ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3:CD012862. doi: 10.1002/14651858.CD012862.pub2.

name: Department of Renal Medicine; Royal Infirmary of Edinburgh; Edinburgh UK

family: Pugh

full_name: Dan Pugh

given: Dan

name: Centre for Inflammation Research; Royal Infirmary of Edinburgh; Edinburgh UK

family: O'Sullivan

full_name: Eoin D O'Sullivan

given: Eoin D

family: Duthie

full_name: Fiona AI Duthie

given: Fiona AI

name: Department of Renal Medicine; Royal Free London NHS Foundation Trust; London UK

family: Masson

full_name: Philip Masson

given: Philip

name: Renal Department; Newcastle University/Freeman Hospital; Newcastle Upon Tyne UK

family: Kavanagh

full_name: David Kavanagh

given: David

ReferenceCitation: Tschumi S, Gugger M, Bucher BS, Riedl M, Simonetti GD. Eculizumab in atypical hemolytic uremic syndrome: long-term clinical course and histological findings. Pediatr Nephrol. 2011 Nov;26(11):2085-8. doi: 10.1007/s00467-011-1989-4. Epub 2011 Aug 30.

family: Tschumi

full_name: Sibylle Tschumi

given: Sibylle

family: Gugger

full_name: Mathias Gugger

given: Mathias

family: Bucher

full_name: Barbara S. Bucher

given: Barbara S.

family: Riedl

full_name: Magdalena Riedl

given: Magdalena

family: Simonetti

full_name: Giacomo D. Simonetti

given: Giacomo D.

journal_name: Pediatric Nephrology

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: reroDoc Digital Library

lead_sponsor: Alexion Pharmaceuticals

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

acronym: aHUS

title: An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome

summary: The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.


type: EudraCT Number

title: An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors

summary: The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gandara DR, Leighl N, Delord JP, Barlesi F, Bennouna J, Zalcman G, Infante JR, Reckamp KL, Kelly K, Shepherd FA, Mazieres J, Janku F, Gardner OS, Mookerjee B, Wu Y, Cox DS, Schramek D, Peddareddigari V, Liu Y, D'Amelio AM Jr, Blumenschein G Jr. A Phase 1/1b Study Evaluating Trametinib Plus Docetaxel or Pemetrexed in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Mar;12(3):556-566. doi: 10.1016/j.jtho.2016.11.2218. Epub 2016 Nov 19.

family: Gandara

full_name: David R. Gandara

given: David R.

sequence: first

family: Leighl

full_name: Natasha Leighl

given: Natasha

sequence: additional

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Zalcman

full_name: Gerald Zalcman

given: Gerald

family: Infante

full_name: Jeffrey R. Infante

given: Jeffrey R.

family: Reckamp

full_name: Karen L. Reckamp

given: Karen L.

family: Kelly

full_name: Karen Kelly

given: Karen

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Janku

full_name: Filip Janku

given: Filip

family: Gardner

full_name: Olivia S. Gardner

given: Olivia S.

family: Mookerjee

full_name: Bijoyesh Mookerjee

given: Bijoyesh

family: Wu

full_name: Yuehui Wu

given: Yuehui

family: Cox

full_name: Donna S. Cox

given: Donna S.

family: Schramek

full_name: Dan Schramek

family: Peddareddigari

full_name: Vijay Peddareddigari

given: Vijay

family: Liu

full_name: Yuan Liu

given: Yuan

family: D'Amelio

full_name: Anthony M. D'Amelio

given: Anthony M.

suffix: Jr.

family: Blumenschein

full_name: George Blumenschein

given: George

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Thoracic Oncology

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: A Phase 1/1b Study Evaluating Trametinib Plus Docetaxel or Pemetrexed in Patients With Advanced Non–Small Cell Lung Cancer

location_country:
United States
Canada
France
Korea, Republic of


title: Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro™ Tablets, QD, Compared to Prograf® Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant

summary: This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Veloxis Pharmaceuticals

location_country:
Italy
Brazil
Sweden
Serbia
Mexico
Germany
France
Poland
Singapore
Argentina
Australia
New Zealand
Spain
United States
Korea, Republic of

location_facility:
Clinical Site 54163
Clinical Site 1035
Clinical Site 1006
Clinical Site 1044
Clinical Site 1050
Clinical Site 34157
Clinical Site 381141
Clinical Site 49137
Clinical Site 1055
Clinical Site 1018
Clinical Site 33134
Clinical Site 49139
Clinical Site 61101
Clinical Site 1012
Clinical Site 55179
Clinical Site 61106
Clinical Site 52184
Clinical Site 55172
Clinical Site 1042
Clinical Site 55171
Clinical Site 1020
Clinical Site 64112
Clinical Site 1009
Clinical Site 1051
Clinical Site 61104
Clinical Site 39144
Clinical Site 1061
Clinical Site 34151
Clinical Site 1045
Clinical Site 64121
Clinical Site 1052
Clinical Site 1023
Clinical Site 48151
Clinical Site 1048
Clinical Site 52182
Clinical Site 33132
Clinical Site 381140
Clinical Site 1031
Clinical Site 52183
Clinical Site 55178
Clinical Site 1037
Clinical Site 1054
Clinical Site 52181
Clinical Site 1010
Clinical Site 1003
Clinical Site 1053
Clinical Site 1027
Clinical Site 1032
Clinical Site 92113
Clinical Site 1013
Clinical Site 1026
Clinical Site 1049
Clinical Site 1039
Clinical Site 55173
Clinical Site 1011
Clinical Site 34155
Clinical Site 1019
Clinical Site 1047
Clinical Site 1060
Clinical Site 48148
Clinical Site 1058
Clinical Site 54164
Clinical Site 61105
Clinical Site 381142
Clinical Site 48149
Clinical Site 1046
Clinical Site 1005
Clinical Site 1008
Clinical Site 1056
Clinical Site 1033
Clinical Site 61100
Clinical Site 1040
Clinical Site 1021
Clinical Site 65126
Clinical Site 1014
Clinical Site 61102
Clinical Site 65127
Clinical Site 1025
Clinical Site 55175
Clinical Site 33136
Clinical Site 1038
Clinical Site 1029
Clinical Site 33131
Clinical Site 1036
Clinical Site 46161
Clinical Site 1022

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: background

ReferenceCitation: Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.

ReferenceCitation: Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11.

ReferenceType: result

ReferenceCitation: Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

family: Marso

full_name: Steven P. Marso

given: Steven P.

family: Daniels

full_name: Gilbert H. Daniels

given: Gilbert H.

family: Brown-Frandsen

full_name: Kirstine Brown-Frandsen

given: Kirstine

family: Kristensen

full_name: Peter Kristensen

given: Peter

family: Mann

full_name: Johannes F.E. Mann

given: Johannes F.E.

family: Nauck

full_name: Michael A. Nauck

given: Michael A.

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

family: Pocock

full_name: Stuart Pocock

given: Stuart

family: Poulter

full_name: Neil R. Poulter

given: Neil R.

family: Ravn

full_name: Lasse S. Ravn

given: Lasse S.

family: Steinberg

full_name: William M. Steinberg

given: William M.

family: Stockner

full_name: Mette Stockner

given: Mette

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: Bergenstal

full_name: Richard M. Bergenstal

given: Richard M.

family: Buse

full_name: John B. Buse

given: John B.

journal_name: New England Journal of Medicine

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Imperial College London - Spiral

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: Koç University - Digital Collections portal

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_institution: Koç University - Digital Collections portal

repositories_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

title: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

ReferenceCitation: Petrie JR, Marso SP, Bain SC, Franek E, Jacob S, Masmiquel L, Leiter LA, Haluzik M, Satman I, Omar M, Shestakova M, Van Gaal L, Mann JF, Baeres FM, Zinman B, Poulter NR; LEADER investigators. LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial. J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

publisher: Ovid Technologies (Wolters Kluwer Health)

title: LEADER-4

ReferenceCitation: Masmiquel L, Leiter LA, Vidal J, Bain S, Petrie J, Franek E, Raz I, Comlekci A, Jacob S, van Gaal L, Baeres FM, Marso SP, Eriksson M; LEADER investigators. LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial. Cardiovasc Diabetol. 2016 Feb 10;15:29. doi: 10.1186/s12933-016-0341-5.

ReferenceCitation: Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Ørsted D, F Mann J; LEADER Trial Investigators. LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population. J Diabetes Complications. 2016 Nov - Dec;30(8):1631-1639. doi: 10.1016/j.jdiacomp.2016.06.001. Epub 2016 Jun 3.

journal_name: Journal of Diabetes and its Complications

title: LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population

ReferenceCitation: Rutten GE, Tack CJ, Pieber TR, Comlekci A, Ørsted DD, Baeres FM, Marso SP, Buse JB; LEADER Investigators. LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ. Diabetol Metab Syndr. 2016 Jun 2;8:37. doi: 10.1186/s13098-016-0153-5. eCollection 2016.

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

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

title: LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ

ReferenceCitation: Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2.

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repositories_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

title: Design of the liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results (LEADER) trial

ReferenceCitation: Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JF, Steen Ravn L, Moses AC, Stockner M, Baeres FM, Marso SP, Buse JB; LEADER Trial investigators. LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial. Pancreas. 2014 Nov;43(8):1223-31. doi: 10.1097/MPA.0000000000000229.

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

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

title: LEADER 3—Lipase and Amylase Activity in Subjects With Type 2 Diabetes

ReferenceCitation: Daniels GH, Hegedüs L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann JF, Derving Karsbøl J, Moses AC, Buse JB, Tuttle RM; LEADER Trial Investigators. LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations. Diabetes Obes Metab. 2015 May;17(5):477-86. doi: 10.1111/dom.12444. Epub 2015 Feb 23.

name: Thyroid Unit and Department of Medicine Massachusetts General Hospital, Harvard Medical School  Boston MA USA

name: Department of Endocrinology and Metabolism Odense University Hospital, University of Southern Denmark  Odense Denmark

name: Division of Cardiology, Department of Internal Medicine University of Texas Southwestern  Dallas TX USA

name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto  Toronto Canada

name: International Diabetes Center at Park Nicollet  Minneapolis MN USA

name: Dept. of Nephrology, Hypertension & Rheumatology, Friedrich Alexander University of Erlangen  Munchen Germany

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

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

name: on behalf of the LEADER trial investigators

title: LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the L iraglutide E ffect and A ction in D iabetes: E valuation of cardiovascular outcome R esults ( LEADER ) trial: preliminary observations

ReferenceCitation: Steinberg WM, Buse JB, Ghorbani MLM, Ørsted DD, Nauck MA; LEADER Steering Committee; LEADER Trial Investigators. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Diabetes Care. 2017 Jul;40(7):966-972. doi: 10.2337/dc16-2747. Epub 2017 May 5.

ReferenceCitation: Mann JFE, Ørsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornøe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/NEJMoa1616011.

repository_institution: James Cook University - ResearchOnline at James Cook University

repositories_institution: James Cook University - ResearchOnline at James Cook University

title: Liraglutide and Renal Outcomes in Type 2 Diabetes

ReferenceCitation: Hegedüs L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbøl JD, Daniels GH; LEADER Publication Committee on behalf of the LEADER Trial Investigators. No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial. Diabetes Care. 2018 Mar;41(3):620-622. doi: 10.2337/dc17-1956. Epub 2017 Dec 26.

ReferenceCitation: Marso SP, Nauck MA, Monk Fries T, Rasmussen S, Treppendahl MB, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therapy (from the LEADER Trial). Am J Cardiol. 2018 Jun 15;121(12):1467-1470. doi: 10.1016/j.amjcard.2018.02.030. Epub 2018 Mar 15.

ReferenceCitation: Verma S, Bhatt DL, Bain SC, Buse JB, Mann JFE, Marso SP, Nauck MA, Poulter NR, Pratley RE, Zinman B, Michelsen MM, Monk Fries T, Rasmussen S, Leiter LA; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial. Circulation. 2018 May 15;137(20):2179-2183. doi: 10.1161/CIRCULATIONAHA.118.033898.

name: St. Michael’s Hospital, and Departments of Surgery and Pharmacology and Toxicology (S.V.)

name: Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.)

name: Institute of Life Science, Swansea University, United Kingdom (S.C.B.)

name: University of North Carolina School of Medicine, Chapel Hill (J.B.B.)

name: Friedrich Alexander University of Erlangen, Germany (J.F.E.M.)

name: HCA Midwest Health Heart and Vascular Institute, Kansas City, MO (S.P.M.)

name: Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Germany (M.A.N.)

name: Faculty of Medicine, National Heart & Lung Institute, Imperial College London, United Kingdom (N.R.P.)

name: Florida Hospital Translational Research Institute for Metabolism and Diabetes, Orlando, FL (R.E.P.)

name: Lunenfeld Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Canada (B.Z.)

name: Novo Nordisk A/S, Søborg, Denmark (M.M.M., T.M.F., S.R.).

name: Li Ka Shing Knowledge Institute (L.A.L.)

repositories_institution:
Imperial College London - Spiral
Swansea University - Cronfa

title: Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease

ReferenceCitation: Nauck MA, Jensen TJ, Rosenkilde C, Calanna S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial. Diabetes Care. 2018 Aug;41(8):1663-1671. doi: 10.2337/dc17-1825. Epub 2018 Jun 13.

name: the LEADER Publication Committee on behalf of the LEADER Trial Investigators

title: Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial

ReferenceCitation: Zinman B, Marso SP, Christiansen E, Calanna S, Rasmussen S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience. Diabetes Care. 2018 Aug;41(8):1783-1791. doi: 10.2337/dc17-2677. Epub 2018 Jun 14.

title: Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience

ReferenceCitation: Nauck MA, Tornøe K, Rasmussen S, Treppendahl MB, Marso SP; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Cardiovascular outcomes in patients who experienced a myocardial infarction while treated with liraglutide versus placebo in the LEADER trial. Diab Vasc Dis Res. 2018 Sep;15(5):465-468. doi: 10.1177/1479164118783935. Epub 2018 Jun 27.

name: Diabetes Center Bochum-Hattingen, Medical Department I, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany

name: Heart & Vascular Institute, HCA Midwest Health, Kansas City, MO, USA

ReferenceCitation: Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornøe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators. The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Diabetes Care. 2018 Oct;41(10):2229-2235. doi: 10.2337/dc18-1094. Epub 2018 Aug 2.

ReferenceCitation: Verma S, Leiter LA, Mazer CD, Bain SC, Buse J, Marso S, Nauck M, Zinman B, Bosch-Traberg H, Rasmussen S, Michelsen MM, Bhatt DL. Liraglutide Reduces Cardiovascular Events and Mortality in Type 2 Diabetes Mellitus Independently of Baseline Low-Density Lipoprotein Cholesterol Levels and Statin Use. Circulation. 2018 Oct 9;138(15):1605-1607. doi: 10.1161/CIRCULATIONAHA.118.036862.

name: Division of Cardiac Surgery, St. Michael’s Hospital and University of Toronto, Ontario, Canada (S.V.).

name: Division of Endocrinology and Metabolism, St. Michael’s Hospital, and University of Toronto, Ontario, Canada (L.A.L.).

name: Department of Anasthesia, St. Michael’s Hospital, and University of Toronto, Ontario, Canada (C.D.M.).

name: Institute of Life Science, Swansea University, United Kingdom (S.C.B.).

name: University of North Carolina School of Medicine, Chapel Hill, NC (J.B.).

name: HCA Midwest Health Heart and Vascular Institute, Kansas City, MO (S.M.).

name: Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University Bochum, Germany (M.N.).

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Ontario, Canada (B.Z.).

name: Novo Nordisk A/S, Søborg, Denmark (H.B.-T., S.R., M.M.M.).

name: Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).

name: The LEADER Publication Committee on behalf of the LEADER Trial Investigators

ReferenceCitation: Mann JFE, Fonseca V, Mosenzon O, Raz I, Goldman B, Idorn T, von Scholten BJ, Poulter NR. Effects of Liraglutide Versus Placebo on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease. Circulation. 2018 Dec 18;138(25):2908-2918. doi: 10.1161/CIRCULATIONAHA.118.036418.

name: Kuratorium für Dialyse Kidney Center, Munich, Germany (J.F.E.M.).

name: Department of Nephrology, Friedrich Alexander University of Erlangen, Germany (J.F.E.M.).

name: Division of Endocrinology, Tulane University Health Sciences Center, School of Medicine, New Orleans, LA (V.F.).

name: Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).

name: Novo Nordisk A/S, Søborg, Denmark (B.G., T.I., B.J.v.S.).

name: Imperial Clinical Trials Unit, Imperial College London, UK (N.R.P.).

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Verma S, Poulter NR, Bhatt DL, Bain SC, Buse JB, Leiter LA, Nauck MA, Pratley RE, Zinman B, Ørsted DD, Monk Fries T, Rasmussen S, Marso SP. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke. Circulation. 2018 Dec 18;138(25):2884-2894. doi: 10.1161/CIRCULATIONAHA.118.034516.

name: Division of Cardiac Surgery (S.V.), Canada.

name: Imperial College London, United Kingdom (N.R.P.).

name: University of North Carolina School of Medicine, Chapel Hill (J.B.B.).

name: St Michael’s Hospital and University of Toronto (L.A.L.), Canada.

name: Diabetes Center Bochum-Hattingen, St Josef-Hospital, Ruhr-University Bochum, Germany (M.A.N.).

name: Florida Hospital Translational Research Institute for Metabolism and Diabetes, Orlando (R.E.P.).

name: Lunenfeld Tanebaum Research Institute, Mount Sinai Hospital, University of Toronto, Canada (B.Z.).

name: Novo Nordisk A/S, Søborg, Denmark (D.D.Ø., T.M.F., S.R.).

name: Hospital Corporation of America (HCA) Midwest Health Heart & Vascular Institute, Kansas City, MO (S.P.M.).

name: For the LEADER Publication Committee on Behalf of the LEADER Trial Investigators

ReferenceCitation: Nauck MA, Buse JB, Mann JFE, Pocock S, Bosch-Traberg H, Frimer-Larsen H, Ye Q, Gray A; LEADER Publication Committee for the LEADER Trial Investigators. Health-related quality of life in people with type 2 diabetes participating in the LEADER trial. Diabetes Obes Metab. 2019 Mar;21(3):525-532. doi: 10.1111/dom.13547. Epub 2018 Oct 25.

name: Diabetes Centre Bochum-Hattingen, Medical Department I; St. Josef-Hospital, Ruhr-University; Bochum Germany

name: Division of Endocrinology, Department of Medicine; University of North Carolina School of Medicine; Chapel Hill North Carolina

name: Department of Nephrology; Friedrich Alexander University of Erlangen; Erlangen Germany

name: Department of Medical Statistics; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine; London UK

name: Nuffield Department of Population Health; Health Economics Research Centre, University of Oxford; Oxford UK

name: LEADER Publication Committee for the LEADER Trial Investigators

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

title: Health-related quality of life in people with type 2 diabetes participating in the LEADER trial

ReferenceCitation: Zinman B, Nauck MA, Bosch-Traberg H, Frimer-Larsen H, Ørsted DD, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Liraglutide and Glycaemic Outcomes in the LEADER Trial. Diabetes Ther. 2018 Dec;9(6):2383-2392. doi: 10.1007/s13300-018-0524-z. Epub 2018 Nov 3.

title: Liraglutide and Glycaemic Outcomes in the LEADER Trial

ReferenceCitation: Gilbert MP, Bain SC, Franek E, Jodar-Gimeno E, Nauck MA, Pratley R, Réa RR, Kerr Saraiva JF, Rasmussen S, Tornøe K, von Scholten BJ, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial. Ann Intern Med. 2019 Mar 19;170(6):423-426. doi: 10.7326/M18-1569. Epub 2018 Dec 4.

name: Larner College of Medicine at The University of Vermont, South Burlington, Vermont (M.P.G.)

name: Institute of Life Science, Swansea University Medical School, Singleton Hospital, Swansea, United Kingdom (S.C.B.)

name: Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland (E.F.)

name: Quirónsalud Madrid and Ruber Juan Bravo University Hospitals, Universidad Europea de Madrid, Madrid, Spain (E.J.)

name: Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University of Bochum, Bochum, Germany (M.A.N.)

name: Florida Hospital Diabetes Institute, Florida Hospital Translational Research Institute for Metabolism and Diabetes, Orlando, Florida (R.P.)

name: Hospital de Clínicas da Universidade Federal do Paraná, Curitiba, Brazil (R.R.R.)

name: Pontifícia Universidade Católica de Campinas, Campinas, Brazil (J.F.K.)

name: Novo Nordisk A/S, Søborg, Denmark (S.R., K.T., B.J.V.)

name: Diabetes Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina (J.B.B.)

name: and the LEADER Publication Committee on behalf of the LEADER Trial Investigators

title: Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial

ReferenceCitation: Heller SR, Geybels MS, Iqbal A, Liu L, Wagner L, Chow E. A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study. Diabetologia. 2021 Oct 26. doi: 10.1007/s00125-021-05556-7. [Epub ahead of print]

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Persson F, Bain SC, Mosenzon O, Heerspink HJL, Mann JFE, Pratley R, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Rossing P; LEADER Trial Investigators. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial. Diabetes Care. 2021 Apr;44(4):1020-1026. doi: 10.2337/dc20-1622. Epub 2021 Jan 27.

title: Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial

ReferenceCitation: Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4.

name: Li Ka Shing Knowledge Institute, St. Michael's Hospital and University of Toronto  Toronto Ontario Canada

name: Division of Cardiology University of Texas Southwestern Medical Center  Dallas Texas USA

name: Institute of Life Science, Swansea University  Swansea UK

name: Brigham and Women's Hospital Heart and Vascular Center & Harvard Medical School  Boston Massachusetts USA

name: AdventHealth Translational Research Institute  Orlando Florida USA

name: Lunenfeld–Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto  Toronto Ontario Canada

name: University of North Carolina School of Medicine  Chapel Hill North Carolina USA

title: Effects of glucagon‐like peptide‐1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials

ReferenceCitation: Crowley MJ, McGuire DK, Alexopoulos AS, Jensen TJ, Rasmussen S, Saevereid HA, Verma S, Buse JB. Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial. Diabetes Care. 2020 Sep;43(9):e108-e110. doi: 10.2337/dc20-0437. Epub 2020 Jul 9.

ReferenceCitation: Verma S, Bain SC, Honoré JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12.

name: St. Michael's Hospital and University of Toronto  Toronto Ontario Canada

name: Swansea University Medical School  Swansea UK

name: KfH Kidney Center, Munich, and Department of Nephrology Friedrich Alexander University of Erlangen  Erlangen Germany

name: Diabetes Center Bochum‐Hattingen St Josef Hospital (Ruhr‐Universität Bochum)  Bochum Germany

name: Lunenfeld–Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto  Toronto Ontario Canada

ReferenceCitation: Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3.

name: Li Ka Shing Knowledge InstituteSt. Michael's Hospital and University of Toronto Toronto Ontario Canada

name: Institute of Life ScienceSwansea University Swansea UK

name: Brigham and Women's Hospital Heart and Vascular Center & Harvard Medical School Boston Massachusetts USA

name: University of North Carolina School of Medicine Chapel Hill North Carolina USA

name: AdventHealth Hospital Translational Research Institute Orlando Florida USA

title: The effect of glucagon‐like peptide‐1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials

ReferenceCitation: Buse JB, Bain SC, Mann JFE, Nauck MA, Nissen SE, Pocock S, Poulter NR, Pratley RE, Linder M, Monk Fries T, Ørsted DD, Zinman B; LEADER Trial Investigators. Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial. Diabetes Care. 2020 Jul;43(7):1546-1552. doi: 10.2337/dc19-2251. Epub 2020 May 4.

title: Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial

ReferenceCitation: Marso SP, Baeres FMM, Bain SC, Goldman B, Husain M, Nauck MA, Poulter NR, Pratley RE, Thomsen AB, Buse JB; LEADER Trial Investigators. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure. J Am Coll Cardiol. 2020 Mar 17;75(10):1128-1141. doi: 10.1016/j.jacc.2019.12.063.

journal_name: Journal of the American College of Cardiology

title: Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure

ReferenceCitation: Mann JFE, Fonseca VA, Poulter NR, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Mosenzon O; LEADER Trial Investigators. Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease. Clin J Am Soc Nephrol. 2020 Apr 7;15(4):465-473. doi: 10.2215/CJN.11881019. Epub 2020 Mar 4.

name: on behalf of the LEADER Trial Investigators

journal_name: Clinical Journal of the American Society of Nephrology

title: Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease

ReferenceCitation: Nauck MA, Kreiner E, Rasmussen S, Saevereid HA, Buse JB; LEADER Trial Investigators. Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920. Diabetes Care. 2020 Feb;43(2):e30-e31. doi: 10.2337/dci19-0067.

title: Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912–1920

ReferenceCitation: Verma S, Bain SC, Buse JB, Idorn T, Rasmussen S, Ørsted DD, Nauck MA. Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2019 Dec 1;4(12):1214-1220. doi: 10.1001/jamacardio.2019.3080.

name: Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada

name: Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, United Kingdom

name: Department of Medicine, University of North Carolina School of Medicine at Chapel Hill, Chapel Hill

name: Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: Nauck MA, Muus Ghorbani ML, Kreiner E, Saevereid HA, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care. 2019 Oct;42(10):1912-1920. doi: 10.2337/dc19-0415. Epub 2019 Aug 9.

ReferenceCitation: Tack CJ, Jacob S, Desouza C, Bain SC, Buse JB, Nauck MA, Petrie JR, Poulter NR, Pratley RE, Stegmann HVBK, Bosch-Traberg H, Startseva E, Zinman B; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial. Diabetes Obes Metab. 2019 Nov;21(11):2450-2458. doi: 10.1111/dom.13826. Epub 2019 Jul 7.

name: Radboud University Medical Center Nijmegen Nijmegen the Netherlands

name: Praxis für Prävention und TherapieKardio Metabolisches Institut Villingen‐Schwenningen Germany

name: Veterans Affairs Medical Center Omaha Nebraska

name: Swansea University Medical School Swansea UK

name: University of North Carolina School of Medicine Chapel Hill North Carolina

name: Diabetes Center Bochum‐HattingenSt Josef Hospital (Ruhr‐Universität Bochum) Bochum Germany

name: Institute of Cardiovascular and Medical SciencesUniversity of Glasgow Glasgow UK

name: International Centre for Circulatory HealthImperial College London London UK

name: AdventHealth Translational Research Institute Orlando Florida

name: Lunenfeld–Tanenbaum Research Institute, Mt. Sinai HospitalUniversity of Toronto Toronto Canada

title: Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Poland
Norway
Canada
Korea, Republic of
South Africa
Sweden
United Arab Emirates
Netherlands
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


title: A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B

acronym: EPIC B

summary: The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric population. Family history and history of HBV transmission is essential to assess the course of the disease and can be used to determine the best mode of treatment This information will be used to assist with the feasibility and design of studies for the Novartis clinical pediatric development program, as the current epidemiology of ediatric CHB is not accurately known in Western countries or the rest of the world making pediatric studies difficult to plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a post marketing approval commitment to the EMEA Pediatric Committee.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
Peru
India
Spain
Philippines
France
Poland
Greece
Thailand
Romania
Singapore
Argentina
Russian Federation
China
United States
United Kingdom
Taiwan

location_facility: The First Affiliated Hospital of Lanzhou University

location_facility: Research Institute for Infectious Childhood Diseases

location_facility: Istituto G. Gaslini Ospedale Pediatrico IRCCS

location_facility: Central Research Institute for Epidemiology of Rospotrebnadz

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Institute of Hematol., Union Hospital, Tongji Med. College

location_facility: University General Hospital of Heraklion, Heraklion

location_facility: Hospital Oswaldo Cruz - Universidade de Pernambuco

location_facility: St. John's Medical College Hospital, Banglaore

location_facility: Hebei Medical University The Third Hospital, Shijiazhuang

location_facility: Second Hospital of Xian Jiaotong University

location_facility: Maulana Azad Medical College & LNJP Hospital

location_facility: The Third Xiangya Hospital of Central South University, Changsha

location_facility: First Hospital University of Jilin, Changchun

location_facility: V. Babes Pneumology and Infectious Diseases Clin. Hosp

location_facility: Saint- Petersburg State Mtchnikov's Medical Academy

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux

location_facility: 1st Affliated Hospital of 3rd Military Med. Univ. of PLA

location_facility: Peripheral University General Hospital of Alexandroupoli

location_facility: The First Affiliated Hospital of Chongqing Med. University

location_facility: Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou

location_facility: Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi

location_facility: Saint Vincent Healthcare Pediatric Specialty Clinics

location_facility: "Agia Sofia" Childrens Hospital of Athens

location_facility: Hospital of Chengdu Military Area Command, Kunming

location_facility: Childrens' General Hospital of Athens 'P&A Kyriakou'

location_facility: "Matei Bals" Institute of Infectious Diseases

location_facility: Hospital Universitario San Cecilio, Granada

location_facility: Hospital de Clínicas de Porto Alegre, Porto

location_facility: Shands Hospital at University of Florida

location_facility: Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia

location_facility: The First Affiliated Hospital of Medical College, Kunming

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal

location_facility: Research Institute for Tropical Medicine

location_facility: National Kidney and Transplant Institute


title: Study of GSK2302032A Antigen-Specific Cancer Immunotherapeutic in Patients With Resectable Non-Small Cell Lung Cancer

summary: The purpose of this clinical study is to assess the safety and immunogenicity of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.

status: Terminated

ReferenceCitation: Pujol JL, De Pas T, Rittmeyer A, Vallières E, Kubisa B, Levchenko E, Wiesemann S, Masters GA, Shen R, Tjulandin SA, Hofmann HS, Vanhoutte N, Salaun B, Debois M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non-Small Cell Lung Cancer: A Phase I Dose Escalation Study. J Thorac Oncol. 2016 Dec;11(12):2208-2217. doi: 10.1016/j.jtho.2016.08.120. Epub 2016 Aug 17.

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

family: De Pas

full_name: Tommaso De Pas

given: Tommaso

family: Rittmeyer

full_name: Achim Rittmeyer

given: Achim

family: Vallières

full_name: Eric Vallières

given: Eric

family: Kubisa

full_name: Bartosz Kubisa

given: Bartosz

family: Levchenko

full_name: Eugeny Levchenko

given: Eugeny

family: Wiesemann

full_name: Sebastian Wiesemann

given: Sebastian

family: Masters

full_name: Gregory A. Masters

given: Gregory A.

family: Shen

full_name: Robert Shen

given: Robert

family: Tjulandin

full_name: Sergei A. Tjulandin

given: Sergei A.

family: Hofmann

full_name: Hans-Stefan Hofmann

given: Hans-Stefan

family: Vanhoutte

full_name: Nicolas Vanhoutte

given: Nicolas

family: Salaun

full_name: Bruno Salaun

given: Bruno

family: Debois

full_name: Muriel Debois

given: Muriel

family: Jarnjak

full_name: Silvija Jarnjak

given: Silvija

family: De Sousa Alves

full_name: Pedro Miguel De Sousa Alves

given: Pedro Miguel

family: Louahed

full_name: Jamila Louahed

given: Jamila

family: Brichard

full_name: Vincent G. Brichard

given: Vincent G.

family: Lehmann

full_name: Frédéric F. Lehmann

given: Frédéric F.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non–Small Cell Lung Cancer: A Phase I Dose Escalation Study

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

location_country:
Italy
United States
France
Poland
Russian Federation
Germany


ReferenceCitation: Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Mück W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.

family: Willmann

full_name: Stefan Willmann

given: Stefan

family: Thelen

full_name: Kirstin Thelen

given: Kirstin

family: Kubitza

full_name: Dagmar Kubitza

given: Dagmar

family: Lensing

full_name: Anthonie W. A. Lensing

given: Anthonie W. A.

family: Frede

full_name: Matthias Frede

given: Matthias

family: Coboeken

full_name: Katrin Coboeken

given: Katrin

family: Stampfuss

full_name: Jan Stampfuss

given: Jan

family: Burghaus

full_name: Rolf Burghaus

given: Rolf

family: Mück

full_name: Wolfgang Mück

given: Wolfgang

family: Lippert

full_name: Jörg Lippert

given: Jörg

bso_classification: Chemistry

currency_apc_doaj: GBP

journal_name: Thrombosis Journal

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandão LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.

family: Becka

full_name: Michael Becka

given: Michael

family: Young

full_name: Guy Young

given: Guy

family: Brandão

full_name: Leonardo R. Brandão

given: Leonardo R.

family: Monagle

full_name: Paul Monagle

given: Paul

family: Male

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Mück W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.

title: Development of a Paediatric Population-Based Model of the Pharmacokinetics of Rivaroxaban

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Israel
Ireland
Australia
Canada

title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

summary: The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.


ReferenceCitation: Keystone EC, Ahmad HA, Yazici Y, Bergman MJ. Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials. Rheumatology (Oxford). 2020 Aug 1;59(8):2090-2098. doi: 10.1093/rheumatology/kez455.

name: Department of Rheumatology, University of Toronto, Toronto, ON, Canada

family: Keystone

full_name: Edward C Keystone

given: Edward C

name: Rheumatology, Bristol-Myers Squibb, Princeton, NJ

family: Ahmad

full_name: Harris A Ahmad

given: Harris A

name: Department of Internal Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY

family: Yazici

full_name: Yusuf Yazici

given: Yusuf

name: Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA

family: Bergman

full_name: Martin J Bergman

given: Martin J

journal_name: Rheumatology

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Ahmad HA, Baker JF, Østergaard M, Ye J, Emery P, Conaghan PG. Determining MRI Inflammation Targets When Considering a Rheumatoid Arthritis Treat-to-Target Strategy: Results of a Randomized, Placebo-Controlled Trial. Adv Ther. 2019 Sep;36(9):2384-2393. doi: 10.1007/s12325-019-01020-6. Epub 2019 Jul 5.

full_name: Harris A. Ahmad

given: Harris A.

family: Baker

full_name: Joshua F. Baker

given: Joshua F.

family: Østergaard

full_name: Mikkel Østergaard

given: Mikkel

family: Ye

full_name: June Ye

given: June

family: Emery

full_name: Paul Emery

family: Conaghan

full_name: Philip G. Conaghan

given: Philip G.

journal_name: Advances in Therapy

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

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
eprints.whiterose.ac.uk

ReferenceCitation: Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Maldonado MA, Huizinga TW. Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study. RMD Open. 2019 Feb 8;5(1):e000840. doi: 10.1136/rmdopen-2018-000840. eCollection 2019.

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

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

repositories:
HAL
PubMed Central
eprints.whiterose.ac.uk

ReferenceCitation: Bykerk VP, Burmester GR, Combe BG, Furst DE, Huizinga TWJ, Ahmad HA, Emery P. On-drug and drug-free remission by baseline symptom duration: abatacept with methotrexate in patients with early rheumatoid arthritis. Rheumatol Int. 2018 Dec;38(12):2225-2231. doi: 10.1007/s00296-018-4173-3. Epub 2018 Oct 20. Erratum in: Rheumatol Int. 2019 Feb 5;:.

ReferenceCitation: Peterfy C, Burmester GR, Bykerk VP, Combe BG, DiCarlo JC, Furst DE, Huizinga TW, Wong DA, Conaghan PG, Emery P. Sustained improvements in MRI outcomes with abatacept following the withdrawal of all treatments in patients with early, progressive rheumatoid arthritis. Ann Rheum Dis. 2016 Aug;75(8):1501-5. doi: 10.1136/annrheumdis-2015-208258. Epub 2016 Feb 10.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Barré E, Karyekar CS, Wong DA, Huizinga TW. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015 Jan;74(1):19-26. doi: 10.1136/annrheumdis-2014-206106. Epub 2014 Nov 3.

location_country:
Italy
United States
South Africa
Sweden
Mexico
Germany
Finland
France
Poland
Belgium
Australia
Russian Federation
Denmark
Canada
Korea, Republic of

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Johns Hopkins University Division Of Rheumatology

title: A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

summary: The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.


title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus

summary: The primary objective of this study is to evaluate the efficacy of a 200-mcg dose of CEP-33457 compared with placebo in patients with active systemic lupus erythematosus (SLE) as assessed by the proportion of patients achieving a combined clinical response using the SLE responder index (SRI) at week 24.

lead_sponsor: Cephalon

location_country:
United States
United Kingdom
Spain
France
Poland
Hungary
Belgium
Portugal
Germany
Czech Republic
Ukraine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Unica

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Institute of Cardiology named after Strazhesko

location_facility: Scott - White Clinic/Texas A and M University

location_facility: Feinstein Institute for Medical Research

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Országos Reumatológiai és Fizioterápiás Intézet

location_facility: Box Arthritis and Rheumatology of the Carolinas PLLC

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Regional Clinical Hospital for Professional Diseases

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum


title: EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion

acronym: Evolve

summary: The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.

ReferenceCitation: Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Valdés Chávarri M, West NE, Kelbæk H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjögren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 Jul;9(3):308-15. doi: 10.4244/EIJV9I3A52.

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Verheye

full_name: Stefan Verheye

given: Stefan

family: Weissman

full_name: Neil J. Weissman

given: Neil J.

family: Barragan

full_name: Paul Barragan

family: Scott

full_name: Douglas Scott

given: Douglas

family: Valdés Chávarri

full_name: Mariano Valdés Chávarri

given: Mariano

family: West

full_name: Nick E. J. West

given: Nick E. J.

family: Kelbæk

full_name: Henning Kelbæk

given: Henning

family: Whitbourn

full_name: Robert Whitbourn

given: Robert

family: Walters

full_name: Darren L. Walters

given: Darren L.

family: Kubica

full_name: Jacek Kubica

given: Jacek

family: Thuesen

full_name: Leif Thuesen

given: Leif

family: Masotti

full_name: Monica Masotti

given: Monica

family: Banning

full_name: Adrian Banning

given: Adrian

family: Sjögren

full_name: Iwar Sjögren

given: Iwar

family: Stables

full_name: Rod H. Stables

given: Rod H.

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

ReferenceCitation: Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Chávarri MV, West NE, Kelbæk H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjögren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 May 22. pii: 20130416-02. [Epub ahead of print]

ReferenceCitation: Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrié D, Walsh S, Oldroyd KG, Varenne O, El-Jack S, Moreno R, Joshi AA, Allocco DJ, Dawkins KD. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012 Apr 10;59(15):1362-70. doi: 10.1016/j.jacc.2011.12.016. Epub 2012 Feb 15.

family: Dubois

title: Primary Endpoint Results of the EVOLVE Trial

location_country:
Sweden
France
Poland
Belgium
Australia
New Zealand
Spain
Denmark
United Kingdom

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

location_facility: Rigshospitalet Thoraxkirurgisk Klinik RT


type: Other Identifier

title: Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

acronym: EXPEDITION EXT

summary: This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Brazil
United States
Sweden
Germany
France
Japan
Poland
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

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.

status_simplified: Unknown


type: Registry Identifier

title: The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

summary: The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.

ReferenceCitation: Gnesin F, Thuesen ACB, Kähler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6:CD012906. doi: 10.1002/14651858.CD012906.pub2.

name: Department of Endocrinology, Diabetes and Metabolism; Department 7652, Rigshospitalet; Copenhagen Denmark

family: Gnesin

full_name: Filip Gnesin

given: Filip

name: Steno Diabetes Center Copenhagen; Gentofte Denmark

name: Faculty of Health and Medical Sciences, University of Copenhagen; Novo Nordisk Foundation Center for Basic Metabolic Research; Copenhagen Denmark

full_name: Anne Cathrine Baun Thuesen

given: Anne Cathrine Baun

name: Faculty of Health and Medical Sciences; University of Copenhagen; Copenhagen N Denmark

family: Kähler

full_name: Lise Katrine Aronsen Kähler

given: Lise Katrine Aronsen

name: Department of Endocrinology; Hvidovre Hospital, University of Copenhagen; Hvidovre Denmark

family: Madsbad

full_name: Sten Madsbad

given: Sten

name: Cochrane Metabolic and Endocrine Disorders Group; Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf; Düsseldorf Germany

family: Hemmingsen

full_name: Bianca Hemmingsen

given: Bianca

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repositories:
PubMed Central
Pure (Denmark)

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

family: Boustani

full_name: M. A. Boustani

given: M. A.

name: Providence Medical Group  Terre Haute IN USA

family: Pittman

full_name: I. Pittman

given: I.

suffix: IV

name: Eli Lilly and Company  Toronto ON Canada

family: Yu

full_name: M. Yu

given: M.

name: Eli Lilly and Company  Indianapolis IN USA

family: Thieu

full_name: V. T. Thieu

given: V. T.

family: Varnado

full_name: O. J. Varnado

given: O. J.

family: Juneja

full_name: R. Juneja

given: R.

journal_name: Diabetes, Obesity and Metabolism

title: Similar efficacy and safety of once‐weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

name: Lilly Diabetes; Eli Lilly and Company; Indianapolis IN USA

ReferenceCitation: Umpierrez G, Tofé Povedano S, Pérez Manghi F, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014 Aug;37(8):2168-76. doi: 10.2337/dc13-2759. Epub 2014 May 19.

title: Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-3)

location_country:
Brazil
United States
South Africa
India
United Kingdom
Mexico
Germany
Finland
Croatia
France
Poland
Slovakia
Romania
Argentina
Puerto Rico
Spain
Canada
Czech Republic
Korea, Republic of


ReferenceCitation: Galiè N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2021 Oct 30. doi: 10.1007/s12325-021-01898-1. [Epub ahead of print]

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Gaine

full_name: Sean Gaine

given: Sean

family: Channick

full_name: Richard Channick

given: Richard

family: Coghlan

full_name: J. Gerry Coghlan

given: J. Gerry

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Lang

full_name: Irene M. Lang

given: Irene M.

family: McLaughlin

full_name: Vallerie V. McLaughlin

given: Vallerie V.

family: Lassen

full_name: Cheryl Lassen

given: Cheryl

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

family: Hsu Schmitz

full_name: Shu-Fang Hsu Schmitz

given: Shu-Fang

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Tapson

full_name: Victor F. Tapson

given: Victor F.

family: Chin

full_name: Kelly M. Chin

given: Kelly M.

oa_host_type: publisher

status: Active, not recruiting

lead_sponsor: Actelion

location_country:
Peru
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Spain
France
Poland
Thailand
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Switzerland
Netherlands
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Austria
Serbia
Mexico
Czechia
Israel
Belarus
Turkey

acronym: GRIPHON OL

study_completion_date_type: Anticipated

source: euctr

title: Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension

summary: Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

status_simplified: Ongoing


lead_sponsor: PharmaMar

location_country:
Italy
Austria
Netherlands
Spain
Germany
France
Czechia
Greece
Poland
Ireland
Australia
Belgium
New Zealand
Portugal
Puerto Rico
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: ADMYRE

title: Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

summary: Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.


title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer

summary: The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.

lead_sponsor: Achieve Life Sciences

location_country:
France
Spain
United States
United Kingdom
Canada


title: Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease

summary: Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

lead_sponsor: Abbott

location_country:
Italy
Austria
United Kingdom
France
Poland
Norway
Belgium
Spain
Germany
Slovenia

location_facility:
Site Reference ID/Investigator# 9403
Site Reference ID/Investigator# 4910
Site Reference ID/Investigator# 6272
Site Reference ID/Investigator# 15261
Site Reference ID/Investigator# 14802
Site Reference ID/Investigator# 5372
Site Reference ID/Investigator# 6271
Site Reference ID/Investigator# 14682
Site Reference ID/Investigator# 7956
Site Reference ID/Investigator# 18601
Site Reference ID/Investigator# 6275
Site Reference ID/Investigator# 16361
Site Reference ID/Investigator# 13102
Site Reference ID/Investigator# 12222
Site Reference ID/Investigator# 15381
Site Reference ID/Investigator# 6283
Site Reference ID/Investigator# 9621
Site Reference ID/Investigator# 13941
Site Reference ID/Investigator# 5023
Site Reference ID/Investigator# 6249
Site Reference ID/Investigator# 11182
Site Reference ID/Investigator# 18602
Site Reference ID/Investigator# 6280
Site Reference ID/Investigator# 6245
Site Reference ID/Investigator# 6276
Site Reference ID/Investigator#6260
Site Reference ID/Investigator# 17821
Site Reference ID/Investigator# 8277
Site Reference ID/Investigator# 4703
Site Reference ID/Investigator# 6274
Site Reference ID/Investigator# 6270
Site Reference ID/Investigator# 6282
Site Reference ID/Investigator# 14681
Site Reference ID/Investigator# 15702
Site Reference ID/Investigator# 6263
Site Reference ID/Investigator# 6261
Site Reference ID/Investigator# 6244


ReferenceCitation: Sieper J, Braun J, Kay J, Badalamenti S, Radin AR, Jiao L, Fiore S, Momtahen T, Yancopoulos GD, Stahl N, Inman RD. Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN). Ann Rheum Dis. 2015 Jun;74(6):1051-7. doi: 10.1136/annrheumdis-2013-204963. Epub 2014 Feb 18.

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Braun

full_name: Jürgen Braun

given: Jürgen

family: Kay

full_name: Jonathan Kay

given: Jonathan

family: Badalamenti

full_name: Salvatore Badalamenti

given: Salvatore

family: Radin

full_name: Allen R Radin

given: Allen R

family: Jiao

full_name: Lixia Jiao

given: Lixia

family: Fiore

full_name: Stefano Fiore

given: Stefano

family: Momtahen

full_name: Tanya Momtahen

given: Tanya

family: Yancopoulos

full_name: George D Yancopoulos

given: George D

family: Stahl

full_name: Neil Stahl

given: Neil

family: Inman

full_name: Robert D Inman

given: Robert D

journal_name: Annals of the Rheumatic Diseases

evidence: open (via page says license)

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Sanofi

location_country:
Austria
United States
Netherlands
Germany
France
Czechia
Lithuania
Poland
Hungary
Australia
Belgium
Spain
Turkey
Canada

acronym: ALIGN

location_facility:
Investigational Site Number 276001
Investigational Site Number 792001
Investigational Site Number 840027
Investigational Site Number 124007
Investigational Site Number 250005
Investigational Site Number 840016
Investigational Site Number 056005
Investigational Site Number 124008
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 792002
Investigational Site Number 840009
Investigational Site Number 124004
Investigational Site Number 124009
Investigational Site Number 250001
Investigational Site Number 840021
Investigational Site Number 203005
Investigational Site Number 440001
Investigational Site Number 440002
Investigational Site Number 616002
Investigational Site Number 616004
Investigational Site Number 840004
Investigational Site Number 840030
Investigational Site Number 840015
Investigational Site Number 840023
Investigational Site Number 036001
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 616003
Investigational Site Number 276004
Investigational Site Number 724001
Investigational Site Number 036003
Investigational Site Number 124005
Investigational Site Number 616001
Investigational Site Number 056004
Investigational Site Number 250003
Investigational Site Number 840017
Investigational Site Number 348001
Investigational Site Number 840029
Investigational Site Number 840001
Investigational Site Number 840008
Investigational Site Number 124001
Investigational Site Number 840006
Investigational Site Number 840032
Investigational Site Number 840033
Investigational Site Number 040002
Investigational Site Number 056002
Investigational Site Number 840036
Investigational Site Number 124002
Investigational Site Number 840018
Investigational Site Number 840002
Investigational Site Number 040001
Investigational Site Number 203001
Investigational Site Number 840010
Investigational Site Number 528002
Investigational Site Number 724004
Investigational Site Number 036004
Investigational Site Number 276005
Investigational Site Number 840034
Investigational Site Number 724005
Investigational Site Number 124003
Investigational Site Number 203004
Investigational Site Number 036002
Investigational Site Number 348003
Investigational Site Number 840013
Investigational Site Number 840028
Investigational Site Number 203003
Investigational Site Number 124006
Investigational Site Number 056003
Investigational Site Number 056001
Investigational Site Number 348005
Investigational Site Number 840007
Investigational Site Number 124010
Investigational Site Number 203002
Investigational Site Number 276002
Investigational Site Number 276003
Investigational Site Number 348004
Investigational Site Number 724002
Investigational Site Number 528001

title: A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)

summary:
Primary objective:

- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)

Secondary objectives:

to demonstrate that Sarilumab was effective on:

assessment of higher level of response [ASAS 40% response criteria (ASAS40)]
partial remission
disease activity
range of motion
Magnetic Resonance Imaging (MRI) of the spine
to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS


ReferenceCitation: Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.

family: Susser

full_name: Simone Susser

given: Simone

family: Flinders

full_name: Mathieu Flinders

given: Mathieu

family: Reesink

full_name: Henk W. Reesink

given: Henk W.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Lawyer

full_name: Glenn Lawyer

given: Glenn

family: Ghys

full_name: Anne Ghys

given: Anne

family: Van Eygen

full_name: Veerle Van Eygen

given: Veerle

family: Witek

full_name: James Witek

given: James

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

family: Sarrazin

full_name: Christoph Sarrazin

given: Christoph

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Evolution of Hepatitis C Virus Quasispecies during Repeated Treatment with the NS3/4A Protease Inhibitor Telaprevir

lead_sponsor: Janssen Infectious Diseases BVBA

location_country:
United States
Brazil
Sweden
Switzerland
Netherlands
Germany
France
Poland
Israel
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom

title: An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons

summary: The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.


ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5:CD011220. doi: 10.1002/14651858.CD011220.pub2.

name: Medical Oncology Department; St John of God Midland; Perth Australia

name: Medical Oncology Department; Sir Charles Gairdner Hospital; Perth Australia

family: Hoon

full_name: Siao-Nge Hoon

given: Siao-Nge

name: Medical Oncology Department; Peter MacCallum Cancer Centre; Melbourne Australia

family: Lau

full_name: Peter K H Lau

given: Peter K H

name: Murdoch Community Hospice; St John of God Hospital Murdoch; Perth Australia

name: Palliative Care Department; Royal Perth Hospital; Perth Australia

family: White

full_name: Alison M White

given: Alison M

name: Institute for Health Research; University of Notre Dame Australia; Fremantle Australia

name: School of Population and Global Health; The University of Western Australia; Perth Australia

name: Division of Surgery and Interventional Science; University College London; London UK

family: Bulsara

full_name: Max K Bulsara

given: Max K

name: Medical Oncology Department; University Hospital Geelong; Geelong Australia

family: Banks

full_name: Patricia D Banks

given: Patricia D

name: School of Medicine; University of Western Australia; Perth Australia

name: Medical Oncology Department; Fiona Stanley Hospital; Perth Australia

family: Redfern

full_name: Andrew D Redfern

given: Andrew D

ReferenceCitation: Janni W, Sarosiek T, Karaszewska B, Pikiel J, Staroslawska E, Potemski P, Salat C, Brain E, Caglevic C, Briggs K, Mahood K, DeSilvio M, Marini L, Papadimitriou C. Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer. Breast. 2015 Dec;24(6):769-73. doi: 10.1016/j.breast.2015.08.005. Epub 2015 Sep 16.

family: Janni

full_name: Wolfgang Janni

given: Wolfgang

family: Sarosiek

full_name: Tomasz Sarosiek

given: Tomasz

family: Karaszewska

full_name: Boguslawa Karaszewska

given: Boguslawa

family: Pikiel

full_name: Joanna Pikiel

given: Joanna

family: Staroslawska

full_name: Elzbieta Staroslawska

given: Elzbieta

family: Potemski

full_name: Piotr Potemski

given: Piotr

family: Salat

full_name: Christoph Salat

family: Brain

full_name: Etienne Brain

given: Etienne

family: Caglevic

full_name: Christian Caglevic

given: Christian

family: Briggs

full_name: Kathryn Briggs

given: Kathryn

family: Mahood

full_name: Kim Mahood

given: Kim

family: DeSilvio

full_name: Michelle DeSilvio

given: Michelle

family: Marini

full_name: Luca Marini

given: Luca

family: Papadimitriou

full_name: Christos Papadimitriou

given: Christos

journal_name: The Breast

location_country: Italy Chile Serbia Mexico France Bulgaria Greece Poland Spain Germany

title: A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer

summary: This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.


title: A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms

summary: The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

ReferenceCitation: Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400.

ReferenceCitation: Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Marangell LB. A randomized placebo-controlled trial of duloxetine in patients with major depressive disorder and associated painful physical symptoms. Curr Med Res Opin. 2011 Oct;27(10):1849-58. doi: 10.1185/03007995.2011.609539. Epub 2011 Aug 12.

family: Gaynor

full_name: Paula J. Gaynor

given: Paula J.

family: Gopal

full_name: Murali Gopal

given: Murali

family: Zheng

full_name: Wei Zheng

given: Wei

family: Martinez

full_name: James M. Martinez

given: James M.

family: Robinson

full_name: Michael J. Robinson

given: Michael J.

family: Marangell

full_name: Lauren B. Marangell

given: Lauren B.

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country:
United States
Sweden
France
Romania
Puerto Rico
Germany


ReferenceCitation: Steigerwald I, Müller M, Davies A, Samper D, Sabatowski R, Baron R, Rozenberg S, Szczepanska-Szerej A, Gatti A, Kress HG. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study. Curr Med Res Opin. 2012 Jun;28(6):911-36. doi: 10.1185/03007995.2012.679254. Epub 2012 May 9.

name: Medical Affairs Europe & Australia, Grünenthal GmbH AachenGermany

family: Steigerwald

full_name: Ilona Steigerwald

given: Ilona

family: Müller

full_name: Matthias Müller

given: Matthias

name:
Plymouth NHS Trust, Derriford Hospital
PlymouthUK

family: Davies

full_name: Anthony Davies

given: Anthony

name:
Hospital Germans Trias I Pujol
Badalona, BarcelonaSpain

family: Samper

full_name: Daniel Samper

given: Daniel

name:
Comprehensive Pain Center, University Hospital Carl Gustav Carus
DresdenGermany

family: Sabatowski

full_name: Rainer Sabatowski

given: Rainer

name:
Division of Neurological Pain Research and Therapy, Universitätsklinikum Schleswig-Holstein
Campus KielGermany

family: Baron

full_name: Ralf Baron

given: Ralf

name:
Department of Rheumatology, Hôpital Pitié Salpétrière
ParisFrance

family: Rozenberg

full_name: Sylvie Rozenberg

given: Sylvie

name:
Department of Neurology, Medical University of Lublin
LublinPoland

family: Szczepanska-Szerej

full_name: Anna Szczepanska-Szerej

given: Anna

name:
Department of Emergency Care, Critical Care Medicine, Pain Medicine, and Anaesthesiology, Policlinico Tor Vergata, University of Rome - Tor Vergata
RomeItaly

family: Gatti

full_name: Antonio Gatti

given: Antonio

name:
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna/AKH
ViennaAustria

family: Kress

full_name: Hans G. Kress

given: Hans G.

intervention_type: Other

ipd_sharing_description: Information available on the Grünenthal Web Site

lead_sponsor: Grünenthal GmbH

location_country:
Italy
Austria
Switzerland
Croatia
France
Poland
Spain
Germany
United Kingdom

location_facility:
Site 2
Site 5
Site 3
Site 4
Site 1
Site 7
Site 6
Site 8

title: An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.


ReferenceCitation: Hirsch IB, Franek E, Mersebach H, Bardtrum L, Hermansen K. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST(®) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.

ReferenceCitation: Hirsch IB, Bode B, Courreges JP, Dykiel P, Franek E, Hermansen K, King A, Mersebach H, Davies M. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012 Nov;35(11):2174-81. doi: 10.2337/dc11-2503. Epub 2012 Aug 28.

family: Hirsch

full_name: I. B. Hirsch

given: I. B.

family: Bode

full_name: B. Bode

given: B.

family: Courreges

full_name: J.-P. Courreges

family: Dykiel

full_name: P. Dykiel

given: P.

family: Franek

full_name: E. Franek

given: E.

family: Hermansen

full_name: K. Hermansen

given: K.

family: King

full_name: A. King

given: A.

family: Mersebach

full_name: H. Mersebach

given: H.

full_name: M. Davies

given: M.

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Insulin Degludec/Insulin Aspart Administered Once Daily at Any Meal, With Insulin Aspart at Other Meals Versus a Standard Basal-Bolus Regimen in Patients With Type 1 Diabetes: A 26-week, phase 3, randomized, open-label, treat-to-target trial

lead_sponsor: Novo Nordisk A/S

location_country:
France
Poland
Israel
Romania
Australia
Puerto Rico
Russian Federation
Denmark
United States
United Kingdom

acronym: BOOST™

title: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

summary:
This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


ReferenceCitation: Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornøe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-5. doi: 10.1111/hae.12616. Epub 2015 Jan 21.

name: Division of Haematology; University Hospital Zurich; Zurich Switzerland

family: Brand-Staufer

full_name: B. Brand-Staufer

name: Division of Haematology/Oncology and Child Health Evaluative Sciences; Department of Paediatrics; Research Institute; Hospital for Sick Children; Toronto ON Canada

family: Carcao

full_name: M. Carcao

name: Nationwide Children's Hospital; Columbus OH USA

family: Kerlin

full_name: B. A. Kerlin

given: B. A.

name: Royal Manchester Children's Hospital; Manchester UK

family: Will

full_name: A. Will

name: Birmingham Children's Hospital; Birmingham UK

family: Williams

full_name: M. Williams

name: Clinical Pharmacology; Novo Nordisk A/S; Søborg Denmark

family: Tornøe

full_name: C. W. Tornøe

given: C. W.

family: Sandberg Lundblad

full_name: M. Sandberg Lundblad

name: Children's Hospital of Orange County; Children's Hospital and Center for Inherited Blood Disorders; Orange CA USA

family: Nugent

full_name: D. Nugent

given: D.

journal_name: Haemophilia

ReferenceCitation: Kerlin B, Brand B, Inbal A, Halimeh S, Nugent D, Lundblad M, Tehranchi R. Pharmacokinetics of recombinant factor XIII at steady state in patients with congenital factor XIII A-subunit deficiency. J Thromb Haemost. 2014 Dec;12(12):2038-43. doi: 10.1111/jth.12739. Epub 2014 Oct 25.

name: Nationwide Children's Hospital and The Ohio State University College of Medicine; Columbus OH USA

full_name: B. Kerlin

family: Brand

full_name: B. Brand

name: Thrombosis and Hemostasis Unit; Hematology Department; Rabin Medical Center; Petah Tikva and Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv Israel

family: Inbal

full_name: A. Inbal

name: Medical Thrombosis and Haemophilia Treatment Center; Duisburg Germany

family: Halimeh

full_name: S. Halimeh

given: S.

name: Hematology; CHOC Children's Hospital/UC Irvine Medical School; Orange CA USA

name: Clinical Pharmacology Biopharm; Novo Nordisk A/S; Søborg Denmark

family: Lundblad

full_name: M. Lundblad

name: Medical and Science; Haemostasis R&D Portfolio; Novo Nordisk A/S; Søborg Denmark

family: Tehranchi

full_name: R. Tehranchi

given: R.

journal_name: Journal of Thrombosis and Haemostasis

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

title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

summary: This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.


title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

summary: This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

ReferenceCitation: Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Nájera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naïve patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Cooper

full_name: Curtis Cooper

given: Curtis

family: Balart

full_name: Luis Balart

given: Luis

family: Larrey

full_name: Dominique Larrey

given: Dominique

family: Box

full_name: Terry Box

given: Terry

family: Yoshida

full_name: Eric Yoshida

given: Eric

family: Lawitz

full_name: Eric Lawitz

family: Buggisch

full_name: Peter Buggisch

given: Peter

family: Ferenci

full_name: Peter Ferenci

family: Weltman

full_name: Martin Weltman

given: Martin

family: Labriola–Tompkins

full_name: Emily Labriola–Tompkins

given: Emily

family: Le Pogam

full_name: Sophie Le Pogam

given: Sophie

family: Nájera

full_name: Isabel Nájera

given: Isabel

family: Thomas

full_name: Denise Thomas

given: Denise

family: Hooper

full_name: Gregory Hooper

given: Gregory

family: Shulman

full_name: Nancy S. Shulman

given: Nancy S.

family: Zhang

full_name: Ying Zhang

given: Ying

family: Navarro

full_name: Mercidita T. Navarro

given: Mercidita T.

family: Lim

full_name: Chin Yin Lim

given: Chin Yin

family: Brunda

full_name: Michael Brunda

given: Michael

family: Terrault

full_name: Norah A. Terrault

given: Norah A.

family: Yetzer

full_name: Ellen S. Yetzer

given: Ellen S.

journal_name: Gastroenterology

title: Randomized Controlled Trial of Danoprevir Plus Peginterferon Alfa-2a and Ribavirin in Treatment-Naïve Patients With Hepatitis C Virus Genotype 1 Infection

location_country:
Italy
Austria
United States
Germany
France
Australia
Canada


location_country:
Italy
Finland
France
Spain
United States
United Kingdom
Canada
Taiwan

location_facility: UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr

location_facility: Fairfax Northern Virginia Hematology Oncology Fairfax NVH

location_facility: Comprehensive Blood and Cancer Center Dept CBCC (3)

location_facility: Northwest Cancer Specialists Northwest Office (2)

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Texas Oncology, P.A. Presbyterian Hospital

location_facility: Central Coast Medical Oncology Corporation

location_facility: Cancer Care Associates Medical Group Dept. of CCA

location_facility: UCLA/ University of California Los Angeles Div. of Hematology/Oncology

location_facility: Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

location_facility: Texas Oncology, P.A. Dept. of Texas Oncology

location_facility: Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care

location_facility: Texas Oncology, P.A. Texas Oncology - Sammons

title: A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer

summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.