lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
France
Israel
Belgium
Spain
Germany

location_facility:
Novartis Investigative Site
Highlands Oncology Group

title: Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer

summary: The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.


type: Other Grant/Funding Number

title: Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPA-ARTiS

acronym: PAPA-ARTiS

summary:
Aortic aneurysms represent the most common and dangerous aortic diseases. Although conventional aortic repair techniques cure the disease, there is a high risk of paraplegia particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the spinal cord.

The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE (Minimally-Invasive Segmental Artery Coil-Embolization) procedure, a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair.

The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms. Patients will be randomized to one of the two treatment strategies: a) aneurysm repair without MISACE pre-treatment, or b) aneurysm repair with MISACE pre-treatment.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Petroff D, Czerny M, Kölbel T, Melissano G, Lonn L, Haunschild J, von Aspern K, Neuhaus P, Pelz J, Epstein DM, Romo-Avilés N, Piotrowski K, Etz CD. Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Mar 4;9(3):e025488. doi: 10.1136/bmjopen-2018-025488.

family: Petroff

full_name: David Petroff

given: David

sequence: first

family: Czerny

full_name: Martin Czerny

given: Martin

sequence: additional

family: Kölbel

full_name: Tilo Kölbel

given: Tilo

family: Melissano

full_name: Germano Melissano

given: Germano

family: Lonn

full_name: Lars Lonn

given: Lars

family: Haunschild

full_name: Josephina Haunschild

given: Josephina

family: von Aspern

full_name: Konstantin von Aspern

given: Konstantin

family: Neuhaus

full_name: Petra Neuhaus

given: Petra

family: Pelz

full_name: Johann Pelz

given: Johann

family: Epstein

full_name: David Mark Epstein

given: David Mark

family: Romo-Avilés

full_name: Nuria Romo-Avilés

given: Nuria

family: Piotrowski

full_name: Katja Piotrowski

given: Katja

family: Etz

full_name: Christian D Etz

given: Christian D

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

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

repository_institution: University of Granada - Institutional Repository of the University of Granada

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
PubMed Central
Pure (Denmark)
digibug.ugr.es

publisher: BMJ

publisher_dissemination: British Medical Journal

title: Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with ‘minimally invasive staged segmental artery coil embolisation’ (MIS²ACE): trial protocol for a randomised controlled multicentre trial

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
France
Poland
Germany
United Kingdom

location_facility: Westdeutsches Herz und Gefäßzentrum Essen

location_facility: Universitäts-Herzzentrum Freiburg/ Bad Krozingen

location_facility: Paracelsus Universität - Klinikum Nürnberg


intervention_type: Drug

status: Completed

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

lead_sponsor: Eli Lilly and Company

enrollment_type: Actual

location_country:
Italy
United States
France
Poland
Romania
Hungary
Australia
Russian Federation
Spain
Germany
Korea, Republic of
Taiwan
Ukraine

location_facility: Washington University School of Medicine

location_facility: Volgograd regional clinical oncology dispensary

location_facility: St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

ipd_sharing: Yes

study_completion_date_type: Actual

type: Other Identifier

type: EudraCT Number

source: euctr

title: A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

summary: The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

lead_sponsor_type: industriel

status_simplified: Completed


title: Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

summary: The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

family: Di Mario

full_name: Carlo Di Mario

given: Carlo

family: Riley

full_name: Robert F. Riley

given: Robert F.

family: Fajadet

full_name: Jean Fajadet

given: Jean

family: Shlofmitz

full_name: Richard A. Shlofmitz

given: Richard A.

family: Saito

full_name: Shigeru Saito

given: Shigeru

family: Ali

full_name: Ziad A. Ali

given: Ziad A.

family: Klein

full_name: Andrew J. Klein

given: Andrew J.

family: Price

full_name: Matthew J. Price

given: Matthew J.

family: Hill

full_name: Jonathan M. Hill

given: Jonathan M.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

journal_name: JACC: Cardiovascular Interventions

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.

name: St. Francis Hospital, Roslyn, NY (Z.A.A.).

name: NewYork-Presbyterian Hospital, Columbia University (Z.A.A., A.M.).

name: Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.).

name: Department of Cardiology, University of Giessen, Frankfurt, Germany (H.N.).

family: Nef

full_name: Holger Nef

given: Holger

name: Hospital Clínico San Carlos IDISSC, Complutense University of Madrid, Spain (J.E.).

family: Escaned

full_name: Javier Escaned

given: Javier

name: Krankenhaus der Barmherzigen Brüder Trier, Germany (N.W.).

family: Werner

full_name: Nikos Werner

given: Nikos

name: Department of Cardiology, Oxford University Hospitals, United Kingdom (A.P.B.).

family: Banning

full_name: Adrian P. Banning

given: Adrian P.

name: King’s College Hospital, London, United Kingdom (J.M.H.).

name: Department of Cardiology, Cardiovascular Research Centre, OLV Hospital, Aalst, Belgium (B.D.B.).

family: De Bruyne

full_name: Bernard De Bruyne

given: Bernard

name: San Raffaele Hospital, Milan, Italy (M. Montorfano).

family: Montorfano

full_name: Matteo Montorfano

given: Matteo

name: Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Générale de Santé, Massy, France (T.L.).

family: Lefevre

name: The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.).

name: Yale University Medical Center, New Haven, CT (A.J.L.).

name: Clinique Pasteur, Toulouse, France (J.F.).

name: Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy (C.D.M.).

publisher: Ovid Technologies (Wolters Kluwer Health)

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

location_facility: Universitaets-Herzzentrum Freiburg- Bad Krozingen

location_facility: Oxford University Hospitals, John Radcliffe Hospital


intervention_type: Biological

status: Terminated

lead_sponsor: Adienne SA

location_country:
Italy
United States
Switzerland
France
Spain
Germany
United Kingdom

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Huntsman Cancer Center, University of Utah

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Ospedale Casa Sollievo della Sofferenza, IRCCS

location_facility: A.O. Universitaria Policlinico Tor Vergata

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Hospital Saint-Louis APHP (Hôpitaux Universitaires Sant-Louis)

title: Prospective, Phase II/III, Randomized Clinical Study to Compare BEGEDINA® Versus "Conventional Treatment" for Treating Steroid Resistant Acute Graft-versus Host Disease

summary: The objectives of this study are to determine the efficacy and safety of BEGEDINA® in subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and complex immunological disease occurring in some recipients of allogeneic hematopoietic stem cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI) tissues. The disease is life threatening and may be acute or chronic and the first choice treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to this treatment leading to disease progression and a high rate of morbidity and mortality, primarily from infections and/or multi-organ failure. There are currently no other satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells and inhibits the immune response leading to improvement in patients that have shown steroid resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and effective treatment for steroid-resistant GvHD patients where no other such treatments are currently available.

status_simplified: Unknown


title: Validation of the "Toronto Aortic Stenosis Quality of Life Questionnaire" in Patients Undergoing Surgical Aortic Valve Replacement or Transfemoral Transcatheter Aortic Valve Implantation The TASQ Registry

acronym: TASQ

summary: Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical treatment only. All patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (English, French, German, Italian and Spanish). One of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life) questionnaire (TASQ).

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Frank D, Kennon S, Bonaros N, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Kurucova J, Thoenes M, Lüske C, Bramlage P, Styra R. Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry. Open Heart. 2019 May 21;6(1):e001008. doi: 10.1136/openhrt-2019-001008. eCollection 2019.

ReferenceCitation: Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Lüske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2). pii: e001821. doi: 10.1136/openhrt-2021-001821.

family: Kennon

full_name: Simon Kennon

given: Simon

family: Styra

full_name: Rima Styra

given: Rima

family: Bonaros

full_name: Nikolaos Bonaros

given: Nikolaos

family: Stastny

full_name: Lukas Stastny

given: Lukas

family: Romano

full_name: Mauro Romano

given: Mauro

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Di Mario

family: Stefàno

full_name: Pierluigi Stefàno

given: Pierluigi

family: Ribichini

full_name: Flavio Luciano Ribichini

given: Flavio Luciano

family: Himbert

full_name: Dominique Himbert

given: Dominique

family: Urena-Alcazar

full_name: Marina Urena-Alcazar

given: Marina

family: Salgado-Fernandez

full_name: Jorge Salgado-Fernandez

given: Jorge

family: Cuenca Castillo

full_name: Jose Joaquin Cuenca Castillo

given: Jose Joaquin

family: Garcia

full_name: Bruno Garcia

given: Bruno

family: Deutsch

full_name: Cornelia Deutsch

given: Cornelia

family: Sykorova

full_name: Lenka Sykorova

given: Lenka

family: Kurucova

full_name: Jana Kurucova

given: Jana

family: Thoenes

full_name: Martin Thoenes

given: Martin

family: Lüske

full_name: Claudia Lüske

given: Claudia

family: Bramlage

full_name: Peter Bramlage

given: Peter

family: Frank

full_name: Derk Frank

given: Derk

journal_name: Open Heart

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Italy
Austria
Germany
France
Spain
Canada
United Kingdom

location_facility: Structual Interventional Cardiology, University Hospital Careggi

location_facility: UKSH University Clinical Center Schleswig-Holstein

location_facility: Department of Medicine, University of Verona

location_facility: University Health Network, Toronto General Hospital


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy

summary: A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)

lead_sponsor: Sensorion

location_country:
Italy
United States
France
Czechia
Israel
Hungary
Germany
Korea, Republic of

location_facility: Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ

location_facility: Seoul National University Bundang Hospital

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

location_facility: Pécsi Tudományegyetem, ÁOK Klinikai Központ

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet


ReferenceCitation: Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2021 Jul 20. doi: 10.5664/jcsm.9550. [Epub ahead of print]

family: Rosenberg

full_name: Russell Rosenberg

given: Russell

family: Thorpy

full_name: Michael J. Thorpy

given: Michael J.

name: Sleep Unit, Department of Neurology, Gui-de-Chauliac Hospital, CHU Montpellier, INSERM, France

family: Dauvilliers

full_name: Yves Dauvilliers

given: Yves

name: Sleep Medicine and Research Center, St. Luke’s Hospital, Chesterfield, MO

family: Schweitzer

full_name: Paula K. Schweitzer

given: Paula K.

name: Clinilabs Drug Development Corporation, New York, NY

name: Icahn School of Medicine at Mount Sinai, New York, NY

family: Zammit

full_name: Gary Zammit

given: Gary

family: Gotfried

full_name: Mark Gotfried

given: Mark

family: Bujanover

full_name: Shay Bujanover

given: Shay

family: Scheckner

full_name: Brian Scheckner

given: Brian

family: Malhotra

full_name: Atul Malhotra

given: Atul

journal_name: Journal of Clinical Sleep Medicine

publisher: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006.

name: NeuroTrials Research, Inc., Atlanta, Georgia

name: Atlanta School of Sleep Medicine, Atlanta, Georgia

name: Jazz Pharmaceuticals, Palo Alto, California

family: Baladi

full_name: Michelle Baladi

given: Michelle

family: Bron

full_name: Morgan Bron

given: Morgan

ReferenceCitation: Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.

family: Shapiro

full_name: Colin Shapiro

given: Colin

family: Mayer

full_name: Geert Mayer

given: Geert

family: Lammers

full_name: Gert Jan Lammers

given: Gert Jan

family: Emsellem

full_name: Helene Emsellem

given: Helene

family: Plazzi

full_name: Giuseppe Plazzi

given: Giuseppe

family: Chen

full_name: Dan Chen

given: Dan

family: Carter

full_name: Lawrence P. Carter

given: Lawrence P.

family: Lee

full_name: Lawrence Lee

given: Lawrence

family: Black

full_name: Jed Black

given: Jed

ReferenceCitation: Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.

location_country:
United States
Netherlands
Finland
France
Germany
Canada

location_facility: Hickory Research Center, ARSM Research, LLC

location_facility: Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: University of Illinois Chicago, College of Nursing

location_facility: Clinical Research Group of St. Petersburg

location_facility: So Cal Institute For Respiratory Diseases, Inc.

location_facility: Southwest Cleveland Sleep Research Center

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

location_facility: Stanford University Center for Narcolepsy

location_facility: Critical Care Pulmonary & Sleep Associates, LLC

location_facility: medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum

location_facility: Ohio Sleep Medicine & Neuroscience Institute

title: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy

summary: This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.


publications_result: Topp MS, van Meerten T, Wermke M et al. Preliminary Results of Earlier Steroid Use with Axicabtagene Ciloleucel in Patients With Relapsed/Refractory Large B Cell Lymphoma. Poster presented at the American Society of Presented at: American Society of Clinical Oncology Annual Meeting. May 31-June 4, 2019; Chicago, Illinois; Abstract 7558.

ReferenceType: result

ReferenceCitation: Topp, M, van Meerten T, Houot R, et al. (2019). Earlier Steroid Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Large B Cell Lymphoma. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 243. Abstract 626.

ReferenceCitation: Abstract: Oluwole OO, et al. Prophylactic corticosteroid use with axicabtagene ciloleucel in patients with relapsed/refractory large B-cell lymphoma. Transplantation and Cellular Therapy 2021.

ReferenceCitation: Oluwole OO, Bouabdallah K, Muñoz J, De Guibert S, Vose JM, Bartlett NL, Lin Y, Deol A, McSweeney PA, Goy AH, Kersten MJ, Jacobson CA, Farooq U, Minnema MC, Thieblemont C, Timmerman JM, Stiff P, Avivi I, Tzachanis D, Kim JJ, Bashir Z, McLeroy J, Zheng Y, Rossi JM, Johnson L, Goyal L, van Meerten T. Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. Br J Haematol. 2021 Aug;194(4):690-700. doi: 10.1111/bjh.17527. Epub 2021 Jul 22.

name: Vanderbilt‐Ingraham Cancer Center Nashville TN USA

family: Oluwole

full_name: Olalekan O. Oluwole

given: Olalekan O.

name: Service d'Hématologie et Thérapie Cellulaire CHU Bordeaux Bordeaux France

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

name: Banner MD Anderson Cancer Center Gilbert AZ USA

family: Muñoz

full_name: Javier Muñoz

given: Javier

family: De Guibert

full_name: Sophie De Guibert

given: Sophie

name: University of Nebraska Medical Center Omaha NE USA

family: Vose

full_name: Julie M. Vose

given: Julie M.

name: Siteman Cancer Center Washington University School of Medicine St. Louis MO USA

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

family: Lin

full_name: Yi Lin

given: Yi

name: Karmanos Cancer Center Wayne State University Detroit MI USA

family: Deol

full_name: Abhinav Deol

given: Abhinav

name: Colorado Blood Cancer Institute Denver CO USA

family: McSweeney

full_name: Peter A. McSweeney

given: Peter A.

name: John Theurer Cancer Center Hackensack University Medical Center Hackensack NJ USA

family: Goy

full_name: Andre H. Goy

given: Andre H.

name: Amsterdam UMC University of Amsterdam Amsterdam Netherlands on behalf of HOVON/LLPC

family: Kersten

full_name: Marie José Kersten

given: Marie José

name: Dana‐Farber Cancer Institute Boston MA USA

family: Jacobson

full_name: Caron A. Jacobson

given: Caron A.

family: Farooq

full_name: Umar Farooq

given: Umar

name: University Medical Center Utrecht Utrecht Netherlands on behalf of HOVON/LLPC

family: Minnema

full_name: Monique C. Minnema

given: Monique C.

name: Université de Paris AP‐HP, Hôpital Saint‐Louis Hemato‐oncology, DMU HI; Research Unit NF‐kappaB Différenciation et Cancer Paris France

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

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

family: Timmerman

full_name: John M. Timmerman

given: John M.

name: Loyola University Chicago Stritch School of Medicine Maywood IL USA

family: Stiff

full_name: Patrick Stiff

given: Patrick

name: Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel

family: Avivi

full_name: Irit Avivi

given: Irit

name: Moores Cancer Center, UCSD La Jolla CA USA

family: Tzachanis

full_name: Dimitrios Tzachanis

given: Dimitrios

name: Kite, a Gilead Company Santa Monica CA USA

family: Kim

full_name: Jenny J. Kim

given: Jenny J.

family: Bashir

full_name: Zahid Bashir

given: Zahid

family: McLeroy

full_name: Jeff McLeroy

given: Jeff

family: Zheng

full_name: Yan Zheng

given: Yan

family: Rossi

full_name: John M. Rossi

name: University Medical Center Groningen Groningen Netherlands on behalf of HOVON/PPLC

title: Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B‐cell lymphoma

ReferenceCitation: Santa Monica, Calif. New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial. Data presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. December 5, 2020; Abstract 1187

ReferenceCitation: Max S. Topp, Tom van Meerten, Martin Wermke, Pieternella J. Lugtenburg, Monique C. Minnema, Kevin W. Song, Catherine Thieblemont, Yizhou Jiang, Vicki Plaks, Anne Kerber, Marie José Kersten. Preliminary Results of Earlier Steroid Use With Axicabtagene Ciloleucel in Patients With Relapsed/ Refractory Large B Cell Lymphoma. Poster presented at ASCO 2019 Annual Meeting. June 3, 2019; Abstract 7558

ReferenceCitation: Sattva S. Neelapu, Caron A. Jacobson, Olalekan O. Oluwole, Javier Munoz, Abhinav Deol, David B. Miklos, Nancy L. Bartlett, Ira Braunschweig, Yizhou Jiang, Jenny J. Kim, Lianqing Zheng, John M. Rossi, Frederick L. Locke. Axicabtagene Ciloleucel (Axi-Cel) In Refractory Large B Cell Lymphoma: Outcomes in Patients ≥ or < 65 Years of Age in the Pivotal Phase 1/2 ZUMA-1 Study. Poster presented at EHA 2019. June 15, 2019; Abstract 1066

ReferenceCitation: Max S. Topp, Tom van Meerten, Martin Wermke, Pieternella J. Lugtenburg, Monique C. Minnema, Kevin W. Song, Catherine Thieblemont, Yizhou Jiang, Vicki Plaks, Anne Kerber, Marie José Kersten. Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Large B Cell Lymphoma: Preliminary Results of Earlier Steroid Use. Poster presented at EHA 2019. June 15, 2019; Abstract 1067

ReferenceCitation: Sattva S. Neelapu, John M. Rossi, Caron A. Jacobson, Frederick L. Locke, David B. Miklos, Patrick M. Reagan, Scott Rodig, Lazaros J. Lekakis, Ian W. Flinn, Lianqing Zheng, Francesca Milletti, Edmund Chang, Allen Xue, Vicki Plaks, Jenny J. Kim, Adrian Bot. CD19-Loss With Preservation of Other B Cell Lineage Features in Patients With Large B Cell Lymphoma Who Relapsed Post-Axi-Cel. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 203. Abstract 704.

ReferenceCitation: Sattva S. Neelapu, Frederick L. Locke, Nancy L. Bartlett, Lazaros J. Lekakis, Patrick Reagan, David B. Miklos, Caron A. Jacobson, Ira Braunschweig, Olalekan Oluwole, Tanya Siddiqi, Yi Lin, Michael Crump, John Kuruvilla, Eric Van Den Neste, Umar Farooq, Lynn Navale, Venita DePuy, Jenny J. Kim, Christian Gisselbrecht. A Comparison of Two-Year Outcomes in ZUMA-1 (Axicabtagene Ciloleucel) and SCHOLAR-1 in Patients With Refractory Large B Cell Lymphoma. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 4095. Abstract 626.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

name: Department of Surgery; Mayo Clinic; Rochester Minnesota USA

name: Department I of Internal Medicine; University Hospital of Cologne; Cologne Germany

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

ReferenceCitation: Maloney DG, Kuruvilla J, Liu FF, Kostic A, Kim Y, Bonner A, Zhang Y, Fox CP, Cartron G. Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma. J Hematol Oncol. 2021 Sep 8;14(1):140. doi: 10.1186/s13045-021-01144-9.

ReferenceCitation: Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021 Oct 1;96(10):1295-1312. doi: 10.1002/ajh.26301. Epub 2021 Aug 13. Review.

name: Department of Lymphoma and Myeloma The University of Texas MD Anderson Cancer Center  Houston Texas USA

name: Department of Hematology Amsterdam UMC, University of Amsterdam, LYMMCARE (Lymphoma and Myeloma Center Amsterdam)  Amsterdam The Netherlands

name: Memorial Sloan Kettering Cancer Center  New York New York USA

name: Center for Lymphoma Massachusetts General Hospital Cancer Center  Boston Massachusetts USA

name: Lymphoma Program Abramson Cancer Center, University of Pennsylvania  Philadelphia Pennsylvania USA

name: Department of Blood and Marrow Transplant and Cellular Immunotherapy Moffitt Cancer Center  Tampa Florida USA

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

title: Efficacy and safety of CD19 ‐directed CAR‐T cell therapies in patients with relapsed/refractory aggressive B‐cell lymphomas: Observations from the JULIET , ZUMA ‐1, and TRANSCEND trials

ReferenceCitation: Upadhyay R, Boiarsky JA, Pantsulaia G, Svensson-Arvelund J, Lin MJ, Wroblewska A, Bhalla S, Scholler N, Bot A, Rossi JM, Sadek N, Parekh S, Lagana A, Baccarini A, Merad M, Brown BD, Brody JD. A Critical Role for Fas-Mediated Off-Target Tumor Killing in T-cell Immunotherapy. Cancer Discov. 2021 Mar;11(3):599-613. doi: 10.1158/2159-8290.CD-20-0756. Epub 2020 Dec 17.

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

ReferenceCitation: Locke FL, Rossi JM, Neelapu SS, Jacobson CA, Miklos DB, Ghobadi A, Oluwole OO, Reagan PM, Lekakis LJ, Lin Y, Sherman M, Better M, Go WY, Wiezorek JS, Xue A, Bot A. Tumor burden, inflammation, and product attributes determine outcomes of axicabtagene ciloleucel in large B-cell lymphoma. Blood Adv. 2020 Oct 13;4(19):4898-4911. doi: 10.1182/bloodadvances.2020002394.

name: Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL;

name: Kite, a Gilead Company, Santa Monica, CA;

name: Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX;

name: Hematologic Oncology Treatment Center, Dana-Farber Cancer Institute, Boston, MA;

name: Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, CA;

name: Division of Oncology, Washington University School of Medicine, St. Louis, MO;

name: Division of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN;

name: Department of Medicine, Hematology/Oncology, University of Rochester School of Medicine, Rochester, NY;

name: Department of Hematology/Oncology, University of Miami Health System, Sylvester Comprehensive Cancer Center, Miami, FL; and

name: Division of Hematology, Mayo Clinic, Rochester, MN

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. doi: 10.1016/S1470-2045(18)30864-7. Epub 2018 Dec 2.

title: Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1–2 trial

ReferenceCitation: Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and transparency

location_country:
United States
Netherlands
France
Israel
Germany
Canada

location_facility: Sarah Cannon-Methodist Healthcare System - San Antonio

location_facility: Washington University School of Medicine

location_facility: University of California San Diego (UCSD)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: University of California Los Angeles (UCLA)

title: A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

summary:
This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).

The primary objectives of this study are:

Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities


title: A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

summary: The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

ReferenceCitation: Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

name: Georgia Department of Public Health; Chatham Care Center; Savannah GA USA

family: Hagins

full_name: D Hagins

given: D

name: Grahame Hayton Unit; Royal London Hospital and Queen Mary University; London UK

family: Orkin

full_name: C Orkin

given: C

name: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center; Torrance CA USA

family: Daar

full_name: ES Daar

given: ES

name: Mills Clinical Research; Los Angeles CA USA

family: Mills

full_name: A Mills

given: A

name: Central Texas Clinical Research; Austin TX USA

family: Brinson

full_name: C Brinson

name: Orlando Immunology Center; Orlando FL USA

family: DeJesus

full_name: E DeJesus

given: E

family: Post

full_name: FA Post

given: FA

name: Clinical Research Puerto Rico Inc.; San Juan Puerto Rico

family: Morales-Ramirez

full_name: J Morales-Ramirez

given: J

name: AIDS Research Consortium of Atlanta; Atlanta GA USA

family: Thompson

full_name: M Thompson

given: M

name: Triple O Research Institute PA; West Palm Beach FL USA

family: Osiyemi

full_name: O Osiyemi

given: O

name: Capital Medical Associates; Washington DC USA

family: Rashbaum

full_name: B Rashbaum

given: B

family: Stellbrink

full_name: H-J Stellbrink

given: H-J

name: The Research Institute; Springfield MA USA

family: Martorell

full_name: C Martorell

family: Liu

full_name: H Liu

given: H

full_name: Y-P Liu

given: Y-P

family: Porter

full_name: D Porter

family: Collins

full_name: SE Collins

given: SE

family: SenGupta

full_name: D SenGupta

family: Das

full_name: M Das

journal_name: HIV Medicine

oa_colors: green hybrid

ReferenceCitation: Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections, Boston. March 4-7, 2018, Abstract 504.

ReferenceCitation: Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week 48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation at the 16th European AIDS Conference, 2017 25-27 October Milan, Italy.

ReferenceCitation: Porter DP, KulkarniR, Cao H, SenGupta D, and White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster 1381]. ID Week 2017 4-8 October; San Diego, California.

ReferenceCitation: E DeJesus, M Ramgopal, G Crofoot, P Ruane, A LaMarca. J-M Molina et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshop on HIV and Aging 2017 2-3 October, New York, New York.

ReferenceCitation: Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, ThalmeA, et al. Efficacy and Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.

ReferenceCitation: Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science; 2017 23 26 July Paris, France.

ReferenceCitation: DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Martorell CT, de Wet J, Stellbrink HJ, Molina JM, Post FA, Valero IP, Porter D, Liu Y, Cheng A, Quirk E, SenGupta D, Cao H. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e205-e213. doi: 10.1016/S2352-3018(17)30032-2. Epub 2017 Mar 2.

ReferenceCitation: Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster 427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, Washington.

ReferenceCitation: Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Women [Abstract 12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48 Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study 1160) or RPV/FTC/TDF (Study 1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.

location_country:
United States
Switzerland
Germany
France
Belgium
Puerto Rico
Spain
Canada
United Kingdom

location_facility: Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

location_facility: Infectious Diseases Associates of NW Florida, P.A.

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Center for HIV and Hepatogastroenterology

location_facility: North Texas Infectious Diseases Consultants

location_facility: Midway Immunology & Research Center, LLC

location_facility: Long Beach Education and Research Consultants

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)

location_facility: AIDS Research & Treatment Center of the Treasure Coast

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: University of North Carolina at Chapel Hill

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: La Playa Medical Group and Clinical Research

location_facility: Hospital General Universitario de Alicante

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

location_facility: World Health Clinicians' CIRCLE CARE Center

location_facility: University of Puerto Rico School of Medicine

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: Infectious Disease Research Institute Inc.

location_facility: Infectious Disease Specialists of Atlanta

location_facility: St. Joseph's Comprehensive Research Institute


title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTR02 in Patients With Familial Amyloidotic Polyneuropathy Who Have Previously Received ALN-TTR02

summary: The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Coelho T, Adams D, Conceição I, Waddington-Cruz M, Schmidt HH, Buades J, Campistol J, Berk JL, Polydefkis M, Wang JJ, Chen J, Sweetser MT, Gollob J, Suhr OB. A phase II, open-label, extension study of long-term patisiran treatment in patients with hereditary transthyretin-mediated (hATTR) amyloidosis. Orphanet J Rare Dis. 2020 Jul 8;15(1):179. doi: 10.1186/s13023-020-01399-4.

family: Coelho

full_name: Teresa Coelho

given: Teresa

family: Adams

full_name: David Adams

given: David

family: Conceição

full_name: Isabel Conceição

given: Isabel

family: Waddington-Cruz

full_name: Márcia Waddington-Cruz

given: Márcia

family: Schmidt

full_name: Hartmut H. Schmidt

given: Hartmut H.

family: Buades

full_name: Juan Buades

given: Juan

family: Campistol

full_name: Josep Campistol

given: Josep

family: Berk

full_name: John L. Berk

given: John L.

family: Polydefkis

full_name: Michael Polydefkis

given: Michael

family: Wang

full_name: Jing Jing Wang

given: Jing Jing

family: Chen

full_name: Jihong Chen

given: Jihong

family: Sweetser

full_name: Marianne T. Sweetser

given: Marianne T.

family: Gollob

full_name: Jared Gollob

given: Jared

family: Suhr

full_name: Ole B. Suhr

given: Ole B.

journal_name: Orphanet Journal of Rare Diseases

license: cc-by

license_normalized: cc-by

repository_institution: University of Lisbon - Repositório da Universidade de Lisboa

repository_institution: Umeå University - DiVA at Umeå University

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

location_country:
Brazil
Sweden
Spain
Germany
France
Portugal
United States


summary:
The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

time_perspective: Retrospective

lead_sponsor: Santhera Pharmaceuticals

location_country: Italy France Belgium Denmark Slovenia

location_facility: Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology


intervention_type: Device

lead_sponsor: Pierre Fabre Medicament

location_country: Poland France Lithuania Romania Estonia

acronym: Emollients in the management of AD

title: Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.

summary: The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.


title: A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

acronym: FREEDOM

summary: The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country: Austria France Poland Greece Spain Denmark Germany

location_facility:
Univ. Klinik für Innere Medizi
Hôpital Necker
Klinik I für Innere Medizin
Laiko General Hospital
Hospital 12 de Octubre
H. U. de Bellvitge
H.U. Gregorio Maranon
Herlev University Hospital
University Hospital of Crete
Szpital Specjalistyczny w Brzo
Institut Curie
General Hospital of Athens
Universitätsklinikum Halle
Charité
Universitätsklinikum
Metaxa Anticancer Hospital


title: A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation

acronym: ALIGN

summary: The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

lead_sponsor: Mitralign, Inc.

location_country: Paraguay France Colombia Poland

location_facility:
Sanatorio Italiano
Bordeaux Heart University Hospital
Clinique Pasteur
American Heart of Poland S.A.
Antonio Dager, MD
Clinica CardioVID
Instytutem Kardiologii
Centrum Medyczne HZP


title: A Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients With TTR Amyloidosis

summary: This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Suhr OB, Coelho T, Buades J, Pouget J, Conceicao I, Berk J, Schmidt H, Waddington-Cruz M, Campistol JM, Bettencourt BR, Vaishnaw A, Gollob J, Adams D. Efficacy and safety of patisiran for familial amyloidotic polyneuropathy: a phase II multi-dose study. Orphanet J Rare Dis. 2015 Sep 4;10:109. doi: 10.1186/s13023-015-0326-6.

full_name: Ole B Suhr

given: Ole B

family: Pouget

full_name: Jean Pouget

given: Jean

family: Conceicao

full_name: Isabel Conceicao

full_name: John Berk

given: John

full_name: Hartmut Schmidt

given: Hartmut

full_name: Josep M. Campistol

given: Josep M.

family: Bettencourt

full_name: Brian R. Bettencourt

given: Brian R.

family: Vaishnaw

full_name: Akshay Vaishnaw

given: Akshay

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Alnylam Pharmaceuticals


title: Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors

summary:
This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment.

Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Belgium
France
Spain

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Memorial Sloan-Kettering Cancer Center Breast & Imaging Center

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale


title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bortezomib and Dexamethasone (VD) in Previously Treated Patients With Multiple Myeloma (MM)

summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

name: College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea

name: D&D Pharmatech, Seongnam, Republic of Korea

family: Park

full_name: Eun Ji Park

given: Eun Ji

family: Choi

full_name: Jiyoung Choi

given: Jiyoung

name: College of Pharmacy, SungKyunKwan University, Suwon, Republic of Korea

family: Lee

full_name: Kang Choon Lee

given: Kang Choon

full_name: Dong Hee Na

given: Dong Hee

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Emerging PEGylated non-biologic drugs

lead_sponsor: NOXXON Pharma AG

location_country: Italy Austria Germany France

location_facility: University Hospital San Martino, Department of Hematology and Oncology

location_facility: Niguarda Ca'Granda Hospital, Department of Hematology

location_facility: Wilhelminenspital, Department of Medicine I, Center of Oncology and Hematology

location_facility: Sapienza University of Rome, Department of Hematology

location_facility: University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

location_facility: University Hospital Freiburg, Medizinische Universitätsklinik, Innere Medizin I, Haematologie und Onkologie

location_facility: Hôpital Saint Antoine - Service des maladies du sang et de thérapie cellulaire

location_facility: University Hospital Münster, Medizinische Klinik und Poliklinik A

location_facility: Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille

location_facility: University Hospital Ulm, Zentrum für Innere Medizin,


title: Neural Cardiac Therapy for Heart Failure Study

acronym: NECTAR-HF

summary: The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

status: Active, not recruiting

ReferenceCitation: De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.

ReferenceCitation: Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: De Ferrari

full_name: Gaetano M. De Ferrari

given: Gaetano M.

family: Tuinenburg

full_name: Anton E. Tuinenburg

given: Anton E.

family: Wright

full_name: David Wright

given: David

family: Brugada

full_name: Josep Brugada

given: Josep

family: Butter

full_name: Christian Butter

given: Christian

family: Klein

full_name: Helmut Klein

given: Helmut

family: Stolen

full_name: Craig Stolen

given: Craig

family: Meyer

full_name: Scott Meyer

given: Scott

family: Stein

full_name: Kenneth M. Stein

given: Kenneth M.

family: Ramuzat

full_name: Agnes Ramuzat

given: Agnes

family: Schubert

full_name: Bernd Schubert

given: Bernd

family: Daum

full_name: Doug Daum

given: Doug

family: Neuzil

full_name: Petr Neuzil

given: Petr

family: Botman

full_name: Cornelis Botman

given: Cornelis

family: Castel

full_name: Maria Angeles Castel

given: Maria Angeles

family: D'Onofrio

full_name: Antonio D'Onofrio

given: Antonio

family: Solomon

full_name: Scott D. Solomon

given: Scott D.

family: Wold

full_name: Nicholas Wold

given: Nicholas

family: Ruble

full_name: Stephen B. Ruble

given: Stephen B.

journal_name: European Heart Journal

evidence: open (via page says Open Access)

license: implied-oa

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.

location_country:
Italy
Netherlands
France
Czechia
Belgium
Spain
Germany
United Kingdom

location_facility: Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf

location_facility: Clínica Universitaria de Navarra, Avenida Pio XII s/n

location_facility: Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy

location_facility: Imperial College Healthcare NHS Trust, St. Mary's Hospital

location_facility: University Hospitals Bristol, NHS Foundation Trust

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: King's College Hospital NHS Foundation Trust

location_facility: The Heart Hospital, University College London Hospitals, NHS Foundation Trust

location_facility: Liverpool Heart and Chest Hospital, NHS Foundation Trust


ReferenceCitation: Jones SA, Rojas-Caro S, Quinn AG, Friedman M, Marulkar S, Ezgu F, Zaki O, Gargus JJ, Hughes J, Plantaz D, Vara R, Eckert S, Arnoux JB, Brassier A, Le Quan Sang KH, Valayannopoulos V. Survival in infants treated with sebelipase Alfa for lysosomal acid lipase deficiency: an open-label, multicenter, dose-escalation study. Orphanet J Rare Dis. 2017 Feb 8;12(1):25. doi: 10.1186/s13023-017-0587-3.

lead_sponsor: Alexion Pharmaceuticals

location_country:
France
Ireland
Egypt
United States
United Kingdom

acronym: SBC-102 in Children with Growth Failure Due to Lysosomal Acid Lipase Deficiency

ipd_sharing: Undecided

title: An Open Label, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SBC-102 (Sebelipase Alfa) in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency

summary: This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.


title: β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

acronym: ß-SPECIFIC 4

summary: The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

ReferenceCitation: Quartier P, Alexeeva E, Constantin T, Chasnyk V, Wulffraat N, Palmblad K, Wouters C, I Brunner H, Marzan K, Schneider R, Horneff G, Martini A, Anton J, Wei X, Slade A, Ruperto N, Abrams K; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study. Arthritis Rheumatol. 2021 Feb;73(2):336-346. doi: 10.1002/art.41488. Epub 2020 Dec 11.

name: RAISE Reference Centre for Rare Diseases, Necker–Enfants Malades, AP‐HP, Imagine Institute Paris University  Paris France

family: Quartier

full_name: Pierre Quartier

given: Pierre

name: National Medical Research Center of Children’s Health of the Ministry of Health of the Russian Federation Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation  Moscow Russia

family: Alexeeva

full_name: Ekaterina Alexeeva

given: Ekaterina

family: Constantin

full_name: Tamàs Constantin

given: Tamàs

name: Saint‐Petersburg State Pediatric Medical University  Saint‐Petersburg Russian Federation

family: Chasnyk

full_name: Vyacheslav Chasnyk

given: Vyacheslav

name: University Medical Center Utrecht  Utrecht The Netherlands

family: Wulffraat

full_name: Nico Wulffraat

given: Nico

name: Karolinska Institutet Karolinska University Hospital  Stockholm Sweden

family: Palmblad

full_name: Karin Palmblad

given: Karin

name: University Hospitals Leuven  Leuven Belgium

family: Wouters

full_name: Carine Wouters

given: Carine

name: Cincinnati Children’s Hospital Medical Center  Cincinnati Ohio United States

family: I. Brunner

full_name: Hermine I. Brunner

given: Hermine

name: Children’s Hospital Los Angeles  Los Angeles California United States

family: Marzan

full_name: Katherine Marzan

given: Katherine

name: University of Toronto and Hospital for Sick Children  Toronto Ontario Canada

family: Schneider

full_name: Rayfel Schneider

given: Rayfel

name: Asklepios Klinik Sankt Augustin and University Hospital Cologne  Sankt Augustin Cologne Germany

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Martini

full_name: Alberto Martini

given: Alberto

name: Hospital Sant Joan de Déu Esplugues de Llobregat, Spain, and Universitat de Barcelona  Barcelona Spain

family: Anton

full_name: Jordi Anton

given: Jordi

name: China Novartis Institutes for Biomedical Research, Ltd  Beijing China

family: Wei

full_name: Xiaoling Wei

given: Xiaoling

name: Novartis Pharmaceuticals Corporation  East Hanover New Jersey United States

family: Slade

full_name: Alan Slade

given: Alan

name: Clinica Pediatrica e Reumatologia PRINTO Istituto Giannina Gaslini IRCCS  Genoa Italy

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Abrams

full_name: Ken Abrams

given: Ken

family: Emminger

full_name: W. Emminger

given: W.

family: Ulbrich

full_name: A. Ulbrich

given: A.

family: Fodor

full_name: S. Fodor

given: S.

full_name: C. Wouters

given: C.

family: Desomer

full_name: L. Desomer

given: L.

family: Lauwerys

full_name: B. Lauwerys

name: the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group

title: Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open‐Label, Randomized Study

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
United States
Brazil
Sweden
Netherlands
Germany
France
Poland
Israel
Hungary
Belgium
Russian Federation
Spain
Turkey
Canada


title: EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

summary: The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.

ReferenceCitation: Doll N, Sheytanov V, Labrousse L, Chu MWA, Stefàno P, Mokrácek A, Baron O, Li S, Günzinger R. Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair. Eur J Cardiothorac Surg. 2019 Feb 1;55(2):217-223. doi: 10.1093/ejcts/ezy215.

name: Department of Cardiac Surgery, Sana Heart Surgery Stuttgart GmbH, Stuttgart, Germany

family: Doll

full_name: Nicolas Doll

given: Nicolas

family: Sheytanov

full_name: Ventsislav Sheytanov

given: Ventsislav

name: Department of Cardiac and Vascular Surgery, University Hospital of Bordeaux, Bordeaux, France

family: Labrousse

full_name: Louis Labrousse

given: Louis

name: Division of Cardiac Surgery, Department of Surgery, Western University, London Health Sciences Centre, London, Ontario, Canada

family: Chu

full_name: Michael W A Chu

given: Michael W A

name: Department of Cardiac Surgery, Careggi University Hospital, Florence, Italy

family: Stefàno

full_name: Pierluigi Stefàno

given: Pierluigi

name: Department of Cardiac Surgery, Czech Budejovice Hospital, Budejovice, Czech Republic

family: Mokráček

full_name: Aleš Mokráček

given: Aleš

name: Department of Thoracic and Cardiovascular Surgery, North Laennec Hospital, Nantes, France

family: Baron

full_name: Olivier Baron

given: Olivier

name: Department of Biostatistics, Medtronic, Mounds View, MN, USA

family: Li

full_name: Shuzhen Li

given: Shuzhen

name: Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany

family: Günzinger

full_name: Ralf Günzinger

given: Ralf

journal_name: European Journal of Cardio-Thoracic Surgery

evidence: open (via free article)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair†

lead_sponsor: Medtronic Bakken Research Center

location_country: Italy France Czechia Germany Canada

location_facility: London Health Sciences Centre, University Hospital

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux


ReferenceCitation: Martin M, Fumoleau P, Dewar JA, Albanell J, Limentani SA, Campone M, Chang JC, Patre M, Strasak A, de Haas SL, Xu J, Garcia-Saenz JA. Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study. Ann Oncol. 2016 Jul;27(7):1249-56. doi: 10.1093/annonc/mdw157. Epub 2016 Apr 6.

family: Martin

full_name: M. Martin

given: M.

family: Fumoleau

full_name: P. Fumoleau

given: P.

family: Dewar

full_name: J.A. Dewar

family: Albanell

full_name: J. Albanell

given: J.

family: Limentani

full_name: S.A. Limentani

family: Campone

full_name: M. Campone

family: Chang

full_name: J.C. Chang

family: Patre

full_name: M. Patre

family: Strasak

full_name: A. Strasak

family: de Haas

full_name: S.L. de Haas

family: Xu

full_name: J. Xu

family: Garcia-Saenz

full_name: J.A. Garcia-Saenz

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
United States
United Kingdom
France
Spain

title: An Open-Label, Multi-Center Phase I/II Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer

summary: This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with locally advanced breast cancer (LABC). The study comprises an initial dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxel/T-DM1 combination regimen.


title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

acronym: SL

summary: Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

ReferenceCitation: Fea AM, Belda JI, Rękas M, Jünemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.

family: Giamporcaro

full_name: Giamporcaro

family: Belda Sanchis

full_name: Jose Isidro Belda Sanchis

given: Jose Isidro

full_name: Lydia Chang

given: Lydia

family: Pablo

full_name: Luis Pablo

given: Luis

family: Voskanyan

full_name: Lilit Voskanyan

given: Lilit

family: Katz

full_name: L. Jay Katz

given: L. Jay

family: Rekas

full_name: Marek Rekas

given: Marek

family: Juenemann

full_name: Anselm Juenemann

given: Anselm

family: Fea

full_name: Antonio Fea

given: Antonio

currency_apc_doaj: USD

journal_name: Clinical Ophthalmology

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution: University of Turin - Institutional Research Information System University of Turin

title: Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

lead_sponsor: Glaukos Corporation

location_country:
Italy
Armenia
Austria
France
Poland
Greece
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliera S. Maria della Misericordia

location_facility: Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica


title: A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Spain

location_facility: Winship Cancer Institute, Emory University

location_facility: Orlando Health, Inc. M.D. Anderson Cancer Center Orlando


title: A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.

summary: This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Macedonia, The Former Yugoslav Republic of


ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

family: Baulac

full_name: Michel Baulac

given: Michel

family: Hong

full_name: Seung Bong Hong

given: Seung Bong

family: Cleveland

full_name: Jody M. Cleveland

given: Jody M.

family: Reichel

full_name: Christoph Reichel

given: Christoph

family: Schulz

full_name: Anne-Liv Schulz

given: Anne-Liv

family: Wagener

full_name: Gilbert Wagener

given: Gilbert

family: Brandt

full_name: Christian Brandt

given: Christian

journal_name: Epilepsy Research

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

title: Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht–Lundborg disease: An open-label, long-term follow-up trial

ReferenceCitation: Kälviäinen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

name: Kuopio Epilepsy Center; Kuopio University Hospital and Institute of Clinical Medicine; School of Medicine; Faculty of Health Sciences; University of Eastern Finland; Kuopio Finland

family: Kälviäinen

full_name: Reetta Kälviäinen

given: Reetta

name: Henri Gastaut-Centre Saint Paul Hospital; Marseille France

family: Genton

full_name: Pierre Genton

given: Pierre

name: Neurogenetics Unit and Epilepsy Research Group; Montreal Neurological Hospital and Institute; Montreal Quebec Canada

name: Department of Neurology & Neurosurgery and Human Genetics; McGill University; Montreal Quebec Canada

family: Andermann

full_name: Eva Andermann

given: Eva

name: Seizure Clinic and Epilepsy Research Group; Montreal Neurological Hospital and Institute; Montreal Quebec Canada

name: Departments of Neurology & Neurosurgery and Pediatrics; McGill University; Montreal Quebec Canada

full_name: Frederick Andermann

given: Frederick

name: Department of Neurosciences; Epilepsy Center; University of Messina; Messina Italy

family: Magaudda

full_name: Adriana Magaudda

given: Adriana

name: Department of Neurology; Columbia University Medical Center; New York New York USA

family: Frucht

full_name: Steven J. Frucht

given: Steven J.

family: Schlit

full_name: Anne-Françoise Schlit

given: Anne-Françoise

family: Gerard

full_name: Danielle Gerard

given: Danielle

family: de la Loge

full_name: Christine de la Loge

given: Christine

family: von Rosenstiel

full_name: Philipp von Rosenstiel

location_country: Italy Sweden Netherlands Finland Réunion France Tunisia

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

summary: The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.


title: Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC

summary:
Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.

The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.

ReferenceCitation: Lindsay JO, Allez M, Clark M, Labopin M, Ricart E, Rogler G, Rovira M, Satsangi J, Farge D, Hawkey CJ; ASTIC trial group; European Society for Blood and Marrow Transplantation Autoimmune Disease Working Party; European Crohn's and Colitis Organisation. Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):399-406. doi: 10.1016/S2468-1253(17)30056-0. Epub 2017 Apr 6.

family: Lindsay

full_name: James O Lindsay

given: James O

family: Allez

full_name: Mathieu Allez

given: Mathieu

family: Clark

full_name: Miranda Clark

given: Miranda

family: Labopin

full_name: Myriam Labopin

given: Myriam

family: Ricart

full_name: Elenor Ricart

given: Elenor

family: Rogler

full_name: Gerhard Rogler

given: Gerhard

family: Rovira

full_name: Montserrat Rovira

given: Montserrat

family: Satsangi

full_name: Jack Satsangi

given: Jack

family: Farge

full_name: Dominique Farge

given: Dominique

family: Hawkey

full_name: Christopher J Hawkey

given: Christopher J

full_name: Matthieu Allez

given: Matthieu

full_name: Elena Ricart

given: Elena

family: Danese

full_name: Silvio Danese

given: Silvio

family: Russell

full_name: Nigel Russell

given: Nigel

family: Gribben

full_name: John Gribben

given: John

family: Johnson

full_name: Peter Johnson

given: Peter

family: Larghero

journal_name: The Lancet Gastroenterology & Hepatology

repository_institution: University of Nottingham - Repository@Nottingham

url: https://nottingham-repository.worktribe.com/1126797/1/lindsay lancet gastroent   hepat 2017 aam

url_for_landing_page: https://nottingham-repository.worktribe.com/1126797/1/Lindsay Lancet Gastroent   Hepat 2017 AAM

repository_institution: University of Zurich - Zurich Open Repository and Archive

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

ReferenceCitation: Hawkey CJ, Allez M, Clark MM, Labopin M, Lindsay JO, Ricart E, Rogler G, Rovira M, Satsangi J, Danese S, Russell N, Gribben J, Johnson P, Larghero J, Thieblemont C, Ardizzone S, Dierickx D, Ibatici A, Littlewood T, Onida F, Schanz U, Vermeire S, Colombel JF, Jouet JP, Clark E, Saccardi R, Tyndall A, Travis S, Farge D. Autologous Hematopoetic Stem Cell Transplantation for Refractory Crohn Disease: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2524-34. doi: 10.1001/jama.2015.16700.

name: Nottingham Digestive Diseases Centre, School of Clinical Sciences, Queens Medical Centre, Nottingham, United Kingdom

name: APHP, Hôpital Saint Louis, Department of Gastroenterology, INSERM UMRS 1160, Paris Diderot, Sorbonne Paris-Cité University, Paris, France

name: European Group for Blood and Marrow Transplantation, Paris, France

name: Centre for Immunobiology, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom

name: Gastroenterology Department, Hospital Clinic, CIBER-EHD, Barcelona, Spain

name: Division of Gastroenterology and Hepatology, University Hospital, University of Zurich, Zurich, Switzerland

name: Hematology Department, Hospital Clinic, Barcelona, Spain

name: Gastro-intestinal Unit, Institute of Genetics and Molecular Medicine, Western General Hospital University of Edinburgh, Edinburgh, United Kingdom

name: IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy

name: Haematology School of Medicine, University of Nottingham, Nottingham City Hospital, Nottingham, United Kingdom

name: Centre for Haemato-Oncology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom

name: Department of Haematology, Western General Hospital, Edinburgh, United Kingdom

name: Biotherapies and Cell Therapy Unit, AP-HP Hôpital Saint-Louis, Paris 7 University, France

name: Haematology/Transplantation, AP-HP Hôpital Saint-Louis, Paris 7 University, Paris, France

name: IBD Unit, Department of Gastroenterology, “L. Sacco” University Hospital, Milan, Italy

name: Department of Hematology, University hospitals Leuven, Gasthuisberg, Belgium University Hospital, Belgium

name: Divisione Ematologia e Trapianto di Midollo, IRCCS San Martino-IST, Genova, Italy

name: Department of Haematology, Oxford University Hospitals NHS Trust, Oxford, United Kingdom

name: Hematology–BMT Center, Fondazione IRCCS Ospedale Maggiore Policlinico, University of Milan, Milan, Italy

name: Division of Hematology, University Hospital Zurich, Zurich, Switzerland

name: Department of Gastroenterology University Hospital Gasthuisberg Herestraat, Leuven, Belgium

name: Department of Hepato-Gastroenterology, Hopital Huriez, Lille, France23Department of Gastroenterology, Icahn School of Medicine, New York, New York

name: Departement of Hematology, Hôpital Claude-Huriez, Lille, France

name: EBMT Clinical Trials, European Group for Blood and Marrow Transplantation, London, United Kingdom

name: European Blood & Marrow Transplantation Group, Hematology Department, Careggi University Hospital, Florence, Italy

name: Department of Rheumatology, University Hospital, Basel, Switzerland

name: Translational Gastroenterology Unit, Oxford University Hospital, Oxford, United Kingdom

name: Internal Medicine and Vascular Disease Unit AP-HP Hôpital Saint-Louis, Paris 7 University, France

location_country:
Italy
Switzerland
France
Belgium
Spain
Canada
United Kingdom

location_facility: Casa Sollievo Della Sofferenza IRCCS Hospital

location_facility: Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology

location_facility: Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

location_facility: Dipatimento di Medicina Interna E Gastroenterologia


title: Randomized, Double-blind, Placebo-controlled, Parallel-group Pilot Study to Assess Efficacy, Safety and Pharmacokinetics of 2 Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplant in High Risk Patients

summary: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.

primary_purpose: Prevention

lead_sponsor: Dompé Farmaceutici S.p.A

location_facility: Service de Nephrologie et Transplantation, Hopital Lapeyronie, Centre Hospitalier Universitaire Montpellier

location_facility: Service de Transplantation et Soins Intensifs Nephrologiques, Hopital Necker

location_facility: Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Università degli Studi di Padova, Clinica Chirurgica III

location_facility: Renal Transplant Unit, Hopital Clinic i Provincial de Barcelona

location_facility: Transplant Center, University of Minnesota Medical School

location_facility: Division of Nephrology, Institut Catala de la Salut, Ciutat Sanitaria i Universitaria de Bellvitge

location_facility: Division of Transplantation, Drexel University College of Medicine

location_facility: Divisione di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo

intervention_type: Other


title: Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

ReferenceCitation: Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.

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

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

intervention_type: Procedure


title: A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.

acronym: rhAT

summary: Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.

ReferenceCitation: DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

name: LAP&P Consultants BV, Leiden, the Netherlands

family: DeJongh

full_name: Joost DeJongh

given: Joost

family: Frieling

full_name: Johan Frieling

given: Johan

family: Lowry

full_name: Simon Lowry

given: Simon

family: Drenth

full_name: Henk-Jan Drenth

given: Henk-Jan

journal_name: Clinical and Applied Thrombosis/Hemostasis

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Pharmacokinetics of Recombinant Human Antithrombin in Delivery and Surgery Patients With Hereditary Antithrombin Deficiency

lead_sponsor: rEVO Biologics

location_country:
Italy
United States
Sweden
France
Germany
United Kingdom


title: Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating patients who have advanced non-small cell lung cancer that cannot be treated with surgery.

location_country: Italy Austria France Spain Denmark Germany

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Haemato-Onkologische Praxis und Tagesklinik

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori


title: AnaTomic Stenosis Severity Derived From Computed Tomography as a Prognostic Marker in Patients With Low-flow Low-gradient Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

acronym: ATLAS TAVI

summary: The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

status: Recruiting

ReferenceCitation: Cueff C, Serfaty JM, Cimadevilla C, Laissy JP, Himbert D, Tubach F, Duval X, Iung B, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Measurement of aortic valve calcification using multislice computed tomography: correlation with haemodynamic severity of aortic stenosis and clinical implication for patients with low ejection fraction. Heart. 2011 May;97(9):721-6. doi: 10.1136/hrt.2010.198853. Epub 2010 Aug 18.

ReferenceCitation: Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA, Michelena HI, Cueff C, Larose E, Capoulade R, Vahanian A, Enriquez-Sarano M. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol. 2013 Dec 17;62(24):2329-38. doi: 10.1016/j.jacc.2013.08.1621. Epub 2013 Sep 24.

ReferenceCitation: Clavel MA, Pibarot P, Messika-Zeitoun D, Capoulade R, Malouf J, Aggarval S, Araoz PA, Michelena HI, Cueff C, Larose E, Miller JD, Vahanian A, Enriquez-Sarano M. Impact of aortic valve calcification, as measured by MDCT, on survival in patients with aortic stenosis: results of an international registry study. J Am Coll Cardiol. 2014 Sep 23;64(12):1202-13. doi: 10.1016/j.jacc.2014.05.066.

ReferenceCitation: Ludwig S, Goßling A, Waldschmidt L, Linder M, Bhadra OD, Voigtländer L, Schäfer A, Deuschl F, Schirmer J, Reichenspurner H, Blankenberg S, Schäfer U, Westermann D, Seiffert M, Conradi L, Schofer N. TAVR for low-flow, low-gradient aortic stenosis: Prognostic impact of aortic valve calcification. Am Heart J. 2020 Jul;225:138-148. doi: 10.1016/j.ahj.2020.03.013. Epub 2020 Apr 8.

ReferenceCitation: Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391.

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_country:
Netherlands
Germany
France
Israel
Denmark
Canada
United Kingdom

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval

location_facility: University Heart and Vascular Center Hamburg

lead_sponsor_type: academique

status_simplified: Ongoing


study_start_date_type: Anticipated

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
France
Australia
Spain
Denmark
United States
Korea, Republic of

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

title: A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

summary: This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.


ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
Australia
France
Spain

location_facility: The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services

location_facility: H. Universitario Valle de Hebrón Servicio de Hematología

location_facility: University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine

location_facility: H. Universitario La Fe Servicio de Hematologia

title: Phase I/II, International, Multicentre, Open-label, Non-randomised, Non-comparative, Study Evaluating the Safety, Tolerability and Clinical Activity of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Azacitidine in Patients With Acute Myeloid Leukaemia (AML)

summary: The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.


title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

summary: The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

primary_purpose: Other

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Sweden
Netherlands
France
Poland
Georgia
Romania
Belgium
Spain
Moldova, Republic of
United States
United Kingdom
Ukraine

location_facility: Sir Bobby Robson Unit, Northern Centre for Cancer Care

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Institut Bergonié, Centre de Lutte Contre le Cancer


title: Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness

summary: Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness

lead_sponsor: CorNeat Vision Ltd.

location_country:
Netherlands
France
Israel
United States
Canada

location_facility:
Hopital Fondation Adolphe de Rothschild
Amsterdam UMC - Location AMC
Maastricht UMC+
University of British Columbia
Rabin Medical Center - Beilinson
CHU de Montpellier
Cincinnati Eye Institute
UHN - University Health Network


title: A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

summary:
Primary Objective:

To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives:

To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

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

lead_sponsor: Sanofi

location_country:
United States
Belgium
France
Netherlands

location_facility:
Investigational Site Number 2501002
Investigational Site Number 5281002
Investigational Site Number 0561002
Investigational Site Number 8400001
Investigational Site Number 5281001
Investigational Site Number 0561001
Investigational Site Number 2501001


title: A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination With Durvalumab ± Oleclumab in Advanced Solid Tumors

summary: The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

ipd_sharing: No

lead_sponsor: MedImmune LLC

location_country:
United States
France
Switzerland
Spain