title: A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

summary: For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

ReferenceCitation: Huss M, Dirks B, Gu J, Robertson B, Newcorn JH, Ramos-Quiroga JA. Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1283-1294. doi: 10.1007/s00787-018-1113-4. Epub 2018 Feb 13.

family: Huss

full_name: Michael Huss

given: Michael

family: Dirks

full_name: Bryan Dirks

given: Bryan

family: Gu

full_name: Joan Gu

given: Joan

family: Robertson

full_name: Brigitte Robertson

given: Brigitte

family: Newcorn

full_name: Jeffrey H. Newcorn

given: Jeffrey H.

family: Ramos-Quiroga

full_name: J. Antoni Ramos-Quiroga

given: J. Antoni

journal_name: European Child & Adolescent Psychiatry

oa_host_type: publisher

evidence: open (via page says license)

lead_sponsor: Shire

location_country:
Italy
Austria
Sweden
Netherlands
France
Poland
Romania
Ireland
Belgium
Spain
Germany
United Kingdom
Ukraine

location_facility: Poltava Regional Clinical Psychiatric Hospital

location_facility: Friedrich Schiller Universitat Jena Klinik fur Kinder und Jugendpsychiatrie

location_facility: Klinik und Poliklinik fur Kinder-und Jugendpsychiatrie un psychotherapie

location_facility: Institute of Neurology, Psychiatry and Narcology

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Medizinische Universitat Graz Univ fur Kinder

location_facility: Vinnitsya regional psychoneurological hospital

location_facility: Indywidualna Specjalisyczna Praktyka Lekarska

location_facility: Hospital Infanta Leonor, Servicio de Psiquiatria

location_facility: Somni bene GmbH Institut fur Medizinische Forschung und Schlatmedizin

location_facility: Odesa Regional Psychoneurological Dispensary

location_facility: Centenary House Child and Adolescent Mental Health Services

location_facility: Instituto Valenciano de Neurologia Pediatrica

location_facility: Institut fur Ganzheitliche Medizin und Wissenschaft GmbH

location_facility: Centre de Reference Neuropediatrique Multidisciplinaire

location_facility: Institute of Health Care for Children and Teenagers

location_facility: Lviv Regional Clinical Psychiatric Hospital

location_facility: Centrum Badari Klinicznych House Sp. z.o.o.

location_facility: Azienda Ospedallera G Salvini - Ospedale Di Circolo de RHO

location_facility: Zlekenhuis Inkendaal Koninklijke Instelling v.z.w.

location_facility: Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy


title: A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy

summary: The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Chen LT, Macarulla T, Blanc JF, Mirakhur B, de Jong FA, Belanger B, Bekaii-Saab T, Siveke JT. Early dose reduction/delay and the efficacy of liposomal irinotecan with fluorouracil and leucovorin in metastatic pancreatic ductal adenocarcinoma (mPDAC): A post hoc analysis of NAPOLI-1. Pancreatology. 2021 Jan;21(1):192-199. doi: 10.1016/j.pan.2020.10.029. Epub 2020 Oct 10.

family: Chen

full_name: Li-Tzong Chen

given: Li-Tzong

sequence: first

family: Macarulla

full_name: Teresa Macarulla

given: Teresa

sequence: additional

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: Mirakhur

full_name: Beloo Mirakhur

given: Beloo

family: de Jong

full_name: Floris A. de Jong

given: Floris A.

family: Belanger

full_name: Bruce Belanger

given: Bruce

family: Bekaii-Saab

full_name: Tanios Bekaii-Saab

given: Tanios

family: Siveke

full_name: Jens T. Siveke

given: Jens T.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Pancreatology

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Macarulla Mercadé T, Chen LT, Li CP, Siveke JT, Cunningham D, Bodoky G, Blanc JF, Lee KH, Dean A, Belanger B, Wang-Gillam A. Liposomal Irinotecan + 5-FU/LV in Metastatic Pancreatic Cancer: Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial. Pancreas. 2020 Jan;49(1):62-75. doi: 10.1097/MPA.0000000000001455. Erratum in: Pancreas. 2020 Mar;49(3):e27.

family: Macarulla Mercadé

full_name: Teresa Macarulla Mercadé

family: Li

full_name: Chung-Pin Li

given: Chung-Pin

family: Cunningham

full_name: David Cunningham

given: David

family: Bodoky

full_name: György Bodoky

given: György

family: Lee

full_name: Kyung-Hun Lee

given: Kyung-Hun

family: Dean

full_name: Andrew Dean

given: Andrew

family: Wang-Gillam

full_name: Andrea Wang-Gillam

given: Andrea

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Bang YJ, Li CP, Lee KH, Chiu CF, Park JO, Shan YS, Kim JS, Chen JS, Shim HJ, Rau KM, Choi HJ, Oh DY, Belanger B, Chen LT. Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study. Cancer Sci. 2020 Feb;111(2):513-527. doi: 10.1111/cas.14264. Epub 2019 Dec 20.

name: Division of Gastroenterology and Hepatology Department of Medicine Taipei Veterans General Hospital Taipei Taiwan

name: National Yang‐Ming University School of Medicine Taipei Taiwan

name: Seoul National University Hospital Cancer Research Institute Seoul National University College of Medicine Seoul Korea

name: China Medical University Hospital Taichung Taiwan

name: Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea

name: Department of Surgery National Cheng Kung University Hospital Tainan Taiwan

name: Korea University Guro Hospital Seoul Korea

name: Department of Hematology‐Oncology Linkou Chang Gung Memorial Hospital and Chang Gung University Tao‐Yuan Taiwan

name: Chonnam National University Hwasun Hospital Gwangju Korea

name: Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan

name: Severance Hospital Yonsei University Seoul Korea

name: Ipsen Bioscience, Inc Cambridge Massachusetts USA

name: National Institute of Cancer Research National Health Research Institutes (NHRI) Tainan Taiwan

name: Department of Internal Medicine National Cheng Kung University Hospital National Cheng Kung University Tainan Taiwan

name: Department of Internal Medicine Kaohsiung Medical University Hospital Kaohsiung Medical University Kaohsiung Taiwan

title: Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI‐1 study

ReferenceCitation: Macarulla T, Blanc JF, Wang-Gillam A, Chen LT, Siveke JT, Mirakhur B, Chen J, de Jong FA. Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial. J Geriatr Oncol. 2019 May;10(3):427-435. doi: 10.1016/j.jgo.2019.02.011. Epub 2019 Mar 4.

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

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

title: Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer – A subgroup analysis of the pivotal NAPOLI-1 trial

ReferenceCitation: Wang-Gillam A, Hubner RA, Siveke JT, Von Hoff DD, Belanger B, de Jong FA, Mirakhur B, Chen LT. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer. 2019 Feb;108:78-87. doi: 10.1016/j.ejca.2018.12.007. Epub 2019 Jan 14.

ReferenceCitation: Chen LT, Siveke JT, Wang-Gillam A, Li CP, Bodoky G, Dean AP, Shan YS, Jameson GS, Macarulla T, Lee KH, Cunningham D, Blanc JF, Chiu CF, Schwartsmann G, Braiteh FS, Mamlouk K, Belanger B, de Jong FA, Hubner RA. Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial. Eur J Cancer. 2018 Dec;105:71-78. doi: 10.1016/j.ejca.2018.09.010. Epub 2018 Nov 8.

repository_institution: Universidade Federal do Rio Grande do Sul - Lume

ReferenceCitation: Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29. Erratum in: Lancet. 2016 Feb 6;387(10018):536.

location_country:
Italy
Brazil
United States
South Africa
United Kingdom
Germany
France
Hungary
Argentina
Australia
Spain
Canada
Czech Republic
Korea, Republic of
Taiwan


type: EudraCT Number

title: Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

summary: Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Pharmacyclics LLC.

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Israel
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: The Edmond and Lily Safra Children's Hospital

location_facility: S.C. Farmacia Pediatrica - Presidio Ospedaliero Infantile Regina Margherita

location_facility: Safari Day Care, Great Ormond Street Hospital

location_facility: Federal State Budgetary Educational Institution of Higher Professional Education "LP.Pavlov First Saint Petersburg State Medical

location_facility: Cancer Center for Children. The Children's Hospital at Westmead

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: children's and Women's Health Centre of British Columbia

location_facility: Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

location_facility: Hospital Universitario Universitario La Paz

location_facility: U.O.C. Ematologia Oncoematologia Pediatrica

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Minnesota Masonic Children's Hospital

location_facility: Schneider Children's Medical Center in Israel

location_facility: Federal State Budgetary Institution "Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

summary: This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Switzerland
Germany
France
Slovakia
Hungary
Spain
United States
Canada

status_simplified: Completed


title: A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

acronym: ADAPT+

summary: This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

ReferenceCitation: Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9. Erratum in: Lancet Neurol. 2021 Aug;20(8):e5.

family: Howard

full_name: James F Howard

given: James F

suffix: Jr

family: Bril

full_name: Vera Bril

given: Vera

family: Vu

full_name: Tuan Vu

given: Tuan

family: Karam

full_name: Chafic Karam

given: Chafic

family: Peric

full_name: Stojan Peric

given: Stojan

family: Margania

full_name: Temur Margania

given: Temur

family: Murai

full_name: Hiroyuki Murai

given: Hiroyuki

family: Bilinska

full_name: Malgorzata Bilinska

given: Malgorzata

family: Shakarishvili

full_name: Roman Shakarishvili

given: Roman

family: Smilowski

full_name: Marek Smilowski

given: Marek

family: Guglietta

full_name: Antonio Guglietta

given: Antonio

family: Ulrichts

full_name: Peter Ulrichts

given: Peter

family: Vangeneugden

full_name: Tony Vangeneugden

given: Tony

family: Utsugisawa

full_name: Kimiaki Utsugisawa

given: Kimiaki

family: Verschuuren

full_name: Jan Verschuuren

given: Jan

family: Mantegazza

full_name: Renato Mantegazza

given: Renato

family: De Bleecker

full_name: Jan L. De Bleecker

given: Jan L.

family: De Koning

full_name: Kathy De Koning

given: Kathy

family: De Mey

full_name: Katrien De Mey

given: Katrien

family: De Pue

full_name: Annelien De Pue

given: Annelien

family: Mercelis

full_name: Rudolf Mercelis

given: Rudolf

family: Wyckmans

full_name: Maren Wyckmans

given: Maren

family: Vinck

full_name: Caroline Vinck

location_country:
Italy
United States
Serbia
Netherlands
Germany
France
Czechia
Japan
Poland
Georgia
Hungary
Belgium
Russian Federation
Denmark
Canada

location_facility:
Investigator Site 5
Investigator Site 24
Investigator Site 51
Investigator Site 2
Investigator Site 23
Investigator Site 48
Investigator Site 22
Investigator Site 37
Investigator Site 26
Investigator Site 12
Investigator Site 36
Investigator Site 18
Investigator Site 39
Investigator Site 27
Investigator Site 4
Investigator Site 19
Investigator Site 7
Investigator Site 9
Investigator Site 32
Investigator Site 47
Investigator Site 20
Investigator Site 43
Investigator Site 21
Investigator Site 15
Investigator Site 11
Investigator Site 10
Investigator Site 16
Investigator Site 38
Investigator Site 17
Investigator Site 45
Investigator Site 31
Investigator Site 13
Investigator Site 6
Investigator Site 35
Investigator Site 8
Investigator Site 46
Investigator Site
Investigator Site 25
Investigator Site 41
Investigator Site 29
Investigator Site 33
Investigator Site 42
Investigator Site 30
Investigator Site 14
Investigator Site 50
Investigator Site 28
Investigator Site 40
Investigator Site 49
Investigator Site 44
Investigator Site 34
Investigator Site 3


status: Recruiting

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

lead_sponsor: Genzyme, a Sanofi Company

enrollment_type: Anticipated

location_country:
Italy
United States
South Africa
India
Germany
France
Japan
Malaysia
Israel
Hungary
Australia
Ireland
China
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

acronym: ATLAS-OLE

location_facility:
Investigational Site Number 3560004
Investigational Site Number 8400012
Investigational Site Number 4100004
Investigational Site Number 7920002
Investigational Site Number 8260002
Investigational Site Number 4100002
Investigational Site Number 1240001
Investigational Site Number 1560004
Investigational Site Number 8400008
Investigational Site Number 3920003
Investigational Site Number 4580002
Investigational Site Number 8040003
Investigational Site Number 3920008
Investigational Site Number 8400009
Investigational Site Number 8040004
Investigational Site Number 1560006
Investigational Site Number 1560005
Investigational Site Number 1560011
Investigational Site Number 2500002
Investigational Site Number 3560010
Investigational Site Number 8400001
Investigational Site Number 0360003
Investigational Site Number 2760003
Investigational Site Number 3920001
Investigational Site Number 4100001
Investigational Site Number 1580007
Investigational Site Number 7920005
Investigational Site Number 2500003
Investigational Site Number 4580001
Investigational Site Number 8260004
Investigational Site Number 1580004
Investigational Site Number 3800002
Investigational Site Number 3800004
Investigational Site Number 2760001
Investigational Site Number 3760001
Investigational Site Number 1580003
Investigational Site Number 3920005
Investigational Site Number 1580008
Investigational Site Number 3920004
Investigational Site Number 7920004
Investigational Site Number 7920006
Investigational Site Number 8400019
Investigational Site Number 8400016
Investigational Site Number 0360001
Investigational Site Number 8040002
Investigational Site Number 1560007
Investigational Site Number 3560005
Investigational Site Number 3720001
Investigational Site Number 7920007
Investigational Site Number 1560010
Investigational Site Number 8400006
Investigational Site Number 4580003
Investigational Site Number 3920002
Investigational Site Number 1560003
Investigational Site Number 1560002
Investigational Site Number 7920008
Investigational Site Number 8400002
Investigational Site Number 4100003
Investigational Site Number 7100002
Investigational Site Number 1580002
Investigational Site Number 8260001
Investigational Site Number 2080001
Investigational Site Number 3480002
Investigational Site Number 1560013
Investigational Site Number 1560008
Investigational Site Number 3720002
Investigational Site Number 8400011
Investigational Site Number 1580005
Investigational Site Number 1580001
Investigational Site Number 3560001
Investigational Site Number 8040001
Investigational Site Number 3560002
Investigational Site Number 1560009
Investigational Site Number 7920003
Investigational Site Number 0360002
Investigational Site Number 3560007
Investigational Site Number 8400007

ipd_sharing: Yes

type: Other Identifier

source: euctr

title: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

summary:
Primary Objective:

To characterize the long-term safety and tolerability of fitusiran

Secondary Objectives:

To characterize the long-term efficacy of fitusiran as assessed by the frequency of:

Bleeding episodes
Spontaneous bleeding episodes
Target joint bleeding episodes
To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age


title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

summary: This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

ReferenceCitation: Wedemeyer H, Forns X, Hézode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Nájera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.

family: Wedemeyer

full_name: Heiner Wedemeyer

given: Heiner

family: Forns

full_name: Xavier Forns

given: Xavier

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Lee

full_name: Samuel S. Lee

given: Samuel S.

family: Scalori

full_name: Astrid Scalori

given: Astrid

family: Voulgari

full_name: Athina Voulgari

given: Athina

family: Le Pogam

full_name: Sophie Le Pogam

given: Sophie

family: Nájera

full_name: Isabel Nájera

given: Isabel

family: Thommes

full_name: James A. Thommes

given: James A.

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Puerto Rico
Spain
Germany
Canada


title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

summary: This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

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

title: Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Hospital Universitario de Canarias; Servicio de Digestivo

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: GI Research Institute; Gastroenterology & Hepatology

location_facility: Uni of Cincinnati College of Medicine; Div. of Digestive Diseases

location_facility: University Health Network - Toronto Western Hospital; Hepatology

location_facility: Winnipeg Regional Health Authority; Section of Hepatology

location_facility: Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

location_facility: Uniklinik Freiburg; Abteilung Innere Medizin II

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

location_facility: Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility

location_facility: King'S College Hospital; Institute of Liver Studies

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive

location_facility: Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology

location_facility: Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons

location_facility: Hospital Carlos III; Laboratorio de Biologia Molecular

location_facility: Hospital Clinic I Provincial; Servicio de Digestivo

location_facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

location_facility: McGill University, Montreal Chest Institute; Viral and other Infectious

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Royal Bournemouth Hospital, Gastroenterology

location_facility: Universitäts Klinikum; Schleswig-Holstein Kiel

location_facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In


title: A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

summary:
Primary Objective:

The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
Percentage of participants reaching HbA1c <7% or ≤6.5%;
7-point Self-Monitored Plasma Glucose (SMPG) profile;
Body weight;
Insulin glargine dose
Fasting Plasma Glucose (FPG);
Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
To assess safety and tolerability of insulin glargine/lixisenatide FRC.

ReferenceType: result

ReferenceCitation: Rosenstock J, Diamant M, Aroda VR, Silvestre L, Souhami E, Zhou T, Perfetti R, Fonseca V; LixiLan PoC Study Group. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial. Diabetes Care. 2016 Sep;39(9):1579-86. doi: 10.2337/dc16-0046. Epub 2016 Jun 9.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Diamant

full_name: Michaela Diamant

given: Michaela

family: Aroda

full_name: Vanita R. Aroda

given: Vanita R.

family: Silvestre

full_name: Louise Silvestre

given: Louise

family: Souhami

full_name: Elisabeth Souhami

given: Elisabeth

family: Zhou

full_name: Tianyue Zhou

given: Tianyue

family: Perfetti

full_name: Riccardo Perfetti

given: Riccardo

family: Fonseca

full_name: Vivian Fonseca

given: Vivian

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: Sanofi

location_country:
Chile
Sweden
Mexico
Germany
France
Poland
Lithuania
Slovakia
Romania
Hungary
Denmark
United States
Czech Republic

location_facility:
Investigational Site Number 152403
Investigational Site Number 616407
Investigational Site Number 840414
Investigational Site Number 840411
Investigational Site Number 203401
Investigational Site Number 840408
Investigational Site Number 752401
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Investigational Site Number 616402
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Investigational Site Number 208403
Investigational Site Number 616403
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Investigational Site Number 752402
Investigational Site Number 642401
Investigational Site Number 642404
Investigational Site Number 703403
Investigational Site Number 840401
Investigational Site Number 203402
Investigational Site Number 484403
Investigational Site Number 276403
Investigational Site Number 440401
Investigational Site Number 250402
Investigational Site Number 840417
Investigational Site Number 152404
Investigational Site Number 152402
Investigational Site Number 250404
Investigational Site Number 208401
Investigational Site Number 440403
Investigational Site Number 440404
Investigational Site Number 642402
Investigational Site Number 840415
Investigational Site Number 208404
Investigational Site Number 840413
Investigational Site Number 348401
Investigational Site Number 203405
Investigational Site Number 484405
Investigational Site Number 703401
Investigational Site Number 840407
Investigational Site Number 840402
Investigational Site Number 484402
Investigational Site Number 840410
Investigational Site Number 642405
Investigational Site Number 642403
Investigational Site Number 276401
Investigational Site Number 348404
Investigational Site Number 484401
Investigational Site Number 276402
Investigational Site Number 152401
Investigational Site Number 348402


title: A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

summary: The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.

ReferenceCitation: von Stackelberg A, Locatelli F, Zugmaier G, Handgretinger R, Trippett TM, Rizzari C, Bader P, O'Brien MM, Brethon B, Bhojwani D, Schlegel PG, Borkhardt A, Rheingold SR, Cooper TM, Zwaan CM, Barnette P, Messina C, Michel G, DuBois SG, Hu K, Zhu M, Whitlock JA, Gore L. Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2016 Dec 20;34(36):4381-4389. Epub 2016 Oct 31.

lead_sponsor: Amgen Research (Munich) GmbH

location_country:
Italy
Austria
Netherlands
Germany
France
United States
Canada

location_facility: Charité Campus Virchow Klinikum, Otto-Heubner-Centrum (OHC) für Kinder- und Jugendmedizin

location_facility: University of Milano-Bicocca, Hospital San Gerardo

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen

location_facility: Cincinnati Children's Hospital Medical Center

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

location_facility: Children's Healthcare of Atlanta at Egleston

location_facility: Klinikum der Universität München, Dr. von Haunersches Kinderspital

intervention_type: Biological


family: Howard

full_name: James F Howard

given: James F

family: Bril

full_name: Vera Bril

given: Vera

family: Vu

full_name: Tuan Vu

given: Tuan

family: Karam

full_name: Chafic Karam

given: Chafic

family: Peric

full_name: Stojan Peric

given: Stojan

family: Margania

full_name: Temur Margania

given: Temur

family: Murai

full_name: Hiroyuki Murai

given: Hiroyuki

family: Bilinska

full_name: Malgorzata Bilinska

given: Malgorzata

family: Shakarishvili

full_name: Roman Shakarishvili

given: Roman

family: Smilowski

full_name: Marek Smilowski

given: Marek

family: Guglietta

full_name: Antonio Guglietta

given: Antonio

family: Ulrichts

full_name: Peter Ulrichts

given: Peter

family: Vangeneugden

full_name: Tony Vangeneugden

given: Tony

family: Utsugisawa

full_name: Kimiaki Utsugisawa

given: Kimiaki

family: Verschuuren

full_name: Jan Verschuuren

given: Jan

family: Mantegazza

full_name: Renato Mantegazza

given: Renato

family: De Bleecker

full_name: Jan L. De Bleecker

given: Jan L.

family: De Koning

full_name: Kathy De Koning

given: Kathy

family: De Mey

full_name: Katrien De Mey

given: Katrien

family: De Pue

full_name: Annelien De Pue

given: Annelien

family: Mercelis

full_name: Rudolf Mercelis

given: Rudolf

family: Wyckmans

full_name: Maren Wyckmans

given: Maren

family: Vinck

full_name: Caroline Vinck

given: Caroline

family: Wagemaekers

full_name: Linda Wagemaekers

given: Linda

family: Baets

full_name: Jonathan Baets

title: Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial

location_country:
Italy
United States
Serbia
Netherlands
Germany
France
Czechia
Japan
Poland
Georgia
Hungary
Belgium
Russian Federation
Denmark
Canada
United Kingdom

location_facility:
Investigator Site 59
Investigator Site 5
Investigator Site 24
Investigator Site 51
Investigator Site 2
Investigator Site 23
Investigator Site 52
Investigator Site 54
Investigator Site 53
Investigator Site 48
Investigator Site 22
Investigator Site 37
Investigator Site 26
Investigator Site 60
Investigator Site 12
Investigator Site 36
Investigator Site 18
Investigator Site 39
Investigator Site 27
Investigator Site 4
Investigator Site 58
Investigator Site 19
Investigator Site 7
Investigator Site 9
Investigator Site 32
Investigator Site 47
Investigator Site 20
Investigator Site 43
Investigator Site 21
Investigator Site 63
Investigator Site 15
Investigator Site 65
Investigator Site 11
Investigator Site 38
Investigator Site 16
Investigator Site 10
Investigator Site 17
Investigator Site 45
Investigator Site 31
Investigator Site 13
Investigator Site 6
Investigator Site 35
Investigator Site 8
Investigator Site 46
Investigator Site
Investigator Site 57
Investigator Site 61
Investigator Site 25
Investigator Site 56
Investigator Site 29
Investigator Site 41
Investigator Site 33
Investigator Site 42
Investigator Site 64
Investigator Site 30
Investigator Site 66
Investigator Site 40
Investigator Site 50
Investigator Site 44
Investigator Site 28
Investigator Site 49
Investigator Site 34
Investigator Site 14
Investigator Site 62
Investigator Site 3
Investigator Site 55

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

summary: This is a randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.


title: Phase I/II Pharmacokinetic Multi-Tumor Study of Subcutaneous Formulation of Nivolumab Monotherapy

summary:
The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:

non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
unresectable or metastatic melanoma
hepatocellular carcinoma (HCC)
microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
Chile
Netherlands
France
Poland
Argentina
New Zealand
Spain
United States
United Kingdom

location_facility: Texas Oncology - Baylor Charles A. Simmons Cancer Center

location_facility: Willamette Valley Cancer Institute And Research Center

location_facility: Hospital Universitario Virgen De La Victoria


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

lead_sponsor: AbbVie

location_country:
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Lithuania
Poland
Norway
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Switzerland
Netherlands
Singapore
Hungary
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Estonia
Latvia

acronym: U-Accomplish

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 205672

location_facility: Froedtert Memorial Lutheran Hospital /ID# 206945

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208053

location_facility: Louisana Research Center, LLC /ID# 206064

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 205246

location_facility: University Clinical Center Serbia /ID# 205256

location_facility: Texas Digestive Disease Consultants /ID# 209805

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554

location_facility: Moore UC San Diego Cancer Center /ID# 204919

location_facility: Healthcare Research Consultant /ID# 206706

location_facility: Citrus Valley Gastroenterology /ID# 205627

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 207061

location_facility: National University Hospital /ID# 209099

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059

location_facility: Hospital Universitario Dr. Negrin /ID# 206905

location_facility: Universitair Ziekenhuis Leuven /ID# 205988

location_facility: Virginia Mason - Seattle Orthapedics /ID# 206070

location_facility: University of New Mexico Department of Internal Medicine /ID# 214397

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 209573

location_facility: Duplicate_Universitaetsklinikum Tuebingen /ID# 206737

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314

location_facility: University Clinical Center Tuzla /ID# 208057

location_facility: Basingstoke & North Hampshire /ID# 207985

location_facility: Washington Gastroenterology Associates /ID# 206177

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052

location_facility: Kazan State Medical University /ID# 208256

location_facility: Hospital Universitario Reina Sofia /ID# 204412

location_facility: Hospital Universitario Ramon y Cajal /ID# 204410

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332

location_facility: InSite Digestive Health Care - Oxnard /ID# 205628

location_facility: Immanuel Kant Baltic Federal University /ID# 208264

location_facility: Hospital Privado Univesitario /ID# 206030

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 206717

location_facility: Universal Axon Clinical Research /ID# 213462

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271

location_facility: Dayton Gastroenterology, Inc. /ID# 205639

location_facility: Clin Res Inst of Michigan, LLC /ID# 207078

location_facility: Duplicate_Mater Misericordiae /ID# 212687

location_facility: Advanced Research Institute, Inc /ID# 206077

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068

location_facility: Agaplesion Markus Krankenhaus /ID# 206731

location_facility: Fakultna nemocnica s poliklini /ID# 211372

location_facility: Vanderbilt University Medical Center /ID# 210405

location_facility: Hospital Clinico Universitario de Salamanca /ID# 205013

location_facility: United Medical Doctors - Murrieta /ID# 205313

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 206413

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 207137

location_facility: Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082

location_facility: Hospital Nossa Senhora das Graças /ID# 206981

location_facility: Huddersfield Royal Infirmary /ID# 217660

location_facility: Atrium Health Carolinas Medical Center /ID# 206085

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887

location_facility: Hospital Universitario y Politecnico La Fe /ID# 206904

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 206885

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 211326

location_facility: Kanazawa University Hospital /ID# 206316

location_facility: Indianapolis Gastroenterology /ID# 206381

location_facility: Next Innovative Clinical Research - Chicago /ID# 217324

location_facility: Akershus Universitetssykehus_MAIN /ID# 205293

location_facility: Premier Medical Group - GI Division /ID# 206097

location_facility: Duplicate_Tyler Research Institue /ID# 206075

location_facility: Hospital Universitario San Vic /ID# 208888

location_facility: Richmond University Medical Center /ID# 213185

location_facility: Hometown Urgent Care and Resea /ID# 205630

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611

location_facility: Hospital Santo Antonio dos Cap /ID# 206145

location_facility: North Estonia Medical Centre /ID# 207357

location_facility: Western Connecticut Medical Group /ID# 208290

location_facility: Taipei Veterans General Hosp /ID# 207849

location_facility: University of Michigan Health Systems /ID# 206918

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626

location_facility: Hospital Britanico de Buenos Aires /ID# 209497

location_facility: P. Stradins Clinical Univ Hosp /ID# 206827

location_facility: The University of Chicago Medical Center /ID# 206172

location_facility: Encore Borland-Groover Clinical Research /Id# 208128

location_facility: Hospital de Clinicas de Porto Alegre /ID# 206985

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 206079

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576

location_facility: Hospital Universitario La Paz /ID# 214540

location_facility: Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067

location_facility: Hamamatsu University Hospital /ID# 206459

location_facility: University Clinical Hospital Mostar /ID# 208054

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147

location_facility: Nature Coast Clinical Research - Inverness /ID# 206087

location_facility: East View Medical Research, LLC /ID# 216933

location_facility: Hiroshima University Hospital /ID# 206464

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 216622

location_facility: Universitetssykehuset Nord-Norge /ID# 205691

location_facility: Yeungnam University Medical Center /ID# 206959

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504

location_facility: Japanese Red Cross Osaka Hospital /ID# 209478

location_facility: Revival Research Institute, LLC /ID# 207282

location_facility: Klinicki bolnicki centar Rijeka /ID# 208650

location_facility: National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710

location_facility: Inland Empire Clinical Trials, LLC /ID# 216164

location_facility: Fukuoka University Chikushi Hospital /ID# 214405

location_facility: Options Health Research, LLC /ID# 206707

location_facility: Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652

location_facility: Juntendo University Urayasu Hospital /ID# 208784

location_facility: Asahikawa Medical University Hospital /ID# 206404

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212426

location_facility: Gastroenterology Center of CT /ID# 208291

location_facility: CCA Braga - Hospital de Braga /ID# 206144

location_facility: Clinical Hosp Center Zvezdara /ID# 205258

location_facility: Tokyo Women's Medical University Hospital /ID# 206460

location_facility: Sapporo Medical University Hospital /ID# 206314

location_facility: St.Luke's International Hospital /ID# 208076

location_facility: Yonsei University Health System, Severance hospital /ID# 206958

location_facility: Toho University Medical Center Sakura Hospital /ID# 207705

location_facility: Texas Digestive Disease Consultants /ID# 209948

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 206069

location_facility: National Hospital Organization Sendai Medical Center /ID# 209528

location_facility: Hospital Garcia de Orta, EPE /ID# 206143

location_facility: AGA Clinical Research Associates, LLC /ID# 206880

location_facility: Duplicate_Toronto Digestive Disease Asso /ID# 205498

location_facility: St. Marianna University School of Medicine Hospital /ID# 209451

location_facility: Digestive Health Partners, P.A /ID# 206842

location_facility: Klaipeda University Hospital /ID# 208790

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 213540

location_facility: St Vincent's Hospital Melbourne /ID# 205758

location_facility: Kaiser Clinica e Hospital Dia /ID# 206982

location_facility: Medical University of Vienna /ID# 205763

location_facility: Mentahaz Maganorvosi Kozpont /ID# 205882

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208055

location_facility: University Clinical Center Kragujevac /ID# 206410

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653

location_facility: Gazi University Med. Faculty /ID# 208040

location_facility: Queen Elizabeth University Hos /ID# 205154

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813

location_facility: Nagoya City University Hospital /ID# 206058

location_facility: Digestive Disease Specialists /ID# 206076

location_facility: Shimane University School of Medicine /ID# 208905

location_facility: Ctr for Gastrointestinal Healt /ID# 208475

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 206907

location_facility: Riga East Clinical Univ Hosp /ID# 206828

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266

location_facility: Medical centre of CONSILIUM MEDICAL LLC /ID# 217447

location_facility: Pusan National University Hospital /ID# 206956

location_facility: Clinical Center University of Sarajevo /ID# 208058

location_facility: Tokai University Hachioji Hospital /ID# 208903

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556

location_facility: Wake Forest Baptist Medical Center /ID# 206067

location_facility: Toyohashi Municipal Hospital /ID# 207625

location_facility: M y F Estudios Clínicos Ltda. /ID# 208035

location_facility: West Tallinn Central Hospital /ID# 207356

location_facility: Faculdade de Medicina do ABC /ID# 206984

location_facility: CB Flock Research Corporation /ID# 206094

location_facility: Duplicate_Plains Clinical Research Center, LLC /ID# 205111

location_facility: Macquarie University Hospital /ID# 211955

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886

location_facility: Umraniye Training and Res Hosp /ID# 208206

location_facility: University of Mississippi Medical Center /ID# 213116

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208494

location_facility: University of Iowa Hospitals and Clinics /ID# 206167

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 206175

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 206710

location_facility: TX Clinical Research Institute /ID# 206718

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992

location_facility: Yamagata University Hospital /ID# 206465

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 208460

location_facility: National Taiwan University Hospital /ID# 207847

location_facility: Shoyukai Fujita Gastroenterological Hospital /ID# 216493

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117

location_facility: The Sixth Affiliated Hosp Sun /ID# 205268

location_facility: Hyogo College of Medicine Hospital /ID# 206455

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333

location_facility: Percuro Clinical Research, Ltd /ID# 205501

location_facility: Centex Studies, Inc. - Houston /ID# 206168

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 210119

location_facility: China Medical University Hosp /ID# 207845

location_facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939

location_facility: The First Affiliated Hospital of Nanchang University /ID# 212186

location_facility: Mautalen Salud e Investigacion /ID# 206033

location_facility: Erciyes University Medical Fac /ID# 207506

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 217218

location_facility: University Clinical Center of Nis /ID# 206411

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 206098

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 205563

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070

location_facility: Duplicate_Praxis am Bayrischen Platz /ID# 206733

location_facility: Bekes Megyei Kozponti Korhaz /ID# 205885

location_facility: Clinical Research Trials of Florida, Inc. /ID# 206068

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 209118

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 207051

location_facility: Southern Star Research Institute, LLC /ID# 205379

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351

location_facility: Private Practice Dr MN Rajabally /ID# 205273

location_facility: Barts and the London NHS Trust /ID# 205153

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207426

location_facility: The First Hospital of Jilin University /ID# 210088

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 209482

location_facility: Huron Gastroenterology Assoc /ID# 205109

location_facility: Klinicki bolnicki centar Split /ID# 217027

location_facility: Center Hospital of the National Center for Global Health and Medicine /ID# 209532

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 212913

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354

location_facility: Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138

location_facility: NW State Medical Univ na Mechn /ID# 208258

location_facility: East Tallinn Central Hospital /ID# 207564

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 206453

location_facility: Inselspital, Universitaetsklinik /ID# 211312

location_facility: The Vancouver Clinic, INC. PS /ID# 204973

location_facility: Yokkaichi Hazu Medical Center /ID# 214348

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 206096

location_facility: Osaka City University Hospital /ID# 206457

location_facility: Republican hospital named after V.A. Baranov /ID# 206507

location_facility: Universitatsklinikum Mannheim /ID# 206811

location_facility: Hospital Clinic de Barcelona /ID# 206906

location_facility: Houma Digestive Health Special /ID# 206176

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 211167

location_facility: Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822

location_facility: Atlantic Digestive Health Inst /ID# 208748

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300

location_facility: Atlanta Gastroenterology Spec /ID# 206173

location_facility: Lenasia Clinical Trial Centre /ID# 214359

location_facility: East Tennessee Research Institute /ID# 206169

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 216940

location_facility: West China Hospital, Sichuan University /ID# 205332

location_facility: Niigata University Medical & Dental Hospital /ID# 218049

location_facility: Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791

location_facility: MediSphere Medical Research Center /ID# 206073

location_facility: General Hospital of Athens Laiko /ID# 208671

location_facility: Great Lakes Gastroenterology Research LLC /ID# 205631

location_facility: Gastro Health & Nutrition - Victoria /ID# 205378

location_facility: Showa University Fujigaoka Hospital /ID# 208224

location_facility: Duplicate_CHA Bundang Medical Center /ID# 207432

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 204411

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).


title: Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway

summary: This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

ipd_sharing: No

lead_sponsor: Rhythm Pharmaceuticals, Inc.

location_country:
United States
Netherlands
France
Greece
Spain
Germany
United Kingdom
Canada

location_facility: Synexus Clinical Research US, Inc. - Phoenix Southeast

location_facility: University of Florida College of Medicine

location_facility: Wellcome Trust-MRC Institute of Metabolic Science

location_facility: Synexus Clinical Research US, Inc.- Primary Care Associates, PC

location_facility: University Hospitals Birmingham NHS Foundation Trust


title: A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects With Familial Adenomatous Polyposis

summary: The purpose of this study is to determine the effect of treatment with guselkumab in participants with familial adenomatous polyposis (FAP) on rectal/pouch polyp burden.

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Sweden
Netherlands
France
Poland
Israel
Puerto Rico
Spain
Germany

location_facility: Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: Washington University School of Medicine

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Pan American Center for Oncology Trials LLC

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Po

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

location_facility: Wexner Medical Center at the Ohio State University


intervention_type: Other

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

lead_sponsor: Amgen

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

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Indiana University - Riley Hospital for Children

title: Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta

summary: To evaluate long-term safety of denosumab in subjects with pediatric osteogenesis imperfecta (OI) who completed end of study (EOS) on Study 20130173.


lead_sponsor: Regeneron Pharmaceuticals

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

location_facility:
Regeneron Study Site #2
Regeneron Study Site
Regeneron Study Site #1

title: A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

summary:
The primary objectives of the study by study part are:

Part A:

To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B.

Part B:

To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.

Part C:

To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.

The secondary objectives of the study are:

To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE
To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids


title: An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis

summary: This is an open-label, single arm, Phase 2 study evaluating the efficacy and safety of avapritinib (BLU-285) in patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive SM (ASM), SM with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL)

lead_sponsor: Blueprint Medicines Corporation

location_country:
Italy
Austria
Netherlands
Germany
France
Poland
Norway
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltranslplantation

location_facility: A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno

location_facility: University Medical Center Groningen (UMCG)

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Klinice Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Oslo University Hospital-Rikshospitalet, Hematology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie

location_facility: Odense University Hospital, Department of Haematology

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Beatson West of Scotland Cancer Centre - NHS Greater Glasgow and Clyde

location_facility: Azienda Ospedaliero-Universitaria Careggi, CRIMM - Centro di Ricerca ed Innovazione per le Malattie Mieloproliferative

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo

location_facility: Centro Ricerche Cliniche di Verona - Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Universitätsmedizin Mannheim III. Medizinische Klinik

location_facility: Klinik und Poliklinik für Innere Medizin III, Klinikum rechts der Isar der TU München

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, lnternistische Onkologie, Hämostaseologie


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

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

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

acronym: ELARA

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)

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

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Michigan Medicine University of Michigan

title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

summary: This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.


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

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Malaysia
Greece
Romania
Belgium
Russian Federation
Taiwan
Ukraine
India
Spain
France
Poland
Thailand
Slovakia
Montenegro
Korea, Republic of
Philippines
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Lebanon
Czechia
Israel
Belarus
Turkey

location_facility: Siriraj Hospital, Mahidol University, Faculty of Medicine

location_facility: Gabinet lekarski Neurologii I Leczenia padaczki

location_facility: The Barberry National Centre for Mental Health

location_facility: NZOZ "IGNIS" Dr. n. med. Alicja Lobinska

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: General Children's Hospital of Athens "P&A Kyriakou"

location_facility: Spitalul clinic de copii Dr. Victor Gomoiu

location_facility: Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly

location_facility: Saint George Hospital - University Medical Center

location_facility: A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital

location_facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5

location_facility: The First Bethune Hospital of Jilin University

location_facility: Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

location_facility: KU "Odeska oblasna dytiacha klinichna likarnia"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fakultni nemocnice Brno - Detska nemocnice

location_facility: Dokuz Eylül University medical Faculty Internal Medicine Disease

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.

location_facility: Heim Pal Gyermekkorhaz, Neurologiai Osztaly

location_facility: Katedra i Klinika Neurologii Wieku Rozwojowego

location_facility: "Multiprofile Hospital for Active Treatment Puls" AD

location_facility: RSBHI Smolensk Regional Clinical Hospital

location_facility: Behcet Uz Children Disease and Surgery Training and Research Hospital

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

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,

location_facility: Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia

location_facility: FSBI V.M. Bekhterev National Research Medical Center

location_facility: Eskisehir Osmangazi University Medical Faculty

location_facility: Phramongkutklao Hospital, Neurology Unit,

location_facility: Dr. Kenessey Albert Kórház és Rendelőintézet

location_facility: Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv

location_facility: SPHI Leningrad Regional Psychoneurological Dispensary

location_facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

location_facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"

location_facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/

location_facility: MAI Children's City Clinical Hospital No 9

location_facility: GU Republican Scientific and Practical Center Mother and Child

location_facility: GBOU VPO "Smolensk State Medical University"

location_facility: Mother and Child Healthcare Institute Dr Vukan Cupic

location_facility: Pharmacy of Tel Aviv Sourasky Medical Center

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

location_facility: UMHAT "Sveti Georgi" Ltd., Pediatric Clinic

location_facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

location_facility: Pediatric Epilepsy Center Of Central Florida

location_facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2

location_facility: State Budgetary Healthcare Institution of Stavropol region

location_facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

location_facility: Pediatric Epilepsy and Neurology Specialists, PA

location_facility: Institute for Child and Youth Healthcare of Vojvodina

location_facility: UZ Brussel - Campus Jette - Pediatric Neurology

location_facility: Regional State Budgetary Institution of Ministry of Health

location_facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"

location_facility: Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"

location_facility: Neurologicka ambulancia MUDr. Eva Gasparova

location_facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

location_facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria"

location_facility: Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi

location_facility: American University of Beirut Medical Center

location_facility: UZ Vitebsk Regional Childrens Clinical Centre

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

location_facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li

location_facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia

location_facility: DCC Sveta Anna - Sofia\ Neurological room

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

location_facility: Ege University Medical Faculty Department of Pediatrics Health and Diseases,

location_facility: Perm State Medical University n. a. acad. E.A. Vagner

location_facility: Public Health Institution Hospital "Dr. Mladen Stojanovic"

title: A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

summary: Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.


title: An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

summary: Study AG348-C-007 is a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, subjects with pyruvate kinase deficiency (PKD), who are regularly receiving blood transfusions. The study is comprised of two parts. During the Part 1 Dose Optimization Period of the study, all participants will start on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose will be optimized individually, up to a maximum dose of 50 milligrams (mg), twice daily. During the Part 2 Fixed-Dose Period, participants will receive AG-348 at their optimized dose from Part 1.

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

family: Rab

full_name: Minke A.E. Rab

given: Minke A.E.

family: Van Oirschot

full_name: Brigitte A. Van Oirschot

given: Brigitte A.

family: Kosinski

full_name: Penelope A. Kosinski

given: Penelope A.

family: Hixon

full_name: Jeffrey Hixon

given: Jeffrey

family: Johnson

full_name: Kendall Johnson

given: Kendall

family: Chubukov

full_name: Victor Chubukov

given: Victor

family: Dang

full_name: Lenny Dang

given: Lenny

family: Pasterkamp

full_name: Gerard Pasterkamp

given: Gerard

family: Van Straaten

full_name: Stephanie Van Straaten

given: Stephanie

family: Van Solinge

full_name: Wouter W. Van Solinge

given: Wouter W.

family: Van Beers

full_name: Eduard J. Van Beers

given: Eduard J.

family: Kung

full_name: Charles Kung

given: Charles

family: Van Wijk

full_name: Richard Van Wijk

given: Richard

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Italy
Switzerland
Netherlands
France
Thailand
Ireland
Turkey
Denmark
United States
United Kingdom
Canada

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: AOU Policlinico, Università della Campania "Luigi Vanvitelli"

location_facility: Toronto General Hospital, University Health Network

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Department of Paediatrics and Thalassaemia Center, Faculty of Medicine Siriraj Hospital, Mahidol University

location_facility: University of Copenhagen, Herlev Hospital

location_facility: St James's Hospital Department of Haematology

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico


title: A Non-Interventional Retrospective Correlation Of Tumor Mutation Status To Clinical Benefit From The SU011248, A6181036 Treatment Protocol Titled: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

summary: Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Reichardt P, Demetri GD, Gelderblom H, Rutkowski P, Im SA, Gupta S, Kang YK, Schöffski P, Schuette J, Soulières D, Blay JY, Goldstein D, Fly K, Huang X, Corsaro M, Lechuga MJ, Martini JF, Heinrich MC. Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial. BMC Cancer. 2016 Jan 15;16:22. doi: 10.1186/s12885-016-2051-5.

family: Reichardt

full_name: Peter Reichardt

given: Peter

family: Demetri

full_name: George D. Demetri

given: George D.

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Gupta

full_name: Sudeep Gupta

given: Sudeep

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Schuette

full_name: Jochen Schuette

given: Jochen

family: Soulières

full_name: Denis Soulières

given: Denis

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Goldstein

full_name: David Goldstein

given: David

family: Fly

full_name: Kolette Fly

given: Kolette

family: Huang

full_name: Xin Huang

given: Xin

family: Corsaro

full_name: Massimo Corsaro

given: Massimo

family: Lechuga

full_name: Maria Jose Lechuga

given: Maria Jose

family: Martini

full_name: Jean-Francois Martini

given: Jean-Francois

family: Heinrich

full_name: Michael C. Heinrich

given: Michael C.

currency_apc_doaj: GBP

journal_name: BMC Cancer

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

repository_institution: Seoul National University - Seoul National University Open Repository

location_country:
United States
India
Switzerland
Netherlands
Germany
Finland
France
Poland
Slovakia
Belgium
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Shands Cancer Hospital at the University of Florida

location_facility: Leids Universitair Medisch Centrum/ Klinische Oncologie

location_facility: Klinika Nowotworow Tkanek Miekkich i Kosci

location_facility: Schwerpunktpraxis fuer ambulante Tumortherapie

location_facility: Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Asan Medical Center, Department of Internal Medicine

location_facility: Peter MacCallum Cancer Institute, Department of Medical Oncology

location_facility: Seoul National University Hospital/Department of Internal Medicine

location_facility: Helsingin yliopistollinen keskussairaala/Syopatautien klinikka

location_facility: CHU La Timone, Service d'Oncologie Medicale

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal

location_facility: Shands Hospital at the University of Florida

location_facility: HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie

location_facility: Masonic Cancer Center - Clinical Trials Office

location_facility: Prince of Wales Hospital, Oncology Day Center


title: Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive

summary:
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.

The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.

The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD

primary_purpose: Diagnostic

lead_sponsor: Biotronik AG

location_country: Austria France Australia Belgium Spain Germany

location_facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen

intervention_type: Diagnostic Test


title: CHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

summary: This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)

ipd_sharing: Undecided

lead_sponsor: Orphalan

location_country:
Italy
Brazil
Germany
France
Poland
Belgium
Denmark
United States
United Kingdom

location_facility: KU Leuven, Department of Clinical and Experimental Medicine

location_facility: Nucleo de Pesquisa e Desenvolvimento de Medicamentos - Universidade Federal do Ceará - Rodolfo Teófilo

location_facility: University of Surrey, Department of Clinical and Experimental Medicine

location_facility: Hospital Nossa Senhora das Graças (HNSG)

location_facility: Centre National de Référence Wilson, Hôpital Lariboisière

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


title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

acronym: ASPIRE

summary: The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

status: Terminated

ReferenceCitation: Come CE, Kramer MR, Dransfield MT, Abu-Hijleh M, Berkowitz D, Bezzi M, Bhatt SP, Boyd MB, Cases E, Chen AC, Cooper CB, Flandes J, Gildea T, Gotfried M, Hogarth DK, Kolandaivelu K, Leeds W, Liesching T, Marchetti N, Marquette C, Mularski RA, Pinto-Plata VM, Pritchett MA, Rafeq S, Rubio ER, Slebos DJ, Stratakos G, Sy A, Tsai LW, Wahidi M, Walsh J, Wells JM, Whitten PE, Yusen R, Zulueta JJ, Criner GJ, Washko GR. A randomised trial of lung sealant versus medical therapy for advanced emphysema. Eur Respir J. 2015 Sep;46(3):651-62. doi: 10.1183/09031936.00205614. Epub 2015 Apr 2.

family: Come

full_name: Carolyn E. Come

given: Carolyn E.

family: Kramer

full_name: Mordechai R. Kramer

given: Mordechai R.

family: Dransfield

full_name: Mark T. Dransfield

given: Mark T.

family: Abu-Hijleh

full_name: Muhanned Abu-Hijleh

given: Muhanned

family: Berkowitz

full_name: David Berkowitz

family: Bezzi

full_name: Michela Bezzi

given: Michela

family: Bhatt

full_name: Surya P. Bhatt

given: Surya P.

family: Boyd

full_name: Michael B. Boyd

given: Michael B.

family: Cases

full_name: Enrique Cases

given: Enrique

family: Chen

full_name: Alexander C. Chen

given: Alexander C.

family: Cooper

full_name: Christopher B. Cooper

given: Christopher B.

family: Flandes

full_name: Javier Flandes

given: Javier

family: Gildea

full_name: Thomas Gildea

given: Thomas

family: Gotfried

full_name: Mark Gotfried

given: Mark

family: Hogarth

full_name: D. Kyle Hogarth

given: D. Kyle

family: Kolandaivelu

full_name: Kumaran Kolandaivelu

given: Kumaran

family: Leeds

full_name: William Leeds

given: William

family: Liesching

full_name: Timothy Liesching

given: Timothy

family: Marchetti

full_name: Nathaniel Marchetti

given: Nathaniel

family: Marquette

full_name: Charles Marquette

given: Charles

family: Mularski

full_name: Richard A. Mularski

given: Richard A.

family: Pinto-Plata

full_name: Victor M. Pinto-Plata

given: Victor M.

family: Pritchett

full_name: Michael A. Pritchett

given: Michael A.

location_country:
Italy
Netherlands
France
Greece
Israel
Spain
United States

location_facility: Miami VA Healthcare System (accepting Miami VA patients only)

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Athens - Sotiria General Hospital

location_facility: Kaiser Foundation Hospitals (accepting Kaiser patients only)

location_facility: University of South Carolina School of Medicine

location_facility: Azienda Ospedaliera Spedali Civili de Brescia


title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma

summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

ReferenceCitation: Peters SP, Bleecker ER, Canonica GW, Park YB, Ramirez R, Hollis S, Fjallbrant H, Jorup C, Martin UJ. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. N Engl J Med. 2016 Sep 1;375(9):850-60. doi: 10.1056/NEJMoa1511190.

family: Peters

full_name: Stephen P. Peters

given: Stephen P.

family: Bleecker

full_name: Eugene R. Bleecker

given: Eugene R.

family: Canonica

full_name: Giorgio W. Canonica

given: Giorgio W.

family: Park

full_name: Yong B. Park

given: Yong B.

family: Ramirez

full_name: Ricardo Ramirez

given: Ricardo

family: Hollis

full_name: Sally Hollis

given: Sally

family: Fjallbrant

full_name: Harald Fjallbrant

given: Harald

family: Jorup

full_name: Carin Jorup

given: Carin

family: Martin

full_name: Ubaldo J. Martin

given: Ubaldo J.

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: AstraZeneca

location_country:
Peru
Romania
Russian Federation
Czech Republic
Ukraine
India
France
Panama
Poland
Slovakia
Thailand
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Vietnam
Philippines
Bulgaria
Puerto Rico
Germany
United States
United Kingdom
Italy
Brazil
Mexico


location_country:
Finland
Russian Federation
Denmark
Taiwan
France
Poland
Norway
Argentina
Canada
Slovenia
South Africa
Sweden
Netherlands
Bulgaria
Hungary
United States
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Spain
Turkey

location_facility:
Investigational Site Number 3800001
Investigational Site Number 7920002
Investigational Site Number 1000002
Investigational Site Number 8400003
Investigational Site Number 3800003
Investigational Site Number 1240001
Investigational Site Number 4840007
Investigational Site Number 2030002
Investigational Site Number 0760003
Investigational Site Number 6430004
Investigational Site Number 2460001
Investigational Site Number 2500002
Investigational Site Number 8400001
Investigational Site Number 7240003
Investigational Site Number 7240002
Investigational Site Number 5280001
Investigational Site Number 0400001
Investigational Site Number 2030001
Investigational Site Number 7520001
Investigational Site Number 4220001
Investigational Site Number 7050001
Investigational Site Number 6430007
Investigational Site Number 7920001
Investigational Site Number 3800002
Investigational Site Number 0760001
Investigational Site Number 6430001
Investigational Site Number 2500001
Investigational Site Number 4840008
Investigational Site Number 6430006
Investigational Site Number 8400006
Investigational Site Number 3480001
Investigational Site Number 7240004
Investigational Site Number 0760004
Investigational Site Number 0320001
Investigational Site Number 8400002
Investigational Site Number 7100002
Investigational Site Number 7240001
Investigational Site Number 2080001
Investigational Site Number 4220003
Investigational Site Number 6430005
Investigational Site Number 6430002
Investigational Site Number 1580001
Investigational Site Number 8400005
Investigational Site Number 5780001
Investigational Site Number 6160002
Investigational Site Number 6160001

title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

summary:
Primary Objective:

To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in patients with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins.

Secondary Objective:

To evaluate the efficacy of alirocumab versus placebo on low-density lipoprotein cholesterol (LDL-C) levels.
To evaluate the effects of alirocumab versus placebo on other lipid parameters.
To evaluate the safety and tolerability of alirocumab in comparison with placebo.
To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.
To evaluate the development of anti-alirocumab antibodies.


title: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

acronym: PRISM

summary: To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.

lead_sponsor: Trevi Therapeutics

location_country:
Austria
Germany
France
Poland
United States

location_facility:
Study Site 304
Study Site 216
Study Site 144
Study Site 213
Study Site 135
Study Site 157
Study Site 303
Study Site 308
Study Site 137
Study Site 314
Study Site 134
Study Site 150
Study Site 145
Study Site 205
Study Site 102
Study Site 130
Study Site 202
Study Site 312
Study Site 209
Study Site 101
Study Site 502
Study Site 214
Study Site 118
Study Site 132
Study Site 401
Study Site 212
Study Site 159
Study Site 313
Study Site 108
Study Site 131
Study Site 306
Study Site 136
Study Site 103
Study Site 140
Study Site 158
Study Site 122
Study Site 222
Study Site 302
Study Site 147
Study Site 315
Study Site 121
Study Site 220
Study Site 138
Study Site 309
Study Site 146
Study Site 151
Study Site 106
Study Site 107
Study Site 142
Study Site 201
Study Site 139
Study Site 501
Study Site 204
Study Site 206
Study Site 143
Study Site 128
Study Site 120
Study Site 208
Study Site 221
Study Site 305
Study Site 310
Study Site 301
Study Site 153
Study Site 148
Study Site 316
Study Site 141
Study Site 402
Study Site 219
Study Site 109
Study Site 215


title: A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis

summary: A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)

lead_sponsor: Orphazyme

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

location_facility: Groupe Hospitalier Pitie-Salpetriere - Centre d'Investigation Clinique Neurosciences 1422

location_facility: Hospital Universitario Vall d'Hebron ALS Unit. Consultas Externas; Office: 9-10-11

location_facility: Instituti Clinica Scientifici Maugeri - IRCCS

location_facility: Kantonsspital St.Gallen, Muskelzentrum/ALS Clinic

location_facility: University of Pensylvania, Perelman Center for Advanced Medicine - Penn Neuroscience Center

location_facility: University of Kansas Medical Center (KUMC) - Landon Center on Aging

location_facility: UC Irvine Health ALS and Neuromuscular Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: Hospital Carlos III - Hospital Universitario La Paz, ALS Unit

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: Universitaetsklinikum Ulm - Klinik fuer Neurologie

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Neurologie

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) - Ambulanz fuer ALS und andere Motoneuronenerkrankungen

location_facility: Azienda Ospedaliero Universitaria (AUO) di Torino - Citta'della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Gui De Chauliac

location_facility: University of Texas Southwestern Medical Center


title: A Phase II, Open-Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy

summary: Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.

ReferenceCitation: Powles T, Lackner MR, Oudard S, Escudier B, Ralph C, Brown JE, Hawkins RE, Castellano D, Rini BI, Staehler MD, Ravaud A, Lin W, O'Keeffe B, Wang Y, Lu S, Spoerke JM, Huw LY, Byrtek M, Zhu R, Ware JA, Motzer RJ. Randomized Open-Label Phase II Trial of Apitolisib (GDC-0980), a Novel Inhibitor of the PI3K/Mammalian Target of Rapamycin Pathway, Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2016 May 10;34(14):1660-8. doi: 10.1200/JCO.2015.64.8808. Epub 2016 Mar 7.

name: Thomas Powles, Queen Mary University of London, London; Christy Ralph, University of Leeds, Leeds; Janet E. Brown, University of Sheffield, Sheffield; Robert E. Hawkins, University of Manchester, Manchester, United Kingdom; Mark R. Lackner, Wei Lin, Bridget O’Keeffe, Yulei Wang, Shan Lu, Jill M. Spoerke, Ling Yuh Huw, Michelle Byrtek, Rui Zhu, and Joseph A. Ware, Genentech, South San Francisco, CA; Robert J. Motzer, Memorial Sloan Kettering Cancer Center, New York, NY; Brian I. Rini, Cleveland Clinic...

family: Powles

full_name: Thomas Powles

given: Thomas

family: Lackner

full_name: Mark R. Lackner

given: Mark R.

family: Oudard

full_name: Stéphane Oudard

given: Stéphane

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Ralph

full_name: Christy Ralph

given: Christy

family: Brown

full_name: Janet E. Brown

given: Janet E.

family: Hawkins

full_name: Robert E. Hawkins

given: Robert E.

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Staehler

full_name: Michael D. Staehler

given: Michael D.

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Lin

full_name: Wei Lin

given: Wei

family: O’Keeffe

full_name: Bridget O’Keeffe

given: Bridget

family: Wang

full_name: Yulei Wang

given: Yulei

family: Lu

full_name: Shan Lu

given: Shan

family: Spoerke

full_name: Jill M. Spoerke

given: Jill M.

family: Huw

full_name: Ling-Yuh Huw

given: Ling-Yuh

family: Byrtek

full_name: Michelle Byrtek

given: Michelle

family: Zhu

full_name: Rui Zhu

given: Rui

family: Ware

full_name: Joseph A. Ware

given: Joseph A.

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

publisher: American Society of Clinical Oncology (ASCO)

location_country:
United States
France
Spain
Germany
United Kingdom