title: Multi-Center Randomized Placebo-controlled Trial of Nocturnal Oxygen Therapy in Chronic Obstructive Pulmonary Disease. The International Nocturnal Oxygen (INOX) Trial

acronym: INOX

summary: This multicenter randomized placebo controlled trial aims to determine if in patients with COPD not qualifying for LTOT but presenting significant nocturnal arterial oxygen desaturation, whether nocturnal oxygen therapy provided for a period of 4 years decreases mortality or delay the prescription of LTOT.

primary_purpose: Supportive Care

ReferenceCitation: Lacasse Y, Sériès F, Martin S, Maltais F. Nocturnal oxygen therapy in patients with chronic obstructive pulmonary disease: a survey of Canadian respirologists. Can Respir J. 2007 Sep;14(6):343-8.

ReferenceCitation: Lacasse Y, Sériès F, Corbeil F, Baltzan M, Paradis B, Simão P, Abad Fernández A, Esteban C, Guimarães M, Bourbeau J, Aaron SD, Bernard S, Maltais F; INOX Trial Group. Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease. N Engl J Med. 2020 Sep 17;383(12):1129-1138. doi: 10.1056/NEJMoa2013219.

name: From Institut Universitaire de Cardiologie et de Pneumologie de Québec–Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute,...

family: Lacasse

full_name: Yves Lacasse

given: Yves

family: Sériès

full_name: Frédéric Sériès

given: Frédéric

family: Corbeil

full_name: François Corbeil

given: François

family: Baltzan

full_name: Marc Baltzan

given: Marc

family: Paradis

full_name: Bruno Paradis

family: Simão

full_name: Paula Simão

given: Paula

family: Abad Fernández

full_name: Araceli Abad Fernández

given: Araceli

family: Esteban

full_name: Cristóbal Esteban

given: Cristóbal

family: Guimarães

full_name: Miguel Guimarães

given: Miguel

family: Bourbeau

full_name: Jean Bourbeau

given: Jean

family: Aaron

full_name: Shawn D. Aaron

given: Shawn D.

family: Bernard

full_name: Sarah Bernard

given: Sarah

family: Maltais

full_name: François Maltais

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Lacasse Y, Bernard S, Sériès F, Nguyen VH, Bourbeau J, Aaron S, Maltais F; International Nocturnal Oxygen (INOX) Research Group. Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med. 2017 Jan 9;17(1):8. doi: 10.1186/s12890-016-0343-9.

name: for the International Nocturnal Oxygen (INOX) Research Group

family: Nguyen

full_name: Van Hung Nguyen

given: Van Hung

full_name: Shawn Aaron

given: Shawn

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_facility: Centro Hospitalara Vila Nova de Gaia-Espinho EPE

location_facility: Hospital Pedro Hispano Unidade Local de Saude de Matosinhos

location_facility: Centro Hospitalar do Barlavento Algarvio - EPE

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Centre de la santé et des services sociaux de Laval (Cité de la Santé de Laval)

location_facility: Hospital Pulido Valente - Centro Hospitalar Lisboa Norte


title: Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

acronym: NEuroSIS

summary:
HYPOTHESIS:

Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%.

PRIMARY OBJECTIVE:

To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA.

SECONDARY OBJECTIVES:

To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen.

RATIONALE:

Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects.

STUDY DESIGN:

Randomised placebo-controlled, multi-centre clinical trial.

RESEARCH PLAN:

Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months.

CLINICAL SIGNIFICANCE:

BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Bassler D, Halliday HL, Plavka R, Hallman M, Shinwell ES, Jarreau PH, Carnielli V, van den Anker J, Schwab M, Poets CF. The Neonatal European Study of Inhaled Steroids (NEUROSIS): an eu-funded international randomised controlled trial in preterm infants. Neonatology. 2010;97(1):52-5. doi: 10.1159/000227294. Epub 2009 Jul 7.

ReferenceType: derived

ReferenceCitation: Bassler D, Shinwell ES, Hallman M, Jarreau PH, Plavka R, Carnielli V, Meisner C, Engel C, Koch A, Kreutzer K, van den Anker JN, Schwab M, Halliday HL, Poets CF; Neonatal European Study of Inhaled Steroids Trial Group. Long-Term Effects of Inhaled Budesonide for Bronchopulmonary Dysplasia. N Engl J Med. 2018 Jan 11;378(2):148-157. doi: 10.1056/NEJMoa1708831.

name: From the Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich (D.B.), and the Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children’s Hospital, Basel (J.N.A.) — both in Switzerland; Ziv Medical Center, Faculty of Medicine in the Galilee, Bar-Ilan University, Ramat Gan, Israel (E.S.S.); the Department of Children and Adolescents, Oulu University Hospital, and PEDEGO Research Unit, Medical Research Center Oulu, University of Oulu, Oulu, Finland ...

family: Bassler

full_name: Dirk Bassler

given: Dirk

sequence: first

family: Shinwell

full_name: Eric S. Shinwell

given: Eric S.

sequence: additional

family: Hallman

full_name: Mikko Hallman

given: Mikko

family: Jarreau

full_name: Pierre-Henri Jarreau

given: Pierre-Henri

family: Plavka

full_name: Richard Plavka

given: Richard

family: Carnielli

full_name: Virgilio Carnielli

given: Virgilio

family: Meisner

full_name: Christoph Meisner

given: Christoph

family: Engel

full_name: Corinna Engel

given: Corinna

family: Koch

full_name: Alexander Koch

given: Alexander

family: Kreutzer

full_name: Karen Kreutzer

given: Karen

family: van den Anker

full_name: Johannes N. van den Anker

given: Johannes N.

family: Schwab

full_name: Matthias Schwab

given: Matthias

family: Halliday

full_name: Henry L. Halliday

given: Henry L.

family: Poets

full_name: Christian F. Poets

given: Christian F.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

ReferenceCitation: Bassler D, Plavka R, Shinwell ES, Hallman M, Jarreau PH, Carnielli V, Van den Anker JN, Meisner C, Engel C, Schwab M, Halliday HL, Poets CF; NEUROSIS Trial Group. Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia. N Engl J Med. 2015 Oct 15;373(16):1497-506. doi: 10.1056/NEJMoa1501917.

repository_institution: Università Politecnica delle Marche - Università Politecnica delle Marche - IRIS

lead_sponsor: University Children's Hospital Tuebingen

location_country:
Italy
Netherlands
Finland
France
Israel
Belgium
Germany
Czech Republic

location_facility: CHU de LilleHôpital Jeanne de Flandres, Pôle de Médecine néonataleUnité de Réanimation néonatale

location_facility: Meir Medical Center, Premature Baby Unit

location_facility: University Hospital Motol Prague 5, Department of Neonatology

location_facility: Tartu University Children's Clinic, Paediatric Intensive Care Unit

location_facility: University Children's Hospital Essen, Dept. of Pediatrics

location_facility: Helsinki University Central Hospital,Hospital for Children and Adolescents, NICU

location_facility: University Hospital Brno, Department of Neonatology

location_facility: Hospital Cochin Saint-Vincent de Paul, Dept. of Neonatology

location_facility: Ben-Gurion University of NegevSoroka Medical Center, Neonatal Department

location_facility: Kaplan Medical Center Rehovot, Dept. of Neonatology

location_facility: University Hospital Plzen, Department of Neonatology

location_facility: Georg-August University Hospital Goettingen, Dept. of Pediatrics

location_facility: Hospital Nuernberg Sued, Dept. of Neonatology

location_facility: University Children´s Hospital Tuebingen, Dept. of Neonatology

location_facility: Hôpital Clocheville, Service de RéanimationNéonatale

location_facility: University Children's Hospital Aachen, Dept. of Neonatology

location_facility: University Hospital Hannover, Dept. of Neonatology

location_facility: ASO S. Croce e Carie, Terapia Intensiva Neonatale-Neonatologia

location_facility: Azienda Ospedaliera Universitaria Pisana, U.O. Neonatologia

location_facility: Bnai Zion Medical Center Haifa, Department of Neonatology

location_facility: Ospedale Sant'Anna, Terapia Intensiva Neonatale Clinica -3°piano

location_facility: University Children's Hospital Carl Gustav Carus Dresden, Dept. of Neonatology

location_facility: University Hospital of Tomas Bati, Department of Neonatology

location_facility: Children's Hospital Hannover auf der Bult, Dept. of Neonatology

location_facility: University Children's Hospital Heidelberg, Dept. of Neonatology

location_facility: AZ Sint-Jan Brugge Oostende AV, Department of Neontalogy

location_facility: Erasmus MC - Sophia, Department of Neonatology

location_facility: University Hospital Hamburg-Eppendorf, Dept. of Neonatology

location_facility: Charles University, General Faculty Hospital and 1st Faculty of Medicine, Department of Obstetrics and Gynecology

location_facility: Hadassah Medical Center, Department of Neonatology

location_facility: University Children's Hospital Erlangen, Dept. of Neonatology

location_facility: University Hospital Ostrava, Department of Neonatology

location_facility: Azienda Ospedaliera di Padova, Dipartimento di Pediatria Salus Pueri


title: A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant (ASCT)

acronym: PATH

summary: The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.

primary_purpose: Treatment

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Brazil
Netherlands
Germany
France
Poland
Israel
Singapore
Belgium
Australia
New Zealand
Russian Federation
Canada

location_facility: Vanderbilt University Medical Center Vanderbilt Clinic - Oncology

location_facility: Mayo Clinic - Rochester Hematology/Oncology Dept.

location_facility: Dana-Farber Cancer Institute Dana-Farber Cancer Institute

location_facility: Medical University of South Carolina Oncology

location_facility: Georgia Health Sciences University Medical College of Georgia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

acronym: CANVAS

summary:
The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

study_start_date_type: Actual

ReferenceCitation: Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17. Erratum in: ESC Heart Fail. 2021 May 3;:.

name: The George Institute for Global Health UNSW Sydney  Sydney Australia

name: Department of Cardiology Peking University Third Hospital  Beijing China

name: Faculty of Medicine University of New South Wales, Sydney  Sydney Australia

family: Yu

full_name: Jie Yu

given: Jie

name: Department of Cardiology Royal Prince Alfred Hospital  Sydney Australia

name: Sydney Medical School University of Sydney  Sydney Australia

family: Arnott

full_name: Clare Arnott

given: Clare

family: Neuen

full_name: Brendon L. Neuen

given: Brendon L.

name: Department of Clinical Pharmacy and Pharmacology University of Groningen, University Medical Center Groningen  Groningen The Netherlands

family: Heersprink

full_name: Hiddo L. Heersprink

given: Hiddo L.

name: Stanford Center for Clinical Research, Department of Medicine Stanford University School of Medicine  Stanford CA USA

family: Mahaffey

full_name: Kenneth W. Mahaffey

given: Kenneth W.

name: Cardiovascular Division Brigham and Women's Hospital  Boston MA USA

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

name: Center for Global Cardiovascular Health Northwestern University Feinberg School of Medicine  710 N. Lake Shore Drive, Suite 800 Chicago IL 60611 USA

family: Khan

full_name: Sadiya S. Khan

given: Sadiya S.

family: Baldridge

full_name: Abigail S. Baldridge

given: Abigail S.

family: Shah

full_name: Sanjiv J. Shah

given: Sanjiv J.

family: Huang

full_name: Yuli Huang

given: Yuli

family: Li

full_name: Chao Li

given: Chao

name: Kolling Institute Royal North Shore Hospital and University of Sydney  Sydney Australia

family: Figtree

full_name: Gemma A. Figtree

given: Gemma A.

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

family: Jardine

full_name: Meg J. Jardine

given: Meg J.

name: The Charles Perkins Centre University of Sydney  Sydney Australia

name: Faculty of Clinical Epidemiology Imperial College London  London UK

family: Neal

full_name: Bruce Neal

given: Bruce

family: Huffman

full_name: Mark D. Huffman

given: Mark D.

journal_name: ESC Heart Failure

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

ReferenceCitation: Januzzi JL Jr, Butler J, Sattar N, Xu J, Shaw W, Rosenthal N, Pfeifer M, Mahaffey KW, Neal B, Hansen MK. Insulin-Like Growth Factor Binding Protein 7 Predicts Renal and Cardiovascular Outcomes in the Canagliflozin Cardiovascular Assessment Study. Diabetes Care. 2021 Jan;44(1):210-216. doi: 10.2337/dc20-1889. Epub 2020 Nov 6.

ReferenceCitation: Januzzi JL Jr, Xu J, Li J, Shaw W, Oh R, Pfeifer M, Butler J, Sattar N, Mahaffey KW, Neal B, Hansen MK. Effects of Canagliflozin on Amino-Terminal Pro-B-Type Natriuretic Peptide: Implications for Cardiovascular Risk Reduction. J Am Coll Cardiol. 2020 Nov 3;76(18):2076-2085. doi: 10.1016/j.jacc.2020.09.004.

journal_name: Journal of the American College of Cardiology

title: Effects of Canagliflozin on Amino-Terminal Pro–B-Type Natriuretic Peptide

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21.

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

repository_institution: University College London - UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21.

journal_name: Journal of the American Society of Nephrology

title: Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program

ReferenceCitation: Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24.

name: Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College University of Oxford  Oxford UK

name: University of Washington  Spokane Washington USA

name: Diabetes Research Centre University of Leicester  Leicester UK

name: Janssen Research & Development, LLC  Raritan New Jersey USA

name: The George Institute for Global Health, UNSW Sydney  Sydney New South Wales Australia

name: Stanford Center for Clinical Research, Department of Medicine Stanford University School of Medicine  Stanford California USA

name: The Charles Perkins Centre University of Sydney  Sydney New South Wales Australia

ReferenceCitation: Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10.

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

title: Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program

ReferenceCitation: Figtree GA, Rådholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17.

name: Kolling Institute, Royal North Shore Hospital and University of Sydney, Australia (G.A.F., G.F.).

name: The George Institute for Global Health, University of New South Wales, Sydney, Australia (G.A.F., K.R., V.P., B.N.).

name: Division of Community Medicine, Primary Care, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University, Department of Local Care West, County Council of Östergötland, Sweden (K.R.).

name: Janssen Research & Development, LLC, Raritan, NJ (T.D.B., W.S.).

name: Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, CA (K.W.M.).

name: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, The Netherlands (D.d.Z.).

name: Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, United Kingdom (D.R.M.).

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (B.N.).

repositories_institution:
Imperial College London - Spiral
Linkoping University - DiVA

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Zhou Z, Lindley RI, Rådholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009.

name: From The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (Z.Z., V.P., B.N.)

name: Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China (Z.Z.)

name: The George Institute for Global Health and University of Sydney, Australia (R.I.L., K.R.)

name: Division of Community Medicine, Primary Care, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University, Department of Local Care West, County Council of Östergötland, Linköping, Sweden (K.R.)

name: Royal North Shore Hospital, St Leonards, Sydney, Australia (B.J.)

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (J.W., B.N.)

name: The Royal North Shore Hospital and University of Sydney, Australia (V.P., G.F.)

name: University of Groningen, University Medical Center Groningen, the Netherlands (D.d.Z.)

name: Janssen Research & Development, LLC, Raritan, NJ (W.S., R.O., M.D.)

name: The Charles Perkins Centre, University of Sydney, Australia (B.N.)

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

title: Canagliflozin and Stroke in Type 2 Diabetes Mellitus

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901.

name: The George Institute for Global Health, University of New South Wales Sydney, Australia (B.L.N., T.O., B.N., Q.L., M.J.J., V.P.).

name: Oxford Centre for Diabetes, Endo-crinology and Metabolism and Harris Manchester College, University of Oxford, United Kingdom (D.R.M.).

name: University of Groningen, University Medical Center Groningen, The Netherlands (D.d.Z.).

name: Royal North Shore Hospital, Sydney, Australia (G.F., V.P.).

name: Janssen Research & Development, LLC, Raritan, NJ (M.D., H.D., N.R.).

name: Concord Repatriation General Hospital, Sydney, Australia (M.J.J.).

name: University of Chicago Medicine, IL (G.B.).

title: Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function

ReferenceCitation: Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Rådholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222.

name: Department of Medicine and Health Sciences, Division of Community Medicine, Primary Care, Faculty of Health Sciences, Department of Local Care West, County Council of Ötergötland, Linköping University, Sweden (K.R.).

name: The George Institute for Global Health (K.R., V.P., B.N.)

name: University of New South Wales, Sydney, Australia. Royal North Shore Hospital (G.F., V.P., G.F.)

name: University of Sydney, Australia. Harvard Medical School and Brigham and Women’s Hospital, Boston, MA (S.D.S.).

name: Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).

name: Janssen Research & Development, LLC, Raritan, NJ (T.D.B., W.S., M.D.).

name: Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, United Kingdom (D.R.M).

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

title: Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus

ReferenceCitation: Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13.

name: George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (B.N., V.P., Q.L.)

name: Charles Perkins Centre, University of Sydney, Australia (B.N.)

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (B.N.)

name: Royal North Shore Hospital and University of Sydney, Australia (V.P., G.F.)

name: University of Groningen, University Medical Center Groningen, The Netherlands (D.d.Z.)

name: Janssen Research & Development, LLC, Raritan, NJ (N.E., W.S., E.F., T.S., M.D.)

name: Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, UK (D.R.M.).

title: Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events

ReferenceCitation: Yale JF, Xie J, Sherman SE, Garceau C. Canagliflozin in Conjunction With Sulfonylurea Maintains Glycemic Control and Weight Loss Over 52 Weeks: A Randomized, Controlled Trial in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2017 Nov;39(11):2230-2242.e2. doi: 10.1016/j.clinthera.2017.10.003. Epub 2017 Nov 3.

ReferenceCitation: Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

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

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

title: Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

name: aEmory University School of Medicine, Atlanta, GA, USA

name: bDiabetes Research Centre, University of Leicester, Leicester, UK

name: cJanssen Scientific Affairs LLC, Raritan, NJ, USA

name: dJanssen Research & Development LLC, Raritan, NJ, USA

title: The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus

ReferenceCitation: Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, Mahaffey KW, Weiss R, Rosenstock J, Capuano G, Desai M, Shaw W, Vercruysse F, Meininger G, Neal B. Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Diabetes Ther. 2015 Sep;6(3):289-302. doi: 10.1007/s13300-015-0117-z. Epub 2015 Jun 17.

ReferenceCitation: Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Ways K, Desai M, Shaw W, Capuano G, Alba M, Jiang J, Vercruysse F, Meininger G, Matthews D; CANVAS Trial Collaborative Group. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):403-11. doi: 10.2337/dc14-1237. Epub 2014 Dec 2.

title: Efficacy and Safety of Canagliflozin, an Inhibitor of Sodium–Glucose Cotransporter 2, When Used in Conjunction With Insulin Therapy in Patients With Type 2 Diabetes

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

name:
Division of Nephrology, University of Maryland School of Medicine
Baltimore, MDUSA

name: Janssen Research & Development, LLC Raritan, NJUSA

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

name:
Drexel University College of Medicine
Philadelphia, PAUSA

name:
Wayne State University School of Medicine
Detroit, MIUSA

name: Janssen Research & Development LLC Raritan, NJUSA

name: Janssen Research & Development LLC Titusville, NJUSA

ReferenceCitation: Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Stein P, Desai M, Shaw W, Jiang J, Vercruysse F, Meininger G, Matthews D. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial. Am Heart J. 2013 Aug;166(2):217-223.e11. doi: 10.1016/j.ahj.2013.05.007. Epub 2013 Jun 24.

title: Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial

location_country:
Luxembourg
Malaysia
Belgium
Australia
Russian Federation
Ukraine
India
France
Poland
Norway
Argentina
Canada
Colombia
Sweden
Netherlands
Hungary
United States
Germany
United Kingdom
Mexico
Czechia
Israel
New Zealand
Spain
Estonia


type: Registry Identifier

title: ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

acronym: ABSORB EXTEND

summary:
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.

ReferenceCitation: Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.

name: Instituto de Cardiologia Dante Pazzanese; Sao Paulo Brazil

family: Costa

full_name: J. Ribamar Costa

given: J. Ribamar

suffix: Jr.

family: Abizaid

full_name: Alexandre Abizaid

given: Alexandre

name: St. Vincent's Hospital; Fitzroy Victoria Australia

family: Whitbourn

full_name: Robert Whitbourn

given: Robert

name: Thoraxcenter Erasmus University Medical Center; Rotterdam The Netherlands

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

name: Prince of Wales Public; Sydney Australia

family: Jepson

full_name: Nigel Jepson

given: Nigel

name: Allgemeines Krankenhaus Linz; Linz Austria

family: Steinwender

full_name: Clemens Steinwender

given: Clemens

family: Stuteville

full_name: Marrianne Stuteville

given: Marrianne

family: Ediebah

full_name: Divine Ediebah

given: Divine

family: Sudhir

full_name: Krishnankutty Sudhir

given: Krishnankutty

name: Centro Cardiologico Monzino, IRCCS; University of Milan; Milan Italy

family: Bartorelli

full_name: Antonio L. Bartorelli

given: Antonio L.

name: on behalf of the ABSORB EXTEND investigators

journal_name: Catheterization and Cardiovascular Interventions

oa_host_type: repository

repository_normalized: University of Melbourne - Minerva Access

publisher_normalized: Wiley

ReferenceCitation: Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051.

family: Moriyama

full_name: Noriaki Moriyama

given: Noriaki

family: Shishido

full_name: Koki Shishido

given: Koki

family: Tanaka

full_name: Yutaka Tanaka

given: Yutaka

family: Yokota

full_name: Shohei Yokota

given: Shohei

family: Hayashi

full_name: Takahiro Hayashi

given: Takahiro

family: Miyashita

full_name: Hirokazu Miyashita

given: Hirokazu

family: Koike

full_name: Tatsuya Koike

given: Tatsuya

family: Yokoyama

full_name: Hiroaki Yokoyama

given: Hiroaki

family: Takada

full_name: Takuma Takada

given: Takuma

ReferenceCitation: Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.

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

ReferenceCitation: Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243.

ReferenceCitation: Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, García-García HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

title: 1-Year Clinical Outcomes of Diabetic Patients Treated With Everolimus-Eluting Bioresorbable Vascular Scaffolds

ReferenceCitation: Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008.

title: Biomechanical Assessment of Fully Bioresorbable Devices

ReferenceCitation: Muramatsu T, Onuma Y, García-García HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.

title: Incidence and Short-Term Clinical Outcomes of Small Side Branch Occlusion After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold

location_country:
Malaysia
Australia
Belgium
Denmark
Taiwan
India
France
Japan
Poland
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Singapore
China
Germany
United Kingdom
Italy
Austria
Brazil
Israel
New Zealand
Spain

location_facility: Eastern Heart Clinic, The Prince of Wales Hospital

location_facility: Escorts Heart Institute & Research Centre

location_facility: Saiseikai Yokohama City Eastern Hospital

location_facility: Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences


title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)

acronym: ENABLE-ALL

summary: The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.

design_allocation: Non-Randomized

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Germany
Pakistan
France
Greece
Australia
Spain
Canada


ReferenceCitation: Foeldvari I, Constantin T, Vojinović J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Sušić G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Doležalová P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

family: Foeldvari

full_name: Ivan Foeldvari

given: Ivan

name: for the Paediatric Rheumatology International Trials Organisation (PRINTO)

family: Constantin

full_name: Tamàs Constantin

given: Tamàs

family: Vojinović

full_name: Jelena Vojinović

given: Jelena

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Chasnyk

full_name: Vyacheslav Chasnyk

given: Vyacheslav

family: Dehoorne

full_name: Joke Dehoorne

given: Joke

family: Panaviene

full_name: Violeta Panaviene

given: Violeta

family: Sušić

full_name: Gordana Sušić

given: Gordana

family: Stanevicha

full_name: Valda Stanevicha

given: Valda

family: Kobusinska

full_name: Katarzyna Kobusinska

given: Katarzyna

family: Zuber

full_name: Zbigniew Zuber

given: Zbigniew

family: Dobrzyniecka

full_name: Bogna Dobrzyniecka

given: Bogna

family: Nikishina

full_name: Irina Nikishina

given: Irina

family: Bader-Meunier

full_name: Brigitte Bader-Meunier

given: Brigitte

family: Breda

full_name: Luciana Breda

given: Luciana

family: Doležalová

full_name: Pavla Doležalová

given: Pavla

family: Job-Deslandre

full_name: Chantal Job-Deslandre

given: Chantal

family: Rumba-Rozenfelde

full_name: Ingrida Rumba-Rozenfelde

given: Ingrida

family: Wulffraat

full_name: Nico Wulffraat

given: Nico

family: Pedersen

full_name: Ronald D. Pedersen

given: Ronald D.

family: Bukowski

full_name: Jack F. Bukowski

given: Jack F.

family: Vlahos

full_name: Bonnie Vlahos

given: Bonnie

family: Martini

full_name: Alberto Martini

given: Alberto

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

currency_apc_doaj: GBP

repository_institution: Ghent University - Ghent University Academic Bibliography

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

location_country:
Italy
Serbia
Mexico
Netherlands
Spain
France
Poland
Lithuania
Slovakia
Slovenia
Norway
Hungary
Belgium
Australia
Latvia
Russian Federation
Germany
Czech Republic
Colombia

title: A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis

summary: This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.


ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44.

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. Epub 2007 Apr 22.

status: Terminated

lead_sponsor: PTC Therapeutics

location_country:
Italy
United States
Canada
France

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: A.Bianchi Bonomi Hemophilia and Thrombosis Center

location_facility: Vanderbilt Hemostatis and Thrombosis Clinic

location_facility: Azienda Ospedaliero-Universitaria Careggi Viale G.B. Morgagni

location_facility: The Bleeding and Clotting Disorders Institute

source: euctr

title: A Phase 2a Study of Ataluren (PTC124) as an Oral Treatment for Nonsense-Mutation-Mediated Hemophilia A and B

summary: Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30% of participants with hemophilia and results in severe manifestations. Ataluren (PTC124) is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional FVIII/FIX. This study is a Phase 2a trial evaluating the safety and efficacy of ataluren in participants with HA or HB due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase FVIII/FIX activity levels.

status_simplified: Unknown


title: A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment

summary: This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.

ReferenceCitation: Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.

name: Antonio Salar, Hospital del Mar, Barcelona, Spain; Irit Avivi, Rambam Medical Center, Haifa; Ofer Shpilberg, Tel Aviv University, Tel Aviv, Israel; Beate Bittner, Olivier Catalani, Florence Hourcade-Potelleret, and Pakeeza Sayyed, F. Hoffmann-La Roche, Basel, Switzerland; Reda Bouabdallah, Institut Paoli-Calmettes, Marseille, France; Mike Brewster and Christine McIntyre, Roche Products, Welwyn Garden City; George Follows, Addenbrooke's Hospital, University of Cambridge, Cambridge; Andrew Haynes,...

family: Salar

full_name: Antonio Salar

given: Antonio

family: Avivi

full_name: Irit Avivi

given: Irit

family: Bittner

full_name: Beate Bittner

given: Beate

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Brewster

full_name: Mike Brewster

given: Mike

family: Catalani

full_name: Olivier Catalani

given: Olivier

family: Follows

full_name: George Follows

given: George

family: Haynes

full_name: Andrew Haynes

given: Andrew

family: Hourcade-Potelleret

full_name: Florence Hourcade-Potelleret

given: Florence

family: Janikova

full_name: Andrea Janikova

given: Andrea

family: Larouche

full_name: Jean-François Larouche

given: Jean-François

family: McIntyre

full_name: Christine McIntyre

given: Christine

full_name: Michael Pedersen

given: Michael

family: Pereira

full_name: Juliana Pereira

given: Juliana

family: Sayyed

full_name: Pakeeza Sayyed

given: Pakeeza

family: Shpilberg

full_name: Ofer Shpilberg

given: Ofer

family: Tumyan

full_name: Gayane Tumyan

given: Gayane

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

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

family: Mao

full_name: Cheng-Ping Mao

given: Cheng-Ping

family: Brovarney

full_name: Martin R. Brovarney

given: Martin R.

family: Dabbagh

full_name: Karim Dabbagh

given: Karim

family: Birnböck

full_name: Herbert F. Birnböck

given: Herbert F.

family: Richter

full_name: Wolfgang F. Richter

given: Wolfgang F.

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

location_country:
Peru
Finland
Australia
Russian Federation
Denmark
Czech Republic
Ecuador
France
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
United Kingdom
Italy
Brazil
Mexico
Israel
Spain


ReferenceCitation: D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.

name:
Department of Family and Community Medicine, University of Toronto
OntarioCanada

family: D’Urzo

full_name: Anthony D’Urzo

given: Anthony

name:
Clinical Research Institute of Southern Oregon
PC, Medford, ORUSA

family: Kerwin

full_name: Edward Kerwin

given: Edward

name:
Novartis Horsham Research Centre
West SussexUK

family: Overend

full_name: Tim Overend

given: Tim

name:
Novartis Pharmaceuticals Corporation
East Hanover, NJUSA

family: D’Andrea

full_name: Peter D’Andrea

given: Peter

family: Chen

full_name: Hungta Chen

given: Hungta

name:
Novartis Pharma AG
BaselSwitzerland

family: Goyal

full_name: Pankaj Goyal

given: Pankaj

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Kerwin E, Hébert J, Gallagher N, Martin C, Overend T, Alagappan VK, Lu Y, Banerji D. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012 Nov;40(5):1106-14. doi: 10.1183/09031936.00040712. Epub 2012 Jul 26.

family: Hébert

full_name: Jacques Hébert

given: Jacques

family: Gallagher

full_name: Nicola Gallagher

given: Nicola

family: Martin

full_name: Carmen Martin

given: Carmen

family: Alagappan

full_name: Vijay K.T. Alagappan

given: Vijay K.T.

family: Lu

full_name: Yimeng Lu

given: Yimeng

family: Banerji

full_name: Donald Banerji

given: Donald

journal_name: European Respiratory Journal

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories:
CiteSeerX
PubMed Central

publisher: European Respiratory Society (ERS)

title: Efficacy and safety of NVA237versusplacebo and tiotropium in patients with COPD: the GLOW2 study

location_country:
Italy
United States
Chile
Peru
Mexico
Netherlands
Germany
France
Poland
Israel
Hungary
Argentina
Russian Federation
New Zealand
Canada
Korea, Republic of

location_facility:
Novartis Investigative site
Novartis Investigator Site
Novartis Investigative Site
Novartis Investigative Center

title: A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open-label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Patients With Chronic Obstructive Pulmonary Disease

summary: This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.


title: CRYptogenic STroke And underLying AF Trial

acronym: CRYSTAL-AF

summary: The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.

primary_purpose: Diagnostic

ReferenceCitation: Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617.

ReferenceCitation: Sinha AM, Diener HC, Morillo CA, Sanna T, Bernstein RA, Di Lazzaro V, Passman R, Beckers F, Brachmann J. Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale. Am Heart J. 2010 Jul;160(1):36-41.e1. doi: 10.1016/j.ahj.2010.03.032.

ReferenceCitation: Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2021 Nov 13;65(2):101540. doi: 10.1016/j.rehab.2021.101540. [Epub ahead of print]

family: Kaffenberger

full_name: Tina Kaffenberger

given: Tina

family: Bernhardt

full_name: Julie Bernhardt

given: Julie

family: Koehler

full_name: Jodi L. Koehler

given: Jodi L.

family: Ziegler

full_name: Paul D. Ziegler

given: Paul D.

family: Thijs

full_name: Vincent N. Thijs

given: Vincent N.

journal_name: Annals of Physical and Rehabilitation Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Witte KK, Tsivgoulis G, Reynolds MR, Tsintzos SI, Eggington S, Ismyrloglou E, Lyon J, Huynh M, Egea M, de Brouwer B, Ziegler PD, Franco N, Joglekar R, Rosemas SC, Liu S, Thijs V. Burden of oral anticoagulation in embolic stroke of undetermined source without atrial fibrillation. BMC Cardiovasc Disord. 2021 Mar 31;21(1):160. doi: 10.1186/s12872-021-01967-x.

family: Witte

full_name: Klaus K. Witte

given: Klaus K.

family: Tsivgoulis

full_name: Georgios Tsivgoulis

given: Georgios

family: Reynolds

full_name: Matthew R. Reynolds

given: Matthew R.

family: Tsintzos

full_name: Stelios I. Tsintzos

given: Stelios I.

family: Eggington

full_name: Simon Eggington

given: Simon

family: Ismyrloglou

full_name: Eleni Ismyrloglou

given: Eleni

family: Lyon

full_name: Julie Lyon

family: Huynh

full_name: Marianne Huynh

given: Marianne

family: Egea

full_name: Marta Egea

given: Marta

family: de Brouwer

full_name: Bonnie de Brouwer

given: Bonnie

family: Franco

full_name: Noreli Franco

given: Noreli

family: Joglekar

full_name: Rashmi Joglekar

given: Rashmi

family: Rosemas

full_name: Sarah C. Rosemas

given: Sarah C.

family: Liu

full_name: Shufeng Liu

given: Shufeng

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Verma N, Ziegler PD, Liu S, Passman RS. Incidence of atrial fibrillation among patients with an embolic stroke of undetermined source: Insights from insertable cardiac monitors. Int J Stroke. 2019 Feb;14(2):146-153. doi: 10.1177/1747493018798554. Epub 2018 Sep 10.

name: Department of Medicine, Northwestern University, Chicago, USA

name: Medtronic Cardiac Rhythm Heart Failure, Mounds View, USA

ReferenceCitation: Brachmann J, Morillo CA, Sanna T, Di Lazzaro V, Diener HC, Bernstein RA, Rymer M, Ziegler PD, Liu S, Passman RS. Uncovering Atrial Fibrillation Beyond Short-Term Monitoring in Cryptogenic Stroke Patients: Three-Year Results From the Cryptogenic Stroke and Underlying Atrial Fibrillation Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003333. doi: 10.1161/CIRCEP.115.003333.

name: From the Department of Cardiology, Hospital Klinikum Coburg, Teaching Hospital of the University of Würzburg, Coburg, Germany (J.B.); Department of Medicine, Population Health Research Institute, McMaster University, Hamilton, ON, Canada (C.A.M.); Department of Cardiac Intensive Care, Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy (T.S.); Department of Neurology, Institute of Neurology, Università Campus Bio-Medico, Rome, Italy (V.D.L.); Department of Neurology &...

journal_name: Circulation: Arrhythmia and Electrophysiology

ReferenceCitation: Bernstein RA, Di Lazzaro V, Rymer MM, Passman RS, Brachmann J, Morillo CA, Sanna T, Thijs V, Rogers T, Liu S, Ziegler PD, Diener HC. Infarct Topography and Detection of Atrial Fibrillation in Cryptogenic Stroke: Results from CRYSTAL AF. Cerebrovasc Dis. 2015;40(1-2):91-6. doi: 10.1159/000437018. Epub 2015 Jul 11.

ReferenceCitation: Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Greece
Slovakia
Belgium
Spain
Denmark
Canada

location_facility: Cliniques Universitaires UCL Mont-Godinne

location_facility: Central Bucks Specialists / Doylestown Hospital

location_facility: Mid America Heart Institute / St. Lukes Hospital

location_facility: University of Texas - Southwestern Medical Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: South Denver Cardiology / Swedish Medical Center

location_facility: Brussels Heart Center (St. Lean - St. Pierre)

location_facility: Greenville Hospital System Cardiology/Cardiovascular Research

location_facility: Neurology clinic, Turku University Central Hospital

location_facility: Clinique Parly II - Centre Hospitalier de Versailles

location_facility: Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald

location_facility: Hamilton Health Sciences / Hamilton General Hospital


ReferenceCitation: San-Miguel J, Bladé J, Shpilberg O, Grosicki S, Maloisel F, Min CK, Polo Zarzuela M, Robak T, Prasad SV, Tee Goh Y, Laubach J, Spencer A, Mateos MV, Palumbo A, Puchalski T, Reddy M, Uhlar C, Qin X, van de Velde H, Xie H, Orlowski RZ. Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma. Blood. 2014 Jun 26;123(26):4136-42. doi: 10.1182/blood-2013-12-546374. Epub 2014 May 15. Erratum in: Blood. 2014 Aug 14;124(7):1201.

name: Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;

family: San-Miguel

full_name: Jesús San-Miguel

given: Jesús

name: Institut d’Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;

family: Bladé

full_name: Joan Bladé

given: Joan

name: Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;

family: Shpilberg

full_name: Ofer Shpilberg

given: Ofer

name: Oddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, Poland;

family: Grosicki

full_name: Sebastian Grosicki

given: Sebastian

name: Clinique Saint Anne, Strasbourg, France;

family: Maloisel

full_name: Frédéric Maloisel

given: Frédéric

name: Seoul St. Mary’s Hospital, Seoul, Republic of Korea;

family: Min

full_name: Chang-Ki Min

given: Chang-Ki

name: Hospital Clinico San Carlos, Madrid, Spain;

family: Polo Zarzuela

full_name: Marta Polo Zarzuela

name: Medical University of Lodz, Lodz, Poland;

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

name: Apollo Hospitals & Research Foundation, Hyderabad, India;

family: Prasad

full_name: Sripada V. S. S. Prasad

given: Sripada V. S. S.

name: Singapore General Hospital, Singapore, Singapore;

family: Tee Goh

full_name: Yeow Tee Goh

given: Yeow

name: Dana Farber Cancer Institute, Boston, MA;

family: Laubach

full_name: Jacob Laubach

given: Jacob

name: Alfred Health-Monash University, Melbourne, Australia;

family: Spencer

full_name: Andrew Spencer

given: Andrew

name: Hospital Universitario Salamanca, Salamanca, Spain;

family: Mateos

full_name: María-Victoria Mateos

given: María-Victoria

family: Palumbo

full_name: Antonio Palumbo

given: Antonio

name: Janssen Research & Development, Spring House, PA;

family: Puchalski

full_name: Tom Puchalski

given: Tom

family: Reddy

full_name: Manjula Reddy

given: Manjula

family: Uhlar

full_name: Clarissa Uhlar

given: Clarissa

family: Qin

full_name: Xiang Qin

given: Xiang

name: Janssen Research & Development, Beerse, Belgium; and

family: van de Velde

full_name: Helgi van de Velde

given: Helgi

family: Xie

full_name: Hong Xie

given: Hong

name: The University of Texas MD Anderson Cancer Center, Houston, TX

family: Orlowski

full_name: Robert Z. Orlowski

given: Robert Z.

journal_name: Blood

title: Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti–IL-6) in multiple myeloma

location_country:
India
France
Poland
Israel
Romania
Singapore
Australia
Russian Federation
Spain
United States
Korea, Republic of

title: A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma

summary: The purpose of this study is to evaluate safety and effectiveness of CNTO 328 (siltuximab) when it is administered together with velcade-melphalan-prednisone (VMP) in comparison with VMP alone in participants with multiple myeloma (a type of cancer that affects the blood and bone marrow).


ReferenceCitation: Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Dřevínek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordoñez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185.

ReferenceCitation: Flume PA, Wainwright CE, Elizabeth Tullis D, Rodriguez S, Niknian M, Higgins M, Davies JC, Wagener JS. Recovery of lung function following a pulmonary exacerbation in patients with cystic fibrosis and the G551D-CFTR mutation treated with ivacaftor. J Cyst Fibros. 2018 Jan;17(1):83-88. doi: 10.1016/j.jcf.2017.06.002. Epub 2017 Jun 24.

family: Flume

full_name: Patrick A. Flume

given: Patrick A.

family: Wainwright

full_name: Claire E. Wainwright

given: Claire E.

family: Elizabeth Tullis

full_name: D. Elizabeth Tullis

given: D.

family: Rodriguez

full_name: Sally Rodriguez

given: Sally

family: Niknian

full_name: Minoo Niknian

given: Minoo

family: Higgins

full_name: Mark Higgins

given: Mark

family: Davies

full_name: Jane C. Davies

given: Jane C.

family: Wagener

full_name: Jeffrey S. Wagener

given: Jeffrey S.

journal_name: Journal of Cystic Fibrosis

evidence: open (via free pdf)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: Imperial College London - Spiral

version: submittedVersion

ReferenceCitation: Solem CT, Vera-Llonch M, Liu S, Botteman M, Castiglione B. Impact of pulmonary exacerbations and lung function on generic health-related quality of life in patients with cystic fibrosis. Health Qual Life Outcomes. 2016 Apr 21;14:63. doi: 10.1186/s12955-016-0465-z.

family: Solem

full_name: Caitlyn T. Solem

given: Caitlyn T.

family: Vera-Llonch

full_name: Montserrat Vera-Llonch

given: Montserrat

family: Liu

full_name: Sizhu Liu

given: Sizhu

family: Botteman

full_name: Marc Botteman

given: Marc

family: Castiglione

full_name: Brenda Castiglione

given: Brenda

journal_name: Health and Quality of Life Outcomes

license: cc-by

license_normalized: cc-by

ReferenceCitation: Quittner A, Suthoff E, Rendas-Baum R, Bayliss MS, Sermet-Gaudelus I, Castiglione B, Vera-Llonch M. Effect of ivacaftor treatment in patients with cystic fibrosis and the G551D-CFTR mutation: patient-reported outcomes in the STRIVE randomized, controlled trial. Health Qual Life Outcomes. 2015 Jul 2;13:93. doi: 10.1186/s12955-015-0293-6.

location_country:
United States
United Kingdom
Germany
France
Ireland
Australia
Canada
Czech Republic

location_facility: National Jewish Medical and Research Center

location_facility: Klinikum der LMU München, Dr. von Haunersches Kinderspital (CHA)

location_facility: Mukoviszidose-Zentrum am Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Kinder- und Jugendmedizin

location_facility: University of North Carolina at Chapel Hill

location_facility: Kinder- und Jugendklinik Universitätsklinikum Erlangen

location_facility: Adult Pulmonary/ CF, University of Nebraska Medical Center

location_facility: Division of Pulmonary and CCM, University of Washington

location_facility: Pediatric & Pulmonary Division, Rainbow Babies/Case Western

location_facility: Women and Children's Hospital of Buffalo

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Pulmonary, Allergy & Critical Care Medicine, University of Minnesota

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Cystic Fibrosis Research Office, Stanford University

location_facility: Queen Elizabeth II Health Sciences Centre

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation

summary: The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.


ReferenceCitation: Grainger JD, Blanchette VS, Grotzinger KM, Roy A, Bussel JB. Health-related quality of life in children with chronic immune thrombocytopenia treated with eltrombopag in the PETIT study. Br J Haematol. 2019 Apr;185(1):102-106. doi: 10.1111/bjh.15732. Epub 2018 Dec 27.

name: Central Manchester University Hospitals NHS Foundation Trust NIHR/Wellcome Trust Manchester CRF Royal Manchester Children's Hospital University of Manchester Manchester England

family: Grainger

full_name: John D. Grainger

given: John D.

name: Division of Hematology/Oncology The Hospital for Sick Children Toronto OntarioCanada

family: Blanchette

full_name: Victor S. Blanchette

given: Victor S.

family: Grotzinger

full_name: Kelly M. Grotzinger

given: Kelly M.

family: Roy

full_name: Anuja Roy

given: Anuja

name: Department of Pediatrics Division of Hematology/Oncology Weill Cornell Medicine New York NY USA

family: Bussel

full_name: James B. Bussel

given: James B.

journal_name: British Journal of Haematology

oa_host_type: publisher

title: Health‐related quality of life in children with chronic immune thrombocytopenia treated with eltrombopag in the PETIT study

ReferenceCitation: Wire MB, Li X, Zhang J, Sallas W, Aslanis V, Ouatas T. Modeling and Simulation Support Eltrombopag Dosing in Pediatric Patients With Immune Thrombocytopenia. Clin Pharmacol Ther. 2018 Dec;104(6):1199-1207. doi: 10.1002/cpt.1066. Epub 2018 Apr 17.

family: Wire

full_name: Mary B. Wire

given: Mary B.

family: Li

full_name: Xiaobin Li

given: Xiaobin

family: Zhang

full_name: Jianping Zhang

given: Jianping

name: Novartis Pharmaceuticals Corp; East Hanover USA

family: Sallas

full_name: William Sallas

given: William

family: Aslanis

full_name: Vassilios Aslanis

given: Vassilios

family: Ouatas

full_name: Taoufik Ouatas

given: Taoufik

journal_name: Clinical Pharmacology & Therapeutics

ReferenceCitation: Bussel JB, de Miguel PG, Despotovic JM, Grainger JD, Sevilla J, Blanchette VS, Krishnamurti L, Connor P, David M, Boayue KB, Matthews DC, Lambert MP, Marcello LM, Iyengar M, Chan GW, Chagin KD, Theodore D, Bailey CK, Bakshi KK. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015 Aug;2(8):e315-25. doi: 10.1016/S2352-3026(15)00114-3. Epub 2015 Jul 28. Erratum in: Lancet Haematol. 2015 Oct;2(10):e407.

full_name: James B Bussel

given: James B

family: de Miguel

full_name: Purificación Garcia de Miguel

given: Purificación Garcia

family: Despotovic

full_name: Jenny M Despotovic

given: Jenny M

full_name: John D Grainger

given: John D

family: Sevilla

full_name: Julián Sevilla

given: Julián

full_name: Victor S Blanchette

given: Victor S

family: Krishnamurti

full_name: Lakshmanan Krishnamurti

given: Lakshmanan

family: Connor

full_name: Philip Connor

location_country:
Netherlands
France
Spain
United States
United Kingdom
Canada

title: A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP.

summary: Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts (Cohort 1: between 12 and 17 years old; Cohort 2: between 6 and 11 years old; Cohort 3: between 1 and 5 years old). Daily dosing with eltrombopag will begin with 5 patients in the oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional patients will be randomised to placebo or eltrombopag (2:1 randomisation). After 7 weeks of randomized treatment, all patients will receive eltrombopag in an open label fashion. The total duration of treatment with eltrombopag will be 24 weeks. If at the time of the aforementioned 12 week review of the first 5 patients no safety issues are identified, dosing will begin in the next lower age cohort with an initial group of 5 patients. The same procedure will be followed in terms of safety review and subsequent enrolment and randomisation of the additional patients. Initiation of the younger age cohort will take place once data from the previous has been evaluated. Doses will be adjusted according to platelet counts and tolerability. The study will include a review of the safety data by a Data Safety Monitoring Board.


title: A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™ System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis With Neurogenic Intermittent Claudication

acronym: NICE

summary: The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Italy
Sweden
France
Poland
Singapore
Belgium
Australia
Germany
United Kingdom
Iceland

location_facility: Centre hospitalier du Grand Hornu - Orthopédie / Traumatologie

location_facility: Ospedale di Circolo - Ortopedia e Traumatologia

location_facility: CHU de Nice Hôpital Pasteur - Neurochirurgie

location_facility: Azienda Ospedaliera Sant'Andrea - Neurochirurgia

location_facility: Szpital Kliniczny Dziecatka Jezus - Orthopaedics

location_facility: Singapore General Hospital - Orthopaedic Surgery

location_facility: Woodend Hospital - Department of Orthopaedics

location_facility: Centre Universitaire Pellegrin Tripode -Orthopédie-Traumatologie

location_facility: Hôpital Roger Salengro - Clinique de Neurochirurgie

location_facility: Klinikum rechts der Isar der TU München - Neurochirurgie

location_facility: Landspitali - National hospital of Iceland

location_facility: Neurochirurgische Klinik - Campus Benjamin Franklin

intervention_type: Procedure


title: A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

acronym: MUSIC

summary:
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).

The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

ReferenceCitation: Raghu G, Million-Rousseau R, Morganti A, Perchenet L, Behr J; MUSIC Study Group. Macitentan for the treatment of idiopathic pulmonary fibrosis: the randomised controlled MUSIC trial. Eur Respir J. 2013 Dec;42(6):1622-32. doi: 10.1183/09031936.00104612. Epub 2013 May 16.

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

family: Million-Rousseau

full_name: Rachel Million-Rousseau

given: Rachel

family: Morganti

full_name: Adele Morganti

given: Adele

family: Perchenet

full_name: Loїc Perchenet

given: Loїc

family: Behr

full_name: Juergen Behr

given: Juergen

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

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

lead_sponsor: Actelion

location_country:
Italy
United States
South Africa
Sweden
Germany
France
Israel
Australia
Spain
Turkey
Canada
Slovenia

location_facility: Università degli Studi di Torino Clinica di Malattie dell'Apparato Respiratorio

location_facility: CHRU - Hopital Calmette Clinique des Maladies Respiratoires

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Stanford University Medical Center - Chest Clinic

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Hôpital Cardiologique et Pneumologique Louis Pradel

location_facility: Karolinska Universitetssjukhuset Lung Allergi kliniken

location_facility: Temple University Hospital - Lung Center

location_facility: National Jewish Medical & Research Center

location_facility: University of Alberta - Health Sciences Center

location_facility: University of California - San Francisco

location_facility: Centre for Chest Diseases, Milpark Hospital


title: TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment-experienced HIV-1 Infected Subjects

summary: The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.

lead_sponsor: Janssen R&D Ireland

location_country:
South Africa
Thailand
France
Argentina
United States


title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

summary:
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

ReferenceCitation: Richter MJ, Schermuly R, Seeger W, Rao Y, Ghofrani HA, Gall H. Relevance of angiopoietin-2 and soluble P-selectin levels in patients with pulmonary arterial hypertension receiving combination therapy with oral treprostinil: a FREEDOM-C2 biomarker substudy. Pulm Circ. 2016 Dec;6(4):516-523. doi: 10.1086/688671.

name: Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany

name: Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, Giessen, Germany

family: Richter

full_name: Manuel J. Richter

given: Manuel J.

family: Schermuly

full_name: Ralph Schermuly

given: Ralph

family: Seeger

full_name: Werner Seeger

given: Werner

name: United Therapeutics, Research Triangle Park, North Carolina, USA

family: Rao

full_name: Youlan Rao

given: Youlan

name: Department of Medicine, Imperial College London, London, United Kingdom

family: Ghofrani

full_name: Hossein A. Ghofrani

given: Hossein A.

family: Gall

full_name: Henning Gall

given: Henning

currency_apc_doaj: USD

journal_name: Pulmonary Circulation

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Relevance of Angiopoietin-2 and Soluble P-Selectin Levels in Patients with Pulmonary Arterial Hypertension Receiving Combination Therapy with Oral Treprostinil: A FREEDOM-C2 Biomarker Substudy

ReferenceCitation: Tapson VF, Jing ZC, Xu KF, Pan L, Feldman J, Kiely DG, Kotlyar E, McSwain CS, Laliberte K, Arneson C, Rubin LJ; FREEDOM-C2 Study Team. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013 Sep;144(3):952-958. doi: 10.1378/chest.12-2875.

family: Tapson

full_name: Victor F. Tapson

given: Victor F.

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

family: Xu

full_name: Kai-Feng Xu

given: Kai-Feng

family: Pan

full_name: Lei Pan

given: Lei

family: Feldman

full_name: Jeremy Feldman

given: Jeremy

family: Kiely

full_name: David G. Kiely

given: David G.

family: Kotlyar

full_name: Eugene Kotlyar

given: Eugene

family: McSwain

full_name: C. Shane McSwain

given: C. Shane

family: Laliberte

full_name: Kevin Laliberte

given: Kevin

family: Arneson

full_name: Carl Arneson

given: Carl

family: Rubin

title: Oral Treprostinil for the Treatment of Pulmonary Arterial Hypertension in Patients Receiving Background Endothelin Receptor Antagonist and Phosphodiesterase Type 5 Inhibitor Therapy (The FREEDOM-C2 Study)

location_country:
Italy
United States
Sweden
Netherlands
Spain
Germany
France
Israel
Belgium
Portugal
Canada
United Kingdom

location_facility: University of Colorado Health Science Center

location_facility: The University of Texas Health Science Center at Houston

location_facility: Vancouver Coastal Health Respiratory Clinic

location_facility: Pulmonary Critical Care Medicine, Brigham and Women's Hospital

location_facility: University Hospitals Case Medical Center

location_facility: Columbia University Presbyterian Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Mary M Parkes Center for Asthma, Allergy and Pulmonary Care

location_facility: Pulmonology Department Rambam Medical Center

location_facility: University of California, San Francisco-Fresno


title: Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

summary: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Cerhan JH, Anderson SK, Butts AM, Porter AB, Jaeckle K, Galanis E, Brown PD. Examiner accuracy in cognitive testing in multisite brain-tumor clinical trials: an analysis from the Alliance for Clinical Trials in Oncology. Neurooncol Pract. 2019 Jul;6(4):283-288. doi: 10.1093/nop/npy048. Epub 2018 Nov 24.

name: Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN

family: Cerhan

full_name: Jane H Cerhan

given: Jane H

name: Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN

family: Anderson

full_name: S Keith Anderson

given: S Keith

family: Butts

full_name: Alissa M Butts

given: Alissa M

name: Department of Neurology, Mayo Clinic in Arizona, Scottsdale

family: Porter

full_name: Alyx B Porter

given: Alyx B

name: Departments of Neurology and Oncology, Mayo Clinic, Jacksonville, FL

family: Jaeckle

full_name: Kurt Jaeckle

given: Kurt

name: Department of Oncology, Mayo Clinic, Rochester, MN

family: Galanis

full_name: Evanthia Galanis

given: Evanthia

name: Department of Radiation Oncology, Mayo Clinic, Rochester, MN

family: Brown

full_name: Paul D Brown

given: Paul D

journal_name: Neuro-Oncology Practice

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Drappatz J, Lieberman F. Chemotherapy of Oligodendrogliomas. Prog Neurol Surg. 2018;31:152-161. doi: 10.1159/000467376. Epub 2018 Jan 25.

family: Drappatz

full_name: Jan Drappatz

given: Jan

family: Lieberman

full_name: Frank Lieberman

given: Frank

genre: book-chapter

genre_raw: book-chapter

journal_name: Progress in Neurological Surgery

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: Chemotherapy of Oligodendrogliomas

lead_sponsor: Alliance for Clinical Trials in Oncology

location_country:
Austria
United States
Netherlands
France
Belgium
Canada

location_facility: Maine Medical Center- Scarborough Campus

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: Anchorage Associates in Radiation Medicine

location_facility: University of Washington Medical Center - Montlake

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: Regional West Medical Center Cancer Center

location_facility: Walter Reed National Military Medical Center

location_facility: Radiation Oncology Centers of Nevada Central

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Minnesota Oncology Hematology PA-Maplewood

location_facility: University of Oklahoma Health Sciences Center

location_facility: Saint Alphonsus Cancer Care Center-Caldwell

location_facility: Odette Cancer Centre- Sunnybrook Health Sciences Centre

location_facility: UC Irvine Health/Chao Family Comprehensive Cancer Center

location_facility: Norton Hospital Pavilion and Medical Campus

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: State University of New York Upstate Medical University

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: Southeast Nebraska Cancer Center - 68th Street Place

location_facility: Maastro Clinic-Maastricht Radiation Oncology

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: Minnesota Oncology Hematology PA-Woodbury

location_facility: Skagit Valley Hospital Regional Cancer Care Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: Kootenai Clinic Cancer Services - Post Falls

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: Washington University School of Medicine

location_facility: Medical Oncology and Hematology Associates-Laurel

location_facility: Dixie Medical Center Regional Cancer Center

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: Cleveland Clinic Wooster Family Health and Surgery Center

location_facility: Memorial Regional Cancer Center Day Road

location_facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: University of Alabama at Birmingham Cancer Center

location_facility: Smilow Cancer Hospital Care Center-Trumbull

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Cancer Care Specialists of Illinois - Decatur

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: Norton Brownsboro Hospital and Medical Campus

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: Radiation Oncology Centers of Nevada Southeast

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: Ottawa Hospital and Cancer Center-General Campus

location_facility: University of Kentucky/Markey Cancer Center

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: University Health Network-Princess Margaret Hospital

location_facility: Western Illinois Cancer Treatment Center

location_facility: Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

location_facility: New York-Presbyterian/Brooklyn Methodist Hospital

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

intervention_type: Radiation

status_simplified: Ongoing


title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

summary: The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

ReferenceCitation: Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Ghalib

full_name: Reem H Ghalib

given: Reem H

family: Rustgi

full_name: Vinod K Rustgi

given: Vinod K

family: Martorell

full_name: Claudia Martorell

given: Claudia

family: Everson

full_name: Greg T Everson

given: Greg T

family: Tatum

full_name: Harvey A Tatum

given: Harvey A

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Lim

full_name: Joseph K Lim

given: Joseph K

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Abrams

full_name: Gary A Abrams

given: Gary A

family: Bräu

full_name: Norbert Bräu

given: Norbert

family: Morris

full_name: David W Morris

given: David W

family: Thuluvath

full_name: Paul J Thuluvath

given: Paul J

family: Reindollar

full_name: Robert W Reindollar

given: Robert W

family: Yin

full_name: Philip D Yin

given: Philip D

family: Diva

full_name: Ulysses Diva

given: Ulysses

family: Hindes

full_name: Robert Hindes

given: Robert

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Hernandez

full_name: Dennis Hernandez

given: Dennis

family: Wind-Rotolo

full_name: Megan Wind-Rotolo

given: Megan

family: Hughes

full_name: Eric A Hughes

given: Eric A

family: Schnittman

full_name: Steven Schnittman

given: Steven

journal_name: The Lancet Infectious Diseases

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of Colorado Denver & Hospital