title: The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

acronym: TNT

summary: The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.

ReferenceCitation: Waters DD, LaRosa JC, Barter P, Fruchart JC, Gotto AM Jr, Carter R, Breazna A, Kastelein JJ, Grundy SM. Effects of high-dose atorvastatin on cerebrovascular events in patients with stable coronary disease in the TNT (treating to new targets) study. J Am Coll Cardiol. 2006 Nov 7;48(9):1793-9. Epub 2006 Oct 17.

ReferenceCitation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.

name: Department of Internal Medicine Amsterdam Cardiovascular Sciences Amsterdam University Medical Centre University of Amsterdam The Netherlands

family: Vogt

full_name: Liffert Vogt

given: Liffert

name: Division of Cardiology New York University School of Medicine New York NY

family: Bangalore

full_name: Sripal Bangalore

given: Sripal

family: Fayyad

full_name: Rana Fayyad

given: Rana

family: Melamed

full_name: Shari Melamed

given: Shari

family: Hovingh

full_name: G. Kees Hovingh

given: G. Kees

family: DeMicco

full_name: David A. DeMicco

given: David A.

name: Division of Cardiology San Francisco General Hospital San Francisco CA

family: Waters

full_name: David D. Waters

given: David D.

journal_name: Journal of the American Heart Association

title: Atorvastatin Has a Dose‐Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double‐Blind Randomized Controlled Trials

ReferenceCitation: Bangalore S, Fayyad R, DeMicco DA, Colhoun HM, Waters DD. Body Weight Variability and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus. Circ Cardiovasc Qual Outcomes. 2018 Nov;11(11):e004724. doi: 10.1161/CIRCOUTCOMES.118.004724.

name: Department of Cardiology, New York University School of Medicine (S.B.).

name: Pfizer, Inc, New York, NY (R.F., D.A.D.)

name: University of Edinburgh, Scotland (H.M.C.).

family: Colhoun

full_name: Helen M. Colhoun

given: Helen M.

name: Department of Cardiology, Zuckerberg San Francisco General Hospital, CA (D.D.W.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

evidence: open (via free pdf)

repository_institution: University of California - eScholarship University of California

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of California - eScholarship University of California

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Kaasenbrood L, Ray KK, Boekholdt SM, Smulders YM, LaRosa JC, Kastelein JJP, van der Graaf Y, Dorresteijn JAN, Visseren FLJ. Estimated individual lifetime benefit from PCSK9 inhibition in statin-treated patients with coronary artery disease. Heart. 2018 Oct;104(20):1699-1705. doi: 10.1136/heartjnl-2017-312510. Epub 2018 Apr 5.

ReferenceCitation: Vallejo-Vaz AJ, Fayyad R, Boekholdt SM, Hovingh GK, Kastelein JJ, Melamed S, Barter P, Waters DD, Ray KK. Triglyceride-Rich Lipoprotein Cholesterol and Risk of Cardiovascular Events Among Patients Receiving Statin Therapy in the TNT Trial. Circulation. 2018 Aug 21;138(8):770-781. doi: 10.1161/CIRCULATIONAHA.117.032318.

name: Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, School of Public Health, Imperial College London, United Kingdom (A.J.V.-V., K.K.R.)

name: Department of Vascular Medicine (G.K.H., J.J.K.), Academic Medical Center, Amsterdam, The Netherlands

name: School of Medical Sciences, University of New South Wales Australia, Sydney (P.B.)

name: Division of Cardiology, Zuckerberg San Francisco General Hospital, CA (D.D.W.).

ReferenceCitation: Ong KL, Waters DD, Fayyad R, Vogt L, Melamed S, DeMicco DA, Rye KA, Barter PJ. Relationship of High-Density Lipoprotein Cholesterol With Renal Function in Patients Treated With Atorvastatin. J Am Heart Assoc. 2018 Jan 22;7(2). pii: e007387. doi: 10.1161/JAHA.117.007387.

name: School of Medical Sciences, University of New South Wales, Sydney, New South Wales, Australia

name: Division of Cardiology, San Francisco General Hospital, University of California at San Francisco, CA

name: Section of Nephrology, Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

title: Relationship of High‐Density Lipoprotein Cholesterol With Renal Function in Patients Treated With Atorvastatin

ReferenceCitation: Ports WC, Fayyad R, DeMicco DA, Laskey R, Wolk R. Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis. Clin Drug Investig. 2017 Aug;37(8):775-785. doi: 10.1007/s40261-017-0533-0.

ReferenceCitation: Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.

title: Body-Weight Fluctuations and Outcomes in Coronary Disease

ReferenceCitation: Stam-Slob MC, van der Graaf Y, Greving JP, Dorresteijn JA, Visseren FL. Cost-Effectiveness of Intensifying Lipid-Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients. J Am Heart Assoc. 2017 Feb 18;6(2). pii: e004648. doi: 10.1161/JAHA.116.004648.

name: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands

title: Cost‐Effectiveness of Intensifying Lipid‐Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients

ReferenceCitation: Deedwania PC, Pedersen TR, DeMicco DA, Breazna A, Betteridge DJ, Hitman GA, Durrington P, Neil A; TNT, CARDS and IDEAL Steering Committees and Investigators. Differing predictive relationships between baseline LDL-C, systolic blood pressure, and cardiovascular outcomes. Int J Cardiol. 2016 Nov 1;222:548-556. doi: 10.1016/j.ijcard.2016.07.201. Epub 2016 Jul 30.

repository_institution: Queen Mary University of London - Queen Mary Research Online

repositories_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Byun YS, Lee JH, Arsenault BJ, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; TNT Trial Investigators. Relationship of oxidized phospholipids on apolipoprotein B-100 to cardiovascular outcomes in patients treated with intensive versus moderate atorvastatin therapy: the TNT trial. J Am Coll Cardiol. 2015 Apr 7;65(13):1286-1295. doi: 10.1016/j.jacc.2015.01.050.

journal_name: Journal of the American College of Cardiology

title: Relationship of Oxidized Phospholipids on Apolipoprotein B-100 to Cardiovascular Outcomes in Patients Treated With Intensive Versus Moderate Atorvastatin Therapy

ReferenceCitation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; Treating to New Targets (TNT) Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients of the treating to new targets randomized controlled trial by lipid and non-lipid biomarkers. PLoS One. 2014 Dec 22;9(12):e114519. doi: 10.1371/journal.pone.0114519. eCollection 2014.

name: the Treating to New Targets (TNT) Investigators

title: Prediction of Cardiovascular Events in Statin-Treated Stable Coronary Patients of the Treating to New Targets Randomized Controlled Trial by Lipid and Non-Lipid Biomarkers

ReferenceCitation: Dorresteijn JA, Boekholdt SM, van der Graaf Y, Kastelein JJ, LaRosa JC, Pedersen TR, DeMicco DA, Ridker PM, Cook NR, Visseren FL. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect. Circulation. 2013 Jun 25;127(25):2485-93. doi: 10.1161/CIRCULATIONAHA.112.000712. Epub 2013 May 14.

name: From the Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands (J.A.N.D., F.L.J.V.); the Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (S.M.B.); the Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands (Y.v.d.G.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands (J.J.P.K.); the Health Science Center, State University of New York, Brooklyn, NY (J.C.L.); the Center for...

title: High-Dose Statin Therapy in Patients With Stable Coronary Artery Disease

ReferenceCitation: Semb AG, Kvien TK, DeMicco DA, Fayyad R, Wun CC, LaRosa JC, Betteridge J, Pedersen TR, Holme I. Effect of intensive lipid-lowering therapy on cardiovascular outcome in patients with and those without inflammatory joint disease. Arthritis Rheum. 2012 Sep;64(9):2836-46. doi: 10.1002/art.34524.

ReferenceCitation: Huijgen R, Boekholdt SM, Arsenault BJ, Bao W, Davaine JM, Tabet F, Petrides F, Rye KA, DeMicco DA, Barter PJ, Kastelein JJ, Lambert G. Plasma PCSK9 levels and clinical outcomes in the TNT (Treating to New Targets) trial: a nested case-control study. J Am Coll Cardiol. 2012 May 15;59(20):1778-84. doi: 10.1016/j.jacc.2011.12.043. Retraction in: J Am Coll Cardiol. 2013 Apr 23;61(16):1751.

title: RETRACTED: Plasma PCSK9 Levels and Clinical Outcomes in the TNT (Treating to New Targets) Trial

ReferenceCitation: Mora S, Wenger NK, Demicco DA, Breazna A, Boekholdt SM, Arsenault BJ, Deedwania P, Kastelein JJ, Waters DD. Determinants of residual risk in secondary prevention patients treated with high- versus low-dose statin therapy: the Treating to New Targets (TNT) study. Circulation. 2012 Apr 24;125(16):1979-87. doi: 10.1161/CIRCULATIONAHA.111.088591. Epub 2012 Mar 29.

name: From the Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.M.); Emory University School of Medicine, Atlanta, GA (N.K.W.); Pfizer, New York, NY (D.A.D., A.B.); University of Amsterdam, Amsterdam, the Netherlands (S.M.B., B.J.A., J.J.P.K.); University of California San Francisco, Fresno (P.D.); and University of California San Francisco, San Francisco (D.D.W.).

title: Determinants of Residual Risk in Secondary Prevention Patients Treated With High- Versus Low-Dose Statin Therapy

ReferenceCitation: Arsenault BJ, Boekholdt SM, Hovingh GK, Hyde CL, DeMicco DA, Chatterjee A, Barter P, Deedwania P, Waters DD, LaRosa JC, Pedersen TR, Kastelein JJ; TNT and IDEAL Investigators. The 719Arg variant of KIF6 and cardiovascular outcomes in statin-treated, stable coronary patients of the treating to new targets and incremental decrease in end points through aggressive lipid-lowering prospective studies. Circ Cardiovasc Genet. 2012 Feb 1;5(1):51-7. doi: 10.1161/CIRCGENETICS.111.960252. Epub 2011 Dec 1.

name: From the Department of Vascular Medicine (B.J.A., S.M.B., G.K.H., J.J.P.K.) and the Department of Cardiology (S.M.B.), Academic Medical Center, University of Amsterdam, The Netherlands; Pfizer Inc, New York, NY (C.L.H., D.A.D., A.C.); The Heart Research Institute, Sydney, Australia (P.B.); Veterans Affairs Central California Healthcare System and University of California San Francisco School of Medicine (P.D.); San Francisco General Hospital, San Francisco, CA (D.D.W.); State University of New York...

title: The 719Arg Variant of KIF6 and Cardiovascular Outcomes in Statin-Treated, Stable Coronary Patients of the Treating to New Targets and Incremental Decrease in End Points Through Aggressive Lipid-Lowering Prospective Studies

ReferenceCitation: Arsenault BJ, Barter P, DeMicco DA, Bao W, Preston GM, LaRosa JC, Grundy SM, Deedwania P, Greten H, Wenger NK, Shepherd J, Waters DD, Kastelein JJ; TNT Study Investigators. Prediction of cardiovascular events in statin-treated stable coronary patients by lipid and nonlipid biomarkers. J Am Coll Cardiol. 2011 Jan 4;57(1):63-9. doi: 10.1016/j.jacc.2010.06.052. Retraction in: J Am Coll Cardiol. 2013 Apr 23;61(16):1750.

title: RETRACTED: Prediction of Cardiovascular Events in Statin-Treated Stable Coronary Patients by Lipid and Nonlipid Biomarkers

ReferenceCitation: Hyde CL, Macinnes A, Sanders FA, Thompson JF, Mazzarella RA, Faergeman O, van Wijk DF, Wood L, Lira M, Paciga SA. Genetic association of the CCR5 region with lipid levels in at-risk cardiovascular patients. Circ Cardiovasc Genet. 2010 Apr;3(2):162-8. doi: 10.1161/CIRCGENETICS.109.897793. Epub 2010 Feb 3.

name: From Molecular Medicine (J.F.T., L.W., M.L., S.A.P.) and Clinical Research Statistics (C.L.H.), Pfizer Global Research and Development, Groton, Conn; Indications Discovery Research Unit (A.M., R.A.M.), Pfizer Global Research and Development, St Louis Laboratories, Chesterfield, Mo; Helicos BioSciences (J.F.T.), Cambridge, Mass; Molecular Medicine (F.A.S.), Pfizer Global Research and Development, Sandwich, UK; Department of Medicine and Cardiology (O.F.), Aarhus Sygehus University Hospital, Aarhus,...

title: Genetic Association of the CCR5 Region With Lipid Levels in At-Risk Cardiovascular Patients

ReferenceCitation: Waters DD. Clinical insights from the Treating to New Targets trial. Prog Cardiovasc Dis. 2009 May-Jun;51(6):487-502. doi: 10.1016/j.pcad.2009.01.001.

title: Clinical Insights From the Treating to New Targets Trial

ReferenceCitation: Shepherd J, Kastelein JP, Bittner VA, Carmena R, Deedwania PC, Breazna A, Dobson S, Wilson DJ, Zuckerman AL, Wenger NK; Treating to New Targets Steering Committee and Investigators. Intensive lipid lowering with atorvastatin in patients with coronary artery disease, diabetes, and chronic kidney disease. Mayo Clin Proc. 2008 Aug;83(8):870-9.

ReferenceCitation: Shah SJ, Waters DD, Barter P, Kastelein JJ, Shepherd J, Wenger NK, DeMicco DA, Breazna A, LaRosa JC. Intensive lipid-lowering with atorvastatin for secondary prevention in patients after coronary artery bypass surgery. J Am Coll Cardiol. 2008 May 20;51(20):1938-43. doi: 10.1016/j.jacc.2007.12.054.

title: Intensive Lipid-Lowering With Atorvastatin for Secondary Prevention in Patients After Coronary Artery Bypass Surgery

ReferenceCitation: Shepherd J, Kastelein JJ, Bittner V, Deedwania P, Breazna A, Dobson S, Wilson DJ, Zuckerman A, Wenger NK; TNT (Treating to New Targets) Investigators. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1448-54. doi: 10.1016/j.jacc.2007.11.072.

title: Intensive Lipid Lowering With Atorvastatin in Patients With Coronary Heart Disease and Chronic Kidney Disease

ReferenceCitation: Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10.

location_country:
Italy
Austria
United States
South Africa
Switzerland
Netherlands
Germany
France
Ireland
Australia
Belgium
Spain
Canada
United Kingdom


title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria

acronym: PLANET 1

summary: The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.

family: de Zeeuw

full_name: Dick de Zeeuw

given: Dick

sequence: first

family: Anzalone

full_name: Deborah A Anzalone

given: Deborah A

sequence: additional

family: Cain

full_name: Valerie A Cain

given: Valerie A

family: Cressman

full_name: Michael D Cressman

given: Michael D

family: Heerspink

full_name: Hiddo J Lambers Heerspink

given: Hiddo J Lambers

family: Molitoris

full_name: Bruce A Molitoris

given: Bruce A

family: Monyak

full_name: John T Monyak

given: John T

family: Parving

full_name: Hans-Henrik Parving

given: Hans-Henrik

family: Remuzzi

full_name: Giuseppe Remuzzi

given: Giuseppe

family: Sowers

full_name: James R Sowers

given: James R

family: Vidt

full_name: Donald G Vidt

given: Donald G

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Diabetes & Endocrinology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: AstraZeneca

location_country:
Italy
Brazil
United States
Mexico
France
Bulgaria
Romania
Hungary
Argentina
Denmark
Canada

location_facility:
Research site
Research Site
Reasearch Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).

summary:
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

design_allocation: Non-Randomized

lead_sponsor: UCB Pharma

location_country: Switzerland Finland France Bulgaria Poland Belgium


title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

ReferenceType: result

ReferenceCitation: Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

family: Rosenstock

full_name: J. Rosenstock

given: J.

family: Davies

full_name: M. Davies

given: M.

family: Home

full_name: P. D. Home

given: P. D.

family: Larsen

full_name: J. Larsen

family: Koenen

full_name: C. Koenen

given: C.

family: Schernthaner

full_name: G. Schernthaner

given: G.

journal_name: Diabetologia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
Germany
France
Ireland
Belgium
United States
United Kingdom


title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone

summary: This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

status: Terminated

location_country:
South Africa
Vietnam
Philippines
France
Israel
Norway
Australia
Spain
United Kingdom
Korea, Republic of

status_simplified: Unknown


type: EudraCT Number

title: A One Year, Open-label, Single-arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Diagnosed With Transfusion-dependent Iron Overload

summary: This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

ReferenceCitation: Porter JB, El-Alfy M, Viprakasit V, Giraudier S, Chan LL, Lai Y, El-Ali A, Han J, Cappellini MD. Utility of labile plasma iron and transferrin saturation in addition to serum ferritin as iron overload markers in different underlying anemias before and after deferasirox treatment. Eur J Haematol. 2016 Jan;96(1):19-26. doi: 10.1111/ejh.12540. Epub 2015 Jun 23.

family: Porter

full_name: John B. Porter

given: John B.

family: El-Alfy

full_name: Mohsen El-Alfy

given: Mohsen

name: Siriraj Hospital; Mahidol University; Bangkok Thailand

family: Viprakasit

full_name: Vip Viprakasit

given: Vip

family: Giraudier

full_name: Stephane Giraudier

given: Stephane

name: University Malaya Medical Centre; Kuala Lumpur Malaysia

family: Chan

full_name: Lee Lee Chan

given: Lee Lee

name: The First Affiliated Hospital of Guangxi Medical University; Nanning China

family: Lai

full_name: Yongrong Lai

given: Yongrong

family: El-Ali

full_name: Ali El-Ali

given: Ali

name: Novartis Pharmaceuticals; East Hanover NJ USA

family: Han

full_name: Jackie Han

given: Jackie

name: Policlinico Foundation IRCCS; Università di Milano; Milan Italy

family: Cappellini

full_name: Maria D. Cappellini

given: Maria D.

journal_name: European Journal of Haematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Lee JW, Yoon SS, Shen ZX, Ganser A, Hsu HC, El-Ali A, Habr D, Martin N, Porter JB. Hematologic responses in patients with aplastic anemia treated with deferasirox: a post hoc analysis from the EPIC study. Haematologica. 2013 Jul;98(7):1045-8. doi: 10.3324/haematol.2012.077669. Epub 2013 Apr 12.

family: Lee

full_name: J. W. Lee

given: J. W.

family: Yoon

full_name: S.-S. Yoon

family: Shen

full_name: Z. X. Shen

given: Z. X.

family: Ganser

full_name: A. Ganser

given: A.

family: Hsu

full_name: H.-C. Hsu

full_name: A. El-Ali

family: Habr

full_name: D. Habr

given: D.

family: Martin

full_name: N. Martin

given: N.

full_name: J. B. Porter

given: J. B.

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Pennell DJ, Porter JB, Cappellini MD, Chan LL, El-Beshlawy A, Aydinok Y, Ibrahim H, Li CK, Viprakasit V, Elalfy MS, Kattamis A, Smith G, Habr D, Domokos G, Roubert B, Taher A. Continued improvement in myocardial T2* over two years of deferasirox therapy in β-thalassemia major patients with cardiac iron overload. Haematologica. 2011 Jan;96(1):48-54. doi: 10.3324/haematol.2010.031468. Epub 2010 Nov 11.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

title: Continued improvement in myocardial T2* over two years of deferasirox therapy in -thalassemia major patients with cardiac iron overload

ReferenceCitation: Lee JW, Yoon SS, Shen ZX, Ganser A, Hsu HC, Habr D, Domokos G, Roubert B, Porter JB; EPIC study investigators. Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial. Blood. 2010 Oct 7;116(14):2448-54. doi: 10.1182/blood-2010-01-261289. Epub 2010 Jun 21.

name: The Catholic University of Korea, Seoul, South Korea;

name: Seoul National University College of Medicine, Seoul, South Korea;

name: Ruijin Hospital, Shanghai Second Medical University, Shanghai, China;

name: Medizinische Hochschule Hannover, Hannover, Germany;

name: Novartis Pharmaceuticals, East Hanover, NJ;

name: Novartis Pharma AG, Basel, Switzerland; and

name: on behalf of the EPIC study investigators

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Pennell DJ, Porter JB, Cappellini MD, El-Beshlawy A, Chan LL, Aydinok Y, Elalfy MS, Sutcharitchan P, Li CK, Ibrahim H, Viprakasit V, Kattamis A, Smith G, Habr D, Domokos G, Roubert B, Taher A. Efficacy of deferasirox in reducing and preventing cardiac iron overload in beta-thalassemia. Blood. 2010 Mar 25;115(12):2364-71. doi: 10.1182/blood-2009-04-217455. Epub 2009 Dec 8.

name: Royal Brompton Hospital, London, United Kingdom;

name: University College London, London, United Kingdom;

name: Universitá di Milano, Policlinico Foundation, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy;

name: University Malaya Medical Centre, Lembah Pantai, Kuala Lumpur, Malaysia;

name: Ege University Medical Faculty, Izmir, Turkey;

name: Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand;

name: Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong;

name: Hospital Kuala Lumpur, Kuala Lumpur, Malaysia;

name: Faculty of Medicine Siriraj Hospital, Department of Pediatrics, Division of Haematology-Oncology, Bangkoknoi, Bangkok, Thailand;

name: First Department of Pediatrics, University of Athens, Athens, Greece;

name: Novartis Pharma, Basel, Switzerland; and

name: American University of Beirut, Beirut, Lebanon

title: Efficacy of deferasirox in reducing and preventing cardiac iron overload in β-thalassemia

ReferenceCitation: Cappellini MD, Porter J, El-Beshlawy A, Li CK, Seymour JF, Elalfy M, Gattermann N, Giraudier S, Lee JW, Chan LL, Lin KH, Rose C, Taher A, Thein SL, Viprakasit V, Habr D, Domokos G, Roubert B, Kattamis A; EPIC Study Investigators. Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias. Haematologica. 2010 Apr;95(4):557-66. doi: 10.3324/haematol.2009.014696. Epub 2009 Nov 30.

location_country:
Malaysia
Greece
Australia
Belgium
Denmark
Taiwan
France
Thailand
Korea, Republic of
South Africa
Hong Kong
Netherlands
Switzerland
China
Germany
United Kingdom
Italy
Austria
Lebanon
Israel
Egypt
Spain
Turkey


title: Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis

summary: This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.

ReferenceCitation: Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

family: Hsia

full_name: Cyrus C. Hsia

given: Cyrus C.

family: Chin-Yee

full_name: Ian H. Chin-Yee

given: Ian H.

family: McAlister

full_name: Vivian C. McAlister

given: Vivian C.

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Use of Recombinant Activated Factor VII in Patients Without Hemophilia

location_country:
Italy
Austria
Hong Kong
United Kingdom
Finland
France
Poland
Spain
Denmark
Germany
Czech Republic
Taiwan


title: A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

summary: This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).

ReferenceCitation: Khawaja MN, Bergman MJ, Yourish J, Pei J, Reiss W, Keystone E. Routine Assessment of Patient Index Data 3 and the American College of Rheumatology/European League Against Rheumatism Provisional Remission Definitions as Predictors of Radiographic Outcome in a Rheumatoid Arthritis Clinical Trial With Tocilizumab. Arthritis Care Res (Hoboken). 2017 May;69(5):609-615. doi: 10.1002/acr.23008. Epub 2017 Apr 7.

name: Mercy Catholic Medical Center; Darby Pennsylvania

family: Khawaja

full_name: Muznay N. Khawaja

given: Muznay N.

name: Drexel University College of Medicine; Philadelphia Pennsylvania

family: Bergman

full_name: Martin J. Bergman

given: Martin J.

name: Genentech; South San Francisco California

family: Yourish

full_name: Jeffrey Yourish

given: Jeffrey

family: Pei

full_name: Jinglan Pei

given: Jinglan

family: Reiss

full_name: William Reiss

given: William

name: University of Toronto and Mount Sinai Hospital; Toronto Ontario Canada

family: Keystone

full_name: Edward Keystone

given: Edward

journal_name: Arthritis Care & Research

ReferenceCitation: Kremer JM, Blanco R, Halland AM, Brzosko M, Burgos-Vargas R, Mela CM, Rowell L, Fleischmann RM. Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial. Clin Exp Rheumatol. 2016 Jul-Aug;34(4):625-33. Epub 2016 Apr 15.

ReferenceCitation: Bay-Jensen AC, Platt A, Siebuhr AS, Christiansen C, Byrjalsen I, Karsdal MA. Early changes in blood-based joint tissue destruction biomarkers are predictive of response to tocilizumab in the LITHE study. Arthritis Res Ther. 2016 Jan 20;18:13. doi: 10.1186/s13075-015-0913-x.

family: Bay-Jensen

full_name: Anne C. Bay-Jensen

given: Anne C.

family: Platt

full_name: Adam Platt

given: Adam

family: Siebuhr

full_name: Anne Sofie Siebuhr

given: Anne Sofie

family: Christiansen

full_name: Claus Christiansen

given: Claus

family: Byrjalsen

full_name: Inger Byrjalsen

given: Inger

family: Karsdal

full_name: Morten A. Karsdal

given: Morten A.

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

full_name: Edward C. Keystone

given: Edward C.

title: Continued Benefit of Tocilizumab Plus Disease-modifying Antirheumatic Drug Therapy in Patients with Rheumatoid Arthritis and Inadequate Clinical Responses by Week 8 of Treatment

ReferenceCitation: Siebuhr AS, Bay-Jensen AC, Leeming DJ, Plat A, Byrjalsen I, Christiansen C, van de Heijde D, Karsdal MA. Serological identification of fast progressors of structural damage with rheumatoid arthritis. Arthritis Res Ther. 2013 Aug 14;15(4):R86. doi: 10.1186/ar4266.

ReferenceCitation: Fleischmann RM, Halland AM, Brzosko M, Burgos-Vargas R, Mela C, Vernon E, Kremer JM. Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol. 2013 Feb;40(2):113-26. doi: 10.3899/jrheum.120447. Epub 2013 Jan 15.

title: Tocilizumab Inhibits Structural Joint Damage and Improves Physical Function in Patients with Rheumatoid Arthritis and Inadequate Responses to Methotrexate: LITHE Study 2-year Results

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

ReferenceCitation: Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-21. doi: 10.1002/art.30158.

title: Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: Results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structu

location_country:
Italy
Brazil
South Africa
Switzerland
Mexico
Spain
Finland
France
Poland
Greece
Norway
Australia
Puerto Rico
China
Denmark
United States


type: Other Identifier

title: An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

summary:
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to:

Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
Determine the blood levels of IM olanzapine depot in patients during long-term treatment

ReferenceCitation: McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038.

family: McDonnell

full_name: David P. McDonnell

given: David P.

family: Landry

full_name: John Landry

given: John

family: Detke

full_name: Holland C. Detke

given: Holland C.

bso_classification: Social sciences

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.

family: Atkins

full_name: Susan Atkins

given: Susan

full_name: Holland C Detke

given: Holland C

full_name: David P McDonnell

given: David P

family: Case

full_name: Michael G Case

given: Michael G

family: Wang

full_name: Shufang Wang

given: Shufang

journal_name: BMC Psychiatry

ReferenceCitation: Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.

family: Peuskens

full_name: Joseph Peuskens

given: Joseph

family: Porsdal

full_name: Vibeke Porsdal

given: Vibeke

family: Pecenak

ReferenceCitation: McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.

ReferenceCitation: Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.

location_country:
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Croatia
France
Poland
Slovakia
Argentina
South Africa
Sweden
Netherlands
Hungary
Puerto Rico
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
Israel
Spain

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


type: Registry Identifier

title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

acronym: ExCel

summary:
RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen.

PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

study_start_date_type: Actual

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Richardson H, Johnston D, Pater J, Goss P. The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial. Curr Oncol. 2007 Jun;14(3):89-96.

ReferenceCitation: Goss PE, Richardson H, Chlebowski R, Johnston D, Sarto GE, Maunsell E, Ingle JN, Alés-Martinez JE. National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer. 2007 Dec;7(11):895-900. doi: 10.3816/CBC.2007.n.057.

family: Goss

full_name: Paul E. Goss

given: Paul E.

family: Richardson

full_name: Harriet Richardson

given: Harriet

family: Chlebowski

full_name: Rowan Chlebowski

given: Rowan

family: Johnston

full_name: Dianne Johnston

given: Dianne

family: Sarto

full_name: Gloria E. Sarto

given: Gloria E.

family: Maunsell

full_name: Elizabeth Maunsell

given: Elizabeth

family: Ingle

full_name: James N. Ingle

given: James N.

family: Alés-Martinez

full_name: José E. Alés-Martinez

given: José E.

journal_name: Clinical Breast Cancer

title: National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: Evaluation of Exemestane to Prevent Breast Cancer in Postmenopausal Women

ReferenceCitation: Moy B, Richardson H, Johnston D, et al.: NCIC CTG MAP.3: enrollment and study drug adherence of ethnic minority women in a breast cancer prevention trial. [Abstract] Breast Cancer Res Treat 106 (1): A-3048, S141-2, 2007.

ReferenceCitation: Richardson H, Johnston D, Goss PE, et al.: Participant characteristics on an international NCIC CTG breast cancer prevention trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1531, 2007.

ReferenceCitation: Goss PE, Ingle JN, Alés-Martinez J, Cheung A, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson K, Martin L, Winquist E, Sarto G, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H. Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 - A randomized placebo-controlled clinical trial. J Clin Oncol 29[suppl; abstr LBA504], 2011.

ReferenceCitation: Goss PE, Ingle JN, Alés-Martínez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson KC, Martin LW, Winquist E, Sarto GE, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H; NCIC CTG MAP.3 Study Investigators. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4. Erratum in: N Engl J Med. 2011 Oct 6;365(14):1361.

family: Alés-Martínez

full_name: José E. Alés-Martínez

family: Cheung

full_name: Angela M. Cheung

given: Angela M.

full_name: Rowan T. Chlebowski

given: Rowan T.

family: Wactawski-Wende

full_name: Jean Wactawski-Wende

given: Jean

family: McTiernan

full_name: Anne McTiernan

given: Anne

family: Robbins

full_name: John Robbins

family: Johnson

full_name: Karen C. Johnson

given: Karen C.

family: Martin

full_name: Lisa W. Martin

given: Lisa W.

family: Winquist

full_name: Eric Winquist

given: Eric

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

title: Exemestane for Breast-Cancer Prevention in Postmenopausal Women

ReferenceCitation: Maunsell E, Goss PE, Chlebowski RT, Ingle JN, Alés-Martínez JE, Sarto GE, Fabian CJ, Pujol P, Ruiz A, Cooke AL, Hendrix S, Thayer DW, Rowland KM, Dubé P, Spadafora S, Pruthi S, Lickley L, Ellard SL, Cheung AM, Wactawski-Wende J, Gelmon KA, Johnston D, Hiltz A, Brundage M, Pater JL, Tu D, Richardson H. Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. J Clin Oncol. 2014 May 10;32(14):1427-36. doi: 10.1200/JCO.2013.51.2483. Epub 2014 Apr 7.

name: Elizabeth Maunsell, Centre de recherche du Centre hospitalier universitaire (CHU) de Québec, (Axe Oncologie), Québec; Pierre Dubé, Hôpital Maisonneuve-Rosemont, Montreal, QC; Andrew L. Cooke, CancerCare Manitoba, Winnipeg, MB; Silvana Spadafora, Algoma District Cancer Program, Sault Ste. Marie, ON; Lavina Lickley, Women's College Hospital; Angela M. Cheung, University Health Network, University of Toronto, Toronto; Dianne Johnston, Andrea Hiltz, Michael Brundage, Dongsheng Tu, and Harriet Richardson,...

publisher: American Society of Clinical Oncology (ASCO)

title: Quality of Life in MAP.3 (Mammary Prevention 3): A Randomized, Placebo-Controlled Trial Evaluating Exemestane for Prevention of Breast Cancer

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Mid-Illinois Hematology and Oncology Associates, Ltd.

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: The University of Chicago Medical Center

location_facility: Washington University School of Medicine

location_facility: Los Angeles Biomedical Research Institute

location_facility: BCCA - Cancer Centre for the Southern Interior

location_facility: Cancer Centre of Southeastern Ontario at Kingston

location_facility: Univ. Health Network-Princess Margaret Hospital

location_facility: Univ. of Wisconsin Center for Women's Health and

location_facility: University of Cincinnati, Barrett Cancer Centre

location_facility: Ottawa Health Research Institute - General Division

location_facility: Whittingham Cancer Center at Norwalk Hospital

location_facility: John H. Stroger, Jr Hospital of Cook County

location_facility: University of Medicine and Dentistry of New Jersey


title: A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease

summary: This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Greece
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom


title: A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

summary: This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

ReferenceCitation: Raza A, Reeves JA, Feldman EJ, Dewald GW, Bennett JM, Deeg HJ, Dreisbach L, Schiffer CA, Stone RM, Greenberg PL, Curtin PT, Klimek VM, Shammo JM, Thomas D, Knight RD, Schmidt M, Wride K, Zeldis JB, List AF. Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1 risk myelodysplastic syndromes with karyotypes other than deletion 5q. Blood. 2008 Jan 1;111(1):86-93. Epub 2007 Sep 24.

lead_sponsor: Celgene Corporation

location_country:
Italy
Sweden
Switzerland
Netherlands
United Kingdom
Germany
France
Greece
Belgium
Australia
Russian Federation
Spain
Denmark
United States
Czech Republic

location_facility: King's College Hospital - Haematology Clinical Trials

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier Départemental Vendée - Onco-hematologie

location_facility: Universita degli Studi di Padova - Clinical & Experimental Medicine

location_facility: A.O.U. San Giovanni Battista - Hematology

location_facility: Hospital Clinic i Provincial de Barcelona - Hematology

location_facility: Royal Wolverhampton hospitals trust - Research and development

location_facility: Inselspital, Institut für Medizinische Onkologie

location_facility: Hôpital Saint Louis - Immuno-hematologie

location_facility: Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

location_facility: Peter McCallum Cancer Institute - Directorate of Cancer Medecine

location_facility: Universitätsklinikum Ulm - Klinik fur Innere Medizin III

location_facility: Centre Hospitalier de la côte basque - Hematologie

location_facility: Royal Adelaide Hospital - SA Pathology Haematology

location_facility: Royal Prince Alfred Hospital - Institute of Haematology

location_facility: Princess Alexandra Hospital - Haematology

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

location_facility: Sahlgrenska Hospital, University of Goteborg - Hematology

location_facility: University of Athens - Alexandra Hospital; Clinical Therapeutics

location_facility: Hôpital Bretonneau - Hématologie & Thérapie cellulaire

location_facility: Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

location_facility: Rush Presbyterian-St. Luke's Medical Center

location_facility: Karolinska University Hospital Solna- medicine

location_facility: CHU Angers - Service des maladies du sang

location_facility: Cliniques Universitaires ULC de Mont-Godinne - Hematology

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: Hospital Germans Trias i Pujol - Hematology

location_facility: Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

location_facility: Royal Bournemouth Hospital - Haematology

location_facility: Hôpitaux Universitaire de Genève - Oncologie

location_facility: Russian Research Institute of Hematology and Blood Transfusion - Hematology

location_facility: Hospital Universitario Marqués de Valdecilla - Hematology

location_facility: Royal hallamshire Hospital - Haematology

location_facility: Nottingham City Hospital - Centre for Clinical Haematology

location_facility: Freeman Hospital - Northern Centre for Cancer Care

location_facility: Centre Hospitalier Lyon sud - Hematologie

location_facility: Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

location_facility: Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

location_facility: Karolinska University Hospital Huddinge - Center of hematology

location_facility: The Alfred Hospital - malignant haematology & stem cell transplantation

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Wake Forest University School of Medicine

location_facility: Northwest Georgia Oncology - Wellstar Cancer Research

location_facility: CHU Saint Antoine - Service des maladies du sang

location_facility: AO Universitaria San Martino - hematooncology

location_facility: Wayne State University School of Medicine

location_facility: Royal Marsden NHS Foundation Trust - Haematology

location_facility: Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

location_facility: Frankston Hospital-peninsula Health - Oncology Day Unit

location_facility: Ospedale Guglielmo da Saliceto - hematooncology

location_facility: University of Rochester-James P. Wilmot Cancer Center

location_facility: Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

location_facility: St. Luke's Oncology and Hematology Associates

location_facility: St James's University Hospital - Haematology

location_facility: Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

location_facility: CHRU de Lille - Service des maladies du sang

location_facility: Ospedale San Luigi AO Luigi Gonzaga - Hematology

location_facility: St Bartholomew's Hospital - Medical Oncology

location_facility: St. Vincents Comprehensive Cancer Center

location_facility: Charles university Hospital - Internal Medicine

location_facility: Fakultní nemocnice Hradec Králové - Hematology

location_facility: University of Miami- Sylvester Comp Cancer Center


title: The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy plus steroid therapy is more effective for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus steroid therapy in treating children who have acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Ducassou S, Ferlay C, Bergeron C, Girard S, Laureys G, Pacquement H, Plantaz D, Lutz P, Vannier JP, Uyttebroeck A, Bertrand Y. Clinical presentation, evolution, and prognosis of precursor B-cell lymphoblastic lymphoma in trials LMT96, EORTC 58881, and EORTC 58951. Br J Haematol. 2011 Feb;152(4):441-51. doi: 10.1111/j.1365-2141.2010.08541.x. Epub 2011 Jan 7.

ReferenceCitation: Clappier E, Collette S, Grardel N, Girard S, Suarez L, Brunie G, Kaltenbach S, Yakouben K, Mazingue F, Robert A, Boutard P, Plantaz D, Rohrlich P, van Vlierberghe P, Preudhomme C, Otten J, Speleman F, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cavé H; EORTC-CLG. NOTCH1 and FBXW7 mutations have a favorable impact on early response to treatment, but not on outcome, in children with T-cell acute lymphoblastic leukemia (T-ALL) treated on EORTC trials 58881 and 58951. Leukemia. 2010 Dec;24(12):2023-31. doi: 10.1038/leu.2010.205. Epub 2010 Sep 23.

ReferenceCitation: Clappier E, Collette S, Grardel N, et al.: Prognostic significance of NOTCH1 and FBXW7 mutations in childhood T-cell acute lymphoblastic leukemia (T-ALL): results from the EORTC Children Leukemia Group. [Abstract] Blood 114 (22): A-909, 2009.

ReferenceCitation: Renneville A, Kaltenbach S, Clappier E, et al.: Wilms' tumor 1 (WT1) gene mutations in pediatric T-acute lymphoblastic leukemia. [Abstract] Blood 114 (22): A-3075, 2009.

ReferenceCitation: Cavé H, Suciu S, Preudhomme C, Poppe B, Robert A, Uyttebroeck A, Malet M, Boutard P, Benoit Y, Mauvieux L, Lutz P, Méchinaud F, Grardel N, Mazingue F, Dupont M, Margueritte G, Pages MP, Bertrand Y, Plouvier E, Brunie G, Bastard C, Plantaz D, Vande Velde I, Hagemeijer A, Speleman F, Lessard M, Otten J, Vilmer E, Dastugue N; EORTC-CLG. Clinical significance of HOX11L2 expression linked to t(5;14)(q35;q32), of HOX11 expression, and of SIL-TAL fusion in childhood T-cell malignancies: results of EORTC studies 58881 and 58951. Blood. 2004 Jan 15;103(2):442-50. Epub 2003 Sep 22.

ReferenceCitation: Mirebeau D, Acquaviva C, Suciu S, et al.: Is CDKN2A +/- CDKN2B and MTAP inactivation of prognostic significance in B-precursor childhood acute lymphoblastic leukemia? Results of EORTC studies 58881 and 58951. [Abstract] Blood 104 (11): A-1076, 2004.

ReferenceCitation: Cavé H, Suciu S, Preudhomme C, et al.: HOX11L2 expression linked to t(5;14)(q35;q32) is not associated with poor prognosis in childhood T-ALL treated in EORTC trials 58 881 and 58 951. [Abstract] Blood 100(11 pt 1): A-576, 153a, 2002.

ReferenceCitation: De Moerloose B, Suciu S, Bertrand Y, Mazingue F, Robert A, Uyttebroeck A, Yakouben K, Ferster A, Margueritte G, Lutz P, Munzer M, Sirvent N, Norton L, Boutard P, Plantaz D, Millot F, Philippet P, Baila L, Benoit Y, Otten J; Children's Leukemia Group of the European Organisation for Research and Treatment of Cancer (EORTC). Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951. Blood. 2010 Jul 8;116(1):36-44. doi: 10.1182/blood-2009-10-247965. Epub 2010 Apr 20.

name: Department of Pediatric Hematology-Oncology, Ghent University Hospital, Ghent, Belgium;

family: De Moerloose

full_name: Barbara De Moerloose

given: Barbara

family: Suciu

full_name: Stefan Suciu

given: Stefan

name: Department of Immuno-Hemato-Pediatrics, Debrousse Hospital, Lyon, France;

family: Bertrand

full_name: Yves Bertrand

given: Yves

name: Department of Pediatric Hematology-Oncology, CHR, Lille, France;

family: Mazingue

full_name: Françoise Mazingue

given: Françoise

name: Department of Hematology, Children's Hospital, Toulouse, France;

family: Robert

full_name: Alain Robert

given: Alain

name: Department of Pediatrics, University Hospital Gasthuisberg, Leuven, Belgium;

family: Uyttebroeck

full_name: Anne Uyttebroeck

name: Department of Hemato-Immunology, Robert Debré Hospital, Paris, France;

family: Yakouben

full_name: Karima Yakouben

given: Karima

name: Department of Hemato-Oncology, HUDE, Brussels, Belgium;

family: Ferster

full_name: Alice Ferster

given: Alice

name: Department of Hemato-Oncology, A. Villeneuve Hospital, Montpellier, France;

family: Margueritte

full_name: Geneviève Margueritte

given: Geneviève

name: Department of Hematology, Hautepierre, Strasbourg, France;

family: Lutz

full_name: Patrick Lutz

given: Patrick

name: Department of Hematology, American Hospital, Reims, France;

family: Munzer

full_name: Martine Munzer

given: Martine

name: Department of Pediatric Hematology-Oncology, CHU, Nice, France;

family: Sirvent

full_name: Nicolas Sirvent

given: Nicolas

name: Department of Pediatrics, Escolar San Joao Hospital, Porto, Portugal;

family: Norton

full_name: Lucilia Norton

given: Lucilia

name: Department of Hematology, CHRU, Caen, France;

family: Boutard

full_name: Patrick Boutard

name: Department of Pediatrics, CHR La Tronche, Grenoble, France;

family: Plantaz

full_name: Dominique Plantaz

given: Dominique

name: Department of Hematology, J. Bernard Hospital, Poitiers, France;

family: Millot

full_name: Frederic Millot

given: Frederic

name: Department of Pediatrics, CHC-Esperance, Montegnée, Belgium; and

family: Philippet

full_name: Pierre Philippet

given: Pierre

family: Baila

full_name: Liliana Baila

given: Liliana

family: Benoit

full_name: Yves Benoit

name: Department of Pediatrics, University Hospital, Brussels, Belgium

family: Otten

full_name: Jacques Otten

given: Jacques

name: for the Children's Leukemia Group (CLG) of the European Organisation for Research and Treatment of Cancer (EORTC)

journal_name: Blood

ReferenceCitation: Bertrand Y, Suciu S, Benoit Y, et al.: Dexamethasone(DEX)(6mg/sm/d) and prednisolone(PRED)(60mg/sm/d) in induction therapy of childhood ALL are equally effective: results of the 2nd interim analysis of EORTC trial 58951. [Abstract] Blood 112 (11): A-8, 2008.

ReferenceCitation: Sirvent N, Suciu S, Benoit Y, et al.: Prognostic significance of central nervous system (CNS) status of children with acute lymphoblastic leukemia (ALL) treated without cranial irradiation: results of European Organization for Research and Treatment of Cancer (EORTC) Children Leukemia Group study 58951. [Abstract] Blood 112 (11): A-303, 2008.

ReferenceCitation: Bertrand Y, Goutagny MP, Poulat AL, et al.: Asparagine depletion, safety and antibody production after E coli asparaginase treatment in children with newly diagnosed acute lymphoblastic leukaemia treated with EORTC 58951 protocol: a single center report. [Abstract] Blood 110 (11): A-4337, 2007.

ReferenceCitation: Sirvent N, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Paillard C, Costa V, Simon P, Pluchart C, Poirée M, Minckes O, Millot F, Freycon C, Maes P, Hoyoux C, Cavé H, Rohrlich P, Bertrand Y, Benoit Y; Children's Leukemia Group of the European Organisation for Research Treatment of Cancer. CNS-3 status remains an independent adverse prognosis factor in children with acute lymphoblastic leukemia (ALL) treated without cranial irradiation: Results of EORTC Children Leukemia Group study 58951. Arch Pediatr. 2021 Jul;28(5):411-416. doi: 10.1016/j.arcped.2021.04.009. Epub 2021 May 24.

ReferenceCitation: Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poirée M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cavé H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repositories_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Ghazavi F, Clappier E, Lammens T, Suciu S, Caye A, Zegrari S, Bakkus M, Grardel N, Benoit Y, Bertrand Y, Minckes O, Costa V, Ferster A, Mazingue F, Plat G, Plouvier E, Poirée M, Uyttebroeck A, van der Werff-Ten Bosch J, Yakouben K, Helsmoortel H, Meul M, Van Roy N, Philippé J, Speleman F, Cavé H, Van Vlierberghe P, De Moerloose B. CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol. Haematologica. 2015 Oct;100(10):1311-9. doi: 10.3324/haematol.2015.126953. Epub 2015 Jul 2.

repositories:
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be

ReferenceCitation: Clappier E, Grardel N, Bakkus M, Rapion J, De Moerloose B, Kastner P, Caye A, Vivent J, Costa V, Ferster A, Lutz P, Mazingue F, Millot F, Plantaz D, Plat G, Plouvier E, Poirée M, Sirvent N, Uyttebroeck A, Yakouben K, Girard S, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cavé H; European Organisation for Research and Treatment of Cancer, Children's Leukemia Group (EORTC-CLG). IKZF1 deletion is an independent prognostic marker in childhood B-cell precursor acute lymphoblastic leukemia, and distinguishes patients benefiting from pulses during maintenance therapy: results of the EORTC Children's Leukemia Group study 58951. Leukemia. 2015 Nov;29(11):2154-61. doi: 10.1038/leu.2015.134. Epub 2015 Jun 8.

ReferenceCitation: Domenech C, Suciu S, De Moerloose B, Mazingue F, Plat G, Ferster A, Uyttebroeck A, Sirvent N, Lutz P, Yakouben K, Munzer M, Röhrlich P, Plantaz D, Millot F, Philippet P, Dastugue N, Girard S, Cavé H, Benoit Y, Bertrandfor Y; Children's Leukemia Group (CLG) of European Organisation for Research and Treatment of Cancer (EORTC). Dexamethasone (6 mg/m2/day) and prednisolone (60 mg/m2/day) were equally effective as induction therapy for childhood acute lymphoblastic leukemia in the EORTC CLG 58951 randomized trial. Haematologica. 2014 Jul;99(7):1220-7. doi: 10.3324/haematol.2014.103507. Epub 2014 Apr 11.

ReferenceCitation: Dastugue N, Suciu S, Plat G, Speleman F, Cavé H, Girard S, Bakkus M, Pagès MP, Yakouben K, Nelken B, Uyttebroeck A, Gervais C, Lutz P, Teixeira MR, Heimann P, Ferster A, Rohrlich P, Collonge MA, Munzer M, Luquet I, Boutard P, Sirvent N, Karrasch M, Bertrand Y, Benoit Y. Hyperdiploidy with 58-66 chromosomes in childhood B-acute lymphoblastic leukemia is highly curable: 58951 CLG-EORTC results. Blood. 2013 Mar 28;121(13):2415-23. doi: 10.1182/blood-2012-06-437681. Epub 2013 Jan 15.

name: Hematology Laboratory, Purpan Hospital, Toulouse, France;

name: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium;

name: Department of Hematology, Children’s Hospital, Toulouse, France;

name: Center for Medical Genetics, Universiteit Ziekenhuis, Ghent, Belgium;

name: Department of Genetics, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, Paris, France;

name: Paris-Diderot University, Paris, France;

name: Hematology Laboratory, Lyon Sud Hospital, Lyon, France;

name: Molecular Hematology Laboratory, UZ Brussels, Brussels, Belgium;

name: University Lille Nord de France and Pediatric Hematology Unit, Centre Hospitalier Universitaire, Lille, France;

name: Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium;

name: Hematology Laboratory, Hautepierre, Strasbourg, France;

name: Department of Pediatric Hematology, Hautepierre, Strasbourg, France;

name: Department of Genetics, Portuguese Oncology Institute, Porto and Biomedical Sciences Institute, University of Porto, Porto, Portugal;

name: Laboratory of Cytogenetics, Bordet Institute, Brussels, Belgium;

name: Department of Hemato-Oncology, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium;

name: Department of Pediatric Hematology-Oncology, Centre Hospitalier Universitaire, Besançon, France;

name: Department of Genetics, Centre Hospitalier Universitaire, Besançon, France;

name: Department of Pediatric Hematology-Oncology and

name: Hematology Laboratory, Centre Hospitalier Universitaire, Reims, France;

name: Department of Pediatric Hematology-Oncology, Centre Hospitalier Universitaire, Caen, France;

name: Department of Pediatric Hematology-Oncology, Centre Hospitalier Universitaire, Nice, France;

name: Department of Immuno-Hemato-Pediatrics, Hospices Civils de Lyon et Université Claude Bernard, Lyon, France; and

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients

summary:
RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective treatment for aspergillosis. It is not yet known whether voriconazole is more effective than amphotericin B in treating patients with aspergillosis.

PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis.

primary_purpose: Supportive Care

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

location_facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Virchow Klinikum Humboldt Universitaet Berlin

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: National Institute of Haematology and Immunology

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis

acronym: Rhapsody

summary:
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)

The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.

The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: ALK-Abelló A/S

location_country: Poland France Czechia Lithuania Latvia

location_facility: Daugavpils Regional hospital, Outpatient clinic

location_facility: Ambulance alergologie a klinicke imunologie - Ceske Budejovice

location_facility: The Centre of Investigation and Treatment of Allergic Diseases

location_facility: Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

location_facility: Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń

location_facility: Lekarze Specjaliści Malolepszy i Partnerzy

location_facility: Alergo-Med Specjalistycza Przychodnia Lekarska S p zo.o.

location_facility: Vevere Viktorija - Doctor's Practice in Pneumology and Allergology

location_facility: ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.

location_facility: Service transversal d'allergologie et immunologie clinique

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: JSC Center for Diagnosis and Treatment of Allergic Diseases

location_facility: Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos

status_simplified: Ongoing


ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Uganda
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Poland
Thailand
Korea, Republic of
Kenya
Hong Kong
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain
Turkey

acronym: Astefania

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie

location_facility: Hospital Universitario Clínico San Cecilio; Servicio de oncologia

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Manipal Hospital; Department of Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Filantropia Clinical Hospital; Medical oncology

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Rajiv Gandhi Cancer Institute & Research Center

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

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

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Guangdong Provincial People's Hospital; Breast

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Klinikum Ernst von Bergmann; Frauenklinik

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik

location_facility: Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

location_facility: Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: KOC Plovdiv; First Medical Oncology Department

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Oncology Dispensary#1; Out-Patient Oncology Dept

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Henry Ford Health System; Dept of Transplantation Surgery

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: China Medical University Hospital; Surgery

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: Velindre Cancer Centre; Clinical Trials Unit

location_facility: HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale.

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

location_facility: Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy

location_facility: Nizhny Novgorod Regional Clinical Oncology Center

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: National Cancer Centre; Medical Oncology

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

location_facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk

location_facility: Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center

location_facility: Greater Baltimore Med Ctr; Dept Berman Cancer Institute

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

location_facility: Kyungpook National University Medical Center

location_facility: AKH - Medizinische Universität Wien; Department of Oncology

location_facility: Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

location_facility: State Healthcare Institution "Regional Clinical Oncology Dispensary"

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: California Cancer Associate for Research & Excellence

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Inonu University Medical Faculty of Medicine; Medical Oncology Department

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: Sf. Nectarie Oncology Center; Medical oncology

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

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

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Municipal Institution Kirovograd Regional Oncology Dispensary

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Multiprofile Hospital for Active Treatment "Nadezhda"; Medical Oncology Department

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: Srinagarind Hospital; Department of Surgery

location_facility: Virginia Oncology Associates - Virginia Beach

location_facility: Städtische Klinik Lüneburg; Frauenklinik

location_facility: Antalya Training and Research Hospital ; Oncology Department

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: West China Hospital - Sichuan University

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Bradford Royal Infirmary; Oncology Department

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: The First Affilicated Hospital, Sun Yat-sen University

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

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Cancer Therapy and Research Center CTRC at UTHSCSA

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: University of Eastern Piedmont - Maggiore della Carità University Hospital

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Virginia Oncology Associates - New Port News

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: SBI of Healthcare Leningrad Regional Oncology Dispensary

location_facility: Hospital Alvaro Cunqueiro; Servicio de Oncologia

location_facility: University General Hospital of Heraklion

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

location_facility: National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center

location_facility: Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: LLC Medical and Sanitary Unit "Clinician"

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Max Super Speciality Hospital; Medical Oncology

ipd_sharing: Yes

source: euctr

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.


title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

acronym: DELTA 1

summary:
This is a 16-week study in adult participants with chronic hand eczema (CHE). The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Italy
France
Poland
Germany
United Kingdom
Canada


title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)

summary:
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.

Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.

The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.

Participants must have a study partner, who is willing to take part in the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
Spain
Turkey


intervention_type: Other

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
Austria
United States
Hong Kong
Spain
Germany
France
Czechia
Greece
Israel
Japan
Poland
Ireland
Australia
Belgium
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

acronym: INDEPENDENCE

location_facility: First St Petersburg State Medical University na IP Pavlov

location_facility: West Penn Allegheny Lupus Center of Excellence

location_facility: CTRC at The UT Health Science Center at San Antonio

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Prince of Wales Hospital the Chinese University of Hong Kong

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Centre Hospitalier Peltzer - La Tourelle

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Tokyo Women's Medical University Hospital

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions

summary:
The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions.

The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.


title: SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

summary: The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Malaysia
Belgium
Russian Federation
Taiwan
India
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Switzerland
Bulgaria
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Mexico
Czechia
Spain
Turkey