title: A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms

summary: This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

ReferenceCitation: Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, García MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.

family: Niederman

full_name: Michael S. Niederman

given: Michael S.

family: Chastre

full_name: Jean Chastre

given: Jean

family: Corkery

full_name: Kevin Corkery

given: Kevin

family: Fink

full_name: James B. Fink

given: James B.

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

family: García

full_name: Miguel Sánchez García

given: Miguel Sánchez

journal_name: Intensive Care Medicine

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Bayer

location_country:
United States
France
Spain


ReferenceType: result

ReferenceCitation: Kowey PR, Crijns HJ, Aliot EM, Capucci A, Kulakowski P, Radzik D, Roy D, Connolly SJ, Hohnloser SH; ALPHEE Study Investigators. Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study. Circulation. 2011 Dec 13;124(24):2649-60. doi: 10.1161/CIRCULATIONAHA.111.072561. Epub 2011 Nov 14.

name: From Lankenau Hospital and Institute of Medical Research, Wynnewood, PA, and Jefferson Medical College, Philadelphia, PA (P.R.K.); Academisch Ziekenhuis Maastricht, Maastricht, Netherlands (H.J.G.M.C.); CHU de Brabois, Vandoeuvre-les-Nancy, France (E.M.A.); Ospedale Civile, Piacenza, Italy (A.C.); Grochowski Hospital, Postgraduate Medical School, Warsaw, Poland (P.K.); Sanofi R&D, Paris, France (D. Radzik); Montreal Heart Institute, Université de Montreal, Montreal, Quebec, Canada (D. Roy);...

family: Kowey

full_name: Peter R. Kowey

given: Peter R.

sequence: first

family: Crijns

full_name: Harry J.G.M. Crijns

given: Harry J.G.M.

sequence: additional

family: Aliot

full_name: Etienne M. Aliot

given: Etienne M.

family: Capucci

full_name: Alessandro Capucci

given: Alessandro

family: Kulakowski

full_name: Piotr Kulakowski

given: Piotr

family: Radzik

full_name: David Radzik

given: David

family: Roy

full_name: Denis Roy

given: Denis

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Efficacy and Safety of Celivarone, With Amiodarone as Calibrator, in Patients With an Implantable Cardioverter-Defibrillator for Prevention of Implantable Cardioverter-Defibrillator Interventions or Death

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_type: Interventional

lead_sponsor: Sanofi

enrollment_type: Actual

primary_purpose: Prevention

location_country:
Finland
Belgium
Australia
Russian Federation
Denmark
Czech Republic
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
South Africa
Chile
Sweden
Netherlands
Hungary
Portugal
United States
Germany
Italy
Mexico
Israel
Spain
Turkey

acronym: ALPHEE

location_facility:
Investigational Site Number 376003
Investigational Site Number 124007
Investigational Site Number 250005
Investigational Site Number 840016
Investigational Site Number 616002
Investigational Site Number 036010
Investigational Site Number 376004
Investigational Site Number 703001
Investigational Site Number 840031
Investigational Site Number 710002
Investigational Site Number 036013
Investigational Site Number 616008
Investigational Site Number 036008
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Investigational Site Number 276006
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Investigational Site Number 056002
Investigational Site Number 792002
Investigational Site Number 620003
Investigational Site Number 208004
Investigational Site Number 643006
Investigational Site Number 032002
Investigational Site Number 208002
Investigational Site Number 392004
Investigational Site Number 792003
Investigational Site Number 392003
Investigational Site Number 840043
Investigational Site Number 056001
Investigational Site Number 724007
Investigational Site Number 840007
Investigational Site Number 208005
Investigational Site Number 276003
Investigational Site Number 032004
Investigational Site Number 724002
Investigational Site Number 380008
Investigational Site Number 840049
Investigational Site Number 840045
Investigational Site Number 840042
Investigational Site Number 124008
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 528005
Investigational Site Number 840009
Investigational Site Number 124009
Investigational Site Number 124004
Investigational Site Number 250001
Investigational Site Number 724009
Investigational Site Number 840020
Investigational Site Number 643007
Investigational Site Number 036009
Investigational Site Number 056007
Investigational Site Number 392001
Investigational Site Number 036007
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Investigational Site Number 152001
Investigational Site Number 250003
Investigational Site Number 124001
Investigational Site Number 124002
Investigational Site Number 203001
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Investigational Site Number 724003
Investigational Site Number 036004
Investigational Site Number 643011
Investigational Site Number 840034
Investigational Site Number 348003
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Investigational Site Number 703002
Investigational Site Number 792001
Investigational Site Number 056005
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Investigational Site Number 392005
Investigational Site Number 203005
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Investigational Site Number 752003
Investigational Site Number 528004
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Investigational Site Number 124005
Investigational Site Number 380007
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Investigational Site Number 616011
Investigational Site Number 203006
Investigational Site Number 724006
Investigational Site Number 752002
Investigational Site Number 752001
Investigational Site Number 840032
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Investigational Site Number 840002
Investigational Site Number 643004
Investigational Site Number 032003
Investigational Site Number 203004
Investigational Site Number 380002
Investigational Site Number 203003
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Investigational Site Number 124006
Investigational Site Number 348004
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Investigational Site Number 620004
Investigational Site Number 528007
Investigational Site Number 276001
Investigational Site Number 250004
Investigational Site Number 376001
Investigational Site Number 840004
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Investigational Site Number 484002
Investigational Site Number 246001
Investigational Site Number 616003
Investigational Site Number 250006
Investigational Site Number 036012
Investigational Site Number 056004
Investigational Site Number 643008
Investigational Site Number 616006
Investigational Site Number 376002
Investigational Site Number 840017
Investigational Site Number 348001
Investigational Site Number 840029
Investigational Site Number 392002
Investigational Site Number 528003
Investigational Site Number 840006
Investigational Site Number 616001
Investigational Site Number 528002
Investigational Site Number 724004
Investigational Site Number 036005
Investigational Site Number 276005
Investigational Site Number 643005
Investigational Site Number 643003
Investigational Site Number 840025
Investigational Site Number 208001
Investigational Site Number 056003
Investigational Site Number 616007
Investigational Site Number 840012
Investigational Site Number 124010
Investigational Site Number 250007
Investigational Site Number 528001

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death

summary:
The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.

Secondary objectives were:

To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population.
To document Celivarone plasma levels during the study.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects

acronym: FITNESS

summary: The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Rodriguez-Torres M, Yoshida EM, Marcellin P, Srinivasan S, Purohit VS, Wang C, Hammond JL. A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV. Ann Hepatol. 2014 Jul-Aug;13(4):364-75.

lead_sponsor: Pfizer

location_country:
United States
Germany
France
Hungary
Belgium
Puerto Rico
Spain
Canada
Korea, Republic of


ReferenceCitation: Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

name: Division of Endocrinology, Department of Medicine, Georgetown University School of Medicine Washington DC USA

family: Ratner

full_name: R. E. Ratner

given: R. E.

name: Oxford Centre for Diabetes Endocrinology and Metabolism and NIHR Oxford Biomedical Research Centre  Oxford UK

family: Gough

full_name: S. C. L. Gough

given: S. C. L.

name: University Hospitals (UZ) Leuven KU Leuven  Leuven Belgium

family: Mathieu

full_name: C. Mathieu

given: C.

family: Del Prato

full_name: S. Del Prato

given: S.

name: Atlanta Diabetes Associates  Atlanta GA USA

family: Bode

full_name: B. Bode

given: B.

family: Mersebach

full_name: H. Mersebach

given: H.

family: Endahl

full_name: L. Endahl

given: L.

name: University of Toronto Mount Sinai Hospital  Toronto ON Canada

family: Zinman

full_name: B. Zinman

journal_name: Diabetes, Obesity and Metabolism

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre‐planned meta‐analysis of phase 3 trials

ReferenceCitation: Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

family: Sorli

full_name: Christopher Sorli

given: Christopher

family: Warren

full_name: Mark Warren

given: Mark

family: Oyer

full_name: David Oyer

full_name: Henriette Mersebach

given: Henriette

family: Johansen

full_name: Thue Johansen

given: Thue

full_name: Stephen C. L. Gough

given: Stephen C. L.

journal_name: Drugs & Aging

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

title: Elderly Patients with Diabetes Experience a Lower Rate of Nocturnal Hypoglycaemia with Insulin Degludec than with Insulin Glargine: A Meta-Analysis of Phase IIIa Trials

ReferenceCitation: Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

title: Patients Achieving Good Glycemic Control (HBA1c <7%) Experience A Lower Rate of Hypoglycemia With Insulin Degludec Than with Insulin Glargine: A Meta-Analysis of Phase 3A Trials

ReferenceCitation: Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18. Review.

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

ReferenceCitation: Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

name: Department of Diabetes and Endocrinology Royal Liverpool University Hospitals  Liverpool UK

name: Division of Endocrinology and Diabetology, Department of Internal Medicine II University Hospital of Freiburg  Freiburg Germany

ReferenceCitation: Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjøth TV, Rana A, Mathieu C; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013 Nov;30(11):1298-304. doi: 10.1111/dme.12303. Epub 2013 Sep 30.

name: Endocrine and Metabolic Consultants Rockville MD USA

name: Clinique d'Endocrinologie l'Institut du Thorax CHU Nantes Nantes France

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

name: Metabolic Institute of America Tarzana CA USA

name: Scripps Whittier Diabetes Institute La Jolla CA USA

name: UZ Leuven University of Leuven Leuven Belgium

title: Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial

location_country:
Austria
United States
Former Serbia and Montenegro
Serbia
Germany
Finland
France
Slovenia
Norway
Belgium
Puerto Rico
Spain
Denmark
Canada
Czech Republic

title: NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.


title: Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

acronym: START rollover

summary: This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Finland
Belgium
Australia
Russian Federation
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Brazil
Israel
Spain

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Ut Southwestern Medical Center At Dallas


title: A Phase III Randomised Controlled Trial of Continuous Beta-lactam Infusion Compared With Intermittent Beta-lactam Dosing in Critically Ill Patients

acronym: BLING III

summary:
The purpose of this study is to find out whether continuous infusion of beta-lactam antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health advantages to patients or if there is no difference.

The investigators will be looking to see whether patients receiving beta-lactams via one administration method or the other have a better chance of recovering from their illness. They will also be looking at long term outcomes such as quality-of-life and healthcare resource use.

Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body.

Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in patients with sepsis and septic shock.

Currently, beta-lactam antibiotics are most commonly given to patients be intermittent infusions, that is, given at regular intervals throughout 24 hours. New research suggests that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic concentrations in the blood remain more consistent and may be more effective at killing bacteria.

However, the benefit to the patient by giving beta-lactams via continuous infusion has not been tested in a high-quality, large clinical trial.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Lipman J, Brett SJ, De Waele JJ, Cotta MO, Davis JS, Finfer S, Glass P, Knowles S, McGuinness S, Myburgh J, Paterson DL, Peake S, Rajbhandari D, Rhodes A, Roberts JA, Shirwadkar C, Starr T, Taylor C, Billot L, Dulhunty JM. A protocol for a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis: BLING III. Crit Care Resusc. 2019 Mar;21(1):63-68.

ipd_sharing: Undecided

ipd_sharing_description: Yet to be decided

lead_sponsor: The George Institute

location_country:
Sweden
France
Malaysia
Belgium
Australia
New Zealand
United Kingdom

location_facility: Basingstoke and North Hampshire Hospital

location_facility: James Cook University Hospital South Tees

location_facility: University Hospital Coventry & Warwickshire

location_facility: Northumbria Specialist Emergency Hospital

intervention_type: Other

status_simplified: Ongoing


title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis

summary: To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

study_start_date_type: Anticipated

status: Withdrawn

location_country:
Greece
Romania
Australia
Belgium
Denmark
France
Poland
Canada
Sweden
Switzerland
Netherlands
Bulgaria
Ireland
Germany
United States
United Kingdom
Italy
Austria
Serbia
Spain
Estonia

status_simplified: Unknown


ReferenceCitation: Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

family: Heller

full_name: S. Heller

family: Kapur

full_name: R. Kapur

given: R.

family: Wolden

full_name: M. L. Wolden

given: M. L.

name: The Lunenfeld-Tanenbaum Research Institute; Mount Sinai Hospital; University of Toronto; Toronto Canada

journal_name: Diabetic Medicine

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials

ReferenceCitation: Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

title: Insulin Degludec Versus Insulin Glargine in Type 1 and Type 2 Diabetes Mellitus: A Meta-Analysis of Endpoints in Phase 3a Trials

ReferenceCitation: Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014. Review.

title: Patient safety and minimizing risk with insulin administration – role of insulin degludec

ReferenceCitation: Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, Renard E, Russell-Jones D, Philotheou A, Francisco AM, Pei H, Bode B; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1489-97. doi: 10.1016/S0140-6736(12)60204-9.

ReferenceCitation: Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.

location_country:
United States
South Africa
France
Russian Federation
Germany
United Kingdom

title: NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

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

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.


ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Fevery

full_name: Bart Fevery

given: Bart

family: Tambuyzer

full_name: Lotke Tambuyzer

given: Lotke

family: Vijgen

full_name: Leen Vijgen

given: Leen

family: Peeters

full_name: Monika Peeters

given: Monika

family: Buelens

full_name: Annemie Buelens

given: Annemie

family: Ceulemans

full_name: Hugo Ceulemans

given: Hugo

family: Beumont

full_name: Maria Beumont

given: Maria

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.

family: Scott

full_name: Jane Scott

given: Jane

family: Rosa

full_name: Kathleen Rosa

given: Kathleen

family: Fu

full_name: Min Fu

given: Min

family: Cerri

full_name: Karin Cerri

given: Karin

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Evon

full_name: Donna M Evon

given: Donna M

family: Gilles

full_name: Leen Gilles

currency_apc_doaj: GBP

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

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

ReferenceCitation: Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, Hezode C, Hirschfield GM, Jacobson I, Nikitin I, Pockros PJ, Poordad F, Scott J, Lenz O, Peeters M, Sekar V, De Smedt G, Sinha R, Beumont-Mauviel M. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014 Feb;146(2):430-41.e6. doi: 10.1053/j.gastro.2013.10.058. Epub 2013 Nov 1.

title: Simeprevir Increases Rate of Sustained Virologic Response Among Treatment-Experienced Patients With HCV Genotype-1 Infection: A Phase IIb Trial

location_country:
Austria
United States
Germany
France
Poland
Israel
Norway
Australia
Belgium
New Zealand
Portugal
Russian Federation
Canada
United Kingdom

title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

summary: The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).


title: A Pilot Study to Assess the Antiviral Activity of GSK1349572 Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance

summary:
Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying.

GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in adults with no previous exposure to integrase inhibitors. The purpose of this study is to determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no longer respond to treatment with the approved integrase inhibitor raltegravir and carry viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily in combination with the background HIV drugs previously administered (unless discontinuation of a particular drug is required) will be assessed over 10 days (functional monotherapy phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new optimised background regimen from Day 11 through at least Week 24.

ReferenceType: background

ReferenceCitation: Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

lead_sponsor: ViiV Healthcare

location_country:
Italy
France
Spain
United States
Canada


ReferenceCitation: Jackisch C, Stroyakovskiy D, Pivot X, Ahn JS, Melichar B, Chen SC, Meyenberg C, Al-Sakaff N, Heinzmann D, Hegg R. Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):e190339. doi: 10.1001/jamaoncol.2019.0339. Epub 2019 May 9.

name: Department of Obstetrics and Gynecology, Sana Klinikum Offenbach GmbH, Offenbach, Germany

family: Jackisch

full_name: Christian Jackisch

given: Christian

name: Chemotherapeutic Department, City Clinical Oncology Hospital 62, Moscow, Russian Federation

family: Stroyakovskiy

full_name: Daniil Stroyakovskiy

given: Daniil

name: Centre de Lutte contre le Cancer Paul Strauss de Strasbourg, Strasbourg, France

family: Pivot

full_name: Xavier Pivot

given: Xavier

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

family: Ahn

full_name: Jin Seok Ahn

given: Jin Seok

name: Department of Oncology, Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic

family: Melichar

full_name: Bohuslav Melichar

given: Bohuslav

name: Department of Surgery, Chang Gung Memorial Hospital, Taoyuan City, Taiwan

family: Chen

full_name: Shin-Cheh Chen

given: Shin-Cheh

name: Biostatistics, Product Development, F. Hoffmann–La Roche Ltd, Basel, Switzerland

family: Meyenberg

full_name: Christoph Meyenberg

given: Christoph

name: Product Development–Oncology, F. Hoffmann–La Roche Ltd, Basel, Switzerland

family: Al-Sakaff

full_name: Nedal Al-Sakaff

given: Nedal

family: Heinzmann

full_name: Dominik Heinzmann

given: Dominik

name: Department of Gynecology and Obstetrics, Hospital Pérola Byington, São Paulo, Brazil

family: Hegg

full_name: Roberto Hegg

given: Roberto

journal_name: JAMA Oncology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep;13(9):869-78. doi: 10.1016/S1470-2045(12)70329-7. Epub 2012 Aug 9.

family: Ismael

full_name: Gustavo Ismael

given: Gustavo

family: Muehlbauer

full_name: Susanne Muehlbauer

given: Susanne

family: Lum

full_name: Bert Lum

given: Bert

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Lichinitser

full_name: Mikhail Lichinitser

given: Mikhail

title: Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial

location_country:
Peru
Guatemala
Russian Federation
Taiwan
France
Panama
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Hong Kong
Hungary
Germany
Italy
Brazil
Mexico
Czechia
Israel
Spain
Estonia

location_facility: Prince of Songkla Uni ; Unit of Medical Oncology

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

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

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Wojewodzki Szpital Zespolony; Oddział Onkologii

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Institut Daniel Hollard; Chimiotherapie Ambulatoire

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

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

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

location_facility: Saratov Regional Clinical Hospital & Pathology Centre

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o.

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Johanniter GmbH; Johanniter-Krankenhaus; Internistische Onkologie

location_facility: Hospital of Aladar Petz; Dept of Oncoradiology

location_facility: Gachon Medical School Gil Medical Center; Medical Oncology

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Sankt Elisabeth Krankenhaus; Gynaekology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: GUZ Vladimir Regional Clinical Oncological Dispensary

location_facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

location_facility: Hospital das Clinicas - UFPR; Quimioterapia

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Dokuz Eylul Uni Medical Faculty; Oncology Dept

location_facility: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

title: A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)

summary: In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.


location_country: Italy Chile Mexico France Argentina Australia Spain Germany

acronym: EU/LA/AUS Pearl Index study – transdermal contraceptive patch

type: Other Identifier

title: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

summary: The aim of the present study is to prove efficacy and safety of a new contraceptive patch.


title: A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

summary: This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
United States
Peru
South Africa
Costa Rica
Mexico
Spain
Germany
France
Poland
Thailand
Slovakia
Australia
Puerto Rico
New Zealand
Russian Federation
Canada
United Kingdom
Ukraine


title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)

summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.

ReferenceCitation: Mavroudi I, Pyrovolaki K, Pavlaki K, Kozana A, Psyllaki M, Kalpadakis C, Pontikoglou C, Papadaki HA. Effect of the nonpeptide thrombopoietin receptor agonist eltrombopag on megakaryopoiesis of patients with lower risk myelodysplastic syndrome. Leuk Res. 2011 Mar;35(3):323-8. doi: 10.1016/j.leukres.2010.06.029. Epub 2010 Aug 4.

ReferenceCitation: Platzbecker U, Wong RS, Verma A, Abboud C, Araujo S, Chiou TJ, Feigert J, Yeh SP, Götze K, Gorin NC, Greenberg P, Kambhampati S, Kim YJ, Lee JH, Lyons R, Ruggeri M, Santini V, Cheng G, Jang JH, Chen CY, Johnson B, Bennett J, Mannino F, Kamel YM, Stone N, Dougherty S, Chan G, Giagounidis A. Safety and tolerability of eltrombopag versus placebo for treatment of thrombocytopenia in patients with advanced myelodysplastic syndromes or acute myeloid leukaemia: a multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial. Lancet Haematol. 2015 Oct;2(10):e417-26. doi: 10.1016/S2352-3026(15)00149-0. Epub 2015 Oct 1.

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

family: Wong

full_name: Raymond S M Wong

given: Raymond S M

family: Verma

full_name: Amit Verma

given: Amit

family: Abboud

full_name: Camille Abboud

given: Camille

family: Araujo

full_name: Sergio Araujo

given: Sergio

family: Chiou

full_name: Tzeon-Jye Chiou

given: Tzeon-Jye

family: Feigert

full_name: John Feigert

given: John

family: Yeh

full_name: Su-Peng Yeh

given: Su-Peng

family: Götze

full_name: Katharina Götze

given: Katharina

family: Gorin

full_name: Norbert-Claude Gorin

given: Norbert-Claude

family: Greenberg

full_name: Peter Greenberg

given: Peter

family: Kambhampati

full_name: Suman Kambhampati

given: Suman

full_name: Yoo-Jin Kim

given: Yoo-Jin

family: Lee

full_name: Je-Hwan Lee

given: Je-Hwan

family: Lyons

full_name: Roger Lyons

given: Roger

family: Ruggeri

full_name: Marco Ruggeri

given: Marco

family: Santini

full_name: Valeria Santini

given: Valeria

family: Cheng

full_name: Gregory Cheng

given: Gregory

family: Jang

full_name: Jun Ho Jang

given: Jun Ho

full_name: Chien-Yuan Chen

given: Chien-Yuan

family: Johnson

full_name: Brendan Johnson

given: Brendan

family: Bennett

full_name: John Bennett

family: Mannino

full_name: Frank Mannino

given: Frank

location_country:
Italy
Brazil
Hong Kong
Germany
France
Puerto Rico
Denmark
United States
United Kingdom
Korea, Republic of
Taiwan


family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Fevery

full_name: Bart Fevery

given: Bart

family: Tambuyzer

full_name: Lotke Tambuyzer

given: Lotke

family: Vijgen

full_name: Leen Vijgen

given: Leen

family: Peeters

full_name: Monika Peeters

given: Monika

family: Buelens

full_name: Annemie Buelens

given: Annemie

family: Ceulemans

full_name: Hugo Ceulemans

given: Hugo

family: Beumont

full_name: Maria Beumont

given: Maria

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: De Meyer

full_name: Sandra De Meyer

given: Sandra

title: Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies

family: Scott

full_name: Jane Scott

given: Jane

family: Rosa

full_name: Kathleen Rosa

given: Kathleen

family: Fu

full_name: Min Fu

given: Min

family: Cerri

full_name: Karin Cerri

given: Karin

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Evon

full_name: Donna M Evon

given: Donna M

family: Gilles

full_name: Leen Gilles

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

title: Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection

ReferenceCitation: Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013 Dec;58(6):1918-29. doi: 10.1002/hep.26641. Epub 2013 Oct 11.

name: University of North Carolina at Chapel Hill; NC

name: Hospital Vall d'Hebron and Ciberehd del Instituto Carlos III; Barcelona Spain

name: St Vincent's Hospital, Sydney, Australia and Kirby Institute; University of New South Wales; Sydney Australia

name: Medical University of Bialystok; Bialystok Poland

name: Allgemeines Krankenhaus der Stadt Wien; Vienna Austria

name: Weill Cornell Medical College; Cornell NY

name: Medizinische Hochschule Hannover; Hannover Germany

name: Russian State Medical University; Moscow Russia

name: University of Texas Health Science Center; San Antonio TX

name: Toronto General Hospital; Toronto Ontario Canada

name: Klinikum der Johann-Wolfgang-Goethe-Universität-Med. Klinik I; Frankfurt Germany

name: Janssen Global Services LLC; High Wycombe Buckinghamshire UK

name: Janssen Infectious Diseases BVBA; Beerse Belgium

name: Janssen Research & Development, LLC; Titusville NJ

title: Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naïve genotype 1 hepatitis C: The randomized PILLAR study

location_country:
Austria
United States
Spain
Germany
France
Poland
Norway
Australia
Belgium
New Zealand
Russian Federation
Denmark
Canada

title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects

summary: The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.


ReferenceCitation: Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.

family: Strand

full_name: Vibeke Strand

given: Vibeke

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

family: Ranza

full_name: Roberto Ranza

given: Roberto

family: Leung

full_name: Ying-Ying Leung

given: Ying-Ying

family: Drescher

full_name: Edit Drescher

given: Edit

family: Zueger

full_name: Patrick Zueger

given: Patrick

family: Saffore

full_name: Christopher D. Saffore

given: Christopher D.

family: Lertratanakul

full_name: Apinya Lertratanakul

given: Apinya

family: Lippe

full_name: Ralph Lippe

given: Ralph

family: Nash

full_name: Peter Nash

given: Peter

journal_name: Rheumatology and Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, Keiserman MW, Bu X, Chen L, McCaskill RM, Zueger P, McDearmon-Blondell EL, Pangan AL, Tillett W. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.

family: Mease

full_name: Philip J. Mease

given: Philip J.

family: Papp

full_name: Kim A. Papp

given: Kim A.

family: van den Bosch

full_name: Filip E. van den Bosch

given: Filip E.

family: Tsuji

full_name: Shigeyoshi Tsuji

given: Shigeyoshi

family: Dokoupilova

full_name: Eva Dokoupilova

given: Eva

family: Keiserman

full_name: Mauro W. Keiserman

given: Mauro W.

family: Bu

full_name: Xianwei Bu

given: Xianwei

family: Chen

full_name: Liang Chen

given: Liang

family: McCaskill

ReferenceCitation: Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, Dokoupilova E, Keiserman M, Wang X, Zhong S, McCaskill RM, Zueger P, Pangan AL, Tillett W. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020 Dec 3. pii: annrheumdis-2020-218870. doi: 10.1136/annrheumdis-2020-218870. [Epub ahead of print]

repository_institution: Ghent University - Ghent University Academic Bibliography

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

location_country:
Italy
United States
Brazil
Chile
Netherlands
Spain
France
Czechia
Greece
Japan
Hungary
Belgium
Australia
New Zealand
Portugal
Puerto Rico
Canada
United Kingdom
Korea, Republic of

location_facility: Diagnostic Group Integrated He /ID# 161406

location_facility: Rheumatic Disease Clin Res Ctr /ID# 161252

location_facility: Rheumatology Consultants, PLLC /ID# 161408

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773

location_facility: AOU Arcispedale Sant Anna di /ID# 164127

location_facility: Clinical Res of West FL, Inc. /ID# 159840

location_facility: Kansai Medical University Hospital /ID# 162081

location_facility: Asahikawa Medical University Hospital /ID# 200684

location_facility: USF Health Morsani Center for /ID# 161291

location_facility: Juntendo University Hospital /ID# 162089

location_facility: Heidelberg Repatriation Hospital /ID# 167441

location_facility: CIP - Centro Internacional de Pesquisa /ID# 161808

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 161294

location_facility: Revita Reumatologiai Rendelo /ID# 162575

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793

location_facility: Hospital Universitario Reina Sofia /ID# 170764

location_facility: Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794

location_facility: Hospital Universitario Ramon y Cajal /ID# 161020

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 165895

location_facility: Clinical Investigation Specialists - Skokie /ID# 160068

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 164126

location_facility: MAV Korhaz ess Rendelointezet /ID# 162574

location_facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 162571

location_facility: Debreceni Egyetem Kenezy Gyula /ID# 162572

location_facility: Inland Rheum Clin Trials Inc. /ID# 159839

location_facility: C.V. Mehta MD, Med Corporation /ID# 161192

location_facility: Hospital of the University of Occupational and Environmental Health /ID# 161472

location_facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896

location_facility: Nagoya City University Hospital /ID# 162563

location_facility: Atlanta Research Center for Rheumatology /ID# 161201

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462

location_facility: International Medical Research - Daytona /ID# 160051

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 162749

location_facility: Arthritis & Osteoporosis Clinic /ID# 161400

location_facility: Luton & Dunstable University Hospital /ID# 162713

location_facility: Centro Inter Estud Clin CIEC /ID# 169543

location_facility: Care Access Research, Huntingt /ID# 160049

location_facility: Unidade Local De Saude Do Alto Minho /ID# 165898

location_facility: Faculdade de Medicina do ABC /ID# 163489

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 157836

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317

location_facility: The Center for Rheumatology & Bone Research /ID# 159900

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 161409

location_facility: General Hospital of Athens Laiko /ID# 163474

location_facility: St.Luke's International Hospital /ID# 162013

location_facility: Jefrey D. Lieberman, MD, P.C. /ID# 159842

location_facility: Petz Aladar Megyei Oktato Kor /ID# 162573

location_facility: Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 162751

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 160006

location_facility: AZ Arthritis & Rheum Research /ID# 160047

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 162576

location_facility: Guy's and St Thomas' NHS Found /ID# 161063

location_facility: Osaka City University Hospital /ID# 162082

location_facility: Clinical Research of West Florida, Inc /ID# 160069

location_facility: PMG Research of Wilmington LLC /ID# 161403

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 161019

location_facility: Arth and Osteo Clin Brazo Valley /ID# 163439

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 162589

location_facility: Colorado Arthritis Associates /ID# 159856

location_facility: Adriana Pop-Moody MD Clinic PA /ID# 160009

location_facility: Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897

location_facility: Ctr. de Recherche Musculo-Sque /ID# 163557

location_facility: SunValley Arthritis Center, Lt /ID# 161203

location_facility: Arthritis Clinic of N. VA, P.C /ID# 159858

location_facility: Gulf Region Clinical Res Inst /ID# 159860

location_facility: Instituto Portugues De Reumatologia /ID# 165894

location_facility: The Queen Elizabeth Hospital /ID# 200840

location_facility: Hospital de Clinicas de Porto Alegre /ID# 161795

location_facility: Deerbrook Medical Associates /ID# 159815

location_facility: Oribe Clinic of Rheumatism and Medicine /ID# 163704

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138

location_facility: Stanford University School of Med /ID# 161402

location_facility: Percuro Clinical Research, Ltd /ID# 157835

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170911

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 164123

location_facility: Kitakyushu Municipal Medical Center /ID# 163516

location_facility: Trinity Health Med Arts Clinic /ID# 159811

title: A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)

summary: This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.


ReferenceCitation: Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.

family: Silverberg

full_name: Jonathan I. Silverberg

given: Jonathan I.

family: Pinter

full_name: Andreas Pinter

given: Andreas

family: Pulka

full_name: Grazyna Pulka

given: Grazyna

family: Poulin

full_name: Yves Poulin

given: Yves

family: Bouaziz

full_name: Jean-David Bouaziz

given: Jean-David

family: Wollenberg

full_name: Andreas Wollenberg

family: Murrell

full_name: Dédée F. Murrell

given: Dédée F.

family: Alexis

full_name: Andrew Alexis

given: Andrew

family: Lindsey

full_name: Lisa Lindsey

given: Lisa

family: Ahmad

full_name: Faiz Ahmad

given: Faiz

family: Piketty

full_name: Christophe Piketty

given: Christophe

family: Clucas

full_name: Alan Clucas

given: Alan

journal_name: Journal of Allergy and Clinical Immunology

repository_institution: Jagiellonian University - Jagiellonian University Repository

lead_sponsor: Galderma R&D

location_country:
United States
Germany
France
Poland
Australia
Canada

acronym: Dose-ranging study of nemolizumab in atopic dermatitis

location_facility:
Galderma Investigational Site
Galderma Investigational site

title: Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)

summary: Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.


ReferenceCitation: Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9:CD011612. doi: 10.1002/14651858.CD011612.pub3. Review.

name: Oxford Health NHS Foundation Trust; Oxford UK

family: Dean

full_name: Rebecca L Dean

given: Rebecca L

family: Hurducas

full_name: Claudia Hurducas

given: Claudia

name: Centre for Suicide Research, Department of Psychiatry; University of Oxford; Oxford UK

family: Hawton

full_name: Keith Hawton

given: Keith

name: Department of Rehabilitation Sciences, Faculty of Health Sciences; Cyprus University of Technology; Lemesos Cyprus

family: Spyridi

full_name: Styliani Spyridi

given: Styliani

family: Cowen

full_name: Philip J Cowen

given: Philip J

family: Hollingsworth

full_name: Sarah Hollingsworth

given: Sarah

family: Marquardt

full_name: Tahnee Marquardt

given: Tahnee

family: Barnes

full_name: Annabelle Barnes

given: Annabelle

family: Smith

full_name: Rebecca Smith

given: Rebecca

family: McShane

full_name: Rupert McShane

given: Rupert

name: Portland Veterans Affairs Medical Center; P3MHDC; Portland USA

name: Department of Psychiatry; Oregon Health & Science University; Portland Oregon USA

family: Turner

full_name: Erick H Turner

given: Erick H

family: Cipriani

full_name: Andrea Cipriani

given: Andrea

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Ionescu DF, Fu DJ, Qiu X, Lane R, Lim P, Kasper S, Hough D, Drevets WC, Manji H, Canuso CM. Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II). Int J Neuropsychopharmacol. 2021 Jan 20;24(1):22-31. doi: 10.1093/ijnp/pyaa068.

name: Department of Neuroscience, Janssen Research and Development, LLC, San Diego, CA

family: Ionescu

full_name: Dawn F Ionescu

given: Dawn F

name: Department of Neuroscience, Janssen Research and Development, LLC, Titusville, NJ

family: Fu

full_name: Dong-Jing Fu

given: Dong-Jing

name: Department of Statistics, Janssen Research and Development, LLC, Raritan, NJ

family: Qiu

full_name: Xin Qiu

given: Xin

name: Department of Statistics, Janssen Research and Development, LLC, Titusville, NJ

family: Lane

full_name: Rosanne Lane

given: Rosanne

family: Lim

full_name: Pilar Lim

given: Pilar

name: Center of Brain Research, Medical University of Vienna, Vienna, Austria

family: Kasper

full_name: Siegfried Kasper

given: Siegfried

family: Hough

full_name: David Hough

given: David

family: Drevets

full_name: Wayne C Drevets

given: Wayne C

family: Manji

full_name: Husseini Manji

given: Husseini

family: Canuso

full_name: Carla M Canuso

given: Carla M

journal_name: International Journal of Neuropsychopharmacology

location_country:
Austria
Brazil
France
Czechia
Lithuania
Poland
Argentina
Belgium
Spain
Turkey
United States
Canada

location_facility: Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana Mazurkiewicza

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: University of Conneticut School of Medicine

location_facility: Bursa Sevket Yilmaz Research and Training Hospital

location_facility: University of California San Diego/Psychiatry

location_facility: Institut universitaire en sante mentale de Montreal

location_facility: Hospital Das Clinicas Da Universidade Federal De Minas Gerais

location_facility: University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

location_facility: Hospital Universitario Professor Edgar Santos

location_facility: SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych

location_facility: Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide

summary: The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.


title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

acronym: aHUS

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

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

ReferenceCitation: Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nürnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

family: Legendre

full_name: C.M. Legendre

family: Licht

full_name: C. Licht

given: C.

family: Muus

full_name: P. Muus

given: P.

family: Greenbaum

full_name: L.A. Greenbaum

family: Babu

full_name: S. Babu

given: S.

family: Bedrosian

full_name: C. Bedrosian

family: Bingham

full_name: C. Bingham

family: Cohen

full_name: D.J. Cohen

family: Delmas

full_name: Y. Delmas

given: Y.

family: Douglas

full_name: K. Douglas

given: K.

family: Eitner

full_name: F. Eitner

given: F.

family: Feldkamp

full_name: T. Feldkamp

given: T.

family: Fouque

full_name: D. Fouque

given: D.

family: Furman

full_name: R.R. Furman

family: Gaber

full_name: O. Gaber

given: O.

family: Herthelius

full_name: M. Herthelius

given: M.

family: Hourmant

full_name: M. Hourmant

repository_institution: Lund University - Lund University Publications

title: Terminal Complement Inhibitor Eculizumab in Atypical Hemolytic–Uremic Syndrome

location_country:
Austria
Germany
France
United States
United Kingdom


title: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

summary: A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

ReferenceCitation: Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horváth G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbánek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.

family: Brown

full_name: Robert S. Brown

given: Robert S.

suffix: Jr

family: Buti

full_name: Maria Buti

given: Maria

family: Rodrigues

full_name: Lino Rodrigues

given: Lino

family: Chulanov

full_name: Vladimir Chulanov

given: Vladimir

family: Chuang

full_name: Wan-Long Chuang

given: Wan-Long

family: Aguilar

full_name: Humberto Aguilar

given: Humberto

family: Horváth

full_name: Gábor Horváth

given: Gábor

family: Zuckerman

full_name: Elimelech Zuckerman

given: Elimelech

family: Carrion

full_name: Barbara Rosado Carrion

given: Barbara Rosado

family: Rodriguez-Perez

full_name: Federico Rodriguez-Perez

given: Federico

family: Urbánek

full_name: Petr Urbánek

given: Petr

family: Abergel

full_name: Armand Abergel

given: Armand

full_name: Eric Cohen

given: Eric

family: Lovell

full_name: Sandra S. Lovell

given: Sandra S.

family: Schnell

full_name: Gretja Schnell

given: Gretja

family: Lin

full_name: Chih-Wei Lin

given: Chih-Wei

family: Zha

full_name: Jiuhong Zha

given: Jiuhong

family: Wang

full_name: Stanley Wang

given: Stanley

family: Trinh

full_name: Roger Trinh

given: Roger

family: Mensa

full_name: Federico J. Mensa

given: Federico J.

family: Burroughs

full_name: Margaret Burroughs

given: Margaret

family: Felizarta

full_name: Franco Felizarta

given: Franco

title: Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis: The EXPEDITION-8 trial

location_country:
Italy
Spain
Vietnam
France
Czechia
Bulgaria
Greece
Israel
Poland
Hungary
Ireland
Puerto Rico
Romania
Portugal
Russian Federation
United States
United Kingdom
Canada
Taiwan

location_facility: Texas Digestive Disease Consul /ID# 162648

location_facility: General Hospital of Athens Laiko /ID# 162786

location_facility: CBSI Central scientific and research institute of epidemiology /ID# 161996

location_facility: Icahn School of Med Mt. Sinai /ID# 162294

location_facility: James J. Peters VA Medical Center /ID# 162644

location_facility: HepID - Diagnostyka I Terapia /ID# 162761

location_facility: LLC Medical Company Hepatolog /ID# 161998

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 163785

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 162313

location_facility: St. Josephs Hosp and Med Ctr /ID# 162762

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484

location_facility: Stavropol State Medical Univ /ID# 161999

location_facility: Central Clinical Hospital of R /ID# 163434

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949

location_facility: Taipei Veterans General Hosp /ID# 162776

location_facility: Center for Liver Diseases, Oakland /ID# 162568

location_facility: Centro Hospitalar do Porto EPE /ID# 163765

location_facility: Hospital Parc de Salut del Mar /ID# 162198

location_facility: RSAHI Consulting and Diagnostic Centre /ID# 161995

location_facility: Instituto de Investigacion Cientifica del Sur /ID# 162566

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 162185

location_facility: Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760

location_facility: Uniwersytecki Szpital Kliniczn /ID# 162757

location_facility: Northwestern University Feinberg School of Medicine /ID# 162208

location_facility: University Hospitals Cleveland /ID# 162243

location_facility: Hospital Universitario Reina S /ID# 162200

location_facility: Polo Universitario Luigi Sacco /ID# 162339

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 162340

location_facility: Kaiser Permanente - San Diego (Palm Ave) /ID# 162289

location_facility: The Ottawa Hospital Research /ID# 161179

location_facility: Carolinas Center for Liver Dis /ID# 162569

location_facility: The University of Iowa Hospita /ID# 162214

location_facility: Universita della Campania Luigi Vanvitelli /ID# 162337

location_facility: Duke University Medical Center /ID# 162299

location_facility: Institutul Nat. de Boli Infectioase /ID# 163488

location_facility: Stanford University School of Med /ID# 162209

location_facility: VA Long Beach Healthcare System /ID# 162298

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 162645

location_facility: Centro Hospitalar de Sao Joao /ID# 163766

location_facility: Weill Cornell Medical College /ID# 161051

location_facility: Centro Hosp de Lisboa Central /ID# 163770

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 162241

location_facility: Basildon University Hospital /ID# 162616

location_facility: Klinical Investigations Group /ID# 162565

location_facility: Institut Klinicke a Experimeth /ID# 162900

location_facility: General and Oncology Hospital /ID# 162784

location_facility: Hospital Univ Central Asturias /ID# 162195

location_facility: Percuro Clinical Research, Ltd /ID# 161184

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449

location_facility: Lehigh Valley Health Network /ID# 162603

location_facility: CHI Health Alegent Creighton /ID# 162286

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335

location_facility: National Hospital of Tropical Diseases /ID# 167974

location_facility: CHR Orleans - Hopital de la Source /ID# 163072

location_facility: China Medical University Hosp /ID# 162950


title: An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

summary: A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.

family: Trosch

full_name: Richard M. Trosch

given: Richard M.

family: Misra

full_name: Vijay P. Misra

given: Vijay P.

family: Maisonobe

full_name: Pascal Maisonobe

given: Pascal

family: Om

full_name: Savary Om

given: Savary

currency_apc_doaj: USD

journal_name: Clinical Parkinsonism & Related Disorders

repository_institution: Imperial College London - Spiral

ReferenceCitation: Misra VP, Ehler E, Zakine B, Maisonobe P, Simonetta-Moreau M; INTEREST IN CD group. Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study. BMJ Open. 2012 Jun 14;2(3). pii: e000881. doi: 10.1136/bmjopen-2012-000881. Print 2012. Erratum in: BMJ Open. 2013 May 31;3(5):null.

full_name: Vijay P Misra

given: Vijay P

family: Ehler

full_name: Edvard Ehler

given: Edvard

family: Zakine

full_name: Benjamin Zakine

given: Benjamin

family: Simonetta-Moreau

full_name: Marion Simonetta-Moreau

given: Marion

journal_name: BMJ Open

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_country:
Netherlands
France
Czechia
Belgium
Australia
Russian Federation
Portugal
Germany
United Kingdom

location_facility: Praxis für Neurologie, International Neuroscience Institute

location_facility: Serviço de Neurologia - Hospital de São João

location_facility: Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen

location_facility: Hospital General San Antonio - Centro Hospitalar do Porto

location_facility: National Hospital for Neurology & Neurosurgery

location_facility: Walton Centre for Neurology & Neurosurgery, Hope Hospital

location_facility: Hôpital Neurologique et Neurochirurgical Pierre Wertheimer


title: An Open-Label Study of AMG 386 in Combination With Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects With HER2-positive Locally Recurrent or Metastatic Breast Cancer

summary:
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer.

This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.

ReferenceCitation: Kaufman PA, Wildiers H, Freyer G, Kemeny M, Gonçalves A, Jerusalem G, Stopeck A, Vrindavanam N, Dalenc F, Nanayakkara N, Wu B, Pickett CA. Phase 1b Study of Trebananib Plus Paclitaxel and Trastuzumab in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer. Clin Breast Cancer. 2019 Feb;19(1):47-57. doi: 10.1016/j.clbc.2018.09.012. Epub 2018 Oct 9.

lead_sponsor: Amgen

location_country:
United States
Belgium
France


title: An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia

summary: The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.

ReferenceCitation: Döhner H, Lübbert M, Fiedler W, Fouillard L, Haaland A, Brandwein JM, Lepretre S, Reman O, Turlure P, Ottmann OG, Müller-Tidow C, Krämer A, Raffoux E, Döhner K, Schlenk RF, Voss F, Taube T, Fritsch H, Maertens J. Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. Blood. 2014 Aug 28;124(9):1426-33. doi: 10.1182/blood-2014-03-560557. Epub 2014 Jul 8.

name: Department of Internal Medicine III, Ulm University, Ulm, Germany;

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

name: Department of Internal Medicine I, University of Freiburg, Freiburg, Germany;

family: Lübbert

full_name: Michael Lübbert

given: Michael

name: Hubertus Wald University Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;

family: Fiedler

full_name: Walter Fiedler

given: Walter

name: Centre Hospitalier René Dubos, Cergy Pontoise, France;

family: Fouillard

full_name: Loic Fouillard

given: Loic

family: Haaland

full_name: Alf Haaland

given: Alf

name: Princess Margaret Cancer Centre, Toronto, ON, Canada;

family: Brandwein

full_name: Joseph M. Brandwein

given: Joseph M.

name: Centre de Lutte Contre Le Cancer Henri Becquerel, Rouen, France;

family: Lepretre

full_name: Stephane Lepretre

given: Stephane

name: Centre Hospitalo-Universitaire de Caen, Caen, France;

family: Reman

full_name: Oumedaly Reman

given: Oumedaly

name: Centre Hospitalo-Universitaire de Limoges, Limoges, France;

family: Turlure

full_name: Pascal Turlure

name: Department of Internal Medicine II, Goethe University, Frankfurt, Germany;

family: Ottmann

full_name: Oliver G. Ottmann

given: Oliver G.

name: Department of Medicine A, University of Münster, Münster, Germany;

family: Müller-Tidow

full_name: Carsten Müller-Tidow

given: Carsten

name: University of Heidelberg and German Cancer Research Center (DKFZ), Heidelberg, Germany;

family: Krämer

full_name: Alwin Krämer

given: Alwin

name: University Hospital Saint-Louis, Assistance Publique–Hôpitaux de Paris, Paris, France;

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

full_name: Konstanze Döhner

given: Konstanze

family: Schlenk

full_name: Richard F. Schlenk

given: Richard F.

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; and

family: Voss

full_name: Florian Voss

given: Florian

family: Taube

full_name: Tillmann Taube

given: Tillmann

family: Fritsch

full_name: Holger Fritsch

given: Holger

name: University Hospital Gasthuisberg Leuven, Leuven, Belgium

family: Maertens

full_name: Johan Maertens

given: Johan

journal_name: Blood

oa_host_type: repository

location_country: Italy Austria Germany France Norway Belgium Canada

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: HOP, Centre Hospitalier René Dubos, Hémato, Paris

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel


title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

summary: The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.

status: Active, not recruiting

ReferenceCitation: Kulasekararaj AG, Hill A, Rottinghaus ST, Langemeijer S, Wells R, Gonzalez-Fernandez FA, Gaya A, Lee JW, Gutierrez EO, Piatek CI, Szer J, Risitano A, Nakao S, Bachman E, Shafner L, Damokosh AI, Ortiz S, Röth A, Peffault de Latour R. Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study. Blood. 2019 Feb 7;133(6):540-549. doi: 10.1182/blood-2018-09-876805. Epub 2018 Dec 3.

ReferenceCitation: Schwartz CE, Stark RB, Borowiec K, Nolte S, Myren KJ. Norm-based comparison of the quality-of-life impact of ravulizumab and eculizumab in paroxysmal nocturnal hemoglobinuria. Orphanet J Rare Dis. 2021 Sep 15;16(1):389. doi: 10.1186/s13023-021-02016-8.

family: Schwartz

full_name: Carolyn E. Schwartz

given: Carolyn E.

family: Stark

full_name: Roland B. Stark

given: Roland B.

family: Borowiec

full_name: Katrina Borowiec

given: Katrina

family: Nolte

full_name: Sandra Nolte

given: Sandra

family: Myren

full_name: Karl-Johan Myren

given: Karl-Johan

journal_name: Orphanet Journal of Rare Diseases

ReferenceCitation: Ishiyama K, Nakao S, Usuki K, Yonemura Y, Ikezoe T, Uchiyama M, Mori Y, Fukuda T, Okada M, Fujiwara SI, Noji H, Rottinghaus S, Aguzzi R, Yokosawa J, Nishimura JI, Kanakura Y, Okamoto S. Results from multinational phase 3 studies of ravulizumab (ALXN1210) versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria: subgroup analysis of Japanese patients. Int J Hematol. 2020 Oct;112(4):466-476. doi: 10.1007/s12185-020-02934-6. Epub 2020 Aug 31.

family: Ishiyama

full_name: Ken Ishiyama

given: Ken

family: Nakao

full_name: Shinji Nakao

given: Shinji

family: Usuki

full_name: Kensuke Usuki

given: Kensuke

family: Yonemura

full_name: Yuji Yonemura

given: Yuji

family: Ikezoe

full_name: Takayuki Ikezoe

given: Takayuki

family: Uchiyama

full_name: Michihiro Uchiyama

given: Michihiro

family: Mori

full_name: Yasuo Mori

given: Yasuo

family: Fukuda

full_name: Tetsuya Fukuda

given: Tetsuya

family: Okada

full_name: Masaya Okada

given: Masaya

family: Fujiwara

full_name: Shin-ichiro Fujiwara

given: Shin-ichiro

family: Noji

full_name: Hideyoshi Noji

given: Hideyoshi

family: Rottinghaus

full_name: Scott Rottinghaus

given: Scott

ReferenceCitation: Brodsky RA, Peffault de Latour R, Rottinghaus ST, Röth A, Risitano AM, Weitz IC, Hillmen P, Maciejewski JP, Szer J, Lee JW, Kulasekararaj AG, Volles L, Damokosh AI, Ortiz S, Shafner L, Liu P, Hill A, Schrezenmeier H. Characterization of breakthrough hemolysis events observed in the phase 3 randomized studies of ravulizumab versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria. Haematologica. 2021 Jan 1;106(1):230-237. doi: 10.3324/haematol.2019.236877.

repository_institution: University of Melbourne - Minerva Access

publisher: Ferrata Storti Foundation (Haematologica)

location_country:
Italy
United States
Netherlands
Germany
France
Japan
Australia
Spain
Canada
United Kingdom
Korea, Republic of


title: A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)

acronym: CASPIAN

summary: This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer

ReferenceCitation: Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Özgüroğlu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Każarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.

family: Goldman

full_name: Jonathan W Goldman

given: Jonathan W

family: Dvorkin

full_name: Mikhail Dvorkin

given: Mikhail

family: Chen

full_name: Yuanbin Chen

given: Yuanbin

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

family: Hotta

full_name: Katsuyuki Hotta

given: Katsuyuki

family: Trukhin

full_name: Dmytro Trukhin

given: Dmytro

family: Statsenko

full_name: Galina Statsenko

given: Galina

family: Hochmair

full_name: Maximilian J Hochmair

given: Maximilian J

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

given: Mustafa

family: Ji

full_name: Jun Ho Ji

given: Jun Ho

family: Garassino

full_name: Marina Chiara Garassino

given: Marina Chiara

family: Voitko

full_name: Oleksandr Voitko

given: Oleksandr

family: Poltoratskiy

full_name: Artem Poltoratskiy

given: Artem

family: Ponce

full_name: Santiago Ponce

given: Santiago

family: Verderame

full_name: Francesco Verderame

given: Francesco

family: Havel

full_name: Libor Havel

given: Libor

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Każarnowicz

full_name: Andrzej Każarnowicz

given: Andrzej

family: Losonczy

full_name: György Losonczy

given: György

family: Conev

full_name: Nikolay V Conev

given: Nikolay V

family: Armstrong

full_name: Jon Armstrong

given: Jon

family: Byrne

full_name: Natalie Byrne

given: Natalie

family: Thiyagarajah

full_name: Piruntha Thiyagarajah

title: Durvalumab, with or without tremelimumab, plus platinum–etoposide versus platinum–etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial

ReferenceCitation: Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Özgüroğlu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.

title: Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial

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

location_country:
Romania
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Korea, Republic of
Netherlands
Bulgaria
Hungary
China
Germany
United States
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey


ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

family: de Liaño

full_name: A G de Liaño

given: A G

family: Reig

full_name: O Reig

given: O

family: Mellado

full_name: B Mellado

given: B

family: Martin

full_name: C Martin

given: C

family: Rull

full_name: E U Rull

given: E U

family: Maroto

full_name: J P Maroto

given: J P

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Araujo JC, Trudel GC, Saad F, Armstrong AJ, Yu EY, Bellmunt J, Wilding G, McCaffrey J, Serrano SV, Matveev VB, Efstathiou E, Oudard S, Morris MJ, Sizer B, Goebell PJ, Heidenreich A, de Bono JS, Begbie S, Hong JH, Richardet E, Gallardo E, Paliwal P, Durham S, Cheng S, Logothetis CJ. Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1307-16. doi: 10.1016/S1470-2045(13)70479-0. Epub 2013 Nov 8.

family: Araujo

full_name: John C Araujo

given: John C

family: Trudel

full_name: Géralyn C Trudel

given: Géralyn C

family: Saad

full_name: Fred Saad

given: Fred

full_name: Andrew J Armstrong

given: Andrew J

family: Yu

full_name: Evan Y Yu

given: Evan Y

family: Bellmunt

full_name: Joaquim Bellmunt

given: Joaquim

family: Wilding

full_name: George Wilding

given: George

family: McCaffrey

full_name: John McCaffrey

given: John

family: Serrano

full_name: Sergio V Serrano

given: Sergio V

family: Matveev

full_name: Vsevolod B Matveev

given: Vsevolod B

family: Efstathiou

full_name: Eleni Efstathiou

given: Eleni

family: Oudard

full_name: Stephane Oudard

location_country:
Peru
Finland
Greece
Romania
Australia
Russian Federation
Czech Republic
India
France
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain

location_facility: North Mississippi Hematology And Oncology Associates, Ltd

location_facility: Fort Wayne Medical Oncology And Hematology Inc

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Desert Hematology Oncology Medical Group

location_facility: Piedmont Hematology Oncology Associates, Pllc

location_facility: Associates In Hematology & Oncology, P.C.

location_facility: University Of South Alabama / Mitchell Cancer Institute

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Compassionate Cancer Care Medical Group Inc

title: A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

summary: The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.


ReferenceCitation: Vermorken JB, Peyrade F, Krauss J, Mesía R, Remenar E, Gauler TC, Keilholz U, Delord JP, Schafhausen P, Erfán J, Brümmendorf TH, Iglesias L, Bethe U, Hicking C, Clement PM. Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). Ann Oncol. 2014 Mar;25(3):682-688. doi: 10.1093/annonc/mdu003.

family: Vermorken

full_name: J.B. Vermorken

family: Peyrade

full_name: F. Peyrade

given: F.

family: Krauss

full_name: J. Krauss

given: J.

family: Mesía

full_name: R. Mesía

given: R.

family: Remenar

full_name: E. Remenar

given: E.

family: Gauler

full_name: T.C. Gauler

family: Keilholz

full_name: U. Keilholz

given: U.

family: Delord

full_name: J.P. Delord

family: Schafhausen

full_name: P. Schafhausen

given: P.

family: Erfán

full_name: J. Erfán

family: Brümmendorf

full_name: T.H. Brümmendorf

family: Iglesias

full_name: L. Iglesias

given: L.

family: Bethe

full_name: U. Bethe

family: Hicking

full_name: C. Hicking

given: C.

family: Clement

full_name: P.M. Clement

journal_name: Annals of Oncology

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country: Italy Austria Switzerland France Poland Hungary Belgium Spain Germany

acronym: ADVANTAGE

title: Open-label, Randomized, Controlled Phase I/II Study of Cilengitide to Evaluate the Safety and Efficacy of the Combination of Different Regimens of Cilengitide Added to Cisplatin, 5-FU, and Cetuximab in Subjects With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck

summary:
The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).

The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial, cilengitide is administered at two different doses to two experimental groups. The third group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.

Cilengitide is an experimental anti-cancer substance interacting with so-called integrins. Integrins are protein molecules that are known to be present on the surface of certain cancer cells. Integrins are also found on certain cells that belong to growing blood vessels (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor (angiogenesis) as well as the tumor's growth and further spread throughout the body (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially kills cancer cells, and potentially sensitizes cancer cells to other co-administered therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially inhibits the ingrowth of additional blood vessels towards the tumor.

Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If any unacceptable side effect occurs, treatment with the study drug will be stopped.