acronym: SIDEROS

lead_sponsor: Santhera Pharmaceuticals

summary: The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids

ReferenceType: background

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

ReferenceCitation: McDonald CM, Meier T, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Spagnolo P, Buyse GM; DELOS Study Group. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2016 Aug;26(8):473-80. doi: 10.1016/j.nmd.2016.05.008. Epub 2016 May 12.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Mayer OH, Spagnolo P, Meier T, McDonald CM; DELOS Study Group. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatr Pulmonol. 2017 Apr;52(4):508-515. doi: 10.1002/ppul.23547. Epub 2016 Aug 29.

location_facility: Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System

location_facility: Reparto Di Neurologia dell'Osperdale Di Padova

location_facility: UC Davis Department of Physical Medicine and Rehabilitation

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin

location_facility: Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Servizio di Cardiomiologia e Genetica Medica, AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Gillette Children's Specialty Healthcare

location_facility: Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Centre de Référence Neuromusculaire, CHR Citadelle

location_facility: Great Ormond Street Hospital for Children

location_facility: Semmelweis University 2nd Department of Paediatrics

location_facility: Scientific Coordinator Nemo Sud Clinical Center

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital

location_facility: Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital

location_facility: Universitätsmedizin Berlin Campus Virchow-Klinikum

location_facility: John Walton Muscular Dystrophy Research Centre

location_facility: Oxford University hospitals NHS Foundation Trust

location_facility: Universitätsklinikum Heidelberg Zentrum für Kinder- und Jugendmedizin

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Institute of Neurology at Schneider Children's Medical Center of Israel

location_facility: Banner University of Arizona Medical Center

location_facility: Dipartimento di Clinica Neurologica e Psichiatrica dell'Età Evolutiva della Fondazione IRCCS "C. Mondino" di Pavia

location_facility: I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20

location_facility: UCL, National Hospital for Neurology and Neurosurgery

status: Terminated

title: A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

location_country:
Germany
Ireland
Italy
Hungary
Israel
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Bulgaria
France


type: Other Identifier

type: EudraCT Number

title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

summary: The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: SAGE Publications

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

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

location_facility: New England Institute for Clinical Research

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centre Hospitalier Regional de la Citadelle

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors

summary: This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

lead_sponsor: Genentech, Inc.

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

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

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

acronym: SUNRISE 1

summary: This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

design_allocation: Randomized

ReferenceCitation: Chepke C, Jain R, Rosenberg R, Moline M, Yardley J, Pinner K, Kumar D, Perdomo C, Filippov G, Atkins N, Malhotra M. Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder. Postgrad Med. 2022 Apr;134(3):316-325. doi: 10.1080/00325481.2022.2049553. Epub 2022 Mar 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Texas Tech University - ThinkTech

unpaywall_oa_status: hybrid

publisher_dissemination: Informa

ReferenceCitation: Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82:20m13795. doi: 10.4088/JCP.20m13795.

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

unpaywall_oa_status: bronze

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: Moline M, Zammit G, Cheng JY, Perdomo C, Kumar D, Mayleben D. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021 Jun 1;17(6):1167-1174. doi: 10.5664/jcsm.9150.

oa_colors: green other

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254. Erratum In: JAMA Netw Open. 2020 Apr 1;3(4):e206497. JAMA Netw Open. 2021 Aug 2;4(8):e2127643.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: gold

publisher_dissemination: American Medical Association

lead_sponsor: Eisai Inc.

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Zentralinstitut für Seelische Gesundheit

location_facility: Clinical Research Group of St Petersburg Inc

location_facility: Hospital Universitario Araba - Txagorritxu

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Orange County Neuropsychiatric Research Center, LLC

location_facility: Medical University of South Carolina - PPDS

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

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

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Saint Francis Sleep Allergy and Lung Institute

location_facility: Artemis Institute For Clinical Research LLC

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)

location_facility: Fleming Island Center For Clinical Research

location_facility: Sleep Medicine Centers of Western New York

location_facility: Azienda Ospedaliero Universitaria Pisana


acronym: VENICE I

lead_sponsor: AbbVie

summary: The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL with or without the 17p deletion or TP53 mutation, including those who have received prior treatment with a B-cell receptor inhibitor.

location_facility: Istanbul University Istanbul Medical Faculty /ID# 156040

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 147503

location_facility: Haukeland University Hospital /ID# 147382

location_facility: Vehbi Koc vakfi Amerikan Hasta /ID# 147325

location_facility: Puerto Rico Hematology Oncolog /ID# 150003

location_facility: Cliniques Universitaires Saint Luc /ID# 147388

location_facility: West Virginia Univ School Med /ID# 151602

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 151624

location_facility: CHRU de Brest - Hopital Morvan /ID# 147485

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505

location_facility: Ondokuz mayis University Facul /ID# 147326

location_facility: Hospital Santa Creu i Sant Pau /ID# 151230

location_facility: General Hospital of Athens Laiko /ID# 147517

location_facility: Albert Schweitzer Ziekenhuis /ID# 147495

location_facility: CHU de Quebec-Universite Laval /ID# 150299

location_facility: Cent fuer Haematologie und Onk /ID# 147511

location_facility: Southampton General Hospital /ID# 147646

location_facility: Sunnybrook Health Sciences Ctr /ID# 147462

location_facility: Hospital Clinico Univ de Salamanca /ID# 147392

location_facility: Univ Hosp Bristol NHS Foundati /ID# 147647

location_facility: Skanes Universitetssjukhus Lund /ID# 147439

location_facility: OncoResearch Lerchenfeld GmbH /ID# 164044

location_facility: Hopitaux Universitaires de Geneve /ID# 147930

location_facility: Onkologische Schwerpunktpraxis /ID# 147516

location_facility: The Royal Wolverhampton NHS Tr /ID# 147945

location_facility: Ospedale Regional Bellinzona e /ID# 151232

location_facility: Hanusch Krankenhaus der WGKK /ID# 147548

title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)

source: euctr

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

location_country:
Finland
Germany
Ireland
Turkey
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel


title: A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors

acronym: Bellini

summary: This was a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

ReferenceCitation: Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29.

publisher_dissemination: Elsevier

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

sponsor_collaborators:
AbbVie
Genentech, Inc.

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

location_facility: Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518

location_facility: Concord Repatriation General Hospital /ID# 149106

location_facility: JCHO Kyoto Kuramaguchi Medical /ID# 150781

location_facility: Bashkir State Medical University /ID# 151206

location_facility: Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891

location_facility: A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 152517

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948

location_facility: Duplicate_Centre Hospitalier Lyon Sud /ID# 149300

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939

location_facility: National Taiwan University Hospital /ID# 154444

location_facility: Nottingham University Hospitals NHS Trust /ID# 149047

location_facility: Samara State Medical University /ID# 148952

location_facility: National Cancer Center Hospital /ID# 151039

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 149294

location_facility: Gabrail Cancer Center Research /ID# 149098

location_facility: Japanese Red Cross Osaka Hospital /ID# 150716

location_facility: National Hospital Organization Disaster Medical Center /ID# 150784

location_facility: Gachon University Gil Medical Center /ID# 150893

location_facility: East Kent Hospitals University NHS Foundation Trust /ID# 149059

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242

location_facility: Hospital Universitario 12 de Octubre /ID# 148981

location_facility: CHRU de Brest - Hopital Morvan /ID# 149299

location_facility: Liga Norte Riograndense Contra o Câncer /ID# 149023

location_facility: CHU Grenoble - Hopital Michallon /ID# 149301

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956

location_facility: The Queen Elizabeth Hospital /ID# 149104

location_facility: Hospital Universitario de la Princesa /ID# 148980

location_facility: The Cancer Institute Hospital Of JFCR /ID# 150780

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942

location_facility: Clinical Oncology Dispensary of Omsk /ID# 148953

location_facility: King's College Hospital NHS Foundation Trust /ID# 149045

location_facility: Taipei Veterans General Hosp /ID# 154445

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411

location_facility: National Hospital Organization Shibukawa Medical Center /ID# 150281

location_facility: Seoul National University Hospital /ID# 150890

location_facility: China Medical University Hospital /ID# 154446

location_facility: Kobe City Medical Center General Hospital /ID# 150944

location_facility: Duplicate_Kyoto Prefectural University of Medicine /ID# 150719

location_facility: Seoul National University Bundang Hospital /ID# 150888

location_facility: University College London Hospitals NHS Foundation Trust /ID# 149044

location_facility: Royal Brisbane and Women's Hospital /ID# 149105

location_facility: Nagoya City University Hospital /ID# 150943

location_facility: Royal Prince Alfred Hospital /ID# 149108

location_facility: Hospital Universitario Dr. Peset /ID# 148986

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055

location_facility: Japanese Red Cross Medical Center /ID# 149902

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516

location_facility: Chonnam National University Hospital /ID# 150894

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058

location_facility: Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414

location_facility: Kuzbass Regional Clinical Hospital /ID# 148955

location_facility: The Royal Wolverhampton NHS Trust /ID# 149043

location_facility: Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025

location_facility: Central Clinical Hospital RZHD Medicine /ID# 148954

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895

location_facility: National Hospital Organization Mito Medical Center /ID# 151051

location_facility: Manchester University NHS Foundation Trust /ID# 149046

location_facility: Univ of Colorado Cancer Center /ID# 149130


title: A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

summary:
The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

lead_sponsor: Debiopharm International SA

location_country:
Germany
Poland
Argentina
Australia
Thailand
Vietnam
Turkey
Canada
France
Hungary
Hong Kong
United States
India
Romania
Belgium
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


title: Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.

acronym: Premium

summary: This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

status: Unknown status

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: PregLem SA

location_country:
Germany
Italy
Lithuania
Poland
Portugal
Hungary
United Kingdom
Denmark
Romania
Sweden
Netherlands
Belgium
Latvia
Spain
Czechia
France

location_facility: Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie

location_facility: Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw

location_facility: Rosemere Cancer Centre - Royal Preston Hospital

location_facility: Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust

location_facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona

location_facility: PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie

location_facility: University ""Magna Graecia"" Of Catanzaro

location_facility: Karolinska Institutet, Karolinska University Hospital Huddinge

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust

location_facility: Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

location_facility: Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)

location_facility: Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert

location_facility: Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche

location_facility: Szent Anna Privat Surgery-Szent Anna Magae¡nrendela

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust

location_facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Hospital Universitario de Guadalajara (HUG)

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte

location_facility: Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust

location_facility: Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Groupement Hospitalier Universitaire Sud CHU Bicetre

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

location_facility: University of Torino, S. Anna Hospital- City of Health and Science

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Endoskopie Und Endometriose-Zentrum Munchen

location_facility: Elena Doamna Obstetrics and Gynecology Clinical Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing

location_facility: Instituto Palacios, Salud y Medicina de la Mujer

status_simplified: Unknown


title: A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)

summary: Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

ipd_sharing: No

lead_sponsor: Bellerophon Pulse Technologies

sponsor_collaborators:
Bellerophon Pulse Technologies
Worldwide Clinical Trials

location_country:
Germany
Italy
Colombia
Portugal
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Croatia
Czechia
Canada
Ukraine
Serbia
France

location_facility: Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie

location_facility: Toronto General Hospital, University Health Network

location_facility: Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I

location_facility: Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II

location_facility: National institute of phthisiology and pulmonology

location_facility: Wellstar Medical Group - Pulmonary Medicine

location_facility: Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C)

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension

location_facility: Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B

location_facility: Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville

location_facility: "Universitätsklinikum Freiburg - Medizinische Universitätsklinik

location_facility: Faculty of Medicine / Peter Lougheed Center / Respiratory Research

location_facility: AKH-Vienna, Medical University of Vienna

location_facility: CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie

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

location_facility: University of Arizona Sarver Heart Center

location_facility: New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep

location_facility: A.O.U. Policlinico Umberto I- Università La Sapienza

location_facility: Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie

location_facility: Clinical Center of Serbia, Polyclinic, Pulomology Department

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: National Scientific Centre "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie

location_facility: UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division

location_facility: Bluhm Cardiovascular Institute, Clinical Trials Unit

location_facility: Lawson Clinical Research Services / London Health Sciences Centre - VH

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

location_facility: Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology

location_facility: Medizinische Hochschule Hannover-Abteilung für Pneumologie

location_facility: Clinical Center of Serbia Department of Cardiology and Polyclinic

location_facility: Lviv Regional Clinical Hospital, Department of Intesive Care #2

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: University of California, Davis Medical Center

location_facility: Montefiore Medical Center - Weiler Division

location_facility: Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1

location_facility: University of Texas Southwestern Medical Center of Dallas

location_facility: Clinical Center of Nis, Clinic for Cardiovascular Diseases

location_facility: Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Cardiopulmonology Department

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -

location_facility: Hospital Universitario Marques de Valdecilla (HUMV)

location_facility: University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine

location_facility: Vseobecna Fakultni Nemocnice v Praze (VFN)

location_facility: Hospital Universitario Puerta de Hierro - Madrid

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires

location_facility: NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine

location_facility: Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research


lead_sponsor: Millennium Pharmaceuticals, Inc.

summary: The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.

location_facility: Hackensack University Medical Center PARTNER

location_facility: Groupe Hospitalier Saint Andre - Hopital Saint Andre

location_facility: Instytut MSF, Ulica Pilota Stanislawa Wigury 19

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Institut de Cancerologie de l'Ouest Paul Papin

location_facility: Beskidzkie Centrum Onkologii im.Jana Pawla II

location_facility: ICL-Alexis Vautrin, Departement dOncologie Medicale

location_facility: The Center for Cancer and Blood Disorders

location_facility: The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy

type: Registry Identifier

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

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


title: An Open-label, Multicentre, Dose-escalating Phase I/II Trial of 3-weekly Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)

summary: This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

lead_sponsor: Hoffmann-La Roche

location_country: France Italy Australia Switzerland Canada Sweden


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.

ReferenceCitation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Yao D, Das P, San-Miguel J. Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. J Clin Oncol. 2023 Jan 20;41(3):568-578. doi: 10.1200/JCO.21.02815. Epub 2022 Aug 12.

evidence: open (via page says license)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Bristol-Myers Squibb
Celgene
AbbVie

location_facility: A. O. U. Di Bologna, Policlinico S. Orsola Malpighi

location_facility: Klinikum Der Johannes Gutenberg Universitaet Mainz

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino

location_facility: Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

location_facility: Oddzial Hematologii i Transplantacji Szpiku

title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

location_country:
Germany
Italy
Poland
Australia
Japan
Netherlands
United States
Spain
Greece
Canada
France

collaborators: Celgene AbbVie


title: The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

acronym: RADIANCE-HTN

summary: RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

ReferenceCitation: Azizi M, Mahfoud F, Weber MA, Sharp ASP, Schmieder RE, Lurz P, Lobo MD, Fisher NDL, Daemen J, Bloch MJ, Basile J, Sanghvi K, Saxena M, Gosse P, Jenkins JS, Levy T, Persu A, Kably B, Claude L, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation: Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial. JAMA Cardiol. 2022 Dec 1;7(12):1244-1252. doi: 10.1001/jamacardio.2022.3904.

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories:
HAL
PubMed Central
pure.eur.nl

repositories_concat: HAL;PubMed Central;pure.eur.nl

ReferenceCitation: Sanghvi K, Wang Y, Daemen J, Mathur A, Jain A, Dohad S, Sapoval M, Azizi M, Mahfoud F, Lurz P, Sayer J, Levy T, Zagoria R, Loening AM, Coleman L, Craig D, Horesh-Bar M, Kirtane AJ. Renal Artery Variations in Patients With Mild-to-Moderate Hypertension From the RADIANCE-HTN SOLO Trial. Cardiovasc Revasc Med. 2022 Jun;39:58-65. doi: 10.1016/j.carrev.2021.09.008. Epub 2021 Sep 30.

ReferenceCitation: Fisher NDL, Kirtane AJ, Daemen J, Rader F, Lobo MD, Saxena M, Abraham J, Schmieder RE, Sharp ASP, Gosse P, Claude L, Song Y, Azizi M; RADIANCE-HTN Investigators. Plasma renin and aldosterone concentrations related to endovascular ultrasound renal denervation in the RADIANCE-HTN SOLO trial. J Hypertens. 2022 Feb 1;40(2):221-228. doi: 10.1097/HJH.0000000000002994.

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.

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

repository_institution: Maastricht University - Research Publications

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

ReferenceCitation: Gosse P, Cremer A, Kirtane AJ, Lobo MD, Saxena M, Daemen J, Wang Y, Stegbauer J, Weber MA, Abraham J, Kario K, Bangalore S, Claude L, Liu Y, Azizi M. Ambulatory Blood Pressure Monitoring to Predict Response to Renal Denervation: A Post Hoc Analysis of the RADIANCE-HTN SOLO Study. Hypertension. 2021 Feb;77(2):529-536. doi: 10.1161/HYPERTENSIONAHA.120.16292. Epub 2020 Dec 28.

ReferenceCitation: Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 May 28;139(22):2542-2553. doi: 10.1161/CIRCULATIONAHA.119.040451. Epub 2019 Mar 17.

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

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

ReferenceCitation: Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available.

ReferenceCitation: Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23. Erratum In: Lancet. 2018 Sep 8;392(10150):820.

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
United States
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Renown Institute for Heart& Vascular Health

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

location_facility: University of North Carolina at Chapel Hill School of Medicine

location_facility: The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals

location_facility: Imperial College London, Hammersmith Hospital

location_facility: Columbia University / NewYork Presbyterian Hospital

location_facility: Nottingham University Hospitals NHS Trust


title: An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

summary: This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative

location_facility: Ospedale Policlinico S. Matteo; Phase I Clinical Trial Unit and Experimental Therapy

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

location_facility: Washington University; Division of Oncology

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia


title: Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)

summary:
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates.

The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding.

In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand).

In case a participant develops antibodies, treatment will be provided as part of the study.

lead_sponsor: Baxalta now part of Shire

collaborators: Takeda Development Center Americas, Inc.

location_country:
Finland
Germany
Thailand
Turkey
Canada
France
Hungary
Hong Kong
Denmark
United States
Ukraine
Belgium
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Oslo Universitetssykehus - Rikshospitalet

location_facility: Evelina Children's Hospital - St Thomas' Hospital

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Novant Health Presbyterian Medical Center

location_facility: Texas Tech University Health Sciences Center

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The University of Hong Kong Queen Mary Hospital

intervention_type: Biological


title: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

summary:
This study will include participants with various types of cancer known as soft-tissue sarcomas.

Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments.

Soft tissue cancers are rare and can occur almost anywhere in the body.

Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability).

It is also designed to establish a recommended study drug dosage for the next part of the study.

Part 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).

ReferenceCitation: Gounder M, Schoffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, Attia S, Chugh R, Chen TW, Jahan T, Loggers ET, Gupta A, Italiano A, Demetri GD, Ratan R, Davis LE, Mir O, Dileo P, Van Tine BA, Pressey JG, Lingaraj T, Rajarethinam A, Sierra L, Agarwal S, Stacchiotti S. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020 Nov;21(11):1423-1432. doi: 10.1016/S1470-2045(20)30451-4. Epub 2020 Oct 6.

lead_sponsor: Epizyme, Inc.

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

location_facility: McGill University Health Centre - Royal Victoria Hospital

location_facility: Instituto Nazionale Tumori - National Cancer Institute Via Giacomo Venezian

location_facility: Metro South Hospital and Health Service via Princess Alexandra Hospital

location_facility: Massachusetts General Hospital - Cancer Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Institut Jules Bordet Medical Oncology Clinic


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).

ReferenceCitation: Eron JJ Jr, Lelievre JD, Kalayjian R, Slim J, Wurapa AK, Stephens JL, McDonald C, Cua E, Wilkin A, Schmied B, McKellar M, Cox S, Majeed SR, Jiang S, Cheng A, Das M, SenGupta D. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Lancet HIV. 2018 Dec 13:S2352-3018(18)30296-0. doi: 10.1016/S2352-3018(18)30296-0. Online ahead of print.

location_facility: North Texas Infectious Diseases Consultants

location_facility: University of North Carolina at Chapel Hill / UNC School of Medicine

location_facility: Wake Forest University Baptist Medical Center

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center

location_facility: Midway Immunology & Research Center, LLC

title: A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

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

location_country:
United States
Germany
Austria
France


title: The Medtronic CoreValve™ Evolut R™ FORWARD Study

acronym: FORWARD

summary: Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

ReferenceType: result

ReferenceCitation: Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.

ReferenceCitation: Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.

ReferenceCitation: Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

ReferenceCitation: Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

ReferenceCitation: Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.

ReferenceCitation: Genereux P, Head SJ, Wood DA, Kodali SK, Williams MR, Paradis JM, Spaziano M, Kappetein AP, Webb JG, Cribier A, Leon MB. Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications. Eur Heart J. 2012 Oct;33(19):2388-98. doi: 10.1093/eurheartj/ehs220. Epub 2012 Jul 31.

ReferenceCitation: Buellesfeld L, Gerckens U, Schuler G, Bonan R, Kovac J, Serruys PW, Labinaz M, den Heijer P, Mullen M, Tymchak W, Windecker S, Mueller R, Grube E. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011 Apr 19;57(16):1650-7. doi: 10.1016/j.jacc.2010.11.044.

ReferenceCitation: Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, Violini R, Ramondo A, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, De Carlo M, Napodano M, Fiorina C, De Marco F, Antoniucci D, de Cillis E, Capodanno D, Tamburino C; CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012 Apr;33(8):969-76. doi: 10.1093/eurheartj/ehr491. Epub 2012 Jan 12.

ReferenceCitation: Walther T, Dewey T, Borger MA, Kempfert J, Linke A, Becht R, Falk V, Schuler G, Mohr FW, Mack M. Transapical aortic valve implantation: step by step. Ann Thorac Surg. 2009 Jan;87(1):276-83. doi: 10.1016/j.athoracsur.2008.08.017.

ReferenceCitation: Walther T, Mollmann H, van Linden A, Kempfert J. Transcatheter aortic valve implantation transapical: step by step. Semin Thorac Cardiovasc Surg. 2011 Spring;23(1):55-61. doi: 10.1053/j.semtcvs.2011.05.006.

ReferenceCitation: Lange R, Bleiziffer S, Piazza N, Mazzitelli D, Hutter A, Tassani-Prell P, Laborde JC, Bauernschmitt R. Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients. Eur J Cardiothorac Surg. 2011 Nov;40(5):1105-13. doi: 10.1016/j.ejcts.2011.03.022. Epub 2011 Apr 22.

ReferenceCitation: Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.

ReferenceCitation: Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012 May 15;8(1):129-38. doi: 10.4244/EIJV8I1A20.

ReferenceCitation: Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodes-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1637-43. doi: 10.1016/j.amjcard.2012.01.389. Epub 2012 Mar 15.

ReferenceCitation: Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Muller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. doi: 10.1016/j.jacc.2011.11.048.

ReferenceCitation: Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

ReferenceCitation: Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, Soula P, Gabiache Y, Fournial G, Marcheix B, Carrie D, Fajadet J. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention. 2010 Jan;5(6):659-65. doi: 10.4244/eijv5i6a109.

ReferenceCitation: Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Ligthart J, Schultz C, de Jaegere PP, Serruys PW. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. EuroIntervention. 2010 Jan;5(6):673-9. doi: 10.4244/eijv5i6a111.

ReferenceCitation: Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Garcia-Garcia H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.

ReferenceCitation: Fraccaro C, Buja G, Tarantini G, Gasparetto V, Leoni L, Razzolini R, Corrado D, Bonato R, Basso C, Thiene G, Gerosa G, Isabella G, Iliceto S, Napodano M. Incidence, predictors, and outcome of conduction disorders after transcatheter self-expandable aortic valve implantation. Am J Cardiol. 2011 Mar 1;107(5):747-54. doi: 10.1016/j.amjcard.2010.10.054. Epub 2011 Jan 19.

ReferenceCitation: van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodes-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58.

ReferenceCitation: Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-Chico JL, Nuis RJ, Kauer F, Schultz C, Serruys PW, de Jaegere PP, Geleijnse ML. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction. Am J Cardiol. 2011 Jan 15;107(2):285-9. doi: 10.1016/j.amjcard.2010.09.015. Epub 2010 Dec 2.

ReferenceCitation: Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.

ReferenceCitation: Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. doi: 10.1002/ccd.23003. Epub 2011 Jul 25.

ReferenceCitation: Manoharan G, Van Mieghem NM, Windecker S, Bosmans J, Bleiziffer S, Modine T, Linke A, Scholtz W, Chevalier B, Gooley R, Zeng C, Oh JK, Grube E. 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2326-2334. doi: 10.1016/j.jcin.2018.07.032.

ReferenceCitation: Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchetche D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S; FORWARD Study Investigators. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study. J Am Coll Cardiol. 2017 Aug 15;70(7):845-853. doi: 10.1016/j.jacc.2017.06.045.

ipd_sharing: Undecided

lead_sponsor: Medtronic Cardiovascular

location_country:
Germany
Poland
Australia
Czechia
Canada
France
Colombia
Portugal
Hungary
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Saudi Arabia
Spain
Greece
Panama
South Africa
Israel

location_facility: London Health Sciences Centre - University Campus

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Complejo Hospitalario Dr Arnulfo Arias Madrid

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire - Hopital Henri Mondor

location_facility: The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Royal Victoria Hospital - Belfast Health and Social Care Trust

location_facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

location_facility: Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

location_facility: Hospital Universitario Central de Asturias

location_facility: Herzzentrum Dresden GmbH Universitaetsklinik

intervention_type: Device


title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.

ReferenceCitation: Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.

location_country:
Lithuania
Moldova, Republic of
Poland
Hungary
United Kingdom
Denmark
Australia
Japan
Netherlands
Romania
Belgium
United States
Czechia
Canada
Georgia
France

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.

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.


title: Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A

acronym: PROPEL

summary:
To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)
To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855

primary_purpose: Prevention

ReferenceCitation: Klamroth R, Windyga J, Radulescu V, Collins PW, Stasyshyn O, Ibrahim HM, Engl W, Tangada SD, Savage W, Ewenstein B. Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study. Blood. 2021 Apr 1;137(13):1818-1827. doi: 10.1182/blood.2020005673.

publisher_dissemination: American Society of Hematology

collaborators: Baxalta Innovations GmbH, now part of Shire

location_country:
Germany
Poland
Australia
Turkey
France
Hungary
Hong Kong
Switzerland
United States
Ukraine
Romania
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Austria
Spain
Taiwan
Bulgaria
Israel

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: MHAT 'Sv. Marina', EAD, Clinic of Clinical Hematology

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: M.V. Sklifosovskyi Poltava RCH Dept of Gematology HSEIU Ukrainian Medical Stomatological Academy

location_facility: Hospital Regional Universitario de Malaga

location_facility: University of Florida College of Medicine

location_facility: Arizona Hemophilia & Thrombosis Center, located within The University of Arizona Cancer Center

location_facility: NChSH Okhmatdyt of MoHU Center of Children Oncohematology and Bone Marrow Transplantation

location_facility: Kyiv CCH #9 Dept of Surgery City SPC of Diagnostics & Treatment of Patients with HP

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Klinika Hematologii

location_facility: AOU Citta della Salute e della Scienza - Presidio Molinette

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Inst. f. Experimentelle Hamatologie u. Transfusionsmedizin

location_facility: UOC Ematologia, Azienda ULSS 8 Asolo, Regione Veneto


title: An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib

summary: The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.

status: Recruiting

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
France
Colombia
Hong Kong
United States
Lebanon
Belgium
China
Malaysia
Italy
Singapore
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation


title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis

acronym: IXORA-S

summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

ReferenceCitation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

publisher_dissemination: Springer-Nature

ReferenceCitation: Wasel N, Thaci D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Canada
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

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.


lead_sponsor: GlaxoSmithKline

summary:
Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.

Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).

ReferenceCitation: Moore WC, Kornmann O, Humbert M, Poirier C, Bel EH, Kaneko N, Smith SG, Martin N, Gilson MJ, Price RG, Bradford ES, Liu MC. Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study). Eur Respir J. 2022 Jan 6;59(1):2100396. doi: 10.1183/13993003.00396-2021. Print 2022 Jan.

publisher_dissemination: European Respiratory Society

title: A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)

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

location_country:
Germany
Poland
Argentina
Romania
Australia
Japan
Netherlands
United States
Korea, Republic of
Spain
Canada
Ukraine
Russian Federation
France


lead_sponsor: AstraZeneca

summary: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

ReferenceCitation: Jayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.

publisher_dissemination: British Medical Journal

sponsor_collaborators: AstraZeneca Parexel

title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

location_country:
Germany
Italy
Poland
Hungary
Argentina
United Kingdom
Australia
Mexico
Belgium
United States
Korea, Republic of
Spain
Taiwan
Peru
Serbia
Russian Federation
France


title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension

summary: This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

lead_sponsor: Maruho Co., Ltd.

location_country:
Germany
New Zealand
United Kingdom
Australia
Sweden
Netherlands
United States
Canada
France


title: A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).

ReferenceCitation: Borthakur G, Martinelli G, Raffoux E, Chevallier P, Chromik J, Lithio A, Smith CL, Yuen E, Oakley GJ 3rd, Benhadji KA, DeAngelo DJ. Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T-cell acute lymphoblastic leukemia and lymphoma. Cancer. 2021 Feb 1;127(3):372-380. doi: 10.1002/cncr.33188. Epub 2020 Oct 27.

publisher_dissemination: Wiley

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
France
United States
Israel

location_facility: Johann Wolfgang Goethe-Universität Frankfurt

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)

summary: Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive [NR]).

ReferenceCitation: Munck A, Kerem E, Ellemunter H, Campbell D, Wang LT, Ahluwalia N, Owen CA, Wainwright C. Tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for minimal function CFTR mutations. J Cyst Fibros. 2020 Nov;19(6):962-968. doi: 10.1016/j.jcf.2020.04.015. Epub 2020 Jun 13.

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

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

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Israel
Australia
Austria
United States
Spain
Canada
France


title: A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).

acronym: ADAURA

summary: To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

ReferenceCitation: Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951. No abstract available.

ReferenceCitation: Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.

ReferenceCitation: Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.

license: cc-by-nd

license_normalized: cc-by-nd

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.

ReferenceCitation: Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Canada
France
Hungary
Hong Kong
United States
Ukraine
Romania
Belgium
China
Italy
Sweden
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis

acronym: Compare Absorb

summary:
The primary objectives of this trial are:

In patients at high-risk for restenosis,

To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
To assess superiority of the BRS to the EES in TLF between 3 and 7 years

ReferenceCitation: Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kocka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

repository_institution: Radboud University - Radboud Repository

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

repository_institution: reroDoc Digital Library

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

lead_sponsor: European Cardiovascular Research Center

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Belgium
Spain
Czechia
France

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Università degli Studi di Napoli Federico II

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Cardiocentre, University Hospital Kralovske


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

acronym: ARISE

summary: To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

ReferenceCitation: Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.

ReferenceCitation: Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.

ReferenceCitation: Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.

ReferenceCitation: Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.

ReferenceCitation: Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.

ReferenceCitation: Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18. Erratum In: Neurology. 2020 Jun 9;94(23):1052.

ReferenceCitation: Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.

ReferenceCitation: Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.

lead_sponsor: Amgen

location_country:
Portugal
Denmark
Switzerland
United States
Spain
Greece
Russian Federation
France


title: A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

acronym: ElevateTN

summary:
This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria.

2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS).

ReferenceCitation: Sharman JP, Egyed M, Jurczak W, Skarbnik A, Pagel JM, Flinn IW, Kamdar M, Munir T, Walewska R, Corbett G, Fogliatto LM, Herishanu Y, Banerji V, Coutre S, Follows G, Walker P, Karlsson K, Ghia P, Janssens A, Cymbalista F, Woyach JA, Salles G, Wierda WG, Izumi R, Munugalavadla V, Patel P, Wang MH, Wong S, Byrd JC. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020 Apr 18;395(10232):1278-1291. doi: 10.1016/S0140-6736(20)30262-2. Erratum In: Lancet. 2020 May 30;395(10238):1694.

version: acceptedVersion

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

location_country:
Germany
Italy
Lithuania
Colombia
Poland
New Zealand
Hungary
Israel
United Kingdom
Australia
Brazil
Sweden
Belgium
United States
Spain
Chile
Canada
France


title: A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.

ReferenceCitation: Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.

repository_institution: Imperial College London - Spiral

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repositories_concat: PubMed Central;scholarworks.iupui.edu

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:
Germany
Ireland
Italy
United Kingdom
Denmark
Sweden
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Tarrant County Infectious Disease Associates

location_facility: ifi-Studien und Projekte GmbH an der Asklepiosklinik St. Georg

location_facility: Johann Wolfgang Goethe-University Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Hospital Clínico Universitario San Carlos

location_facility: Ospedale Amedeo di Savoia - Specializzato Malattie infettive

location_facility: Highland Hospital - Alameda Health System

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: La Playa Medical Group and Clinical Research

location_facility: Centre Hospitalier Universitaire CHU Sart Tilman Liege

location_facility: University of California San Diego (UCSD)

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.


acronym: Study of INC280 alone and in combination with erlotinib vs. chemotherapy in EGFR+/cMET amp NSCLC

summary: The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: University of California Irvine Medical Center Chao Family SC

location_facility: Los Angeles Hematology/Oncology Medical Group

title: A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) With Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)

location_country:
Germany
Italy
Singapore
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
France


title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

summary: This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

ReferenceCitation: Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.

ReferenceCitation: Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark);spiral.imperial.ac.uk

ReferenceCitation: Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.

lead_sponsor: Pearl Therapeutics, Inc.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Chile
Czechia
Canada
Serbia
France
Hungary
United States
Belgium
China
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Russian Federation
Sweden