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).

lead_sponsor: Hoffmann-La Roche

location_country:
United States
South Africa
Netherlands
Germany
France
Poland
Belgium
Spain
Canada
United Kingdom

acronym: HAVEN 6

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Children's Hospital of Michigan; Pediatrics

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

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

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

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hemophilia of Georgia Center for Bleeding & Clotting Disorders

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

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

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

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

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

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).


design_allocation: Randomized

intervention_type: Drug

status: Withdrawn

study_start_date_type: Anticipated

study_type: Interventional

lead_sponsor: Bristol-Myers Squibb

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Chile
Mexico
Netherlands
France
Poland
Greece
Norway
Romania
Belgium
Argentina
Spain
Denmark
United States

acronym: CheckMate 79X

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy

summary: This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy

lead_sponsor_type: industriel

status_simplified: Unknown


status: Recruiting

study_start_date_type: Actual

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

enrollment_type: Anticipated

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

location_facility: Golisano Children's Hospital of Southwest Florida

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

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Children Mercy Pediatric Clinical Research Unit

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: University of Texas Southwestern Medical Center at Dallas

ipd_sharing: Yes

type: Other Identifier

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

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.

status_simplified: Ongoing


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

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

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.

status: Active, not recruiting

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


title: A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

summary: To evaluate the efficacy of AKCEA-TTR-LRx compared to placebo for 120 weeks in patients with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com/.

ipd_sharing: No

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Italy
Austria
Brazil
Sweden
Spain
Germany
France
Czechia
Greece
Israel
Argentina
Australia
Belgium
Portugal
Puerto Rico
Denmark
United States
United Kingdom
Canada

location_facility: Veterans Affairs Caribbean Healthcare System

location_facility: The University of Chicago Medical Center

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Louisiana State University Health Sciences Center

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

location_facility: New York University Langone Cardiology Associates

location_facility: University of Colorado Hospital - Anschutz Medical Campus

location_facility: Centro Hospitalar Universitário de São João

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Hospital Da Senhora da Oliveira - Guimarães

location_facility: Universitaetsklinikum Heidelberg - Zentrum fur Innere Medizin

location_facility: Altman Clinical and Translational Research Institute Center for Clinical Research

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Tulane University Heart and Vascular Institute

location_facility: Institut Klinické a Experimentální Medicíny

location_facility: Columbia University Irving Medical Center

location_facility: University Hospital - London Health Sciences Centre

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Emory Heart and Vascular Center - Emory Clifton Campus

location_facility: Froedtert & Medical College of Wisconsin

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

location_facility: The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

location_facility: The University of North Carolina at Chapel Hill

location_facility: University of Texas Southwestern Medical Center

location_facility: The Ohio State University College of Medicine


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
France
Spain

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Methodist Hospital, Houston Methodist Cancer Center

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center


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://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

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

location_facility:
Investigational Site Number :0560001
Investigational Site Number :2500001
Investigational Site Number :0320002
Investigational Site Number :7240001
Investigational Site Number :380002
Investigational Site Number :152001
Investigational Site Number :8400003
Investigational Site Number :0320001
Investigational Site Number :7240004
Investigational Site Number :2760005
Investigational Site Number :7920001
Investigational Site Number :8400002
Investigational Site Number :2030001
Investigational Site Number :7240005
Investigational Site Number :380001
Investigational Site Number :6200001
Investigational Site Number :7920005
Investigational Site Number :7240003
Investigational Site Number :6200002
Investigational Site Number :2500003
Investigational Site Number :7920003
Investigational Site Number :6420001
Investigational Site Number :2760002
Investigational Site Number :0760002
Investigational Site Number :0760001
Investigational Site Number :0760006
Investigational Site Number :2500002
Investigational Site Number :8400001
Investigational Site Number :152002

intervention_type: Procedure


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

location_facility: University of North Carolina School of Medicine - Children's Hospital - Children's Research Institute

location_facility: The Children's Hospital for Cancer and Blood Disorders

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: University of Chicago - Comer Children's Hospital

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

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: New Approaches to Neuroblastoma Therapy (NANT)

title: A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

summary: The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.


intervention_type: Genetic

lead_sponsor: Spark Therapeutics

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

location_facility: Universita Degli Studi Di Milano, Laboratorio di Biochimica e Genetica della Malattie Neuromuscolari

location_facility: Malattie Metaboliche Universita Degli Studi Di Napoli Federico II

location_facility: University of Kansas Medical Center Research Institute

location_facility: CHU Paris IdF Ouest - Hôpital Raymond Poincaré

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Friedrich-Baur-Institut Neurologische Klinik Ludwig-Maximilians-Universität München

location_facility: Universita Degli Studi Di Messina - Dipartimento di Medicina Clinica e Sperimentale

location_facility: UO Neurologia Azienda Ospedaliera Universitaria Pisana

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino - Neurology, Osp. Molinette

location_facility: Hospital Clinico Universitario de Santiago/Fundacion Investigacion, Desenvolvemento e Innovacion Ramon Dominguez

title: Phase 1/2, Dose-escalation Study to Evaluate the Safety, Tolerability and Efficacy of a Single Intravenous Infusion of SPK-3006 in Adults With Late-onset Pompe Disease

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts.


ReferenceType: derived

ReferenceCitation: Deterding R, Griese M, Deutsch G, Warburton D, DeBoer EM, Cunningham S, Clement A, Schwerk N, Flaherty KR, Brown KK, Voss F, Schmid U, Schlenker-Herceg R, Verri D, Dumistracel M, Schiwek M, Stowasser S, Tetzlaff K, Clerisme-Beaty E, Young LR. Study design of a randomised, placebo-controlled trial of nintedanib in children and adolescents with fibrosing interstitial lung disease. ERJ Open Res. 2021 Jun 21;7(2). pii: 00805-2020. doi: 10.1183/23120541.00805-2020. eCollection 2021 Apr.

apc_source: doaj

family: Deterding

full_name: Robin Deterding

given: Robin

sequence: first

family: Griese

full_name: Matthias Griese

given: Matthias

sequence: additional

family: Deutsch

full_name: Gail Deutsch

given: Gail

family: Warburton

full_name: David Warburton

given: David

family: DeBoer

full_name: Emily M. DeBoer

given: Emily M.

family: Cunningham

full_name: Steven Cunningham

given: Steven

family: Clement

full_name: Annick Clement

given: Annick

family: Schwerk

full_name: Nicolaus Schwerk

given: Nicolaus

family: Flaherty

full_name: Kevin R. Flaherty

given: Kevin R.

family: Brown

full_name: Kevin K. Brown

given: Kevin K.

family: Voss

full_name: Florian Voss

given: Florian

family: Schmid

full_name: Ulrike Schmid

given: Ulrike

family: Schlenker-Herceg

full_name: Rozsa Schlenker-Herceg

given: Rozsa

family: Verri

full_name: Daniela Verri

given: Daniela

family: Dumistracel

full_name: Mihaela Dumistracel

given: Mihaela

family: Schiwek

full_name: Marilisa Schiwek

given: Marilisa

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

family: Tetzlaff

full_name: Kay Tetzlaff

given: Kay

family: Clerisme-Beaty

full_name: Emmanuelle Clerisme-Beaty

given: Emmanuelle

family: Young

full_name: Lisa R. Young

given: Lisa R.

bso_classification: Medical research

currency_apc_doaj: EUR

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: ERJ Open Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

location_country:
Finland
Greece
Belgium
Australia
Russian Federation
Denmark
Ukraine
France
Poland
Norway
Argentina
Canada
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain

location_facility: CHUP, EPE - Centro Materno Infantil do Norte

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Regional clinical children hospital, Zaporizhya

location_facility: Independent Public Teaching Children's Hospital

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: General Hospital of Thessaloniki "Ippokrateio"

location_facility: Royal Hospital for Children and Young People

location_facility: Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP

location_facility: Hamburger Zentrum für Kinder- und Jugendrheumatologie

location_facility: Children's Hematology,Oncology&Immunology na Rogachev,Moscow

location_facility: Hospital de Pediatría " Prof. Dr. Juan P. Garrahan"

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Institute of Phthisiology and Pulmonology n. a. F.G.Yanovsky

location_facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Regional Children Clinical Hospital, Pulmonology, Kharkiv

location_facility: Teaching Hospital Motol, Oncology Clinic

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: The University of North Carolina at Chapel Hill

location_facility: St. Petersburg State Pediatric University

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: State Budget Clinical Healthcare Instit.Yaroslavl Region Central City Hosp.

title: A Double Blind, Randomised, Placebo-controlled Trial to Evaluate the Dose-exposure and Safety of Nintedanib Per os on Top of Standard of Care for 24 Weeks, Followed by Open Label Treatment With Nintedanib of Variable Duration, in Children and Adolescents (6 to 17 Year-old) With Clinically Significant Fibrosing Interstitial Lung Disease

summary: The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).


title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole

acronym: CheckMate 7A8

summary: A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

status: Terminated

study_completion_date_type: Actual

location_country:
Germany
France
Belgium
Australia
Puerto Rico
Spain
United States

location_facility: Northside Hospital,Inc.- Central Research Department

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc

location_facility: Centre de Cancerologie du Grand Montpellier


title: Abbott DBS Post-Market Study of Outcomes for Indications Over Time

acronym: ADROIT

summary: The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
Finland
France
Australia
Spain
Germany
United Kingdom
Taiwan

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: University of South Florida - Department of Neurology

location_facility: Allegheny General Hospital Department of Neurosurgery

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: Wright State University & Premier Health

intervention_type: Device


title: A Phase 1b/2, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

summary: COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

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: MedImmune LLC

location_country:
United States
France
Australia
Spain
Canada


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.

name: Preclinical Research, Adaptimmune, Abingdon, UK

family: Sanderson

full_name: Joseph P Sanderson

given: Joseph P

family: Crowley

full_name: Darragh J Crowley

given: Darragh J

family: Wiedermann

full_name: Guy E Wiedermann

given: Guy E

family: Quinn

full_name: Laura L Quinn

given: Laura L

family: Crossland

full_name: Katherine L Crossland

given: Katherine L

family: Tunbridge

full_name: Helen M Tunbridge

given: Helen M

family: Cornforth

full_name: Terri V Cornforth

given: Terri V

name: Translational Sciences, Adaptimmune, Abingdon, UK

family: Barnes

full_name: Christopher S Barnes

given: Christopher S

family: Ahmed

full_name: Tina Ahmed

given: Tina

name: Target Validation, Adaptimmune, Abingdon, UK

family: Howe

full_name: Karen Howe

given: Karen

family: Saini

full_name: Manoj Saini

given: Manoj

family: Abbott

full_name: Rachel J Abbott

given: Rachel J

family: Anderson

full_name: Victoria E Anderson

given: Victoria E

family: Tavano

full_name: Barbara Tavano

given: Barbara

family: Maroto

full_name: Miguel Maroto

given: Miguel

family: Gerry

full_name: Andrew B Gerry

given: Andrew B

currency_apc_doaj: GBP

journal_name: OncoImmunology

evidence: open (via free pdf)

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

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Adaptimmune

location_country:
France
Spain
United States
United Kingdom
Canada

location_facility: Medical College of WI Froedtert Hospital

location_facility: Washington University School of Medicine

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Start Madrid-FJD, Fundación Jimѐnez Díaz


title: A Phase III, Multicenter Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosprine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single or Double Lung Transplantation

summary: Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

status: Enrolling by invitation

design_allocation: Non-Randomized

lead_sponsor: Zambon SpA

location_country:
Austria
Germany
France
Israel
Belgium
Spain
United States
United Kingdom

location_facility:
Stanford University Hospital
Temple University Hospital
Banner Health
LMU Klinikum Groshadern
Cleveland Clinic
University of Florida
Mayo Clinic Jacksonville
Houston Methodist Hospital
Hospital Puerta de Hierro
UCLA
Ohio State University
CHU Hopital Nord
Royal Papworth Hospital
Columbia University Medical Center
University of Maryland
UK Albert B. Chandler Hospital
Inova Hospital
Barnes-Jewish Hospital
Waehringer Guertel
Johns Hopkins University Hospital
University Hospital LA F3
Marie-Lannelongue
Baylor University Medical Center
Hopitaux Universitaires de Strasbourg
CHU Erasme
Hospital Universitari Vall d'Hebron
Indiana University
University of Manchester
Rabin Medical Center
Complexo Hospitalario de A Coruna
Hannover Medical School
University of Pittsburgh Medical Center
UCSF
Hospital Marques de Valdecilla
Duke University
Reina Sofia University Hospital


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.

lead_sponsor: QED Therapeutics, Inc.

location_country:
United States
France
Australia
Spain
Canada
United Kingdom

location_facility: Nemours Alfred I. Dupont Hospital for Children

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Manchester University Children's Hospital


status: Completed

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.

lead_sponsor: Boehringer Ingelheim

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

location_facility: The Guenther Dermatology Research Centre

location_facility: Shirasaki Dermatology and Neurology Clinic

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Shiga University of Medical Science Hospital

location_facility: Veszprem County Csolnoky Ferenc Hospital

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: York Dermatology Clinic and Research Centre

location_facility: The Psoriasis Treatment Center of Central New Jersey

location_facility: Total Skin and Beauty Dermatology Center, PC

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: Markusovszky University Teaching Hospital

location_facility: Dermatovenereological Dispensary #10, St. Petersburg

location_facility: Tokyo Dental College Ichikawa General Hospital

location_facility: SimcoDerm Medical and Surgical Dermatology Centre

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)

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.

status_simplified: Completed


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


lead_sponsor: X4 Pharmaceuticals

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

acronym: A treatment study in patients with WHIM Syndrome.

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

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

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

location_facility: Medical University of Vienna - Medizinische Universität Wien

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

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

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

location_facility: Seoul National University Hospital, Children's Hospital

location_facility: University of Debrecen, Affiliated Department of Infectology

location_facility: University of Texas Southwestern Medical Center

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

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

summary: This study has a double-blind, placebo-controlled Randomized Period and an Open-Label extension Period. The primary objective of the Randomized 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 extension 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:
Austria
France
Czechia
Bulgaria
Poland
Romania
Hungary
Spain
United States
Ukraine

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

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

location_facility: CHRU Strasbourg - Hopital Hautepierre/ ID # 205

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

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

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

location_facility: Next Innovative Clinical Research/ ID # 617

location_facility: Szent Anna Szuleszeti-Nogyogyaszati/ ID # 251

location_facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404

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

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

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

location_facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401

location_facility: UWCR - Lyndhurst Clinical Researc/ ID# 605

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

location_facility: Gynekologicko - Porodnicka Ambulance/ ID # 162

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

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

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

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

location_facility: Hospital Regional Universitario de Málaga/ ID # 303

location_facility: Centrum Medyczne Chodźki Lublin/ ID # 403

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

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

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

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

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

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

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

location_facility: Lubelskie Centrum Diagnostyczne/ ID # 402

location_facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407

location_facility: Affinity Clinical Research Institute/ ID # 622

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

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

location_facility: Chattanooga Medical Research LLC/ ID# 602

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

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

location_facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505

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

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

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

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

location_facility: Hospital General Universitario Reina Sofia/ ID # 304

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

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


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

acronym: PROMISE

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

primary_purpose: Diagnostic

lead_sponsor: Guerbet

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

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

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

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

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

location_facility: UConn Health - University of Connecticut

location_facility: Klinik für Diagnostische und Interventionelle Radiologie

location_facility: The University of Chicago Medical Center

location_facility: Acibadem City Clinic Tokuda Hospital Sofia

location_facility: Hospital Universitario y Politécnico La Fe

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


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 main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative to Process C.

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Universitario Virgen De La Victoria


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:
France
Bulgaria
Israel
Hungary
Spain
United States
United Kingdom

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

location_facility: Specialized Hospital in Active Treatment of Pediatric Diseases

location_facility: University of Califorina, Los Angeles (UCLA)

location_facility: University of Arkansas For Medical Services

location_facility: Szszb County Hospital and Jósa András University Teaching Hospital

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

location_facility: Centre Hospitalier Universitaire de Caen Normandie

location_facility: Associates in Newborn Medicine - Saint Paul

location_facility: Texas Health Presbyterian Hospital - Plano

location_facility: Veszprém County Csolnoky Ferenc Hospital

location_facility: University of Mississippi Medical Center

location_facility: Children'S Hospital of the University of Illinois

location_facility: Sheridan Clinical Research / Plantation General Hospital

location_facility: Banner University Medical Center / University of Arizona

location_facility: Nottingham University Hospitals, Neonatology: City Campus

location_facility: Hospital Universitario Hm Puerta Del Sur

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

location_facility: University of Texas Medical Branch - Ocr

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

location_facility: Nottingham University Hospitals NHS Trust

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

location_facility: Szent György University Teaching Hospital of County Fejér

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

location_facility: University Multiprofile Hospital for Active Treatment

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

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

location_facility: University of Miami/Holtz Children'S Hospital

location_facility: University of Tennessee Health Science Center

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


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.

name: Hospital Ramón y Cajal, Madrid, 28034, Spain

family: Garrido

full_name: Pilar Garrido

given: Pilar

name: Hospital Arnaud de Villeneuve, Montpellier, 34090, France

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

name: Levine Cancer Institute, Atrium Health, Charlotte, NC 28202, USA

family: Kim

full_name: Edward S Kim

given: Edward S

name: David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA

family: Lee

full_name: Jay M Lee

given: Jay M

name: National Cancer Center Hospital East, Kashiwa, 112-0002, Japan

family: Tsuboi

full_name: Masahiro Tsuboi

given: Masahiro

family: Gómez-Rueda

full_name: Ana Gómez-Rueda

given: Ana

family: Benito

full_name: Amparo Benito

given: Amparo

family: Moreno

full_name: Nicolas Moreno

given: Nicolas

family: Gorospe

full_name: Luis Gorospe

given: Luis

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA

family: Dong

full_name: Tuochuan Dong

given: Tuochuan

name: Novartis Pharma AG, Basel, CH-4056, Switzerland

family: Blin

full_name: Cecile Blin

given: Cecile

family: Rodrik-Outmezguine

full_name: Vanessa Rodrik-Outmezguine

given: Vanessa

family: Passos

full_name: Vanessa Q Passos

given: Vanessa Q

name: The Chinese University of Hong Kong, Hong Kong, 999077, China

family: Mok

full_name: Tony SK Mok

given: Tony SK

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

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

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

lead_sponsor: Novartis Pharmaceuticals

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

acronym: CANOPY-N

location_facility: University of Kansas Medical Center Neurology Dept.

location_facility: Methodist Hospital / Methodist Cancer Center

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)

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.


title: Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)

summary: The purpose of this study is to explore the long-term outcomes, durability of effect, and real world treatment patterns in participants previously participating in the Phase 3 oral cladribine in first clinical demyelinating event (ORACLE MS) and Oral Cladribine in participants with relapsing remitting multiple sclerosis (RRMS), extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Ukraine
Croatia
France
Lithuania
Poland
Norway
Canada
Korea, Republic of
Sweden
Switzerland
Bulgaria
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Lebanon
Czechia
Tunisia
Georgia
Spain
Estonia

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I

location_facility: Hôpital Habib Bourguiba - Service de Neurologie

location_facility: Hopital Roger Salengro - CHU Lille - service de neurologie D

location_facility: CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique

location_facility: SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF

location_facility: RSBIH "Smolensk Regional Clinical Hospital"

location_facility: Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie

location_facility: Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia

location_facility: Multiprofile Hospital for Active Treatment - Stara Zagora

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic

location_facility: SEIHPE "Rostov State Medical University of MoH of RF"

location_facility: SBIH of Moscow "City Clinical Hospital # 24" - Branch 1

location_facility: University of Maryland, Baltimore - Maryland Center for MS

location_facility: Fakultni nemocnice v Motole - Interní klinika 2. LF UK a FN Motol

location_facility: A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I

location_facility: Royal Hallamshire Hospital - Dept of Neurology

location_facility: NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko

location_facility: Pavlov First Saint Petersburg State Medical University - PARENT

location_facility: Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie

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

location_facility: Nottingham University Hospital - Division of Clinical Neurology

location_facility: Ospedale San Raffaele - U.O. di Neurologia

location_facility: Empire Neurology, PC - Empire Neurology PC

location_facility: RSHI"State Novosibirsk Regional Clinical Hospital"

location_facility: Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla

location_facility: SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla

location_facility: Fakultni nemocnice Ostrava - Dept of Neurology

location_facility: Szpital im. Mikołaja Kopernika - Neurology

location_facility: CHU de Nîmes - Hôpital Carémeau - Service de Neurologie

location_facility: Department of Neurology, Haukeland University

location_facility: Ospedale Sant'Andrea di Roma - MS Center

location_facility: Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie

location_facility: Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II

location_facility: Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

location_facility: Azienda Ospadaliero Universitaria San Martino - PARENT

location_facility: Fakultni nemocnice Olomouc - Neurologicka klinika

location_facility: Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze

location_facility: MHAT - "National Heart Hospital" EAD - Multiple Clinics

location_facility: Rowan University School of Osteopathic Medicine - Department of Medicine

location_facility: Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia

location_facility: Vinnitsa State Medical University - Neurology dept

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia

location_facility: SBIH "Leningrad Regional Clinical Hospital"

location_facility: Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla

location_facility: Military Medical Academy - MHAT - Pleven

location_facility: SBIH of Moscow region " Moscow Regional Scientific and Research Clinical Institute n.a. M.F. Vladimi

location_facility: Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U

location_facility: American University of Beirut Medical Center

location_facility: Clinical Center Nis - Clinic of Neurology

location_facility: Uniwersyteckie Centrum Kliniczne - Dept of Neurology

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis

location_facility: (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques

location_facility: Saint-Petersburg SU on b.o. City Multifield Hospital #2 - Intensive Pulmonology and Thoracal Surgery

location_facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology

location_facility: SAIH "Kemerovo Regional Clinical Hospital" - PARENT

location_facility: Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica


title: Phase I, Open Label, Multicenter, Dose Escalation Study of CD19-specific CAR-T Cells in Adult Patients With CLL/SLL and DLBCL

summary: This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (DLBCL) and in adult acute lymphoblastic leukemia (ALL).

location_country:
Italy
Austria
France
Australia
Spain
United States

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of Kansas Cancer Center SC - CTL019C2201


intervention_type: Other

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

lead_sponsor: UCB Biopharma SRL

location_country:
Netherlands
Spain
Germany
France
Czechia
Bulgaria
Japan
Poland
Hungary
Belgium
China
Turkey
United States
United Kingdom

acronym: BE MOBILE 1

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

summary: The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA).


lead_sponsor: Wave Life Sciences Ltd.

location_country:
Italy
United States
Sweden
France
Czechia
Belgium
Canada
United Kingdom

acronym: DYSTANCE 51

location_facility: U.O.C di Neurologia e Malattie Neuromuscolari Centro Clinico Nemo Sud

location_facility: London Health Sciences Centre - Hospital

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Drottning Silvias Barn Och Ungdomssjukhus

title: A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy (DYSTANCE 51)

summary: This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping intervention (DYSTANCE 51)


intervention_type: Biological

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

lead_sponsor: GlaxoSmithKline

location_country: Italy Finland France Spain Estonia

acronym: NTHI MCAT-009

title: Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine

summary:
This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01.

The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components.

The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.


title: A Multi-Center, Low-Interventional Study With a Retrospective Component in Participants With Late-Onset Pompe Disease

summary: The purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational SPK-3006 capsid and GAA, GAA activity and GAA antigen levels in the usual care setting of Late-Onset Pompe Disease (LOPD) participants on an enzyme replacement regimen. Additionally, a careful evaluation of laboratory and functional testing in patients with LOPD may provide information to better understand the disease features and better drive the design of a future interventional investigational gene therapy trial. An understanding of the underlying status of liver and muscle health in individuals with LOPD may also inform best surveillance during the conduct of gene therapy trials.

primary_purpose: Screening

lead_sponsor: Spark Therapeutics

location_country:
Italy
United States
Netherlands
France
Germany
United Kingdom

location_facility: Universita degli Studi di Milano - Clinica Oculistica I

location_facility: Azienda Ospedaliero Universitaria Pisana

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

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico

location_facility: Università degli Studi di Napoli Federico II

intervention_type: Diagnostic Test


title: A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options.
Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.

Secondary Objectives:

To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab.
To assess the immunogenicity of SAR441000.
To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab.
To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000.
To determine the recommended dose of SAR441000 for the expansion phase.

lead_sponsor: Sanofi

location_country:
United States
Netherlands
France
Belgium
Spain
Germany

location_facility:
Investigational Site Number :0560003
Investigational Site Number :8400007
Investigational Site Number :0560001
Investigational Site Number :5280002
Investigational Site Number :7240002
Investigational Site Number :5280001
Investigational Site Number :2500001
Investigational Site Number :2760004
Investigational Site Number :2760003
Investigational Site Number :7240001
Investigational Site Number :2500002
Investigational Site Number :7240005
Investigational Site Number :8400003
Investigational Site Number :8400001
Investigational Site Number :2760001
Investigational Site Number :7240004
Investigational Site Number :2760005
Investigational Site Number :2760006
Investigational Site Number :2500004
Investigational Site Number :0560002


title: OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS

summary: To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.

lead_sponsor: TransMedics

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

location_facility: Groupe Hospitalier Hopitaux Universitaries

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of California at San Francisco


title: Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection.

summary: A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed subjects under nucleo(s)tide treatment.

location_country:
Hong Kong
France
Thailand
Belgium
Spain
Germany
United Kingdom
Taiwan


lead_sponsor: UCB Biopharma S.P.R.L.

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

acronym: MyCIDPchoice

title: A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

summary: The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


ReferenceType: background

ReferenceCitation: Stephen Opat, Robert Marcus, MA, FRCP, FRCPath, Craig A. Portell, MD, William Reed, MD, Chris Tankersley, Jane Huang, MD, Judith Trotman, MBChB, FRACP, FRCPA. Phase 2 Study of Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Marginal Zone Lymphoma. Blood. 2019; 134(1):5256. https://doi.org/10.1182/blood-2019-122629

lead_sponsor: BeiGene

location_country:
Italy
France
Czechia
Australia
New Zealand
China
United States
United Kingdom

acronym: MAGNOLIA

location_facility: Institute of Hematology and Hospital of Blood Disease

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Levine Cancer Institute - Carolinas Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità

type: Registry Identifier

title: A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma

summary: This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).


lead_sponsor: miRagen Therapeutics, Inc.

location_country:
United States
Belgium
France

acronym: PRISM

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Washington University School of Medicine

location_facility: The Ohio State University and Wexner Medical Center

title: PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study

summary:
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells.

The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.


ReferenceCitation: Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1). pii: e000564. doi: 10.1136/jitc-2020-000564.

family: Yoo

full_name: Changhoon Yoo

given: Changhoon

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

family: Choi

full_name: Hye Jin Choi

given: Hye Jin

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Ueno

full_name: Makoto Ueno

given: Makoto

family: Kondo

full_name: Shunsuke Kondo

given: Shunsuke

family: Chen

full_name: Li-Tzong Chen

given: Li-Tzong

family: Osada

full_name: Motonobu Osada

given: Motonobu

family: Helwig

full_name: Christoph Helwig

given: Christoph

family: Dussault

full_name: Isabelle Dussault

given: Isabelle

family: Ikeda

full_name: Masafumi Ikeda

given: Masafumi

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

repository_institution: Yonsei University Medical Library - YUHSpace

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_country:
Italy
Spain
France
Japan
China
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: Kindai University Hospital - Dept of Gastroenterology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Seoul National University Bundang Hospital

location_facility: St James's University Hospital - Dept of Oncology

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Mayo Clinic in Florida - Department of Neurology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

location_facility: Kyorin University Hospital - Dept of Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest

location_facility: National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

title: A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

summary: The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.


title: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease

summary: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

lead_sponsor: Medtronic Endovascular

location_country:
United States
Switzerland
Netherlands
France
Australia
Spain
Germany
United Kingdom
Korea, Republic of

location_facility: Praxis fur Innere Medizin und Gefäβkrankheiten

location_facility: Hôpital de Morges - Ensemble Hospitalier de la Côte

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)

location_facility: Sanitas Hospital Universitario La Zarzuela


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

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

location_country:
Jordan
Finland
Greece
Belgium
Oman
India
France
Panama
Canada
Kenya
Colombia
South Africa
United Arab Emirates
Netherlands
United States
Germany
United Kingdom
Italy
Brazil
Lebanon
Ghana
Spain
Turkey

acronym: STAND

location_facility: Levine Cancer Insitute Carolinas Healthcare System

location_facility: Memorial Cancer Institute Regulatory Contact

location_facility: University of Texas Health Science Center at Houston

title: A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND)

summary: The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.


title: An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects With Acute HIT (HITSOVA Study)

acronym: HITSOVA

summary: An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

lead_sponsor: Aspen Global Incorporated

location_country:
Italy
United States
Bosnia and Herzegovina
Serbia
France
Poland
Russian Federation
Germany
Canada

location_facility: Clinical Centre of Serbia, Clinic for Emergency Internal Medicine

location_facility: AOU Careggi, SOD Malattie Aterotrombotiche

location_facility: Universitatstklinikum Halle (Saale), Medizinische Klinik III

location_facility: Zentrum für Klinische Transfusionsmedizin

location_facility: Institute of Cardiovasklar Diseases of Vojvodina, Cardiac Surgery ICU

location_facility: Vivantes Klinikum im Friedrichhain Hämophiliezentrum, Gerinnungssprechstunde Landsberger Allee 49

location_facility: Centre Hospitalier Universitaire Amiens Picardie

location_facility: Universitätsklinikum Gießen und Marburg GmbH, Klinik für Herz-, Kinderherz- und Gefäßchirurgie Standort Gießen

location_facility: Instituto Scientifico San Raffaele- Servizio Coagulazione e Centro Trombosi

location_facility: University Clinical Centre of the Republic of Srpska, Clinic for cardiology

location_facility: Clinical Center University of Sarajevo, Clinic for Lung Diseases

location_facility: Clinical Hospital № 122 N. A. L.G. Sokolov

location_facility: Wojewódzki Szpital Zespolony im. L. Rydygiera

location_facility: Clinical Center University of Sarajevo, Clinic for Heart, Blood Vessels and Rheumatic Diseases

location_facility: Clinical Center of the Republic of Srpska, Medical Intesnive Care Unit

location_facility: Centrum Medyczne HCP Sp. z o.o. Szpital im. Św. Jana Pawła II

location_facility: The Institute for Pulmonary Disease of Vojvodina, Pulmonary thromboembolism department

location_facility: Azienda Ospedaliero Universitaria S.Orsola-Malpighi - UO Angiologia e Malattie della Coagulazione

location_facility: University Clinical Centre of the Republic of Srpska, Lung Clinic

location_facility: Humanitas Research Hospital- Thrombosis Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: First City Hospital N.A. E.E. Volosevich

location_facility: The Ohio State University Wexner Medical Center

location_facility: Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital

location_facility: Instiute of Cardiovascular Diseases "Dedinje"

location_facility: University Hospital Greifswald Dpt. of Hematology

location_facility: ASST Papa Giovanni XIII, Servizio di Immunoematologia e Medicina Trasfusionale

location_facility: Clinical centre of Serbia, Clinic for Pulmonology


ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
United States
Sweden
Netherlands
France
Israel
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus

location_facility: Columbia University/Herbert Irving Cancer Center

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Washington University School of Medicine

location_facility: University of Mississippi Medical Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The University of Texas Southwestern Medical Center Children's Health

location_facility: Schneider Children's Medical Center of Israel

location_facility: NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: Riley Hospital for Children - Indiana University

location_facility: University of Minnesota/Masonic Cancer Center

title: A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

summary:
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.


title: An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

acronym: FORTRESS

summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.

lead_sponsor: Polyphor Ltd.

location_country:
Italy
Brazil
France
Czechia
Belgium
Argentina
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Florida Cancer Specialists NORTH - SCRI - PPDS

location_facility: Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: California Cancer Associates for Research and Excellence

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Florida Cancer Specialists PAN - SCRI - PPDS

location_facility: Saint Luke's Cancer Institute 150 Entrance

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Universidade de Caxias do Sul (IPCEM-UCS)

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: CAIPO Centro para la atención integral del paciente oncológico

location_facility: Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Florida Cancer Specialists EAST - SCRI - PPDS

location_facility: OHSU Knight Cancer Institute Hematology Oncology

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: Herbert-Herman Cancer Center, Sparrow Hospital

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS

location_facility: CHIREC Centre Hospitalier Interregional Edith Cavell

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

location_facility: Research Oncology Institute of Tomsk Scientific Center

location_facility: Florida Cancer Specialists SOUTH - SCRI - PPDS


ReferenceCitation: Choon SE, Lebwohl MG, Marrakchi S, Burden AD, Tsai TF, Morita A, Navarini AA, Zheng M, Xu J, Turki H, Rajeswari S, Deng H, Tetzlaff K, Thoma C, Bachelez H. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021 Mar 30;11(3):e043666. doi: 10.1136/bmjopen-2020-043666.

family: Choon

full_name: Siew Eng Choon

given: Siew Eng

family: Lebwohl

full_name: Mark G Lebwohl

given: Mark G

family: Marrakchi

full_name: Slaheddine Marrakchi

given: Slaheddine

family: Burden

full_name: A David Burden

given: A David

family: Tsai

full_name: Tsen-Fang Tsai

given: Tsen-Fang

family: Morita

full_name: Akimichi Morita

given: Akimichi

family: Navarini

full_name: Alexander A Navarini

given: Alexander A

family: Zheng

full_name: Min Zheng

given: Min

family: Xu

full_name: Jinhua Xu

given: Jinhua

family: Turki

full_name: Hamida Turki

given: Hamida

family: Rajeswari

full_name: Sushmita Rajeswari

given: Sushmita

family: Deng

full_name: Hongjie Deng

given: Hongjie

family: Tetzlaff

full_name: Kay Tetzlaff

given: Kay

family: Thoma

full_name: Christian Thoma

given: Christian

family: Bachelez

full_name: Hervé Bachelez

given: Hervé

journal_name: BMJ Open

lead_sponsor: Boehringer Ingelheim

location_country:
United States
Switzerland
France
Japan
Malaysia
Thailand
Tunisia
Singapore
China
Germany
Korea, Republic of
Taiwan

acronym: Flare Treatment Phase II Trial in GPP

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: The First Hospital of Dalian Medical University

location_facility: Tianjin Medical University General Hospital

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

title: Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of BI 655130 in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity.

summary: To evaluate efficacy, safety, and tolerability of BI 655130 compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.


title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors

summary: The main purpose of this study is to investigate the safety of LY3405105 in participants with advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll in one part.

ReferenceCitation: Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8. Review.

family: Sava

full_name: Georgina P. Sava

given: Georgina P.

family: Fan

full_name: Hailing Fan

given: Hailing

family: Coombes

full_name: R. Charles Coombes

given: R. Charles

family: Buluwela

full_name: Lakjaya Buluwela

given: Lakjaya

family: Ali

full_name: Simak Ali

given: Simak

journal_name: Cancer and Metastasis Reviews

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: Imperial College London - Spiral

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: CDK7 inhibitors as anticancer drugs

lead_sponsor: Eli Lilly and Company

location_country:
France
Spain
United States
Canada
Taiwan

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Texas MD Anderson Cancer Center


title: A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

acronym: SEQUOIA

summary: A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

lead_sponsor: Theravance Biopharma

location_country:
Italy
Austria
United States
Spain
Germany
France
Bulgaria
Poland
Israel
Hungary
Australia
Russian Federation
New Zealand
Portugal
Estonia
Denmark
Canada
United Kingdom
Ukraine

location_facility: Ospedale San Giovanni Battista del Sovrano Militare Ordine di Malta

location_facility: Georgetown University Hospital, Dept. of Neurology

location_facility: Federal State Budgetary Institution National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the Ministry of Healthcare of the Russian Federation

location_facility: Fixel Institute for Neurological Diseases

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: UMHAT Alexandrovska EAD Clinic of Neurological Diseases

location_facility: Universita Gabriele D'Annunzio- Cesi-Met

location_facility: Universitaetsklinikum Freiburg - Klinik fur Neurologie und Neurophysiologie

location_facility: Medizinische Universitat Innsbruck Abteilung Fur Neurologie

location_facility: Colorado Springs Neurological Associates, PC

location_facility: Regional State Budgetary Institution of Healthcare Smolensk Regional Clinical Hospital

location_facility: Wilhelminenspital Wien Abteilung fur Neurologie

location_facility: Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

location_facility: Fondazione PTV - Policlinico Tor Vergata I U.O.C. Neurologia

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona

location_facility: UMHAT Sveti Georgi EAD Clinic of Neurological Diseases

location_facility: Policlinico Umberto I - Universita degli Studi di Roma La Sapienza / Neurologia

location_facility: State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan

location_facility: Pecsi Tudomanyegyetem, Neurologiai Klinika

location_facility: Alexianer St. Joseph-Krankenhaus Berlin-Weißensee, Klinik für Neurologie

location_facility: Gemeinschaftspraxis Dr. med. J. Springub/ W. Schwarz

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Saint Petersburg State Budgetary Institution of Healthcare City Hospital # 40 of Kurortnyi Region

location_facility: Communal Institution City Clinical Hospital #6

location_facility: Charite Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

location_facility: Ospedale San Raffaele I U.O. di Neurologia

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Dept of Neurology

location_facility: Azienda Ospedaliero - Universitaria Policlinico Vittorio Emanuele. - P.O G. Rodolico, Clinica Neurologica

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Montreal Neurological Institute and Hospital

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria

location_facility: Federal State Budgetary Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Postgraduate Education of the Ministry of Healthcare of the Russian Federation

location_facility: University Health Network - Toronto Western Hospital Movement Disorders Clinic

location_facility: Parkinson's Disease and Movement Disorders Center

location_facility: Hospital Senhora da Oliveira - Guimaraes, EPE

location_facility: NHI Central Clinical Hospital #2 of JSC Russian Railways N.A. Semashko

location_facility: CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology

location_facility: Charite - Campus Virchow-Klinikum, Klinik fur Neurologie

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Communal Institution Dnipropetrovsk I.I.Mechnikov RCH

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

location_facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Umberto I - G.M. Lancisi - G. Salesi, SOD Clinica di Neuroriabilitazione

location_facility: Centro Hospitalar e Universitario Lisboa Norte - Hospital de Santa Maria

location_facility: Perron Institute for Neurological and Translational Science, QEII Medical Centre

location_facility: University of Texas Southwestern Medical Center


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

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Belgium
Russian Federation
Spain
Canada
United Kingdom

acronym: FOREMOST

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Municipal Budgetary Healthcare Institution City Emergency Hospital

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Carol and Frank Morsani Center for Advanced Health Care

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation

location_facility: University of Florida College of Medicine

location_facility: Klein and Associates MD, PA - Cumberland

location_facility: Center for Rheumatology, Immunology, and Arthritis

location_facility: Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Arthritis, Rheumatic, and Back Disease Associates

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Assistance Publique- Hopitaux de Paris AP-HP

location_facility: Mechnikov North-Western State Medical University

location_facility: Humanitas Research Hospital Humanitas Mirasole

location_facility: Research Institute of Rheumatology named after V.A.Nasonova

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Moscow Regional Research Institute n.a. Vladimirsky

location_facility: Arthritis and Osteoporosis Center of Southwest Ohio

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I

title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD

summary: This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.