan Drahonovsky, Ustav pro peci o matku a dite/ ID #163

location_facility: AKH Vienna University of Medicine Vienna/ ID # 103

location_facility: Hospital General Universitario Reina Sofia/ ID # 304

location_facility: The Center for Women's Health & Wellnes/ ID # 603

location_facility: Centrum Medyczne Chodźki Lublin/ ID # 403

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411

location_facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401

location_facility: Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405

location_facility: Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409

location_facility: Gynekologie MU Dr.Lubomir Mikulasek / ID # 160

location_facility: Multiprofile Hospital for Active Treatment Sliven/ ID # 131

location_facility: Affinity Clinical Research Institute/ ID # 622

location_facility: AKH Vienna University of Medicine Vienna / ID # 101

location_facility: Hospital Regional Universitario de Málaga/ ID # 303

location_facility: Invocare Medical Research & Healthcare Center/ ID # 607

location_facility: Lubelskie Centrum Diagnostyczne/ ID # 402

location_facility: UWCR - Lyndhurst Clinical Researc/ ID# 605

location_facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407


title: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 in the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury in Adult Subjects, Followed by an Open Label Extension With or Without Combined Upper Limb Treatment

acronym: PATTERN

summary:
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation.

The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Switzerland
United States
France
Belgium
Norway
Germany
Czechia

location_facility: Specjalistyczna Praktyka Lekarska Dr. n. med Stanisław Ochudło, Merz Investigational Site #0480077

location_facility: University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211

location_facility: Sunnaas Rehabilitation Hospital, Merz Investigational Site #0470002

location_facility: Institut Universitaire de Readaptation Clemenceau, Physical Medicine / Rehabilitation Medecine, Merz Investigational site # 0330063

location_facility: Indywidualna Praktyka Lekarska dr. hab. Med. Anna Szczepanska-Szerej, Merz Investigational Site #0480096

location_facility: UT Southwestern Medical Center, Department of Physical Medicine & Rehabilitation, Merz investigational site #0010082

location_facility: IRCCS Ospedale Policlinico S. Martino, U.O.Complessa Riabilitazione e Rieducazione Funzionale; Merz investigational site #0390020

location_facility: State Autonomous Institution of Healthcare of Moscow City "Moscow Scientific and Practical Centre of Medical Rehabilitation, Regenerative and Sports Medicine of Moscow City Healthcare Department", Merz Investigational Site #0070011

location_facility: Raymond Poincaré University Hospital, Service de MPR Pôle Handicap-Rééducation, Merz Investigational site #00330018

location_facility: Hospital Universitario La Paz, Merz Investigational Site #0340007

location_facility: National Hospital for Neurology and Neurosurgery - UCLH; Merz Investigational Site #0440033

location_facility: Uniklinik RWTH Aachen, Neurologie, Merz Investigational Site #0490191

location_facility: Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191

location_facility: Rehabilitation Hospital, Kessler Institute for Rehabilitation, Merz Investigational Site #0010199

location_facility: University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183

location_facility: Rangueil Hospital-University Hospital Center (CHU) of Toulouse, Médecine physique et de réadaptation, Merz investigational site #0330025

location_facility: Neurologie Bewegt; Merz Investigational site #0490378

location_facility: Ospedale Valduce, Villa Beretta Rehabilitation Center, Merz investigational site #0390005

location_facility: UCL Bruxelles, Physical Medicine & Rehabilitation Department, Merz Investigational Site #0320013

location_facility: Fakultni nemocnice Kralovske Vinohrady, Neurology Department, Merz Investigational Site #4200050

location_facility: Ospedale Maggiore della Carita, Dipartimento di Medicina fisica e Riabilitativa, Merz Investigational Site #0390017

location_facility: Mazowiecki Szpital Brodnowski, Merz investigational site #0480064

location_facility: Cambridge University Hospitals NHS Foundation Trust; Merz Investigational Site 0440023

location_facility: Specjalistyczne Gabinety Sp z o.o., Merz Investigational Site #0480059

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti Di Foggia; Merz Investigational Site #0390018

location_facility: The Walton Centre NHS Foundation Trust; Neuroscience Research Centre; Merz Investigational site #0440004

location_facility: Neurologische Klinik und Poliklinik des Universitätsklinikums Würzburg, Merz Investigational Site #0490302

location_facility: Haukeland University Hospital, Dept of Neurology; Merz investigational site #0470001

location_facility: Centre Hospitalier Universitaire Vaudois - Neurorehabilitation and Physical Medicine, Merz Investigational Site #0410013

location_facility: Neurology and Physiotherapy Skopalikova, Merz Investigational Site #4200049

location_facility: CBBM, Institut für Neurogenetik, Haus 66; Merz Investigational Site #0490332

location_facility: Universitätsklinikum Hamburg-Eppendorf, Merz Investigational site #0490079

location_facility: Federal State Budgetary Educational Institution of Higher Education "Krasnoyarsk State Medical University n.a. Professor V.F. Voino-Yasenetskiy of Ministry Healthcare of Russian Federation", Merz Investigational Site #0070306

location_facility: Ospedale Borgo Roma, U.O.C Neuroriabilitazione; Merz investigational site #0390014

location_facility: Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna, Merz Investigational Site #0480023

location_facility: UCL Mont Godinne, Physical Medicine & Rehabilitation Department; Merz Investigational Site #0320008

location_facility: Ospedale Alfredo Fiorini, UOSD Neurologia Universitaria; Merz Investigational site #0390022

location_facility: St George Hospital, Department of Rehabilitation Medicine, Merz Investigational Site #0610004

location_facility: Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283

location_facility: Filia 7 Centrum Kompleksowej Rehabilitacji Sp. z o.o., Merz Investigational Site #0480100

location_facility: Federal State Budgetary Institution "National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, Merz Investigational Site #0070009

location_facility: Hospital Universitari Mútua de Terrassa, Merz Investigational Site #0340003

location_facility: NeuroKlinika Gabinet Lekarski Prof Andrzej Bogucki, Merz Investigational Site #0480101

location_facility: Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology, Merz Investigational Site #0440047

location_facility: Federal State Autonomous Institution "National Medical Research Centre "Treatment and Rehabilitation" of the Ministry of Health of the Russian Federation, Neurology department, Merz Investigational Site # 0070305

location_facility: New England institute for clinical research; Merz Investigational Site #0010441

location_facility: Projekt Samodzielni Sp z o.o., Merz Investigational Site #0480099

location_facility: Heinrich Heine University Duesseldorf, Department of Neurology; Merz Investigational Site #0490071

location_facility: DKD HELIOS Medical Center, Fachbereich Neurologie, Merz Investigational Site #0490081

location_facility: HFR Fribourg - Hôpital Cantonal, Department of Rehabilitation, Merz Investigational site #0410014

location_facility: Royal Melbourne Hospital, Department of Rehabilitation Medicine; Merz Investigational Site #0610002

location_facility: Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237

location_facility: AOUI -Ospedale Borgo Roma, U.O.C Neuroriabilitazione, Merz Investigational Site #0390014

location_facility: Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440


primary_purpose: Diagnostic

acronym: PROMISE

title: Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

lead_sponsor: Guerbet

location_country:
Poland
Spain
Italy
Ukraine
Hungary
Korea, Republic of
United States
France
Mexico
Germany
Bulgaria

location_facility: The University of Chicago Medical Center

location_facility: Acibadem City Clinic Tokuda Hospital Sofia

location_facility: Jagiellońskie Centrum Innowacji Sp. z o. o.

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: UConn Health - University of Connecticut

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

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

location_facility: Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy

location_facility: Klinik für Diagnostische und Interventionelle Radiologie

location_facility: Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center

summary: The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)


title: A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma

summary: The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Romania
Spain
Ireland
Italy
Australia
New Zealand
Argentina
Canada
United States
Chile
France
Mexico

location_facility:
Istituto Oncologico Veneto IOV
Hospital Gral. Univ. Gregorio Maranon
Fundacion Jimenez Diaz
University of Pittsburgh Medical Center
Cross Cancer Institute
Virginia Piper Cancer Institute
Local Institution - 0041
Local Institution - 0016
ASST Papa Giovanni XXIII
Local Institution - 0032
Local Institution - 0035
Local Institution
Hartford Hospital
Nova Clin Medical Research Center
Local Institution - 0028


title: A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study

summary: IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

primary_purpose: Prevention

lead_sponsor: Infant Bacterial Therapeutics

location_country:
Poland
Serbia
Spain
United Kingdom
Hungary
United States
Israel
France
Romania
Bulgaria

location_facility: Maria Fareri Children's Hospital - Westchester Medical Center

location_facility: Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)

location_facility: Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"

location_facility: University of Califorina, Los Angeles (UCLA)

location_facility: Helen DeVos Children's Hospital Spectrum Health Research

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University

location_facility: University of Miami/Holtz Children'S Hospital

location_facility: Texas Health Presbyterian Hospital - Plano

location_facility: Hospital Universitario Hm Puerta Del Sur

location_facility: St David'S Health Care - St. David'S Medical Center/North Austin Medical Center

location_facility: Associates in Newborn Medicine - Saint Paul

location_facility: University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

location_facility: University of Tennessee Health Science Center

location_facility: Szszb County Hospital and Jósa András University Teaching Hospital

location_facility: Medical University of South Carolina (MUSC)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego

location_facility: SIU School of Medicine - HSHS St. John's Children's Hospital

location_facility: Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego

location_facility: University of Szeged, Albert Szent-Györgyi Health Centre

location_facility: Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital

location_facility: Northwell Health Cohen Children'S Medical Center of Ny

location_facility: Specialized Hospital in Active Treatment of Pediatric Diseases

location_facility: Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi

location_facility: University of Mississippi Medical Center

location_facility: Banner University Medical Center / University of Arizona

location_facility: University of Arkansas For Medical Services

location_facility: Nottingham University Hospitals, Neonatology: City Campus

location_facility: Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)

location_facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology

location_facility: Veszprém County Csolnoky Ferenc Hospital

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Connecticut Children'S Medical Center - Uconn - School of Medicine

location_facility: Children'S Hospital of the University of Illinois

location_facility: Sheridan Healthcare of Texas, P.A./Medical City Plano

location_facility: Sheridan Clinical Research / Plantation General Hospital

location_facility: Szent György University Teaching Hospital of County Fejér

location_facility: Children's Clinic of the Clinical Center of Kragujevac

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: University of Texas Medical Branch - Ocr

location_facility: Centre Hospitalier Universitaire de Caen Normandie


acronym: Open-label Active-control Pediatric Safety, Efficacy, PK Study of MK-7655A

title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Spain
Greece
Russian Federation
Mexico
Ukraine
Hungary
Philippines
United States
France
Israel
South Africa
Colombia
Norway
Turkey
Bulgaria

location_facility: Empilweni Services and Research Unit ( Site 1557)

location_facility: Philippine Children s Medical Center ( Site 0317)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0202)

location_facility: Morozovskaya Children City Clinical Hospital ( Site 0241)

location_facility: Szabolcs-Szatmar-Bereg Megyei Kórházak és Egyetemi Otatókórház-Gyermekosztály ( Site 0105)

location_facility: Children's City Clinical Hospital #1 ( Site 0237)

location_facility: SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0121)

location_facility: Ege Universitesi Tıp Fakultesi Hastanesi ( Site 0199)

location_facility: Eskisehir Osmangazi University Medical ( Site 0201)

location_facility: West Virginia University Ruby Memorial Hospital ( Site 0344)

location_facility: Hospital del Nino y Adolescente Morelense ( Site 0286)

location_facility: St.Petersburg State Pediatric Medical University ( Site 0236)

location_facility: Chris Hani Baragwanath Academic Hospital ( Site 0156)

location_facility: MHAT City Clinic Sv. Georgi EOOD ( Site 0167)

location_facility: Smolensk Regional Clinical Hospital ( Site 0231)

location_facility: University of Athens - Aghia Sophia Childrens Hospital ( Site 0243)

location_facility: Tufts Medical Center-Floating Hospital for Children ( Site 0350)

location_facility: Hopitaux Pediatriques CHU Lenval ( Site 0143)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0115)

location_facility: Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0131)

location_facility: Kharkiv City Children Hospital 16 ( Site 0130)

location_facility: Instituto Nacional de Pediatria ( Site 0291)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0188)

location_facility: Wojewodzki Szpital Zespolony im. Rydgiera ( Site 0220)

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region City Childrens Clinical Emergency Hospi

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0100)

location_facility: Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 0233)

location_facility: Hospital Universitario La Paz ( Site 0113)

location_facility: SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 0198)

location_facility: UMHAT Dr. Georgi Stranski EAD ( Site 0174)

location_facility: Miller Children's & Women's Hospital ( Site 0349)

location_facility: Haukeland Universitetssjukehus ( Site 0500)

location_facility: PI Kryvorizka city clinical hospital 8 of Dnipropetrovsk Reg Council ( Site 0128)

location_facility: Municipal Enterprise Children's City Clinical Hospital in Poltava City Council ( Site 0122)

location_facility: Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0290)

location_facility: Instytut Centrum Zdrowia Matki Polki ( Site 0223)

location_facility: Hippokration General Hospital of Thessaloniki ( Site 0244)

location_facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0265)

location_facility: University of the Philippines-Philippine General Hospital ( Site 0318)

location_facility: Children's Hospital of Richmond at VCU ( Site 0359)

location_facility: Hospital General de Tijuana ( Site 0284)

location_facility: Banner University Medical Center ( Site 0356)

location_facility: Regional Childrens Clinical Hospital ( Site 0400)

location_facility: Fundacion Hospital Infantil Universitario de San Jose ( Site 0268)

location_facility: Schneider Children's Medical Center ( Site 0187)

location_facility: Cukurova University Medical Faculty ( Site 0200)

location_facility: SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0226)

location_facility: Pan and Aglaia Kyriakou Children s Hospital ( Site 0247)

location_facility: Fundacion Hospital San Vicente de Paul ( Site 0269)

location_facility: Hospital Infantil Universitario Nino Jesus ( Site 0114)

location_facility: Rady Children's Hospital-San Diego ( Site 0347)

location_facility: Children s City Clinical Hospital 5 n.a. N.F. Filatov ( Site 0235)

summary: The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.


acronym: Centerstone

title: A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

ReferenceCitation: Komeda T, Takazono T, Hosogaya N, Ogura E, Fujiwara M, Miyauchi H, Ajisawa Y, Iwata S, Watanabe H, Honda K, Kitanishi Y, Hara K, Mukae H. Comparison of Household Transmission of Influenza Virus From Index Patients Treated With Baloxavir Marboxil or Neuraminidase Inhibitors: A Health Insurance Claims Database Study. Clin Infect Dis. 2021 Jun 1;72(11):e859-e867. doi: 10.1093/cid/ciaa1622.

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:
Spain
United Kingdom
United States
Costa Rica
South Africa
Japan
Poland
Hong Kong
Argentina
Turkey
India
Israel
Mexico
Singapore
Brazil
Hungary
China
Bulgaria
Greece
New Zealand
France
Chile

location_facility: Olive Branch Family Medical Center; Family Medicine

location_facility: CEMER Centro Medico de Enfermedades Respiratorias

location_facility: First Affiliated Hospital of Soochow University

location_facility: CHU Nantes - Hôtel Dieu; Urgences (Unité d'Investigation Clinique)

location_facility: National Healthcare Group Polyclinics- Yishun

location_facility: Washington University School of Medicine

location_facility: MHAT Sliven - Military Medial Academy; Department of Infectious Diseases

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Ajanta Research centre; Research Department

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Nemours Children's Hospital; Nemour's Research Institute

location_facility: Childern's Hospital of Chongqing Medical University

location_facility: Urgent Care Clinical Trials at Urgent Care Eleven

location_facility: KO-MED Centra Kliniczne Sp. z o.o.; Osrodek Badan Klinicznych

location_facility: Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine

location_facility: CH VICTOR DUPOUY; Reanimation Polyvalente

location_facility: Sir J J Group of Hospitals; Department of Pulmonary Medicine

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Medical Center Hera Sofia; Office of Pulmonology and Phtisiatrics

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Medical corporation Shirayurikai Swing Nozaki Clinic

location_facility: Capital Medical University Beijing Hospital of Traditional Chinese Medicine

location_facility: Dokuz Eylul University Medical Faculty; Infection

location_facility: Medical Corporation Saitadayoshikai Saikatsu Clinic

location_facility: DCC Sveta Paraskeva; Office of Cardiology Diseases

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: Siaal Research Center for Family Medicine and Primary Care; Clalit Neve Zeev

location_facility: Hatakeyama Internal Medicine and Gastroenterology Clinic

location_facility: Medical Center Zdrave 1; Office of Pulmonology and Phtisiatrics

location_facility: Attikon University General Hospital; 4th Academic Department of Internal Medicine

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Queen Mary Hospital; Uni Dept of Medicine, Division of Gastroenterology

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

location_facility: Medizinski Zentrar-1-Sevlievo EOOD; Office of Pulmonology and Phtisiatrics

location_facility: The Village Practice; Thornton Medical Centre

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

location_facility: JLN Medical College and Hospital; TB and Chest Department

location_facility: Siaal Research Center for Family Medicine and Primary Care; Faculty of Health Sciences

location_facility: General Hospital of Ningxia Medical University

location_facility: Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic

location_facility: The Third People's Hospital of Hainan Province

location_facility: III. Háziorvosi Körzet- Dr. Csomós Katalin

location_facility: Centro de Investigacion Clínica GRAMEL S.C

location_facility: Children's hospital of Nanjing medical university

location_facility: Claudia T Martorell MD LLC dba The Research Institute

location_facility: Suzuki internal & circulatory Medical Clinic

location_facility: Igarashi Internal Medicine Surgery Clinic

location_facility: Sterling Hospital; Clinical Research Department

location_facility: Hometown Urgent Care and Occupational Health - Clintonville

location_facility: JSS Hospital; Department of clinical pharmacy

location_facility: Setshaba Research Centre; Clinical Research

location_facility: Gyermekháziorvosi rendelő- Dr. Újhelyi János

location_facility: Into Research; Life Groenkloof Hospital Medical Centre

location_facility: Dr As'ad Ebrahim Bhorat; Soweto Clinical Trial Centre

location_facility: CHU de Grenoble - Hôpital André Michallon; Pôle Urgences

location_facility: Centro de Salud Las Aguilas; Medicina General

location_facility: Jehangir Clinical development Centre Pvt Ltd.

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Mazumdar Shaw Medical Centre- A unit of Narayana Hrudayalaya

location_facility: Guangzhou Women and Children's Medical Center

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Szigony utcai háziorvosi rendelő -Dr. Simon Judit

location_facility: Maccabi health services - Moked Hashalom

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: Lifepoint Multispeciality Hospital; Clinical research department.

location_facility: Metropolitan Clinical Research Institute

location_facility: Jedda Enterprises dba Galen Clinical Research

location_facility: SHAT for Pneumo-Phtysiatric Diseases "Dr. Dimitar Gramatikov" EOOD; Department of Pneumology

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

location_facility: M.V Hospital and Research Centre; Research Hall

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: Criticare Hospital & Research Institute; Research department

location_facility: Kasturba Medical College and Hospital; Department of Medicine

location_facility: MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics

location_facility: MHAT Stamen Iliev AD; Deparment of Infectious Diseases

location_facility: Taizhou People's Hospital; Infectious Diseases

location_facility: SHAT for Pneumo-Phtysiatric Diseases "Dr. Dimitar Gramatikov"; Dept. of Pulmonology and Phtisiatrics

location_facility: Hometown Urgent Care and Research - Dayton

location_facility: Centro de Cancer Pontificie Universidad Catolica de Chile

location_facility: Maccabi health services - Moked Hashalom; Maccabi health services - Moked Ramat Hasharon

location_facility: Medical Centre "Asklepii", OOD; Office of Pulmonology and Phtisiatrics

location_facility: Urgent Care Clinical Trials at Complete Urgent Care

location_facility: Medical Corporation Houmankai Umezu Clinic

location_facility: Premier Pulmonary Critical Care and Sleep Medicine

location_facility: Medical corporation Seijinkai Takei Clinic

location_facility: Karadeniz Technical Uni School of Medicine; Infection Diseases & Clinical Mikrobiology Dept

location_facility: Siaal Research Center for Family Medicine and Primary Care; Clalit Tet Clinic

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Sawada Internal Medicine / Respiratory Clinic

location_facility: Hacettepe University Medical Faculty; Infectious Diseases

location_facility: Medical Center Nevrocentrum; Office of Pulmonology and Phtisiatrics

location_facility: Hometown Urgent Care and Occupational Health - Springdale

location_facility: Toda Internal Medicine & Neurology Clinic

location_facility: Gushiken-Cardiology and Internal medicine

location_facility: Sotiria General Hospital of Athens; 3rd Department of Internal Medicine

location_facility: Medical Corporation Association KANWAKAI Musashikoganei Clinic

summary: Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.


acronym: CANOPY-N

title: A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)

ReferenceCitation: Garrido P, Pujol JL, Kim ES, Lee JM, Tsuboi M, Gómez-Rueda A, Benito A, Moreno N, Gorospe L, Dong T, Blin C, Rodrik-Outmezguine V, Passos VQ, Mok TS. Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design. Future Oncol. 2021 Apr;17(12):1459-1472. doi: 10.2217/fon-2020-1098. Epub 2021 Mar 2.

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

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

location_country:
Taiwan
Spain
Greece
Russian Federation
Netherlands
Canada
United States
France
Turkey
Belgium
Japan
Germany

location_facility: University of Kansas Medical Center Neurology Dept.

location_facility: Methodist Hospital / Methodist Cancer Center

summary: Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.