title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

acronym: Cadenza

summary: The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

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: Bioverativ, a Sanofi company

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Japan
Israel
Norway
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: Hospital of the University of Pennsylvania

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Hospital Clinci i Provincial de Barcelona

location_facility: U.O.C. Ematologia- Policlinico "A. Gemelli"

location_facility: Washington University School of Medicine

location_facility: Univ Ulm, Inst Klin. Transfusions. Immungen

location_facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

location_facility: New York Medical College at Westchester Medical Center

location_facility: St Olavs Hospital, Avdeling for blodsykdommer


title: Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

summary: This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
Netherlands
Spain
Germany
France
Japan
Thailand
Hungary
Argentina
China
Denmark
United States

location_facility: James Cancer Hospital and Solove Research Institute Ohio State

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

summary: This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Jazz Pharmaceuticals

location_country:
Italy
Austria
United States
Spain
Germany
Croatia
Bulgaria
France
Greece
Poland
Belgium
Portugal
Canada
United Kingdom

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centrum Onkologii im. Marii Sklodowskiej-Curie

location_facility: Hospital d Instructions des Armees Percy

location_facility: University of California, San Francisco Medical Center

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Penn State Milton S Hershey Medical Center

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hospital Clinico Universitario de Valencia

status_simplified: Completed


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]

summary:
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism.

In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment.

Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant.

The study doctors will also check for side effects from the study treatments.

After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.

ipd_sharing: Yes

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

location_country:
Italy
United States
Sweden
Netherlands
Spain
Germany
France
Norway
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: Eastern Health - Health Sciences Center- General Hospital

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Ohio State University Wexner Medical Center

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Oslo Universitetssykehus HF Rikshospitalet

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Universita di Firenze, Dipartimento di Chirurgia e Medicina Traslazionale (DCMT)

location_facility: Nova Scotia Health Authority (Capital District Health Authority)

location_facility: Hospital Universitario Fundacion Jimenez Diaz

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
Brazil
Mexico
Germany
France
Poland
Romania
Belgium
Argentina
Russian Federation
Spain
United States
United Kingdom

acronym: A multi-centre, open-label, long term safety study of mepolizumab in subjects with HSE.

source: euctr

title: A Multi-centre, Open-label Extension, Safety Study to Describe the Long-term Clinical Experience of Mepolizumab in Participants With Hypereosinophilic Syndrome (HES) From Study 200622

summary: This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.


type: U.S. FDA Grant/Contract

title: A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy

acronym: ACCOLADE

summary: The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD

ipd_sharing: No

lead_sponsor: ChemoCentryx

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

location_facility:
Clinical Trial Site
Clinical Site


title: Expanded Clinical Study of the Tendyne Mitral Valve System

summary: The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, Denti P, Dumonteil N, Modine T, Jansz P, Chuang ML, Blanke P, Leipsic J, Badhwar V. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.

family: Muller

full_name: David W.M. Muller

given: David W.M.

sequence: first

family: Sorajja

full_name: Paul Sorajja

given: Paul

sequence: additional

family: Duncan

full_name: Alison Duncan

given: Alison

family: Bethea

full_name: Brian Bethea

given: Brian

family: Dahle

full_name: Gry Dahle

given: Gry

family: Grayburn

full_name: Paul Grayburn

family: Babaliaros

full_name: Vasilis Babaliaros

given: Vasilis

family: Guerrero

full_name: Mayra Guerrero

given: Mayra

family: Thourani

full_name: Vinod H. Thourani

given: Vinod H.

family: Bedogni

full_name: Francesco Bedogni

given: Francesco

family: Denti

full_name: Paolo Denti

given: Paolo

family: Dumonteil

full_name: Nicolas Dumonteil

given: Nicolas

family: Modine

full_name: Thomas Modine

given: Thomas

family: Jansz

full_name: Paul Jansz

family: Chuang

full_name: Michael L. Chuang

given: Michael L.

family: Blanke

full_name: Philipp Blanke

given: Philipp

family: Leipsic

full_name: Jonathon Leipsic

given: Jonathon

family: Badhwar

full_name: Vinay Badhwar

given: Vinay

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P; Tendyne Global Feasibility Trial Investigators. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28. Erratum in: J Am Coll Cardiol. 2017 Mar 7;69(9):1213.

family: Farivar

full_name: Robert Saeid Farivar

given: Robert Saeid

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
France
Norway
Australia
Germany
United Kingdom

location_facility: Honor Health Scottsdale Shea Medical Center


title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 986 in Healthy Subjects and Heart Failure Patients

summary: To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy subjects, who received AMG 986 by constant intravenous (IV) infusion or oral (PO) administration and of ascending multiple PO doses of AMG 986 in heart failure patients (Part C).

status: Terminated

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:
United States
Netherlands
Germany
France
Poland
Singapore
Australia
New Zealand
Canada

status_simplified: Unknown


title: A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)

acronym: REFINE

summary: This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

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

lead_sponsor: AbbVie

location_country:
Greece
Belgium
Australia
Russian Federation
Taiwan
Croatia
France
Japan
Poland
Canada
Korea, Republic of
Bulgaria
Hungary
Puerto Rico
United States
United Kingdom
Italy
Serbia
Israel
Spain
Turkey

location_facility: Leningrad Regional Clinical Hospital /ID# 230507

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 230012

location_facility: Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585

location_facility: University General Hospital Attikon /ID# 230395

location_facility: City Clinical Hospital named after S.P. Botkin /ID# 230508

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 230371

location_facility: University Clinical Center Kragujevac /ID# 230550

location_facility: Dana-Farber Cancer Institute /ID# 162675

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214709

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230681

location_facility: Hospital General Universitario Gregorio Maranon /ID# 214676

location_facility: The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299

location_facility: General Hospital of Athens Laiko /ID# 230394

location_facility: New Jersey Cancer Care & Blood Disorders /ID# 230925

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222332

location_facility: Hospital Universitario Central de Asturias /ID# 230884

location_facility: Ascension Providence Southfield Cancer Center /ID# 223876

location_facility: Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011

location_facility: Aomori Prefectural Central Hospital /ID# 221773

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536

location_facility: Weill Cornell Medical College /ID# 162679

location_facility: Southeastern Medical Oncology Center /ID# 230954

location_facility: Ankara Universitesi Fakultesi /ID# 230317

location_facility: Klinicki bolnicki centar Zagreb /ID# 230602

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 162683

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 230504

location_facility: Hadassah Medical Center-Hebrew University /ID# 230310

location_facility: Moore UC San Diego Cancer Center /ID# 164084

location_facility: Hospital Universitario 12 de Octubre /ID# 214710

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318

location_facility: Klinicki bolnicki centar Split /ID# 230601

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159

location_facility: University Clinical Center Serbia /ID# 230629

location_facility: University Cancer & Blood Center /ID# 230939

location_facility: Centre Hospitalier de CHAMBERY /ID# 230889

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 164110

location_facility: Colorado Blood Cancer Institute /ID# 224250

location_facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094

location_facility: Kansai Medical University Hospital /ID# 222690

location_facility: ASST Spedali civili di Brescia /ID# 230420

location_facility: Cancer Specialists of North Florida /ID# 230917

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549

location_facility: Seoul National University Hospital /ID# 230380

location_facility: National Cheng Kung University Hospital /ID# 230372

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 222806

location_facility: Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 214555

location_facility: Assuta Ashdod Medical Center /ID# 230396

location_facility: University of Chicago Medicine /ID# 164115

location_facility: Hospital Universitario Vall d'Hebron /ID# 222415

location_facility: University of Alberta Hospital - Division of Hematology /ID# 217698

location_facility: Indiana Blood & Marrow Transpl /ID# 165075

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718

location_facility: Mary Crowley Cancer Research /ID# 230923

location_facility: Long Beach Memorial Medical Ct /ID# 230148

location_facility: Eastern Connecticut Hematology and Oncology Associates /ID# 230918

location_facility: St Joseph Heritage Healthcare /ID# 230936

location_facility: Capital Region Medical Center /ID# 232627

location_facility: VA Caribbean Healthcare System /ID# 222416

location_facility: Medical University of South Carolina /ID# 222597

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393

location_facility: Prairie Lakes Healthcare System /ID# 224358

location_facility: Tennessee Oncology-Nashville Centennial /ID# 221410

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 214704

location_facility: Hospital Clinic de Barcelona /ID# 231538

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012

location_facility: Memorial Hospital of South Bend /ID# 230912

location_facility: Fujita Health University Hospital /ID# 221539

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306

location_facility: Dokuz Eylul University Medical Faculty /ID# 231321

location_facility: Tel Aviv Sourasky Medical Center /ID# 230311

location_facility: Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548

location_facility: Nippon Medical School Hospital /ID# 222692

location_facility: Northwest Medical Specialties /ID# 230926

location_facility: Southcoast Health Cancer Center /ID# 230934

location_facility: Universtiy of Southern California /ID# 164095

location_facility: Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938

location_facility: Comprehensive Cancer Centers of Nevada /ID# 230916

location_facility: Hematology Oncology Associates of Fredericksburg /ID# 231372

location_facility: St. Joseph Heritage Healthcare /ID# 230935

location_facility: University of Massachusetts Wo /ID# 222547

location_facility: University of Yamanashi Hospital /ID# 221700

location_facility: Belfast Health and Social Care Trust /ID# 216991

location_facility: Princess Margaret Cancer Centre /ID# 214483

location_facility: Aneurin Bevan University Health Board /ID# 230332

location_facility: Ocala Oncology Florida Cancer Affiliates /ID# 230927

location_facility: Juntendo University Hospital /ID# 221484

location_facility: McGill University Health Center Research Institute /ID# 223976

location_facility: Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719

location_facility: Community Cancer Trials of Utah /ID# 230914

location_facility: Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506

location_facility: Ondokuz mayis University Facul /ID# 230314

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553

location_facility: UAB Comprehensive Cancer Cente /ID# 165464


title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

summary: A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

ReferenceCitation: Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.

family: Fontana

full_name: Robert J. Fontana

given: Robert J.

family: Lens

full_name: Sabela Lens

given: Sabela

family: McPherson

full_name: Stuart McPherson

given: Stuart

family: Elkhashab

full_name: Magdy Elkhashab

given: Magdy

family: Ankoma-Sey

full_name: Victor Ankoma-Sey

given: Victor

family: Bondin

full_name: Mark Bondin

given: Mark

family: dos Santos

full_name: Ana Gabriela Pires dos Santos

given: Ana Gabriela Pires

family: Xue

full_name: Zhenyi Xue

given: Zhenyi

family: Trinh

full_name: Roger Trinh

given: Roger

family: Porcalla

full_name: Ariel Porcalla

given: Ariel

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

license_normalized: no license

repository_institution: Newcastle Univesity - Newcastle University ePrints

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

location_country:
United States
France
Bulgaria
Poland
Puerto Rico
Russian Federation
Spain
Germany
United Kingdom
Canada

location_facility: HepID - Diagnostyka I Terapia /ID# 162219

location_facility: CHU de Besancon - Jean Minjoz /ID# 161485

location_facility: Digestive Disease Associates - Baltimore /ID# 161260

location_facility: A. F. Agafonov Republican Clin /ID# 163164

location_facility: South Ural State Medical univ /ID# 163163

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 161492

location_facility: Uniwersytecki Szpital Kliniczn /ID# 162216

location_facility: A.I. Evdokimov Moscow State Un /ID# 163162

location_facility: Digestive and Liver Disease Sp /ID# 161259

location_facility: Univ Maryland School Medicine /ID# 161157

location_facility: University of Vermont Medical Center /ID# 161263

location_facility: Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396

location_facility: Hospital Clinic de Barcelona /ID# 161437

location_facility: Universitätsklinikum Frankfurt /ID# 161397

location_facility: ICH Study Center GmbH & Co KG /ID# 161394

location_facility: Complexo Hospitalario universi /ID# 165603

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 161395

location_facility: Hosp Uni Virgen de la Victoria /ID# 164383

location_facility: Northwest Gastroenterology Cli /ID# 161257

location_facility: Liver Associates of Texas, P.A /ID# 161262

location_facility: University of Michigan Hospitals /ID# 161265


title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

acronym: Pyrenees

summary: This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

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

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Italy
Serbia
Spain
Croatia
Czechia
Bulgaria
France
Georgia
Poland
Hungary
Belgium
Romania
Russian Federation
Portugal
Slovakia
Germany
United Kingdom

location_facility:
Site PT35102
Site BE32004
Site SK42113
Site ES34006
Site BE32017
Site RS38117
Site IT39028
Site RS38116
Site RS38102
Site HR38501
Site BG35916
Site GB44011
Site FR33007
Site BE32013
Site IT39010
Site BE32002
Site RU70005
Site HU36032
Site HU36046
Site IT39022
Site RS38120
Site CZ42021
Site BE32011
Site IT39014
Site PT35128
Site RU70030
Site FR33055
Site BG35919
Site DE49065
Site IT39006
Site HU36027
Site FR33056
Site RU70051
Site RO40019
Site HU36036
Site IT39036
Site IT39005
Site PL48001
Site IT39032
Site RS38101
Site SK42120
Site RU70011
Site PT35127
Site BG35903
Site BG35907
Site RU70014
Site BE32001
Site IT39039
Site GE99508
Site GB44080
Site GE99504
Site FR33010
Site PT35139
Site ES34009
Site ES34011
Site BG35937
Site DE49067
Site PT35122
Site DE49002
Site BE32012
Site GB44087
Site HR38507
Site RO40003
Site ES34008
Site RU70072
Site DE49071
Site BG35906
Site HU36034
Site ES34002
Site BE32003
Site DE49070
Site HU36026
Site PL48005
Site GB44079
Site IT39008
Site PT35121
Site PL48006
Site RU70001
Site GB44008
Site BG35915
Site RU70050
Site BE32019
Site DE49056
Site BG35925
Site PL48013
Site DE49075
Site HR38509
Site RU70008
Site GB44010
Site HU36003
Site RU70037
Site BG35931
Site HR38508
Site PT35117
Site RS38105
Site HR38505
Site SK42119
Site ES34052
Site RU70006
Site HU36004
Site BG35918
Site RO40004
Site PT35114
Site HR38506
Site RU70004
Site HU36035
Site HU36031
Site HR38504
Site RS38104
Site RU70003
Site ES34041
Site DE49054
Site ES34017
Site GB44001
Site HU36006
Site BG35909
Site BG35924
Site DE49073
Site SK42116
Site BG35921
Site ES34030
Site RO40015
Site ES34010
Site FR33005
Site HU36033
Site PL48002
Site SK42102
Site CZ42015
Site RU70002
Site IT39035
Site RO40018
Site GE99503
Site CZ42008
Site ES34037
Site DE49001
Site IT39037
Site DE49020
Site GB44081
Site BG35938
Site DE49008
Site PL48009
Site BG35920
Site PL48014


ReferenceCitation: Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.

family: Rice

full_name: Andrew S.C. Rice

given: Andrew S.C.

family: Dworkin

full_name: Robert H. Dworkin

given: Robert H.

family: Finnerup

full_name: Nanna B. Finnerup

given: Nanna B.

family: Attal

full_name: Nadine Attal

given: Nadine

family: Anand

full_name: Praveen Anand

given: Praveen

family: Freeman

full_name: Roy Freeman

given: Roy

family: Piaia

full_name: Alessandro Piaia

given: Alessandro

family: Callegari

full_name: Francesca Callegari

given: Francesca

family: Doerr

full_name: Christie Doerr

given: Christie

family: Mondal

full_name: Subhayan Mondal

given: Subhayan

family: Narayanan

full_name: Nisha Narayanan

given: Nisha

family: Ecochard

full_name: Laurent Ecochard

given: Laurent

family: Flossbach

full_name: Yanina Flossbach

given: Yanina

family: Pandhi

full_name: Shaloo Pandhi

given: Shaloo

journal_name: Pain

oa_host_type: publisher

evidence: open (via free article)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

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:
Italy
Austria
Spain
Germany
France
Czechia
Japan
Poland
Slovakia
Norway
Hungary
Australia
Belgium
Portugal
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: EMPHENE

title: A Double-blind, Placebo-controlled, Randomized Dose Ranging Trial to Determine the Safety and Efficacy of Three Dose Levels of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Post-herpetic Neuralgia

summary: This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).


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

lead_sponsor: Pfizer

primary_purpose: Prevention

location_country:
Peru
Finland
Belgium
Australia
Taiwan
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Czechia
Spain

acronym: Clover

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: Tampere University Vaccine Research Turku

location_facility: Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly

location_facility: Internal Medicine and Pediatric Associates of Bristol, PC

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Anne Arundel Health System Research Institute

location_facility: Kaiser Permanente Center for Health Research

location_facility: Duke University Hospital Investigational Drug Services (IDS) Pharmacy

location_facility: Lawrence J. Ellison Ambulatory Care Center

location_facility: SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset

location_facility: Coastal Clinical Research, LLC, An AMR Company

location_facility: Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni

location_facility: Multi-Specialty Research Associates, Inc.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Accel Research Sites - DeLand Clinical Research Unit

location_facility: VA Loma Linda Healthcare System Ambulatory Care System

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: University Hospitals Cleveland Medical Center

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem

location_facility: Anne Arundel Medical Center Infusion Center

location_facility: Lehigh Valley Health Network/Network Office of Research and Innovation

location_facility: Alliance for Multispecialty Research, LLC

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Central Kentucky Research Associates, LLC

location_facility: Slezska Nemocnice v Opave, prispevkova organizace

location_facility: Medical Affiliated Research Center, Inc.

location_facility: University of Colorado Clinical & Translational Research Center Outpatient Clinic

location_facility: KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Advanced Clinical Research/Gut Whisperer

location_facility: MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly

location_facility: The Alverton Practise, St Clare Medical Centre

location_facility: Washington University School of Medicine

location_facility: Long Beach Clinical Trials Services, Inc.

location_facility: VA Loma Linda Healthcare System Research Pharmacy

location_facility: SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC

location_facility: Ocean Blue Medical Research Center, Inc.

location_facility: Semmelweis Egyetem, III. sz. Belgyogyaszati Klinika

location_facility: Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann

location_facility: Mayo Clinic Rochester, Methodist Hospital Campus

location_facility: Medplus Centro de Recuperacion Integral S.A.S.

location_facility: Anne Arundel Medical Center Research Pharmacy

location_facility: Universitaetsklinikum Essen, Klinik fuer Infektiologie

location_facility: CHU de Liège - Domaine universitaire du Sart Tilman

location_facility: Social Medical Care Corporation Hose-kai Marunouchi Hospital

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Waterway Primary Care LLC DBA Tabor City Family Medicine

location_facility: Mater Misericordiae Ltd & Mater Medical Research Institute Ltd

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

location_facility: Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus

location_facility: CHU DIJON BOURGOGNE- Hopital Francois Mitterrand

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly

location_facility: University of Colorado Clinical & Translational Research Center Clinic

location_facility: J. Lewis Research, Inc./Foothill Family Clinic

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: VA Northern California Health Care System

location_facility: SPAOLO s.r.o., Ambulancia vnutorneho lekarstva

location_facility: South Texas Veterans Healthcare System, Audie L Murphy Hospital

location_facility: Gothia Forum CTC/Sahlgrenska Universitetssjukhuset

location_facility: PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut

location_facility: Medical Corporation Tokushukai Koga General Hospital

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Synexus Polska Sp. z o.o. Oddział w Poznaniu

location_facility: Synexus Polska Sp. z o.o Oddzial w Gdansku

location_facility: Newcastle upon Tyne Hospitals NHS Foundation trust

location_facility: PMG Research, Inc. d/b/a PMG Research of Knoxville

location_facility: J. Lewis Research, Inc. - Jordan River Family Medicine

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: "Acibadem City Clinic University Hospital" EOOD

location_facility: UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence

location_facility: Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A

location_facility: Asociación IPS Médicos Internistas de Caldas

location_facility: Clinical Research Institute of Arizona, LLC

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: J. Lewis Research Inc. / Foothill Family Clinic Draper

location_facility: Baptist Health Center for Clinical Research

location_facility: Frandsen Family Medicine DBA Sound Medical Research

location_facility: Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI

location_facility: Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec

location_facility: Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research

location_facility: Avdelningen for kliniska provningar, S-huset

location_facility: Veterans Affairs Palo Alto Health Care System

location_facility: Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre

location_facility: Semmelweis Egyetem II. Belgyogyaszati Klinika

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Medak s.r.o., Gastroenterologicka ambulancia

location_facility: St. Vincent Hospital and Health Care Center

location_facility: Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne

location_facility: Malcom Randall VA Medical Center Investigational Drug Services

location_facility: Ochsner Center for Primary Care and Wellness

location_facility: Fleming Island Center for Clinical Research

location_facility: Florida Sleep Disorder Center of Brandon

location_facility: University of Colorado Department of AIP 2. Pharmacy Bulk Storage

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Nuestra Senora de la Misericordia

location_facility: PMG Research,Inc. d/b/a PMG Research of Knoxville

location_facility: ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

location_facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

location_facility: Clinical Trial Center University of Colorado Denver, School of Medicine

location_facility: Fundacion Centro de Investigacion Clinica - CIC

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Bajai Szent Rokus Korhaz, II Belgyogyaszat

location_facility: University of California, Davis Medical Center

location_facility: MultiCare Institute for Research & Innovation

location_facility: Centre de recherche du CHU de Quebec-Universite Laval

location_facility: St. Vincent Hospital & Health Care Center

location_facility: Louis Stokes Cleveland VA Medical Center

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Hospital Senhora de Oliveira - Guimaraes, E.P.E.

type: Other Identifier

title: A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

summary:
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.


ReferenceType: background

ReferenceCitation: Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196. doi: 10.1056/NEJMoa2004325. Epub 2020 May 29.

lead_sponsor: Myovant Sciences GmbH

location_country:
Finland
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Netherlands
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
New Zealand
Spain

acronym: HERO

location_facility:
Kita-gun
Vejle
Hangzhou
Salvador
Lancaster
Nottingham
Yokohama
A Coruna
Sala
Nagasaki
Seinajoki
Dunedin
Ijuí
Joinville
Garden City
Nashville
Orebro
Exeter
London
Sumida-ku
Herlev
Goyang-Si
Hiroshima
Hamilton
Sapporo
Natal
Candiolo
Uppsala
Lublin
Camperdown
Madrid
Bratislava
Suzhou
Southport
Poprad
Chiba
Tauranga
Stockholm
Cincinnati
Maebashi
Albany
Planegg
Taiyuan
Tampere
Osaka-sayama
Beijing Shi
Syracuse
Siedlce
Strasbourg
Redcliffe
Trencin
Sneek
Pompano Beach
Rhyl
Kosice
Seoul
Tucson
Aarhus
Oklahoma City
Fukuoka
Martin
Munster
Plainview
Myrtle Beach
Wichita
Salamanca
Presov
Kortrijk
Curitiba
Christchurch
Nitra
Scunthorpe
Shanghai
Arezzo
Sendai
Denver
Dresden
Turku
Middleburg Heights
Greensboro
Valencia
Kanazawa-shi
Troy
Malmo
Beijing
Orange
Tweed Heads
Meldola
Brick
Lubeck
Amsterdam
Calgary
Quebec
Bunkyō-Ku
Vancouver
Hwasun
Katowice
Emmendingen
Nanchang
Porto Alegre
Ube
Orbassano
Oviedo
Jeffersonville
Cremona
Kaohsiung City
Lanzhou
Gent
Halifax
Pierre Benite
Braunschweig
Taipei
São José Do Rio Preto
Passo Fundo
Montreal
Linz
Brussels
Nanjing
Helsinki
Busan
Changchun
Suita
Itabuna
San Antonio
Des Moines
Nakano-ku
Lyon
Creteil
Las Vegas
Durham
Barcelona
Chongqing
Alborg
Sherbrooke
Kyoto
Albuquerque
Gdynia
Poughkeepsie
Teresina
Milano
Osaka
Rome
Warszawa
Tokyo
Eindhoven
Wahroonga
Baltimore
Daegu
Omaha

title: HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

summary: The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.


title: Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

summary: This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].

lead_sponsor: Tobira Therapeutics, Inc.

location_country:
Italy
Austria
Brazil
Hong Kong
Spain
Switzerland
Germany
France
Poland
Israel
Australia
Belgium
New Zealand
Puerto Rico
United States
United Kingdom

location_facility: The University of Texas - Health Science Center & Medical School at Houston

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Mercy Medical Center - Baltimore, Maryland

location_facility: The Chaim Sheba Medical Center - Tel Hashomer

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

location_facility: Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

location_facility: Digestive Health Specialists of the Southeast - Dothan

location_facility: Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik

location_facility: Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Clinical Institute Humanitas - Humanitas Foundation for Research

location_facility: University of Miami - Schiff Center for Liver Diseases

location_facility: Kantonsspital St.Gallen Klinik für Gastroenterologie und Hepatologie

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Charite - University Hospital Berlin - Campus Virchow - Hospital

location_facility: Central Adelaide Local Health Network Inc - Royal Adelaide Hospital

location_facility: Virginia Commonwealth University Medical College of Virginia

location_facility: University of Buffalo - Erie County Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: AOU Policlinico Paolo Giaccone di Palermo

location_facility: Universitaetsklinikum Heidelberg - Innere Medizin IV

location_facility: Hospital das Clínicas da Universidade Federal de Minas Gerais

location_facility: Johns Hopkins University School of Medicine

location_facility: University Hospital Giessen and Marburg GmbH

location_facility: University of Louisville School of Medicine

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: University of Texas Southwestern Medical Center

location_facility: Consultants for Clinical Research - Cincinnati

location_facility: Royal Brisbane Hospital and Women's Hospital


ReferenceType: result

ReferenceCitation: Tam CS, LeBlond V, Novotny W, Owen RG, Tedeschi A, Atwal S, Cohen A, Huang J, Buske C. A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia. Future Oncol. 2018 Sep;14(22):2229-2237. doi: 10.2217/fon-2018-0163. Epub 2018 Jun 5.

name: Peter MacCallum Cancer Center, Melbourne, Victoria, Australia

name: University of Melbourne, Parkville, Victoria, Australia

name: St Vincent's Hospital, Fitzroy, Victoria, Australia

name: Royal Melbourne Hospital, Parkville, Victoria, Australia

family: Tam

full_name: Constantine S Tam

given: Constantine S

name: UPMC GRC 11, Pitié Salpêtrière Hospital, Paris, France

family: LeBlond

full_name: Veronique LeBlond

given: Veronique

name: BeiGene Company Ltd, San Mateo, CA 94403, USA

family: Novotny

full_name: William Novotny

given: William

name: St James’ University Hospital, Leeds, UK

family: Owen

full_name: Roger G Owen

given: Roger G

family: Tedeschi

full_name: Alessandra Tedeschi

given: Alessandra

family: Atwal

full_name: Siminder Atwal

given: Siminder

family: Cohen

full_name: Aileen Cohen

given: Aileen

family: Huang

full_name: Jane Huang

given: Jane

name: CCC Ulm, University Hospital Ulm, Ulm, Germany

family: Buske

full_name: Christian Buske

given: Christian

journal_name: Future Oncology

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: BeiGene

location_country:
Italy
Sweden
Netherlands
Germany
France
Czechia
Greece
Poland
Belgium
Australia
Spain
United States
United Kingdom

acronym: ASPEN

location_facility: Hospital Duran i Reynals, Instituto Catalán de Oncología

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: Universitätsklinikum Münster Hämatologie und Onkologie

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Azienda Ospedaliera Spedali Civili Di Brescia

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologiczny

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Szpitale Pomorskie Sp. z o.o., Szpital Morski im. PCK Gdansk

location_facility: PU A. Gemelli, Universität Cattolica del Sacro Cuore

location_facility: University of California San Diego (UCSD) - Moores Cancer Center

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Barwon Health, University Hospital Geelong

location_facility: PO A.Ferrarotto, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Germans Trias i Pujol University Hospital

location_facility: Azienda Ospedaliera "Maggiore della Carità" di Novara

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Niguarda Cancer Center Division of Hematology

location_facility: Desert Hematology Oncology Medical Group Inc.

title: A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)

summary: This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 (Zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.


lead_sponsor: Hoffmann-La Roche

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

location_facility: Radboud University Nijmegen Medical Centre; Ophthalmology

location_facility: Hopital Armand Trousseau; centre reference Maladies Neuro-musculaires Est parisien Neuropediatrie

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: University of California Davis Medical Center

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Children's Hospital Westmead; Paediatrics & Child Health

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

location_facility: London Health Sciences Centre; Children's Hospital; Pediatrics

location_facility: Drottning Silvias Barn- och ungdomssjukhus; Kliniken for barnmedicin

location_facility: Universitatsklinikum Essen; Innere Klinik

location_facility: Hotel Dieu; Service Pharmacie Essais Cliniques

location_facility: Az. Osp. Universitaria Pol. G. Martino; Dip. Neuroscienze, Scienze Psichiatriche e Anest.

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Universitari i Politecnic La Fe de Valencia; Servicio de Farmacia

location_facility: Lady Cilento Children's Hospital; Neurosciences Department

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: Nationwide Childrens Hospital; Research Institute at Nationwide Childrens Hospital

location_facility: Cincinnati Childrens Hospital Medical Center;Investigational Pharmacy

location_facility: University of Massachusetts Memorial Childrens Medical Center; Department of Neurology

location_facility: Fondazione Serena Onlus - CENTRO CLINICO NEMO

location_facility: Yale University School of Medicine ; Pulmonary & Critical Care

title: A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy

summary: This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).


ReferenceCitation: Maltais F, Bjermer L, Kerwin EM, Jones PW, Watkins ML, Tombs L, Naya IP, Boucot IH, Lipson DA, Compton C, Vahdati-Bolouri M, Vogelmeier CF. Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial. Respir Res. 2019 Oct 30;20(1):238. doi: 10.1186/s12931-019-1193-9.

ReferenceCitation: Bjermer LH, Boucot IH, Vogelmeier CF, Maltais F, Jones PW, Tombs L, Compton C, Lipson DA, Kerwin EM. Efficacy and Safety of Umeclidinium/Vilanterol in Current and Former Smokers with COPD: A Prespecified Analysis of The EMAX Trial. Adv Ther. 2021 Sep;38(9):4815-4835. doi: 10.1007/s12325-021-01855-y. Epub 2021 Aug 4.

family: Bjermer

full_name: Leif H. Bjermer

given: Leif H.

family: Boucot

full_name: Isabelle H. Boucot

given: Isabelle H.

family: Vogelmeier

full_name: Claus F. Vogelmeier

given: Claus F.

family: Maltais

full_name: François Maltais

given: François

family: Jones

full_name: Paul W. Jones

given: Paul W.

family: Tombs

full_name: Lee Tombs

given: Lee

family: Compton

full_name: Chris Compton

given: Chris

family: Lipson

full_name: David A. Lipson

given: David A.

family: Kerwin

full_name: Edward M. Kerwin

given: Edward M.

license: cc-by

license_normalized: cc-by

repository_institution: St George's University of London - St George's Online Research Archive

version: acceptedVersion

ReferenceCitation: Maltais F, Naya IP, Vogelmeier CF, Boucot IH, Jones PW, Bjermer L, Tombs L, Compton C, Lipson DA, Kerwin EM. Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial. Respir Res. 2020 Oct 22;21(1):280. doi: 10.1186/s12931-020-01451-8.

full_name: F. Maltais

given: F.

family: Naya

full_name: I. P. Naya

given: I. P.

full_name: C. F. Vogelmeier

given: C. F.

full_name: I. H. Boucot

given: I. H.

full_name: P. W. Jones

given: P. W.

full_name: L. Bjermer

given: L.

full_name: L. Tombs

full_name: C. Compton

given: C.

ReferenceCitation: Kerwin EM, Boucot IH, Vogelmeier CF, Maltais F, Naya IP, Tombs L, Jones PW, Lipson DA, Keeley T, Bjermer L. Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD: a post hoc analysis of the EMAX randomised controlled trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620926949. doi: 10.1177/1753466620926949.

name: Crisor LLC, Clinical Research Institute, 3860 Crater Lake Ave., Medford, OR 97504, USA

name: Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Germany

name: Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec City, Québec, Canada

name: Precise Approach Ltd, contingent worker on assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK

name: Respiratory Clinical Sciences, GSK, Collegeville, PA, USA and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

name: Respiratory Medicine and Allergology, Lund University, Lund, Sweden

journal_name: Therapeutic Advances in Respiratory Disease

location_country:
Italy
United States
South Africa
Sweden
Mexico
Netherlands
Germany
France
Argentina
Australia
Spain
Canada

title: A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary:
COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance.

This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks.

Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.

ELLIPTA and DISKUS are trademarks of GSK group of companies.


title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

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

location_facility: Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus

location_facility: Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

location_facility: Washington University School of Medicine

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Emory University - Winship Cancer Institute

location_facility: Oxford University Hospitals Nhs Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Iii Med. Abteilung Für Hämatologie Und Onkologie, Hanuscfhkrankenhaus

location_facility: Hospital Clinico Universitario de Valencia


title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

summary: This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).

ReferenceCitation: Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

name: David Geffen School of Medicine, University of California Los Angeles Medical Center, Los Angeles, CA

family: Finn

full_name: Richard S. Finn

given: Richard S.

name: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

family: Ikeda

full_name: Masafumi Ikeda

given: Masafumi

name: Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA

name: Jiahui International Cancer Center, Jiahui Health, Shanghai, China

family: Zhu

full_name: Andrew X. Zhu

given: Andrew X.

name: Tisch Cancer Institute at Mount Sinai, New York, NY

family: Sung

full_name: Max W. Sung

given: Max W.

name: Sutter Health/California Pacific Medical Center Research Institute, San Francisco, CA

family: Baron

full_name: Ari D. Baron

given: Ari D.

name: Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

name: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan

family: Okusaka

full_name: Takuji Okusaka

given: Takuji

name: Department of Hepatology, Toranomon Hospital, Tokyo, Japan

family: Kobayashi

full_name: Masahiro Kobayashi

given: Masahiro

family: Kumada

full_name: Hiromitsu Kumada

given: Hiromitsu

name: Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan

family: Kaneko

full_name: Shuichi Kaneko

given: Shuichi

family: Pracht

full_name: Marc Pracht

given: Marc

name: Altay Regional Oncological Hospital, Barnaul, Russian Federation

family: Mamontov

full_name: Konstantin Mamontov

given: Konstantin

name: Royal Free London National Health Service Foundation Trust, London, United Kingdom

family: Meyer

full_name: Tim Meyer

given: Tim

family: Kubota

full_name: Tomoki Kubota

given: Tomoki

family: Dutcus

full_name: Corina E. Dutcus

given: Corina E.

family: Saito

full_name: Kenichi Saito

given: Kenichi

family: Siegel

full_name: Abby B. Siegel

given: Abby B.

family: Dubrovsky

full_name: Leonid Dubrovsky

given: Leonid

family: Mody

full_name: Kalgi Mody

given: Kalgi

name: Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

name: Liver Cancer Translational Group, Liver Unit, August Pi i Sunyer Biomedical Research Institute Hospital Clinic, University of Barcelona, Catalonia, Spain

family: Llovet

full_name: Josep M. Llovet

given: Josep M.

journal_name: Journal of Clinical Oncology

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
diposit.ub.edu

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Italy
France
Japan
Russian Federation
Spain
United States
United Kingdom

location_facility: St. Petersburg City Clinical Oncology Dispansery

location_facility: Hôpital Haut-Levêque Centre médico-chirurgical Magellan

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: S.I. Russian Oncological Research Center n.a. N. N. Blokhin RAMS

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: California Pacific Medical Center (CPMC)


title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

acronym: CheckMate 592

summary: The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Netherlands
France
Romania
Belgium
Spain
Germany

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Montefiore - Einstein Center for Cancer Care

location_facility: Washington University School Of Medicine

location_facility: Prof Dr I Chiricuta Institute of Oncology


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181 as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors

summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.

ReferenceCitation: Calvo E, Spira A, Miguel M, Kondo S, Gazzah A, Millward M, Prenen H, Rottey S, Warburton L, Alanko T, Cassier PA, Yoh K, Italiano A, Moreno V, Peltola K, Seto T, Toyozawa R, Afar DE, Englert S, Komarnitsky P, Lambert S, Parikh A, Vosganian G, Gao B. Safety, pharmacokinetics, and efficacy of budigalimab with rovalpituzumab tesirine in patients with small cell lung cancer. Cancer Treat Res Commun. 2021;28:100405. doi: 10.1016/j.ctarc.2021.100405. Epub 2021 May 25.

family: Calvo

full_name: Emiliano Calvo

given: Emiliano

family: Spira

full_name: Alexander Spira

given: Alexander

family: Miguel

full_name: María de Miguel

given: María de

family: Kondo

full_name: Shunsuke Kondo

given: Shunsuke

family: Gazzah

full_name: Anas Gazzah

given: Anas

family: Millward

full_name: Michael Millward

given: Michael

family: Prenen

full_name: Hans Prenen

given: Hans

family: Rottey

full_name: Sylvie Rottey

given: Sylvie

family: Warburton

full_name: Lydia Warburton

given: Lydia

family: Alanko

full_name: Tuomo Alanko

given: Tuomo

family: Cassier

full_name: Philippe A. Cassier

given: Philippe A.

family: Yoh

full_name: Kiyotaka Yoh

given: Kiyotaka

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Moreno

full_name: Victor Moreno

given: Victor

family: Peltola

full_name: Katriina Peltola

given: Katriina

family: Seto

full_name: Takashi Seto

given: Takashi

family: Toyozawa

full_name: Ryo Toyozawa

given: Ryo

family: Afar

full_name: Daniel E. Afar

given: Daniel E.

family: Englert

full_name: Stefan Englert

given: Stefan

family: Komarnitsky

full_name: Philip Komarnitsky

given: Philip

family: Lambert

full_name: Stacie Lambert

given: Stacie

family: Parikh

full_name: Apurvasena Parikh

given: Apurvasena

family: Vosganian

full_name: Gregory Vosganian

given: Gregory

journal_name: Cancer Treatment and Research Communications

ReferenceCitation: Italiano A, Cassier PA, Lin CC, Alanko T, Peltola KJ, Gazzah A, Shiah HS, Calvo E, Cervantes A, Roda D, Tosi D, Gao B, Millward M, Warburton L, Tanner M, Englert S, Lambert S, Parikh A, Afar DE, Vosganian G, Moreno V. First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2021 Jul 3. doi: 10.1007/s00262-021-02973-w. [Epub ahead of print]

ReferenceCitation: Powderly J, Spira A, Kondo S, Doi T, Luke JJ, Rasco D, Gao B, Tanner M, Cassier PA, Gazzah A, Italiano A, Tosi D, Afar DE, Parikh A, Engelhardt B, Englert S, Lambert SL, Kasichayanula S, Mensing S, Menon R, Vosganian G, Tolcher A. Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). Clin Transl Sci. 2021 Jan;14(1):277-287. doi: 10.1111/cts.12855. Epub 2020 Dec 26.

name: Carolina BioOncology Institute  Huntersville North Carolina USA

name: Virginia Cancer Specialists  Fairfax Virginia USA

name: Johns Hopkins School of Medicine  Baltimore Maryland USA

name: Department of Experimental Therapeutics National Cancer Center Hospital  Tokyo Japan

name: Department of Experimental Therapeutics National Cancer Center Hospital East  Kashiwa Japan

name: Division of Hematology/Oncology UPMC Hillman Cancer Center  Pittsburgh Pennsylvania USA

name: START Center for Cancer Care  San Antonio Texas USA

name: Blacktown Cancer and Haematology Centre  Blacktown Australia

name: Department of Oncology Tampere University Hospital  Tampere Finland

name: Department of Medical Oncology Centre Léon Bérard  Lyon France

name: Drug Development Department Gustave Roussy Université Paris‐Saclay  Villejuif France

name: Department of Medical Oncology Institut Bergonié  Bordeaux France

name: Department of Medical Oncology Institut Régional du Cancer de Montpellier  Montpellier France

name: Oncology Early Development AbbVie, Inc.  Redwood City California USA

name: Clinical Pharmacology and Pharmacometrics AbbVie, Inc.  Redwood City California USA

name: Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH & Co. KG  Ludwigshafen am Rhein Germany

name: Data and Statistical Sciences AbbVie Deutschland GmbH & Co KG  Ludwigshafen Germany

name: Clinical Pharmacology and Pharmacometrics AbbVie Inc.  North Chicago Illinois USA

title: Model Informed Dosing Regimen and Phase I Results of the Anti‐PD‐1 Antibody Budigalimab (ABBV‐181)

location_country:
Austria
United States
Finland
France
Japan
Australia
Belgium
Spain
Canada
Taiwan

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 206229

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 163862

location_facility: Hospital Clinico Universitario de Valencia /ID# 163925

location_facility: South Texas Accelerated Research Therapeutics /ID# 157378

location_facility: The University of Chicago Medical Center /ID# 157375

location_facility: Moore UC San Diego Cancer Center /ID# 157374

location_facility: National Cancer Center Hospital /ID# 166279

location_facility: Taipei Medical University Hospital /ID# 163998

location_facility: National Cancer Center Hospital East /ID# 166433

location_facility: Hospital Universitario HM Sanchinarro /ID# 163861

location_facility: Carolina BioOncology Institute /ID# 157376


ReferenceCitation: DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Döhner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hájek R, Porkka K, Illés Á, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Poland
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hungary
Puerto Rico
China
Portugal
Germany
United States
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey

acronym: Viale-a

location_facility: University Hospital St. Polten /ID# 167436

location_facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267

location_facility: Kyiv city clinical hospital #9 /ID# 153510

location_facility: Sepctrum Health Medical Center /ID# 159522

location_facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 153511

location_facility: Konkuk University Medical Ctr /ID# 153973

location_facility: Samara State Medical Universit /ID# 157462

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 155136

location_facility: Medizinische Universität Graz /ID# 157882

location_facility: Juravinski Hosp & Cancer Cntr /ID# 153650

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639

location_facility: Scott & White Mem Hosp & Clin /ID# 157191

location_facility: VA Caribbean Healthcare System /ID# 160507

location_facility: Kyiv Regional Onco Dispensary /ID# 153514

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 152881

location_facility: Beth Israel Deaconess Medical Center /ID# 201155

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 153684

location_facility: Regional Oncology Dispensary /ID# 153264

location_facility: Hospital Universitario de la Princesa /ID# 153256

location_facility: Hospital de Clinicas de Porto Alegre /ID# 157779

location_facility: St Vincent's Hospital Melbourne /ID# 155094

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 153814

location_facility: University of California, Los Angeles /ID# 154107

location_facility: AZ St-Jan Brugge-Oostende AV /ID# 154041

location_facility: AOU Ospedali Riuniti di Ancona - G.M. Lancisi, G. Salesi /ID# 171220

location_facility: Winship Cancer Institute of Emory University /ID# 162534

location_facility: Semmelweis Egyetem I. Belklini /ID# 153816

location_facility: Jiangsu Province People's Hospital /ID# 167489

location_facility: Hospital General Universitario Gregorio Maranon /ID# 153260

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902

location_facility: Dana-Farber Cancer Institute /ID# 167009

location_facility: Hospital Universitario Virgen de la Victoria /ID# 153257

location_facility: Fujian Medical Univ Union Hosp /ID# 167314

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 154885

location_facility: Hospital Santa Creu i Sant Pau /ID# 153193

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487

location_facility: Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 158990

location_facility: Princess Margaret Cancer Centre /ID# 153651

location_facility: Universitaetsklinikum Hamburg /ID# 153056

location_facility: National Hospital Organization Mito Medical Center /ID# 168219

location_facility: University of Fukui Hospital /ID# 167432

location_facility: Hospital Clinic de Barcelona /ID# 153255

location_facility: Nagasaki University Hospital /ID# 168632

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099

location_facility: Massachusetts General Hospital /ID# 200752

location_facility: Ondokuz Mayıs Universitesi Tıp /ID# 155201

location_facility: Complejo Hospitalario de Navarra /ID# 153254

location_facility: Saitama Medical University International Medical Center /ID# 167814

location_facility: Haukeland University Hospital /ID# 154281

location_facility: Aichi Cancer Center Hospital /ID# 200824

location_facility: Hacettepe University Faculty of Medicine /ID# 202073

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813

location_facility: Azienda Ospedaliera Sant' Andrea /ID# 152876

location_facility: Osaka City University Hospital /ID# 169055

location_facility: Sir Charles Gairdner Hospital /ID# 163924

location_facility: Poltava Reg Clin Hosp Sklifoso /ID# 153513

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315

location_facility: Fakultni nemocnice Hradec Kral /ID# 154021

location_facility: Universitaetsklinikum Muenster /ID# 153059

location_facility: Medizinische Hochschule Hannover /ID# 153055

location_facility: Klinicki bolnicki centar Zagreb /ID# 153383

location_facility: Nanfang Hospital of Southern Medical University /ID# 170148

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 153515

location_facility: Assaf Harofeh Medical Center /ID# 158063

location_facility: The First Hosp of Jilin Univ /ID# 167490

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888

location_facility: Qilu Hospital of Shandong Univ /ID# 167485

location_facility: Ankara Universitesi Fakultesi /ID# 155200

location_facility: Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 169854

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882

location_facility: Akershus universitetssykehus /ID# 154279

location_facility: Hospital Universitario 12 de Octubre /ID# 153258

location_facility: Inst Ensino Pesquisa Sao Lucas /ID# 157778

location_facility: Universitatsklinikum Halle (Sa /ID# 153058

location_facility: Kyoto Prefectural University of Medicine /ID# 167661

location_facility: Helsinki University Hospital /ID# 155223

location_facility: The Jikei University Daisan Hospital /ID# 168745

location_facility: Juntendo University Hospital /ID# 168309

location_facility: University of Texas MD Anderson Cancer Center /ID# 154100

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 157461

location_facility: Northwestern University Feinberg School of Medicine /ID# 201133

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 168316

location_facility: Yamagata University Hospital /ID# 167634

location_facility: Columbia Univ Medical Center /ID# 154101

location_facility: Hospital Universitario y Politecnico La Fe /ID# 153259

location_facility: China Medical University Hosp /ID# 153904

location_facility: Seoul National University Hospital /ID# 153675

location_facility: Nizhniy Novgorod Region clinical hospital named N. A. Semashko /ID# 153268

location_facility: The Second Hospital of Hebei /ID# 167316

location_facility: Tennessee Oncology-Nashville Centennial /ID# 200854

location_facility: Duke University Medical Center /ID# 154106

location_facility: Universitaetsklinikum Frankfurt /ID# 153060

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493

location_facility: Klinicki bolnicki centar Osijek /ID# 153623

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 201111

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 152883

location_facility: Azieda Ospedaliera Bianchi Melacrino Morelli /ID# 152877

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 162725

location_facility: City Clinical Hospital Botkina /ID# 155738

location_facility: Karolinska University Hospital /ID# 170003

location_facility: University Of Vermont Medical /ID# 157196

location_facility: Ospedale Policlinico San Martino - IRCCS /ID# 158104

location_facility: The First Affiliated Hospital, Zhejiang University /ID# 167317

title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

summary:
Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.

Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.

This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.

In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

acronym: ClarIDHy

summary: Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Subjects, all personnel involved in the evaluation of subjects' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Subjects are required to have a histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment.IDH1 mutation testing will be performed at participating investigative sites. Subjects must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All subjects must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.

ReferenceCitation: Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021 Sep 23. doi: 10.1001/jamaoncol.2021.3836. [Epub ahead of print]

name: Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston

name: Jiahui International Cancer Center, Jiahui Health, Shanghai, China

family: Zhu

full_name: Andrew X. Zhu

given: Andrew X.

name: Hospital Universitario Vall d’Hebron, Barcelona, Spain

family: Macarulla

full_name: Teresa Macarulla

given: Teresa

name: Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, Texas

family: Javle

full_name: Milind M. Javle

given: Milind M.

name: Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco

family: Kelley

full_name: R. Kate Kelley

given: R. Kate

name: Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison

family: Lubner

full_name: Sam J. Lubner

given: Sam J.

name: Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain

family: Adeva

full_name: Jorge Adeva

given: Jorge

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts

family: Cleary

full_name: James M. Cleary

given: James M.

name: Department of Medicine, University of Chicago Medical Center, Chicago, Illinois

family: Catenacci

full_name: Daniel V. T. Catenacci

given: Daniel V. T.

name: Department of Hematology-Oncology, Mayo Clinic, Scottsdale, Arizona

family: Borad

full_name: Mitesh J. Borad

given: Mitesh J.

name: Department of Medical Oncology, University College London Cancer Institute, London, United Kingdom

family: Bridgewater

full_name: John A. Bridgewater

given: John A.

name: Department of Medicine, University of Washington, Seattle

family: Harris

full_name: William P. Harris

given: William P.

name: Department of Oncology–Gastrointestinal Cancer, Johns Hopkins University, Baltimore, Maryland

family: Murphy

full_name: Adrian G. Murphy

given: Adrian G.

name: Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, South Korea

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

name: Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City

family: Whisenant

full_name: Jonathan R. Whisenant

given: Jonathan R.

name: Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland

family: Lowery

full_name: Maeve A. Lowery

given: Maeve A.

family: Goyal

full_name: Lipika Goyal

given: Lipika

name: Department of Medicine, University of Arizona Cancer Center, Tucson

family: Shroff

full_name: Rachna T. Shroff

given: Rachna T.

name: Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles

family: El-Khoueiry

full_name: Anthony B. El-Khoueiry

given: Anthony B.

name: Agios Pharmaceuticals Inc, Cambridge, Massachusetts

name: Now with Servier Pharmaceuticals, LLC, Boston, Massachusetts

family: Chamberlain

full_name: Christina X. Chamberlain

given: Christina X.

name: Repare Therapeutics, Cambridge, Massachusetts

family: Aguado-Fraile

full_name: Elia Aguado-Fraile

given: Elia

family: Choe

full_name: Sung Choe

given: Sung

name: Bristol Myers Squibb, Cambridge, Massachusetts

family: Wu

full_name: Bin Wu

given: Bin

family: Liu

full_name: Hua Liu

given: Hua

name: Division of Cancer Sciences, University of Manchester, Department of Medical Oncology, The Christie National Health Service Foundation Trust, Manchester, United Kingdom

name: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York

name: Department of Medicine, Weill Medical College at Cornell University, New York, New York

ReferenceCitation: Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. doi: 10.1016/S1470-2045(20)30157-1. Epub 2020 May 13. Erratum in: Lancet Oncol. 2020 Oct;21(10):e462.

repositories_institution: University College London - UCL Discovery

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

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS Candiolo)

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Wisconsin, Carbone Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: The Christie NHS Foundation Trust, the Christie Hospital


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors

summary: This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

location_country:
United States
France
Japan
Australia
Spain
Canada
Korea, Republic of

location_facility: National Cancer Center Hospital /ID# 217758

location_facility: Hospital Universitario HM Sanchinarro /ID# 200127

location_facility: Virginia Cancer Specialists - Fairfax /ID# 155266

location_facility: Hospital Universitario y Politecnico La Fe /ID# 200975

location_facility: Princess Margaret Cancer Centre /ID# 200819

location_facility: Seoul National University Hospital /ID# 166291

location_facility: University of Texas MD Anderson Cancer Center /ID# 155263

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 200128

location_facility: Carolina BioOncology Institute /ID# 155265

location_facility: The University of Chicago Medical Center /ID# 155264

location_facility: Duplicate_Institut Regional du Cancer /ID# 163609

location_facility: National Cancer Center Hospital East /ID# 216870

location_facility: Tennessee Oncology-Nashville Centennial /ID# 158654

location_facility: Yonsei University Health System Severance Hospital /ID# 166292

location_facility: Massachusetts General Hospital /ID# 155267

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129

location_facility: The Angeles Clinic and Researc /ID# 156324


title: A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

acronym: CheckMate 650

summary: The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior docetaxel-containing regimen.

ReferenceCitation: Sharma P, Pachynski RK, Narayan V, Fléchon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.

family: Sharma

full_name: Padmanee Sharma

given: Padmanee

family: Pachynski

full_name: Russell K. Pachynski

given: Russell K.

family: Narayan

full_name: Vivek Narayan

given: Vivek

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Galsky

full_name: Matthew D. Galsky

given: Matthew D.

family: Mahammedi

full_name: Hakim Mahammedi

given: Hakim

family: Patnaik

full_name: Akash Patnaik

given: Akash

family: Subudhi

full_name: Sumit K. Subudhi

given: Sumit K.

family: Ciprotti

full_name: Marika Ciprotti

given: Marika

family: Simsek

full_name: Burcin Simsek

given: Burcin

family: Saci

full_name: Abdel Saci

given: Abdel

family: Hu

full_name: Yanhua Hu

given: Yanhua

family: Han

full_name: G. Celine Han

given: G. Celine

family: Fizazi

full_name: Karim Fizazi

given: Karim

journal_name: Cancer Cell

location_country:
Italy
Austria
United States
Germany
France
Poland
Australia
Spain
Denmark
Canada

location_facility: Klinikum Nuernberg Nord, Urologische Klinik

location_facility: Texas Oncology, PA - Central Austin Cancer Center

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

location_facility: Minnesota Oncology Hematology (Minneapolis) - USOR

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Washington University School Of Medicine


title: A Randomized Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma (TAPPAS)

acronym: TAPPAS

summary: This is a study of TRC105 in combination with standard dose pazopanib compared to single agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g., metastatic or bulky disease, and disease for which surgical resection would carry an unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.

ReferenceCitation: Mehta CR, Liu L, Theuer C. An adaptive population enrichment phase III trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS trial). Ann Oncol. 2019 Jan 1;30(1):103-108. doi: 10.1093/annonc/mdy464.

family: Mehta

full_name: C.R. Mehta

full_name: L. Liu

given: L.

family: Theuer

full_name: C. Theuer

given: C.

journal_name: Annals of Oncology

lead_sponsor: Tracon Pharmaceuticals Inc.

location_country:
Italy
Austria
Germany
France
Poland
Spain
United States
United Kingdom

location_facility: Memorial Cancer Center and Institute of Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Utah, Huntsman Cancer Institute


title: 24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)

summary: The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Oldenburg J, Hay CRM, Jiménez-Yuste V, Peyvandi F, Schved JF, Szamosi J, Winding B, Lethagen S. Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study. BMJ Open. 2019 May 30;9(5):e028012. doi: 10.1136/bmjopen-2018-028012.

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

family: Hay

full_name: Charles R M Hay

given: Charles R M

family: Jiménez-Yuste

full_name: Víctor Jiménez-Yuste

given: Víctor

family: Peyvandi

full_name: Flora Peyvandi

given: Flora

family: Schved

full_name: Jean-François Schved

given: Jean-François

family: Szamosi

full_name: Johan Szamosi

given: Johan

family: Winding

full_name: Bent Winding

given: Bent

family: Lethagen

full_name: Stefan Lethagen

given: Stefan

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Italy
Austria
Sweden
Finland
France
Norway
Belgium
Spain
United Kingdom

location_facility:
Swedish Orphan Biovitrum Reserach site
Swedish Orphan Biovitrum Research Site
Swedish Orphan Biovitrum Research site
Swedish Orphan Biovitrum research site