title: A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma

summary: The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

ReferenceCitation: Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.

family: Smith

full_name: Claire L. Smith

given: Claire L.

family: Thomas

full_name: Zachary Thomas

given: Zachary

family: Enas

full_name: Nathan Enas

given: Nathan

family: Thorn

full_name: Katharine Thorn

given: Katharine

family: Lahn

full_name: Michael Lahn

given: Michael

family: Benhadji

full_name: Karim Benhadji

given: Karim

family: Cleverly

full_name: Ann Cleverly

given: Ann

journal_name: Pharmaceutical Statistics

ReferenceCitation: Brandes AA, Carpentier AF, Kesari S, Sepulveda-Sanchez JM, Wheeler HR, Chinot O, Cher L, Steinbach JP, Capper D, Specenier P, Rodon J, Cleverly A, Smith C, Gueorguieva I, Miles C, Guba SC, Desaiah D, Lahn MM, Wick W. A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma. Neuro Oncol. 2016 Aug;18(8):1146-56. doi: 10.1093/neuonc/now009. Epub 2016 Feb 21.

family: Brandes

full_name: Alba A. Brandes

given: Alba A.

family: Carpentier

full_name: Antoine F. Carpentier

given: Antoine F.

family: Kesari

full_name: Santosh Kesari

given: Santosh

family: Sepulveda-Sanchez

full_name: Juan M. Sepulveda-Sanchez

given: Juan M.

family: Wheeler

full_name: Helen R. Wheeler

given: Helen R.

family: Chinot

full_name: Olivier Chinot

given: Olivier

family: Cher

full_name: Lawrence Cher

given: Lawrence

family: Steinbach

full_name: Joachim P. Steinbach

given: Joachim P.

family: Capper

full_name: David Capper

given: David

family: Specenier

full_name: Pol Specenier

given: Pol

family: Rodon

full_name: Jordi Rodon

given: Jordi

full_name: Claire Smith

given: Claire

family: Gueorguieva

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

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


type: EudraCT Number

title: A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

acronym: ALCANZA

summary: The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma [mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) ]compared to that achieved with therapy in the control arm.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin LJ, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano JM, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Sep 10. pii: bloodadvances.2021004710. doi: 10.1182/bloodadvances.2021004710. [Epub ahead of print]

name: Memorial Sloan Kettering Cancer Center, New York, New York, United States

family: Horwitz

full_name: Steven M. Horwitz

given: Steven M.

sequence: first

name: University Hospital Birmingham, Birmingham, United Kingdom

family: Scarisbrick

full_name: Julia J Scarisbrick

given: Julia J

sequence: additional

name: University Hospital of Zurich, Zurich, Switzerland

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

name: St. John's Institute of Dermatology, London, United Kingdom

family: Whittaker

full_name: Sean Whittaker

given: Sean

name: MD Anderson Cancer Center, Houston, Texas, United States

family: Duvic

full_name: Madeleine Duvic

given: Madeleine

name: Stanford University School of Medicine, Palo Alto, California, United States

family: Kim

full_name: Youn H. Kim

given: Youn H.

family: Quaglino

full_name: Pietro Quaglino

given: Pietro

name: IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia, Bologna, Idaho, Italy

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Bechter

full_name: Oliver Bechter

given: Oliver

name: UCLA, Los Angeles, California, United States

family: Eradat

full_name: Herbert Eradat

given: Herbert

name: Chao Family Comprehensive Cancer Center-UC Irvine, Orange, California, United States

family: Pinter-Brown

full_name: Lauren Pinter-Brown

given: Lauren

name: University of Pittsburgh, Pittsburgh, Pennsylvania, United States

family: Akilov

full_name: Oleg E Akilov

given: Oleg E

name: Columbia University Medical Center, New York, New York, United States

family: Geskin

full_name: Larisa J Geskin

given: Larisa J

name: University of Sao Paulo Medical School, Brazil, Sao Paulo, Brazil

family: Sanches

full_name: Jose Antonio Sanches

given: Jose Antonio

name: University Hospital 12 de Octubre, Institute i+12 Medical School, University Complutense, Madrid, Wyoming, Spain

family: Ortiz-Romero

full_name: Pablo L. Ortiz-Romero

given: Pablo L.

name: University Hospital of Schleswig-Holstein, Kiel, Germany

family: Weichenthal

full_name: Michael Weichenthal

name: Dana-Farber Cancer Institute, Boston, Massachusetts, United States

family: Fisher

full_name: David C. Fisher

given: David C.

name: The Maria Sklodowska-Curie Memorial Institute and Oncology Centre, Warszawa, Poland

family: Walewski

full_name: Jan Walewski

given: Jan

name: Concord Repatriation General Hospital and University of Sydney, Concord, Australia

family: Trotman

full_name: Judith Trotman

given: Judith

name: Icon Cancer Care, South Brisbane, Australia

family: Taylor

full_name: Kerry Taylor

given: Kerry

name: Hospices Civils de Lyon, Pierre-Bénite, France

family: Dalle

full_name: Stephane Dalle

given: Stephane

name: University Hospitals of the Ruhr-University of Bochum, Minden, Germany

family: Stadler

full_name: Rudolf Stadler

given: Rudolf

name: Seagen, Inc., Sunbury, Ohio, United States

family: Lisano

full_name: Julie M Lisano

name: Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceuticals Limited, Cambridge, Massachusetts, United States

name: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, United States

name: Peter MacCallum Cancer Centre, Melbourne, Australia

ReferenceCitation: Kim YH, Prince HM, Whittaker S, Horwitz SM, Duvic M, Bechter O, Sanches JA, Stadler R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown LC, Ortiz-Romero PL, Akilov OE, Trotman J, Taylor K, Weichenthal M, Walewski J, Fisher D, McNeeley M, Gru AA, Brown L, Palanca-Wessels MC, Lisano J, Onsum M, Bunn V, Little M, Trepicchio WL, Dummer R. Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis. Eur J Cancer. 2021 May;148:411-421. doi: 10.1016/j.ejca.2021.01.054. Epub 2021 Mar 29.

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Response to brentuximab vedotin versus physician’s choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis

ReferenceCitation: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

name: Department of Dermatology, Venereology and Allergology; Johann Wolfgang Goethe-University Hospital; Frankfurt am Main Germany

name: Evidence-Based Medicine Frankfurt, Institute of General Practice; Goethe University; Frankfurt Germany

name: Hautklinik; Städtisches Klinikum Karlsruhe; Karlsruhe Germany

name: Department of Dermatology; University of California Davis; Sacramento CA USA

name: Center for Evidence-Based Healthcare; Faculty of Medicine Carl Gustav Carus, Technischen Universität (TU) Dresden; Dresden Germany

name: c/o Cochrane Skin Group; The University of Nottingham; Nottingham UK

title: Interventions for mycosis fungoides

ReferenceCitation: Dummer R, Prince HM, Whittaker S, Horwitz SM, Kim YH, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown L, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Huen A, Walewski J, Wang Y, Lisano J, Richhariya A, Feliciano J, Zhu Y, Bunn V, Little M, Zagadailov E, Dalal MR, Duvic M. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study. Eur J Cancer. 2020 Jul;133:120-130. doi: 10.1016/j.ejca.2020.04.010. Epub 2020 Jun 2.

ReferenceCitation: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. doi: 10.1016/S0140-6736(17)31266-7. Epub 2017 Jun 7.

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

location_country:
Italy
Austria
Brazil
Switzerland
Germany
France
Poland
Australia
Belgium
Spain
United States
United Kingdom


type: Other Identifier

title: Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects

acronym: REPLACE

summary: The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.

lead_sponsor: Janssen-Cilag International NV

location_country:
Austria
France
Belgium
Spain
Germany
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

summary: This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

ReferenceCitation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

family: Florian

full_name: Hana Florian

given: Hana

family: Meier

full_name: Andreas Meier

given: Andreas

name: McGill University Research Center for Studies in Aging, McGill University, Montreal, Quebec, Canada

family: Gauthier

full_name: Serge Gauthier

given: Serge

name: The Dr. Stanley Lipschitz Clinic, Rosebank, Johannesburg, South Africa

family: Lipschitz

full_name: Stanley Lipschitz

given: Stanley

family: Lin

full_name: Yunzhi Lin

given: Yunzhi

family: Tang

full_name: Qi Tang

given: Qi

name: Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Cairo, Egypt

family: Othman

full_name: Ahmed A. Othman

given: Ahmed A.

family: Robieson

full_name: Weining Z. Robieson

given: Weining Z.

family: Gault

full_name: Laura M. Gault

given: Laura M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Alzheimer's Disease

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer’s Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
United States
South Africa
France
Greece
Germany
United Kingdom
Canada

location_facility:
Site Reference ID/Investigator# 68733
Site Reference ID/Investigator# 68706
Site Reference ID/Investigator# 68705
Site Reference ID/Investigator# 68730
Site Reference ID/Investigator# 69602
Site Reference ID/Investigator# 67785
Site Reference ID/Investigator# 68704
Site Reference ID/Investigator# 71798
Site Reference ID/Investigator# 67583
Site Reference ID/Investigator# 66531
Site Reference ID/Investigator# 67786
Site Reference ID/Investigator# 67582
Site Reference ID/Investigator# 66529
Site Reference ID/Investigator# 67787
Site Reference ID/Investigator# 67586
Site Reference ID/Investigator# 67585
Site Reference ID/Investigator# 69959
Site Reference ID/Investigator# 69960
Site Reference ID/Investigator# 66527
Site Reference ID/Investigator# 68764
Site Reference ID/Investigator# 67584
Site Reference ID/Investigator# 71793
Site Reference ID/Investigator# 68768
Site Reference ID/Investigator# 66523
Site Reference ID/Investigator# 71573
Site Reference ID/Investigator# 68767
Site Reference ID/Investigator# 68732
Site Reference ID/Investigator# 66522
Site Reference ID/Investigator# 71795
Site Reference ID/Investigator# 71796
Site Reference ID/Investigator# 71794
Site Reference ID/Investigator# 68731
Site Reference ID/Investigator# 68765
Site Reference ID/Investigator# 66524
Site Reference ID/Investigator# 66526
Site Reference ID/Investigator# 67783
Site Reference ID/Investigator# 68729
Site Reference ID/Investigator# 77833
Site Reference ID/Investigator# 66528
Site Reference ID/Investigator# 67784
Site Reference ID/Investigator# 66530
Site Reference ID/Investigator# 68735
Site Reference ID/Investigator# 66525


title: A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have failed Anti-Tumor Necrosis Factor (anti-TNF) therapy.

status: Terminated

lead_sponsor: CSL Behring

location_country:
Italy
Austria
India
Hong Kong
Mexico
Netherlands
Germany
Switzerland
France
Czechia
Korea, Republic of
Israel
Poland
Hungary
United States
United Kingdom
Canada
Taiwan

location_facility: Premier Medical Group Of The Hudson Valley, Pc

intervention_type: Biological

status_simplified: Unknown


ReferenceCitation: Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martín-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753.

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

family: Armand

full_name: Philippe Armand

given: Philippe

name: Universitaire Ziekenhuizen Leuven, Leuven, Belgium;

family: Janssens

full_name: Ann Janssens

given: Ann

name: Ospedale Papa Giovanni XXIII, Bergamo, Italy;

family: Gritti

full_name: Giuseppe Gritti

given: Giuseppe

name: Department of Medical Oncology, University of Manchester, Manchester, United Kingdom;

name: The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom;

family: Radford

full_name: John Radford

given: John

name: Division of Hematology & Oncology, University of California Los Angeles, Los Angeles, CA;

family: Timmerman

full_name: John Timmerman

name: Istituto Nazionale Tumori, Fondazione Pascale, Istituto di Ricovero e Cura a Carattere Scientifico, Naples, Italy;

family: Pinto

full_name: Antonio Pinto

given: Antonio

name: Institut Català d'Oncologia–Duran y Reynals, Hospitalet de Llobregat, Barcelona, Spain;

family: Mercadal Vilchez

full_name: Santiago Mercadal Vilchez

given: Santiago

name: Cancer Research UK Centre, University of Southampton, Southampton, United Kingdom;

name: NIHR/CRUK Experimental Cancer Medicine Centre, Southampton, United Kingdom;

family: Johnson

full_name: Peter Johnson

given: Peter

name: The Royal Marsden Hospital, Surrey, United Kingdom;

family: Cunningham

full_name: David Cunningham

given: David

name: New York Presbyterian Hospital, New York, NY;

family: Leonard

full_name: John P. Leonard

given: John P.

name: Brigham and Women’s Hospital, Boston, MA;

family: Rodig

full_name: Scott J. Rodig

given: Scott J.

name: Bristol Myers Squibb, Princeton, NJ; and

family: Martín-Regueira

full_name: Patricia Martín-Regueira

given: Patricia

family: Sumbul

full_name: Anne Sumbul

given: Anne

family: Samakoglu

full_name: Selda Samakoglu

given: Selda

full_name: Hao Tang

given: Hao

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

journal_name: Blood

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

status: Active, not recruiting

lead_sponsor: Bristol-Myers Squibb

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

acronym: CheckMate 140, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences

study_completion_date_type: Anticipated

source: euctr

title: A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)

summary: The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

status_simplified: Ongoing


ReferenceCitation: Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.

name: University Medical Center Utrecht Cancer Center, Utrecht, The Netherlands, on behalf of the Lunenburg Lymphoma Phase I/II Consortium–HOVON/LLPC

family: Minnema

full_name: Monique C. Minnema

given: Monique C.

name: University of Southampton, Southampton, United Kingdom

name: University of California, Los Angeles, Los Angeles, CA

full_name: John M. Timmerman

given: John M.

name: Dana-Farber Cancer Institute, Boston, MA

family: Shipp

full_name: Margaret A. Shipp

given: Margaret A.

name: Brigham and Women’s Hospital, Boston, MA

family: Ligon

full_name: Azra H. Ligon

given: Azra H.

family: Roemer

full_name: Margaretha G.M. Roemer

given: Margaretha G.M.

family: Reddy

full_name: Nishitha Reddy

given: Nishitha

family: Cohen

full_name: Jonathon B. Cohen

given: Jonathon B.

name: Jewish General Hospital, Montreal, Quebec, Canada

family: Assouline

full_name: Sarit Assouline

given: Sarit

name: National University Cancer Institute, Singapore, Singapore

family: Poon

full_name: Michelle Poon

given: Michelle

family: Sharma

full_name: Manish Sharma

given: Manish

family: Kato

full_name: Kazunobu Kato

given: Kazunobu

name: Austin Hospital and Olivia Newton-John Cancer Research Institute, Melbourne, VIC, Australia

family: Grigg

full_name: Andrew Grigg

given: Andrew

journal_name: Journal of Clinical Oncology

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Utrecht University - Utrecht University Repository

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

publisher: American Society of Clinical Oncology (ASCO)

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

acronym: CheckMate 139: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 139

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Columbia University Medical Center (Cumc)

title: A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT

summary: The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT


title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)

summary: This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Mexico
France
Singapore
Argentina
New Zealand
Spain
Canada
United Kingdom

location_facility: Emory University School of Medicine; Department of Human Genetics & Pediatrics

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Fundación Síndrome de Down; Fundación Síndrome de Down

location_facility: UVaMID Hospital Santa Caterina;; Servicio de Neurología

location_facility: KK Women's and Children's Hospital; Department of Neonatology

location_facility: Clínica Para la Atención del Neurodesarrollo

location_facility: Ospedale Microcitemico; Clinica Pediatrica

location_facility: University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Hospital Universitario de la Princesa; Medicina Interna

location_facility: CHU de Saint Etienne; Service de Génétique

location_facility: Institut Jérôme Lejeune; Neuropsychology

location_facility: IMIM, Human Pharmacology and Clinical Neurosciences,

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust; Child Development and Family Support Centre

location_facility: University of Utah School of Medicine; Department of Pediatrics

location_facility: Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

location_facility: Hospital Infantil Universitario Niño Jesus; Pediatria Social

location_facility: University of Wisconsin Madison, Waisman Center

location_facility: University of Otago; Psychological Medicine Department

location_facility: Massachusette General Hospital; Medical Genetics

location_facility: Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Doncaster Royal Infirmary

location_facility: Cornwall Partnership NHS Foundation Trust

location_facility: Mental Health of Learning Disability, Kent & Medway NHS and Social Care Partnership Trust

location_facility: Policlinico Universitario "Agostino Gemelli";Dip. Tutela Salute Donna Bambino Adolescente


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

acronym: C-early

summary: This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

ReferenceType: result

ReferenceCitation: Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10.

family: Emery

full_name: P Emery

given: P

family: Bingham

full_name: C O Bingham

given: C O

suffix: III

family: Burmester

full_name: G R Burmester

given: G R

family: Bykerk

full_name: V P Bykerk

given: V P

family: Furst

full_name: D E Furst

given: D E

family: Mariette

full_name: X Mariette

given: X

family: van der Heijde

full_name: D van der Heijde

given: D

family: van Vollenhoven

full_name: R van Vollenhoven

given: R

family: Arendt

full_name: C Arendt

given: C

family: Mountian

full_name: I Mountian

given: I

family: Purcaru

full_name: O Purcaru

given: O

family: Tatla

full_name: D Tatla

family: VanLunen

full_name: B VanLunen

given: B

family: Weinblatt

full_name: M E Weinblatt

given: M E

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12.

name: Brigham and Women's Hospital; Boston Massachusetts

name: Johns Hopkins University; Baltimore Maryland

name: Charité University Medicine Berlin; Berlin Germany

name: Weill Cornell Medical College; New York New York

name: Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184; Le Kremlin Bicêtre France

name: Leiden University Medical Center; Leiden The Netherlands

name: Amsterdam Rheumatology and Immunology Center; Amsterdam The Netherlands

name: University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust; Leeds UK

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

location_country:
Romania
Australia
Belgium
France
Poland
Argentina
Canada
Monaco
Colombia
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Spain


ReferenceCitation: Sommerwerck U, Virella-Lowell I, Angyalosi G, Viegas A, Cao W, Debonnett L. Long-term safety of tobramycin inhalation powder in patients with cystic fibrosis: phase IV (ETOILES) study. Curr Med Res Opin. 2016 Nov;32(11):1789-1795. Epub 2016 Sep 9.

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Mexico
Germany
France
Hungary
Argentina
Australia
Spain
Canada

title: A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

summary: This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.


title: A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

summary: This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

ReferenceCitation: Pozniak A, Flamm J, Antinori A, Bloch M, Ward D, Berenguer J, Cote P, Andreatta K, Garner W, Szwarcberg J, Nguyen-Cleary T, McColl DJ, Piontkowsky D. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.

name: Chelsea and Westminster Hospital, London, UK

family: Pozniak

full_name: Anton Pozniak

given: Anton

family: Flamm

full_name: Jason Flamm

given: Jason

name: Istituto Nazionale Mallattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy

family: Antinori

full_name: Andrea Antinori

given: Andrea

name: Holdsworth House Medical Practice, Darlinghurst, Australia

family: Bloch

full_name: Mark Bloch

given: Mark

name: Dupont Circle Physicians Group, Washington, DC, USA

family: Ward

full_name: Douglas Ward

given: Douglas

name: Hospital General Universitario Gregorio Maranon, Madrid, Spain

family: Berenguer

full_name: Juan Berenguer

given: Juan

name: Clinique Medicale Du Quartier Latin, Montreal, Canada

family: Cote

full_name: Pierre Cote

given: Pierre

name: Gilead Sciences, Inc., Foster City, CA, USA

family: Andreatta

full_name: Kristen Andreatta

given: Kristen

family: Garner

full_name: William Garner

given: William

family: Szwarcberg

full_name: Javier Szwarcberg

given: Javier

family: Nguyen-Cleary

full_name: Thai Nguyen-Cleary

given: Thai

family: McColl

full_name: Damian J. McColl

given: Damian J.

family: Piontkowsky

full_name: David Piontkowsky

given: David

journal_name: HIV Clinical Trials

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

family: Markowitz

full_name: Martin Markowitz

given: Martin

family: Mills

full_name: Anthony Mills

given: Anthony

family: Stellbrink

full_name: Hans-Juergen Stellbrink

given: Hans-Juergen

family: Antela

full_name: Antonio Antela

given: Antonio

family: Domingo

full_name: Pere Domingo

given: Pere

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Henry

full_name: Keith Henry

location_country:
Italy
Austria
United States
Spain
Germany
France
Australia
Belgium
Puerto Rico
Portugal
Canada
United Kingdom

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Southwest Infectious Disease Clinical Researach Inc

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Azienda Ospedaliera Ospedale di Circolo Busto Arsizio

location_facility: Tarrant County Infectious Disease Associates

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: La Playa Medical Group and Clinical Research

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Infectious Diseases Associates of Northwest Florida

location_facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: Clinical Alliance for Research & Education - Infectious Disease

location_facility: HIV Program Hennepin County Medical Center

location_facility: SEAMEO Regional Centre for Tropical Medicine


title: Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.

acronym: ATTRACT

summary:
Study objectives:

To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

lead_sponsor: Galderma R&D

location_country:
United Kingdom
France
Bulgaria
Poland
Romania
Hungary
Russian Federation
Germany
Czech Republic
Ukraine

location_facility:
Galderma Investigational Site
Galderma Invetigational site


title: Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)

acronym: TRACE

summary: The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country:
Austria
Germany
France
Czechia
United States

location_facility: Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere


title: Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator

summary: This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

lead_sponsor: Forest Laboratories

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Poland
Israel
Belgium
Spain
Denmark
Canada
Czech Republic

location_facility:
Forest Investigative Site 018
Forest Investigative Site 060
Forest Investigative Site 085
Forest Investigative Site 109
Forest Investigative Site 358
Forest Investigative Site 802
Forest Investigative Site 087
Forest Investigative Site 264
Forest Investigative Site 022
Forest Investigative Site 030
Forest Investigative Site 049
Forest Investigative Site 354
Forest Investigative Site 072
Forest Investigative Site 451
Forest Investigative Site 800
Forest Investigative Site 043
Forest Investigative Site 705
Forest Investigative Site 092
Forest Investigative Site 006
Forest Investigative Site 270
Forest Investigative Site 301
Forest Investigative Site 401
Forest Investigative Site 058
Forest Investigative Site 048
Forest Investigative Site 269
Forest Investigative Site 555
Forest Investigative Site 751
Forest Investigative Site 073
Forest Investigative Site 034
Forest Investigative Site 406
Forest Investigative Site 090
Forest Investigative Site 112
Forest Investigative Site 502
Forest Investigative Site 259
Forest Investigative Site 805
Forest Investigative Site 028
Forest Investigative Site 014
Forest Investigative Site 405
Forest Investigative Site 041
Forest Investigative Site 801
Forest Investigative Site 079
Forest Investigative Site 020
Forest Investigative Site 091
Forest Investigative Site 350
Forest Investigative Site 016
Forest Investigative Site 124
Forest Investigative Site 088
Forest Investigative Site 082
Forest Investigative Site 066
Forest Investigative Site 119
Forest Investigative Site 604
Forest Investigative Site 122
Forest Investigative Site 075
Forest Investigative Site 065
Forest Investigative Site 004
Forest Investigative Site 083
Forest Investigative Site 300
Forest Investigative Site 453
Forest Investigative Site 023
Forest Investigative Site 113
Forest Investigative Site 504
Forest Investigative Site 706
Forest Investigative Site 450
Forest Investigative Site 074
Forest Investigative Site 076
Forest Investigative Site 753
Forest Investigative Site 853
Forest Investigative Site 084
Forest Investigative Site 850
Forest Investigative Site 804
Forest Investigative Site 042
Forest Investigative Site 253
Forest Investigative Site 353
Forest Investigative Site 069
Forest Investigative Site 095
Forest Investigative Site 851
Forest Investigative Site 117
Forest Investigative Site 012
Forest Investigative Site 263
Forest Investigative Site 015
Forest Investigative Site 045
Forest Investigative Site 062
Forest Investigative Site 754
Forest Investigative Site 750
Forest Investigative Site 854
Forest Investigative Site 302
Forest Investigative Site 008
Forest Investigative Site 071
Forest Investigative Site 055
Forest Investigative Site 267
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 089
Forest Investigative Site 052
Forest Investigative Site 100
Forest Investigative Site 357
Forest Investigative Site 044
Forest Investigative Site 050
Forest Investigative Site 116
Forest Investigative Site 304
Forest Investigative Site 452
Forest Investigative Site 118
Forest Investigative Site 056
Forest Investigative Site 007
Forest Investigative Site 402
Forest Investigative Site 013
Forest Investigative Site 094
Forest Investigative Site 262
Forest Investigative Site 752
Forest Investigative Site 059
Forest Investigative Site 063
Forest Investigative Site 070
Forest Investigative Site 252
Forest Investigative Site 024
Forest Investigative Site 081
Forest Investigative Site 250
Forest Investigative Site 123
Forest Investigative Site 410
Forest Investigative Site 552
Forest Investigative Site 121
Forest Investigative Site 111
Forest Investigative Site 035
Forest Investigative Site 303
Forest Investigative Site 068
Forest Investigative Site 005
Forest Investigative Site 110
Forest Investigative Site 053
Forest Investigative Site 010
Forest Investigative Site 106
Forest Investigative Site 029
Forest Investigative Site 550
Forest Investigative Site 003
Forest Investigative Site 601
Forest Investigative Site 107
Forest Investigative Site 046
Forest Investigative Site 254
Forest Investigative Site 852
Forest Investigative Site 803


title: Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

summary: The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

ReferenceCitation: Everson GT, Sims KD, Thuluvath PJ, Lawitz E, Hassanein T, Rodriguez-Torres M, Desta T, Hawkins T, Levin JM, Hinestrosa F, Rustgi V, Schwartz H, Younossi Z, Webster L, Gitlin N, Eley T, Huang SP, McPhee F, Grasela DM, Gardiner DF. Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients. Liver Int. 2016 Feb;36(2):189-97. doi: 10.1111/liv.12964. Epub 2015 Dec 6.

name: University of Colorado Denver; Aurora CO USA

family: Everson

full_name: Gregory T. Everson

given: Gregory T.

family: Sims

full_name: Karen D. Sims

given: Karen D.

family: Thuluvath

full_name: Paul J. Thuluvath

given: Paul J.

name: The Texas Liver Institute; University of Texas Health Science Center; San Antonio TX USA

family: Lawitz

full_name: Eric Lawitz

given: Eric

name: Southern California GI and Liver Centers; Coronado CA USA

family: Hassanein

full_name: Tarek Hassanein

given: Tarek

name: Fundación de Investigación; San Juan PR USA

family: Rodriguez-Torres

full_name: Maribel Rodriguez-Torres

given: Maribel

name: Precision Research Institute; San Diego CA USA

family: Desta

full_name: Tadesse Desta

given: Tadesse

family: Hawkins

full_name: Trevor Hawkins

given: Trevor

name: Dean Foundation for Health, Research and Education Inc; Madison WI USA

family: Levin

full_name: James M. Levin

given: James M.

name: Orlando Immunology Center; Orlando FL USA

family: Hinestrosa

full_name: Federico Hinestrosa

given: Federico

name: The Thomas Starzl Transplant Institute; University of Pittsburgh Medical Center; Pittsburgh PA USA

family: Rustgi

full_name: Vinod Rustgi

given: Vinod

name: Miami Research Associates; South Miami FL USA

family: Schwartz

full_name: Howard Schwartz

given: Howard

name: Inova Fairfax Hospital; Center for Liver Diseases; Falls Church VA USA

family: Younossi

full_name: Zobair Younossi

given: Zobair

family: Webster

full_name: Lynn Webster

given: Lynn

name: Atlanta Gastroenterology Associates' Liver Center; Atlanta GA USA

family: Gitlin

full_name: Norman Gitlin

given: Norman

family: Eley

full_name: Timothy Eley

given: Timothy

family: Huang

full_name: Shu-Pang Huang

given: Shu-Pang

name: Bristol-Myers Squibb; Wallingford CT USA

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Grasela

full_name: Dennis M. Grasela

given: Dennis M.

family: Gardiner

full_name: David F. Gardiner

given: David F.

journal_name: Liver International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Everson GT, Sims KD, Rodriguez-Torres M, Hézode C, Lawitz E, Bourlière M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014 Feb;146(2):420-9. doi: 10.1053/j.gastro.2013.10.057. Epub 2013 Oct 30.

title: Efficacy of an Interferon- and Ribavirin-Free Regimen of Daclatasvir, Asunaprevir, and BMS-791325 in Treatment-Naive Patients With HCV Genotype 1 Infection

location_facility: Atlanta Gastroenterology Associates, Llc

location_facility: University Of Colorado Denver And Hospital

location_facility: Va Greater Los Angeles Healthcare System


title: PROTEAse Inhibitor (DRV/Rtv) in Mono- or Triple Therapy in Suppressed HIV-1 Infected Subjects

acronym: PROTEA

summary: The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

ReferenceCitation: Girard PM, Antinori A, Arribas JR, Ripamonti D, Bicer C, Netzle-Sveine B, Hadacek B, Moecklinghoff C. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. HIV Med. 2017 Jan;18(1):5-12. doi: 10.1111/hiv.12386. Epub 2016 Jun 9.

name: Department of Infectious and Tropical Diseases; Hôpital Saint-Antoine; AP-HP; INSERM UMR S 1136; Paris France

family: Girard

full_name: PM Girard

given: PM

name: National Institute for Infectious Diseases; L. Spallanzani IRCCS; Rome Italy

family: Antinori

full_name: A Antinori

given: A

name: Hospital University La Paz; IdiPAZ; Madrid Spain

family: Arribas

full_name: JR Arribas

given: JR

family: Ripamonti

full_name: D Ripamonti

given: D

name: Biostatistics; Janssen R&D; Beerse Belgium

family: Bicer

full_name: C Bicer

given: C

name: Janssen EMEA; Issy-les-Moulineaux France

family: Netzle-Sveine

full_name: B Netzle-Sveine

given: B

family: Hadacek

full_name: B Hadacek

family: Moecklinghoff

full_name: C Moecklinghoff

journal_name: HIV Medicine

oa_host_type: publisher

location_country:
Austria
Sweden
Switzerland
France
Poland
Israel
Hungary
Belgium
Ireland
Spain
Denmark
Germany
United Kingdom


title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

summary: The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

ReferenceType: background

ReferenceCitation: Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. Review.

lead_sponsor: Amgen

location_country:
Italy
United States
Mexico
Netherlands
France
Czechia
Poland
Slovakia
Hungary
Belgium
Russian Federation
New Zealand
Germany


title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Of Lurasidone For The Maintenance Treatment Of Subjects With Schizophrenia

summary: Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that Lurasidone is effective in the long term maintenance treatment of schizophrenia.

lead_sponsor: Sunovion

location_country:
Italy
South Africa
Serbia
France
Slovakia
Russian Federation
United States

location_facility: Psychiatricke oddelenie, Nemocnica s poliklinikou sv. Barbory Roznava, a.s.

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Regional Government Institution Kipetsk Regional Psychoneurology Hospital

location_facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex

location_facility: California Neuropsychopharmacology Clinical Research Instit

location_facility: Specialized Hospital for psychiatric diseases "Sveti Vracevi"

location_facility: Medical Research Group of Central Florida

location_facility: Centre Hospitalier Specialise du Jura - Centre Medico Psychiatric

location_facility: Center for Psychiatry and Behavioral Medicine, Inc.

location_facility: St. Petersburg State Government Healthcare Institution City Psychiatric Hospital #4 (St. Petersburg Insane Asylum Distributor)

location_facility: Behavioral Medical Research of Staten Island

location_facility: SC SPDC-Edificio n. 7, Ospedale S. Andrea

location_facility: Clinical Centre Kragujevac, Clinic for Psychiatry

location_facility: CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

location_facility: Department of Psychiatry, University of Utah Health Sciences Center

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia

location_facility: Clinical Centre Vojvodina, Clinic for Psychiatry

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: St. Petersburg State Healthcare Institution (SPbSH) "City Psychiatric Hospital #6"

location_facility: University of New York, Dept. of Psychiatry

location_facility: Nemonnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

location_facility: Hopital Chalucet, Centre hospitalier intercommunal de toulon la Seyne sur mer (CHITS)

location_facility: City Psychoneurological Dispensary #7 (with Hospital)

location_facility: Psychiaticke oddelenie Vseobecna nemocnica Riimavska Sobota, NaP n.o.

location_facility: Limited Liability Company (LLC) Research Center for Treatment and rehabilitation "Phoenix"

location_facility: Military Medical Academy, Clinic for Psychiatry

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: St. Petersburg State Budgetary Healthcare Institution City Psychoneurology Dispensary #7 (with in-patient dept.) (SPb SBHI CPNDD-7), at daycare facility #1


type: Registry Identifier

title: A Phase 1a/1b, Multi-center, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma.

summary: The main purpose of this first in human study with CC-122 is to assess the safety and action of a new class of experimental drug (Pleiotropic Pathway Modulator) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.

ReferenceCitation: Rasco DW, Papadopoulos KP, Pourdehnad M, Gandhi AK, Hagner PR, Li Y, Wei X, Chopra R, Hege K, DiMartino J, Shih K. A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies. Clin Cancer Res. 2019 Jan 1;25(1):90-98. doi: 10.1158/1078-0432.CCR-18-1203. Epub 2018 Sep 10.

ReferenceCitation: Cubillos-Zapata C, Cordoba R, Avendaño-Ortiz J, Arribas-Jiménez C, Hernández-Jiménez E, Toledano V, Villaescusa T, Moreno V, López-Collazo E. CC-122 immunomodulatory effects in refractory patients with diffuse large B-cell lymphoma. Oncoimmunology. 2016 Sep 16;5(12):e1231290. doi: 10.1080/2162402X.2016.1231290. eCollection 2016.

ReferenceCitation: Hagner P, et al. CC-122 Has Potent Anti-Lymphoma Activity through Destruction of the Aiolos and Ikaros Transcription Factors and Induction of Interferon Response Pathways. Presented at American Society of Hematology 2014, December 6-9, 2014, San Francisco, CA. Abstract No. 3035.

ReferenceCitation: Carpio C, Bouabdallah R, Ysebaert L, Sancho JM, Salles G, Cordoba R, Pinto A, Gharibo M, Rasco D, Panizo C, Lopez-Martin JA, Santoro A, Salar A, Damian S, Martin A, Verhoef G, Van den Neste E, Wang M, Couto S, Carrancio S, Weng A, Wang X, Schmitz F, Wei X, Hege K, Trotter MWB, Risueño A, Buchholz TJ, Hagner PR, Gandhi AK, Pourdehnad M, Ribrag V. Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier. Blood. 2020 Mar 26;135(13):996-1007. doi: 10.1182/blood.2019002395. Erratum in: Blood. 2021 Apr 15;137(15):2126.

name: Department of Hematology, Vall d’Hebron Institute of Oncology, University Hospital Vall d’Hebron, Universitat Autònoma of Barcelona, Barcelona, Spain;

family: Carpio

full_name: Cecilia Carpio

given: Cecilia

name: Institut Paoli-Calmettes, Marseille, France;

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

name: Centre Hospitalier Universitaire de Toulouse, Toulouse, France;

family: Ysebaert

full_name: Loïc Ysebaert

given: Loïc

name: Catalan Institute of Oncology (ICO)–Josep Carreras Leukaemia Research Institute (IJC)–Hospital Universitari Germans Trias i Pujol, Badalona, Spain;

family: Sancho

full_name: Juan-Manuel Sancho

given: Juan-Manuel

name: Centre Hospitalier Lyon-Sud, Pierre-Bénite, France;

family: Salles

full_name: Gilles Salles

given: Gilles

name: Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain;

family: Cordoba

full_name: Raul Cordoba

given: Raul

name: Istituto Nazionale Tumori, Fondazione G. Pascale, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Napoli, Italy;

family: Pinto

full_name: Antonio Pinto

given: Antonio

name: Rutgers Cancer Institute of New Jersey, New Brunswick, NJ;

family: Gharibo

full_name: Mecide Gharibo

given: Mecide

name: South Texas Accelerated Research Therapeutics LLC, San Antonio, TX;

family: Rasco

full_name: Drew Rasco

given: Drew

name: Clinica Universidad de Navarra, Pamplona, Spain;

family: Panizo

full_name: Carlos Panizo

given: Carlos

name: 12 de Octubre University Hospital & Research Institute, Grupo Español de Terapias Inmuno-Biológicas en Cáncer (GÉTICA), Madrid, Spain;

family: Lopez-Martin

full_name: Jose A. Lopez-Martin

given: Jose A.

name: Humanitas Clinical and Research Center—IRCCS, Humanitas Cancer Center, Rozzano, Milan, Italy;

family: Santoro

full_name: Armando Santoro

given: Armando

family: Salar

full_name: Antonio Salar

family: Damian

full_name: Silvia Damian

given: Silvia

name: Hospital Universitario de Salamanca and Instituto de Investigación Biomedica de Salamanca (IBSAL), Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, Spain;

family: Martin

full_name: Alejandro Martin

given: Alejandro

name: UZ Gasthuisberg Leuven, Leuven, Belgium;

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

name: Cliniques Universitaires Saint-Luc, Université de Louvain, Brussels, Belgium;

family: Van den Neste

full_name: Eric Van den Neste

given: Eric

family: Wang

full_name: Maria Wang

given: Maria

family: Couto

full_name: Suzana Couto

given: Suzana

family: Carrancio

full_name: Soraya Carrancio

given: Soraya

name: Terry Fox Laboratory, British Columbia Cancer Agency, Vancouver, BC, Canada;

family: Weng

full_name: Andrew Weng

given: Andrew

full_name: Xuehai Wang

given: Xuehai

name: Fred Hutchinson Cancer Research Center, Seattle, WA;

name: Bristol-Myers Squibb, Berkeley Heights, NJ;

name: Bristol-Myers Squibb, San Francisco, CA;

name: Celgene Institute for Translational Research Europe, A Bristol-Myers Squibb Company, Seville, Spain;

name: Institut Gustave Roussy, Villejuif, France

location_country:
Italy
France
Belgium
Spain
United States

location_facility: Weill Medical College of Cornell University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: Hospital Universitario Clinico de Valencia

location_facility: Rutgers Cancer Institute of New Jersey University

location_facility: Swedish Medical Center Cancer Institute Research

location_facility: Institut universitaire du cancer de Toulouse (IUCT) - Oncopole

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Sarah Cannon Research Institute Drug Development Unit

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Henry Ford Medical Center - New Center One

location_facility: Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali

location_facility: Hospital Universitario Fundacion Jimenez Diaz


title: A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

acronym: SCULPTURE

summary: This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

ReferenceCitation: Dehlin M, Fasth AER, Reinhardt M, Jacobsson LTH. Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis-a post-hoc analysis of pooled data from three phase 3 trials with secukinumab. Rheumatol Adv Pract. 2021 Feb 18;5(1):rkab009. doi: 10.1093/rap/rkab009. eCollection 2021.

apc_source: doaj

name: Department of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

family: Dehlin

full_name: Mats Dehlin

given: Mats

name: Medical Affairs, Novartis Sverige AB, Kista, Sweden

family: Fasth

full_name: Andreas E R Fasth

given: Andreas E R

family: Reinhardt

full_name: Maximilian Reinhardt

given: Maximilian

family: Jacobsson

full_name: Lennart T H Jacobsson

given: Lennart T H

currency_apc_doaj: GBP

journal_name: Rheumatology Advances in Practice

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Impact of psoriasis disease activity and other risk factors on serum urate levels in patients with psoriasis and psoriatic arthritis—a post-hoc analysis of pooled data from three phase 3 trials with secukinumab

location_country:
Italy
Austria
India
Switzerland
United Kingdom
Vietnam
Germany
France
Bulgaria
Japan
Poland
Slovakia
Singapore
United States
Czech Republic
Canada


ReferenceCitation: Howard JF Jr, Barohn RJ, Cutter GR, Freimer M, Juel VC, Mozaffar T, Mellion ML, Benatar MG, Farrugia ME, Wang JJ, Malhotra SS, Kissel JT; MG Study Group. A randomized, double-blind, placebo-controlled phase II study of eculizumab in patients with refractory generalized myasthenia gravis. Muscle Nerve. 2013 Jul;48(1):76-84. doi: 10.1002/mus.23839. Epub 2013 Apr 30.

ReferenceCitation: Howard JF Jr, Utsugisawa K, Benatar M, Murai H, Barohn RJ, Illa I, Jacob S, Vissing J, Burns TM, Kissel JT, Muppidi S, Nowak RJ, O'Brien F, Wang JJ, Mantegazza R; REGAIN Study Group. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017 Dec;16(12):976-986. doi: 10.1016/S1474-4422(17)30369-1. Epub 2017 Oct 20. Erratum in: Lancet Neurol. 2017 Dec;16(12 ):954.

family: Howard

full_name: James F Howard

given: James F

suffix: Jr

family: Utsugisawa

full_name: Kimiaki Utsugisawa

given: Kimiaki

family: Benatar

full_name: Michael Benatar

given: Michael

family: Murai

full_name: Hiroyuki Murai

given: Hiroyuki

family: Barohn

full_name: Richard J Barohn

given: Richard J

family: Illa

full_name: Isabel Illa

given: Isabel

family: Jacob

full_name: Saiju Jacob

given: Saiju

family: Vissing

full_name: John Vissing

given: John

family: Burns

full_name: Ted M Burns

given: Ted M

family: Kissel

full_name: John T Kissel

given: John T

family: Muppidi

full_name: Srikanth Muppidi

given: Srikanth

family: Nowak

full_name: Richard J Nowak

family: O'Brien

full_name: Fanny O'Brien

given: Fanny

full_name: Jing-Jing Wang

given: Jing-Jing

family: Mantegazza

full_name: Renato Mantegazza

given: Renato

family: Mazia

full_name: Claudio Gabriel Mazia

given: Claudio Gabriel

family: Wilken

full_name: Miguel Wilken

given: Miguel

family: Ortea

full_name: Carolina Ortea

given: Carolina

family: Saba

full_name: Juliet Saba

given: Juliet

family: Rugiero

full_name: Marcelo Rugiero

given: Marcelo

family: Bettini

full_name: Mariela Bettini

given: Mariela

family: Vidal

full_name: Gonzalo Vidal

given: Gonzalo

family: Garcia

full_name: Alejandra Dalila Garcia

given: Alejandra Dalila

family: Lamont

full_name: Phillipa Lamont

given: Phillipa

family: Leong

ReferenceCitation: Monteleone JPR, Gao X, Kleijn HJ, Bellanti F, Pelto R. Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Generalized Myasthenia Gravis. Front Neurol. 2021 Nov 2;12:696385. doi: 10.3389/fneur.2021.696385. eCollection 2021.

ReferenceCitation: Nowak RJ, Muppidi S, Beydoun SR, O'Brien FL, Yountz M, Howard JF Jr. Concomitant Immunosuppressive Therapy Use in Eculizumab-Treated Adults With Generalized Myasthenia Gravis During the REGAIN Open-Label Extension Study. Front Neurol. 2020 Nov 24;11:556104. doi: 10.3389/fneur.2020.556104. eCollection 2020.

ReferenceCitation: Mantegazza R, Wolfe GI, Muppidi S, Wiendl H, Fujita KP, O'Brien FL, Booth HDE, Howard JF Jr; REGAIN Study Group. Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension. Neurology. 2021 Jan 26;96(4):e610-e618. doi: 10.1212/WNL.0000000000011207. Epub 2020 Nov 23.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Mantegazza R, O'Brien FL, Yountz M, Howard JF Jr; REGAIN study group. Consistent improvement with eculizumab across muscle groups in myasthenia gravis. Ann Clin Transl Neurol. 2020 Aug;7(8):1327-1339. doi: 10.1002/acn3.51121. Epub 2020 Jul 22.

name: Neuroimmunology and Neuromuscular Diseases Unit Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy

name: Department of Neurology University of North Carolina Chapel Hill NC

journal_name: Annals of Clinical and Translational Neurology

ReferenceCitation: Jacob S, Murai H, Utsugisawa K, Nowak RJ, Wiendl H, Fujita KP, O'Brien F, Howard JF Jr. Response to eculizumab in patients with myasthenia gravis recently treated with chronic IVIg: a subgroup analysis of REGAIN and its open-label extension study. Ther Adv Neurol Disord. 2020 May 6;13:1756286420911784. doi: 10.1177/1756286420911784. eCollection 2020.

name: Queen Elizabeth Neuroscience Centre and Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, UK

name: Department of Neurology, International University of Health and Welfare, Narita, Japan

name: Department of Neurology, Hanamaki General Hospital, Hanamaki, Japan

name: Department of Neurology, Yale University School of Medicine, New Haven, CT, USA

name: Department of Neurology, University of Münster, Münster, Germany

name: Alnylam Pharmaceuticals, Cambridge, MA, USA

name: Formerly Alexion Pharmaceuticals, Boston, MA, USA

name: Alexion Pharmaceuticals, Boston, MA, USA

name: Department of Neurology, University of North Carolina, Chapel Hill, NC, USA

journal_name: Therapeutic Advances in Neurological Disorders

ReferenceCitation: Vissing J, Jacob S, Fujita KP, O'Brien F, Howard JF; REGAIN study group. 'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab. J Neurol. 2020 Jul;267(7):1991-2001. doi: 10.1007/s00415-020-09770-y. Epub 2020 Mar 18.

title: ‘Minimal symptom expression’ in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab

ReferenceCitation: Andersen H, Mantegazza R, Wang JJ, O'Brien F, Patra K, Howard JF Jr; REGAIN Study Group. Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res. 2019 Aug;28(8):2247-2254. doi: 10.1007/s11136-019-02148-2. Epub 2019 Mar 23. Erratum in: Qual Life Res. 2019 May 21;:.

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

location_country:
Finland
Greece
Belgium
Australia
Denmark
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Spain
Turkey

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.

location_facility: University of Florida Health Science Center

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital For Special Surgery/New York Presbyterian Hospital Cornell Campus

location_facility: University of California San Francisco-Fresno

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera Sant'Andrea - Università di Roma La Sapienza

location_facility: UNIFESP - Universidade Federal de São Paulo

location_facility: HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

location_facility: Seoul Metropolitan Government Seoul National University

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Johns Hopkins University School Of Medicine

location_facility: University of California Davis Health System

location_facility: Wayne State University School of Medicine

location_facility: Southern Illinois University School of Medicine

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

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

summary: The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.


title: A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma

summary: This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

family: Shi

full_name: Rong Shi

given: Rong

family: Lu

full_name: Tong Lu

given: Tong

family: Ku

full_name: Grace Ku

given: Grace

family: Ding

full_name: Hao Ding

given: Hao

family: Saito

full_name: Tomohisa Saito

given: Tomohisa

family: Gibiansky

full_name: Leonid Gibiansky

given: Leonid

family: Agarwal

full_name: Priya Agarwal

given: Priya

family: Li

full_name: Xiaobin Li

given: Xiaobin

family: Jin

full_name: Jin Yan Jin

given: Jin Yan

family: Girish

full_name: Sandhya Girish

given: Sandhya

family: Miles

full_name: Dale Miles

given: Dale

full_name: Chunze Li

given: Chunze

full_name: Dan Lu

given: Dan

journal_name: Cancer Chemotherapy and Pharmacology

evidence: open (via crossref license)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Tilly H, Morschhauser F, Bartlett NL, Mehta A, Salles G, Haioun C, Munoz J, Chen AI, Kolibaba K, Lu D, Yan M, Penuel E, Hirata J, Lee C, Sharman JP. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study. Lancet Oncol. 2019 Jul;20(7):998-1010. doi: 10.1016/S1470-2045(19)30091-9. Epub 2019 May 14.

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Bartlett

full_name: Nancy L Bartlett

given: Nancy L

family: Mehta

full_name: Amitkumar Mehta

given: Amitkumar

family: Salles

title: Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b–2 study

location_facility: Hopital Henri Mondor, Unite Hemopathies lymphoides

location_facility: Willamette Valley Clinical Studies; Cancer Institute

location_facility: Hopital Claude Huriez - CHU Lille; Service des maladies du sang


title: An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

summary: The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

ReferenceCitation: Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.

family: Vansteenkiste

full_name: Johan F. Vansteenkiste

given: Johan F.

family: Canon

full_name: Jean-Luc Canon

given: Jean-Luc

family: De Braud

full_name: Filippo De Braud

given: Filippo

family: Grossi

full_name: Francesco Grossi

given: Francesco

family: De Pas

full_name: Tommaso De Pas

given: Tommaso

family: Gray

full_name: Jhanelle E. Gray

given: Jhanelle E.

family: Su

full_name: Wu-Chou Su

given: Wu-Chou

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Yoshioka

full_name: Hiroshige Yoshioka

given: Hiroshige

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

family: Dy

full_name: Grace K. Dy

given: Grace K.

family: Thongprasert

full_name: Sumitra Thongprasert

given: Sumitra

family: Reck

full_name: Martin Reck

given: Martin

family: Aimone

full_name: Paola Aimone

given: Paola

family: Vidam

full_name: Gena Atalla Vidam

given: Gena Atalla

family: Roussou

full_name: Pantelia Roussou

given: Pantelia

family: Wang

full_name: Ying A. Wang

given: Ying A.

family: Di Tomaso

full_name: Emmanuelle Di Tomaso

given: Emmanuelle

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

journal_name: Journal of Thoracic Oncology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_country:
Italy
United States
Brazil
Hong Kong
Netherlands
Germany
France
Japan
Thailand
Singapore
Hungary
Belgium
Argentina
Spain
Turkey
Canada
United Kingdom
Taiwan

location_facility: Arizona Oncology Associates Tucson (Rudasill & La Cholla)

location_facility: University of Pittsburgh Medical Center SC-2

location_facility: Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

location_facility: Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

location_facility: University of California at San Diego, Moores Cancer Ctr SC

location_facility: H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt

location_facility: MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)

location_facility: Washington University School of Medicine Washington University (16)

location_facility: Karmanos Cancer Institute Wayne St Karmanos

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: Virginia Oncology Associates VOA - Lake Wright (2)

location_facility: University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: University of Chicago Medical Center Unvi Chi

location_facility: Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Mayo Clinic - Arizona Mayo Scottsdale AZ

location_facility: University of Kansas Cancer Center Univ of KS

location_facility: Emory University School of Medicine/Winship Cancer Institute Emory 2

location_facility: Medical University of South Carolina MUSC

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med

location_facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

location_facility: Massachusetts General Hospital Mass General

location_facility: Memorial Sloan Kettering Cancer Center Sloan Kettering


title: A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin

summary: This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

lead_sponsor: GlaxoSmithKline

location_country:
United States
Sweden
Germany
France
Czechia
Japan
Poland
Norway
Hungary
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of


title: A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

summary: The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

ReferenceCitation: Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hébuterne X, Leong RW, Bressler B, Ullman T, Lakatos PL, Reinisch W, Xu LA, Luo A. Eldelumab [Anti-IP-10] Induction Therapy for Ulcerative Colitis: A Randomised, Placebo-Controlled, Phase 2b Study. J Crohns Colitis. 2016 Apr;10(4):418-28. doi: 10.1093/ecco-jcc/jjv224. Epub 2015 Dec 30.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Colombel

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Dryden

full_name: Gerald Dryden

given: Gerald

family: Hébuterne

full_name: Xavier Hébuterne

given: Xavier

family: Leong

full_name: Rupert W. Leong

given: Rupert W.

family: Bressler

full_name: Brian Bressler

given: Brian

family: Ullman

full_name: Thomas Ullman

given: Thomas

family: Lakatos

full_name: Peter L. Lakatos

given: Peter L.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Xu

full_name: Li-An Xu

given: Li-An

family: Luo

full_name: Allison Luo

given: Allison

journal_name: Journal of Crohn's and Colitis

location_country:
Italy
Austria
Brazil
South Africa
Mexico
Netherlands
Germany
France
Poland
Hungary
Australia
Belgium
United States
Canada

location_facility: Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

location_facility: University Of North Carolina At Chapel Hill

location_facility: Long Island Clinical Research Assoc., Llp

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Gastroenterology Research Of Tyler (Gerty)

location_facility: Gastroenterology Research Of San Antonio

location_facility: Gastroenterology Research Of New Orleans


title: An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL

summary: This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

ReferenceCitation: Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.

family: Assouline

full_name: Sarit Assouline

given: Sarit

family: Buccheri

full_name: Valeria Buccheri

given: Valeria

family: Delmer

full_name: Alain Delmer

given: Alain

family: Gaidano

full_name: Gianluca Gaidano

given: Gianluca

family: Trneny

full_name: Marek Trneny

given: Marek

family: Berthillon

full_name: Natalia Berthillon

given: Natalia

family: Brewster

full_name: Michael Brewster

given: Michael

family: Catalani

full_name: Olivier Catalani

given: Olivier

family: Li

full_name: Sai Li

given: Sai

family: McIntyre

full_name: Christine McIntyre

given: Christine

family: Sayyed

full_name: Pakeeza Sayyed

given: Pakeeza

family: Badoux

full_name: Xavier Badoux

journal_name: The Lancet Haematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Assouline S, Buccheri V, Delmer A, Gaidano G, McIntyre C, Brewster M, Catalani O, Hourcade-Potelleret F, Sayyed P, Badoux X. Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2015 Nov;80(5):1001-9. doi: 10.1111/bcp.12662. Epub 2015 Jul 29.

name: Jewish General Hospital; Montreal Canada

name: Hematology Division; Hospital das Clinicas da Faculdade de Medicina da Universidade de Săo Paulo; Săo Paulo Brazil

name: Hematologie Clinique; Hôpital Robert Debré; Reims France

name: Division of Hematology, Department of Translational Medicine; Amedeo Avogadro University of Eastern Piedmont; Novara Italy

name: Roche Products Ltd; Welwyn Garden City UK

name: F. Hoffmann-La Roche Ltd; Basel Switzerland

family: Hourcade-Potelleret

full_name: Florence Hourcade-Potelleret

given: Florence

name: Department of Haematology; St. George Hospital; Kogarah Australia

journal_name: British Journal of Clinical Pharmacology

ReferenceCitation: Mao CP, Brovarney MR, Dabbagh K, Birnböck HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

title: Subcutaneous versus Intravenous Administration of Rituximab: Pharmacokinetics, CD20 Target Coverage and B-Cell Depletion in Cynomolgus Monkeys

ReferenceCitation: Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

location_country:
Italy
Brazil
Chile
Mexico
Spain
Germany
Croatia
Czechia
France
Greece
Poland
Slovakia
Argentina
Australia
New Zealand
Portugal
Russian Federation
Canada
Turkey

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Hematologia

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Klinikum Frankfurt; Medizinische Klinik I

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

location_facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

location_facility: City Clinical Hospital After Botkin; Hematology

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

location_facility: Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo

location_facility: University Hospital; Clinic of Hematology & Transfusiology

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Royal Brisbane and Women'S Hospital; Haematology

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Gemeinschaftspraxis Dr. Siehl & Dr. Soeling

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Papageorgiou General Hospital of Thessaloniki; Hematology Clinic

location_facility: St George Hospital; Department of Haematology

location_facility: University Hospital and Medical School; IV.Dept. of Internal Medicine and Hematology

location_facility: Haematology Research Center; Haematology

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Wellington Hospital; Wellington Blood and Cancer Centre

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

location_facility: Policlinico G. B. Rossi; Divisione Di Ematologia

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: Clinical Hospital Merkur; Dept of Haematology


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

summary: The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

ReferenceCitation: Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, Shalimar, Buti M, Cox S, Parhy B, Zhou E, Martin R, Chang S, Lin L, Flaherty JF, Kitrinos KM, Gaggar A, Izumi N, Lim YS. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018 Sep 24;62(10). pii: e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

name: Gilead Sciences, Foster City, California, USA

family: Cathcart

full_name: Andrea L. Cathcart

given: Andrea L.

name: Department of Medicine and Therapeutics, Institute of Digestive Disease and State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong

family: Chan

full_name: Henry Lik-Yuen Chan

given: Henry Lik-Yuen

family: Bhardwaj

full_name: Neeru Bhardwaj

given: Neeru

family: Liu

full_name: Yang Liu

given: Yang

name: Service d'Hépatologie, Hôpital Beaujon, Clichy, France

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

name: Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Medical Center, NYU School of Medicine, New York, New York, USA

family: Pan

full_name: Calvin Q. Pan

given: Calvin Q.

name: Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India

family: Shalimar

full_name: Shalimar

name: Hospital Universitari Vall d'Hebron, Barcelona, Spain

family: Buti

full_name: Maria Buti

given: Maria

family: Cox

full_name: Stephanie Cox

given: Stephanie

family: Parhy

full_name: Bandita Parhy

given: Bandita

family: Zhou

full_name: Eric Zhou

given: Eric

family: Martin

full_name: Ross Martin

given: Ross

family: Chang

full_name: Silvia Chang

given: Silvia

family: Lin

full_name: Lanjia Lin

given: Lanjia

family: Flaherty

full_name: John F. Flaherty

given: John F.

family: Kitrinos

full_name: Kathryn M. Kitrinos

given: Kathryn M.

family: Gaggar

full_name: Anuj Gaggar

given: Anuj

name: Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan

family: Izumi

full_name: Namiki Izumi

given: Namiki

name: Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Lim

full_name: Young-Suk Lim

given: Young-Suk

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

ReferenceCitation: Seto WK, Asahina Y, Brown TT, Peng CY, Stanciu C, Abdurakhmanov D, Tabak F, Nguyen TT, Chuang WL, Inokuma T, Ikeda F, Santantonio TA, Habersetzer F, Ramji A, Lau AH, Suri V, Flaherty JF, Wang H, Gaggar A, Subramanian GM, Mukewar S, Brunetto MR, Fung S, Chan HL. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol. 2018 Jun 20. pii: S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. [Epub ahead of print]

journal_name: Clinical Gastroenterology and Hepatology

ReferenceCitation: Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Çelen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.

ReferenceCitation: Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22. Erratum in: Lancet Gastroenterol Hepatol. 2016 Nov;1(3):e2.

journal_name: The Lancet Gastroenterology & Hepatology

location_country:
Italy
United States
India
Hong Kong
France
Bulgaria
Japan
Poland
Romania
Singapore
Australia
Russian Federation
New Zealand
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: YR Gaitonde Centre for AIDS Research and Education

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

location_facility: S. R Kalla Memorial Gastro & General Hospital

location_facility: Peerless Hospital & B.K.Roy Research Center

location_facility: MHAT Alexandrovska Medical University, Sofia

location_facility: Waikato Hospital (District Health Board)

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Spitatul Clinic de Boli Infectioase Constanta

location_facility: Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"

location_facility: Severance Hospital Yonsei University Health System

location_facility: Pusan National University Yangsan Hospital

location_facility: Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon

location_facility: Policlinico Universitario G. Martino via Consolare

location_facility: University Health Network / Toronto General Hospital

location_facility: Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine

location_facility: 1st Moscow State Medical University University Clinical Hospital #3

location_facility: Seth GS Medical College and KEM Hospital

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Government Medical College and Superspecialty Hospital

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Institute of Clinical Immunology RAMS, Clinic of Immunopathology

location_facility: Dicle University Medical Faculty Department of Infectious Diseases

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Kyoto Prefectural University of Medicine

location_facility: Kaohsiung Med. College Hosp. Dept. of Internal Medicine

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals

location_facility: Seoul National University Bundang Hospital

location_facility: SoonChunHyang University Hospital Cheonan

location_facility: Scientific Research Institute of Nutrition

location_facility: University of Manitoba, Health Sciences Center

location_facility: People's Friendship University of Russia

location_facility: Kobe City Medical Center General Hospital

location_facility: Limited Liability Company "Modern Medicine Clinic"

location_facility: Keimyung University Dongsan Medical Center

location_facility: Scientific Research Institute of Clinical Immunology

location_facility: Gastrointestinal Research Institute (GIRI)

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: SPZOZ, Wojewódzki Specjalistyczny Szpital

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di

location_facility: Global Hospital Super Specialty & Transplant Centre