title: ABLATOR Ablation Observational Registry

acronym: ABLATOR

summary: The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

lead_sponsor: Abbott Medical Devices

location_country:
Portugal
Saudi Arabia
Italy
Austria
Netherlands
Spain
Canada
United Kingdom
Korea, Republic of
France
India
China
Belgium
Germany
Czechia

location_facility: Ospedale San Giovanni di Dio - Torregalli

location_facility: Fuwai Heart Hospital & Cardiovascular Institute

location_facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem

location_facility: Hospital general Universitario de Alicante

location_facility: Märkische Kliniken GmbH Klinikum Lüdenscheid

location_facility: Escorts Heart Institute and Research Centre

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Third Xiangya Hospital of Central South University


type: EudraCT Number

title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids

summary: This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Spain
United Kingdom
Australia
Netherlands
Finland
Canada
Switzerland
Korea, Republic of
United States
France
Germany
Czechia

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center

location_facility: Hospital Ramon y Cajal; servicio dermatologia

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: National Taiwan University Hospital; Department of Dermatology

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: Hospital Universitario La Paz; Servicio de dermatologia

location_facility: National Cheng-Kung University Hospital; Department of Dermatology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: University Medical Center Groningen; Department of Dermatology

location_facility: Masarykova nemocnice o.z; kozni oddeleni

location_facility: Oregon Health & Science University; Department of Dermatology

location_facility: Faculty Hospital; Department of Dermatology

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit

location_facility: St George Dermatology and Skin Cancer Centre

location_facility: Helsinki University Central Hospital; Skin & Allergy Hospital

location_facility: Tampere University Hospital; Dermatology and allergology

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: HUGregorio Marañón, Servicio de dermatología

location_facility: Hospital General Universitario de Valencia; servicio de dermatología

location_facility: Universitätsspital Zürich; Dermatologische Klinik

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

location_facility: Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Charles University School of Medicine; Deptartment of Dermatology

location_facility: Turku Central University Hospital; Dermatology and allergology

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: University of Texas Medical School-Houston

location_facility: Royal Melbourne Hospital; Dermatology Department

location_facility: Dr. Melinda Gooderham Medicine Professional Corporation

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology

location_facility: University of Iowa Healthcare; Dermatology

location_facility: SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie

location_facility: Hospital Universitario La Princesa, Servicio dermatologia

location_facility: Clinica Universitaria de Navarra; Servicio de Dermatologia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

summary: A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

primary_purpose: Prevention

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
France

location_facility: Wake Forest University School of Medicine


ipd_sharing: Yes

primary_purpose: Other

intervention_type: Biological

acronym:
ANNEXA-4

 ANNEXA-4

title: Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

lead_sponsor: Alexion Pharmaceuticals

source: euctr

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2016 Sep 22;375(12):1131-41. doi: 10.1056/NEJMoa1607887. Epub 2016 Aug 30.

ReferenceCitation: Birocchi S, Fiorelli EM, Podda GM. Andexanet Alfa for Factor Xa Inhibitor Reversal. N Engl J Med. 2016 Dec 22;375(25):2498-9.

ReferenceCitation: Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr; ANNEXA-4 Investigators. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2019 Apr 4;380(14):1326-1335. doi: 10.1056/NEJMoa1814051. Epub 2019 Feb 7.

ReferenceType: derived

ReferenceCitation: Costa OS, Connolly SJ, Sharma M, Beyer-Westendorf J, Christoph MJ, Lovelace B, Coleman CI. Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis. Crit Care. 2022 Jun 16;26(1):180. doi: 10.1186/s13054-022-04043-8.

ReferenceCitation: Huttner HB, Gerner ST, Kuramatsu JB, Connolly SJ, Beyer-Westendorf J, Demchuk AM, Middeldorp S, Zotova E, Altevers J, Andersohn F, Christoph MJ, Yue P, Stross L, Schwab S. Hematoma Expansion and Clinical Outcomes in Patients With Factor-Xa Inhibitor-Related Atraumatic Intracerebral Hemorrhage Treated Within the ANNEXA-4 Trial Versus Real-World Usual Care. Stroke. 2022 Feb;53(2):532-543. doi: 10.1161/STROKEAHA.121.034572. Epub 2021 Oct 14.

ReferenceCitation: Demchuk AM, Yue P, Zotova E, Nakamya J, Xu L, Milling TJ Jr, Ohara T, Goldstein JN, Middeldorp S, Verhamme P, Lopez-Sendon JL, Conley PB, Curnutte JT, Eikelboom JW, Crowther M, Connolly SJ; ANNEXA-4 Investigators. Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal With Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy. Stroke. 2021 Jun;52(6):2096-2105. doi: 10.1161/STROKEAHA.120.030565. Epub 2021 May 10. Erratum in: Stroke. 2021 Aug;52(8):e525.

location_country:
Spain
United Kingdom
Netherlands
Canada
United States
France
Belgium
Japan
Germany

summary: The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.


title: Expanded Clinical Study of the Tendyne Mitral Valve System

summary: The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, Denti P, Dumonteil N, Modine T, Jansz P, Chuang ML, Blanke P, Leipsic J, Badhwar V. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.

ReferenceCitation: Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P; Tendyne Global Feasibility Trial Investigators. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28. Erratum in: J Am Coll Cardiol. 2017 Mar 7;69(9):1213.

location_country:
United Kingdom
Italy
Australia
Netherlands
Switzerland
Sweden
United States
France
Norway
Germany

location_facility: Honor Health Scottsdale Shea Medical Center

intervention_type: Device

status_simplified: Ongoing


title: A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

lead_sponsor: Janssen Research & Development, LLC

type: Other Identifier

ReferenceCitation: Chari A, Munder M, Weisel K, Jenner M, Bygrave C, Petrucci MT, Boccadoro M, Cavo M, van de Donk NWCJ, Turgut M, Demirkan F, Karadogan I, Libby E, Kleiman R, Kuppens S, Bandekar R, Neff T, Heuck C, Qi M, Clemens PL, Goldschmidt H. Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy. Adv Ther. 2021 Feb;38(2):1328-1341. doi: 10.1007/s12325-020-01601-w. Epub 2021 Jan 20.

ReferenceCitation: Landgren CO, Chari A, Cohen YC, Spencer A, Voorhees P, Estell JA, Sandhu I, Jenner MW, Williams C, Cavo M, van de Donk NWCJ, Beksac M, Moreau P, Goldschmidt H, Kuppens S, Bandekar R, Clemens PL, Neff T, Heuck C, Qi M, Hofmeister CC. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS). Leukemia. 2020 Jul;34(7):1840-1852. doi: 10.1038/s41375-020-0718-z. Epub 2020 Feb 5.

location_country:
United Kingdom
Russian Federation
Australia
Netherlands
Canada
United States
France
Israel
Turkey
Germany
Czechia

summary: The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.


title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

summary: The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

lead_sponsor: Amgen

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Iceland
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Norway
Malaysia
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands


title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

summary: To investigate if Riociguat is effective in the treatment of systemic sclerosis

ReferenceType: background

ReferenceCitation: Distler O, Pope J, Denton C, Allanore Y, Matucci-Cerinic M, de Oliveira Pena J, Khanna D. RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respir Med. 2017 Jan;122 Suppl 1:S14-S17. doi: 10.1016/j.rmed.2016.09.011. Epub 2016 Sep 28.

lead_sponsor: Bayer

location_country:
United Kingdom
Italy
Australia
Netherlands
Canada
New Zealand
Switzerland
Hungary
United States
France
Turkey
Belgium
Japan
Germany
Czechia

location_facility: Medical University of South Carolina Medical Center

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: Centre Hospitalier Universitaire - Grenoble

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Cukurova Univ. Tip. Fak. Balcali Hastanesi

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Universitair Medisch Centrum St. Radboud


acronym: TROPOS

title: A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents With Oral Corticosteroid Dependent Asthma (TROPOS)

lead_sponsor: AstraZeneca

ReferenceCitation: Busse WW, Brusselle GG, Korn S, Kuna P, Magnan A, Cohen D, Bowen K, Piechowiak T, Wang MM, Colice G. Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma. Eur Respir J. 2019 Jan 31;53(2). pii: 1800948. doi: 10.1183/13993003.00948-2018. Print 2019 Feb.

ReferenceCitation: Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14. Review.

location_country:
Poland
Netherlands
Ukraine
United States
France
Belgium
Germany

summary: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.


title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

acronym: Pyrenees

summary: This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Croatia
Poland
Portugal
Romania
Serbia
Italy
Georgia
Russian Federation
Spain
United Kingdom
Hungary
France
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility:
Site RU70072
Site RU70050
Site BE32004
Site DE49056
Site RO40015
Site IT39010
Site RO40018
Site GE99504
Site RO40004
Site DE49002
Site BG35915
Site RU70030
Site GE99503
Site BG35907
Site DE49067
Site PL48002
Site HU36006
Site SK42120
Site BG35916
Site FR33007
Site RU70011
Site IT39022
Site CZ42021
Site HU36027
Site IT39037
Site RO40019
Site ES34052
Site GB44087
Site DE49073
Site GB44079
Site HU36003
Site GE99508
Site BE32012
Site RU70004
Site CZ42015
Site IT39008
Site BG35906
Site HR38504
Site IT39028
Site RS38120
Site HR38505
Site GB44080
Site BE32001
Site FR33010
Site DE49054
Site HU36032
Site SK42116
Site IT39014
Site PL48005
Site ES34009
Site HU36026
Site BG35918
Site PT35127
Site RS38117
Site GB44081
Site BG35937
Site DE49065
Site IT39036
Site PT35121
Site HU36031
Site CZ42008
Site GB44011
Site DE49075
Site DE49001
Site SK42119
Site PT35139
Site BG35903
Site HR38506
Site BG35921
Site RU70008
Site RU70037
Site BE32017
Site RU70002
Site IT39035
Site IT39032
Site PL48013
Site HR38508
Site HR38507
Site GB44001
Site BG35931
Site BE32013
Site BE32002
Site ES34010
Site IT39005
Site BE32019
Site PT35102
Site PT35122
Site FR33055
Site ES34002
Site BG35925
Site HR38501
Site FR33056
Site PL48006
Site BG35938
Site RS38116
Site RO40003
Site PT35114
Site RU70003
Site RS38104
Site ES34011
Site FR33005
Site IT39006
Site PL48009
Site HU36004
Site PL48014
Site ES34008
Site PL48001
Site RS38101
Site GB44008
Site BG35909
Site DE49020
Site HU36036
Site SK42102
Site DE49071
Site RU70014
Site HU36033
Site PT35117
Site ES34006
Site RU70051
Site RU70005
Site RS38105
Site HR38509
Site RU70001
Site BG35924
Site ES34030
Site ES34037
Site HU36035
Site BE32011
Site DE49070
Site GB44010
Site DE49008
Site BG35919
Site HU36034
Site RS38102
Site SK42113
Site IT39039
Site BE32003
Site BG35920
Site RU70006
Site PT35128
Site HU36046
Site ES34017
Site ES34041


title: Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

acronym: WRAP-IT

summary: Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

ReferenceCitation: Poole JE, Swerdlow CD, Tarakji KG, Mittal S, Ellenbogen KA, Greenspon AJ, Kennergren C, Philbert BT, Moore J, Jones RC, Schaller RD, Hansalia R, Simmers T, Mihalcz A, DeBus B, Lexcen DR, Gunderson B, Wilkoff BL. Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics. Heart Rhythm. 2022 Mar;19(3):363-371. doi: 10.1016/j.hrthm.2021.10.032. Epub 2021 Nov 9.

ReferenceCitation: Sohail MR, Corey GR, Wilkoff BL, Poole JE, Mittal S, Kennergren C, Greenspon AJ, Cheng A, Lande JD, Lexcen DR, Tarakji KG. Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial. JACC Clin Electrophysiol. 2021 Jan;7(1):50-61. doi: 10.1016/j.jacep.2020.07.021. Epub 2020 Oct 28.

ReferenceCitation: Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Krahn AD, Schloss EJ, Gallastegui JL, Pickett RA, Evonich RF, Roark SF, Sorrentino DM, Sholevar DP, Cronin EM, Berman BJ, Riggio DW, Khan HH, Silver MT, Collier J, Eldadah Z, Holbrook R, Lande JD, Lexcen DR, Seshadri S, Tarakji KG. Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008503. doi: 10.1161/CIRCEP.120.008503. Epub 2020 Sep 11.

ReferenceCitation: Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Love JC, Augostini R, Faerestrand S, Wiggins SS, Healey JS, Holbrook R, Lande JD, Lexcen DR, Willey S, Tarakji KG; WRAP-IT Investigators. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e008280. doi: 10.1161/CIRCEP.119.008280. Epub 2020 Apr 12.

ReferenceCitation: Mittal S, Wilkoff BL, Kennergren C, Poole JE, Corey R, Bracke FA, Curnis A, Addo K, Martinez-Arraras J, Issa ZF, Redpath C, Moubarak J, Khelae SK, Boersma LVA, Korantzopoulos P, Krueger J, Lande JD, Morss GM, Seshadri S, Tarakji KG. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up. Heart Rhythm. 2020 Jul;17(7):1115-1122. doi: 10.1016/j.hrthm.2020.02.011. Epub 2020 Feb 19.

ReferenceCitation: Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, Gallastegui J, Pickett RA, Evonich R, Philippon F, McComb JM, Roark SF, Sorrentino D, Sholevar D, Cronin E, Berman B, Riggio D, Biffi M, Khan H, Silver MT, Collier J, Eldadah Z, Wright DJ, Lande JD, Lexcen DR, Cheng A, Wilkoff BL; WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. 2019 May 16;380(20):1895-1905. doi: 10.1056/NEJMoa1901111. Epub 2019 Mar 17.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Poland
Portugal
Austria
Israel
Norway
Malaysia
Singapore
Sweden
Slovakia
Canada
Switzerland
China
Germany
Denmark
Greece
Finland
France
Chile
Netherlands

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital

location_facility: Novant Health Heart and Vascular Institute

location_facility: Centennial Heart Cardiovascular Consultants LLC

location_facility: Upper Michigan Cardiovascular Associates PC

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: University Hospitals Case Medical Center

location_facility: Oregon Health & Science University Hospital

location_facility: University of Oklahoma Health Science Center (OUHSC)

location_facility: Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Hamilton General Hospital / Hamilton Health Sciences

location_facility: Great Lakes Heart and Vascular Institute PC

location_facility: University of California San Francisco UCSF Medical Center

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

location_facility: University of Pittsburgh Medical Center UPMC Hamot

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Clearwater Cardiovascular & Interventional Consultants

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: SCL Physicians Heart Institute of Colorado

location_facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Prairie Education & Research Cooperative (Springfield IL)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Virginia Commonwealth University Health System

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: The University of Vermont Medical Center Inc

location_facility: Saint Mary Medical Center (Langhorne PA)

location_facility: University General Hospital of Heraklion

location_facility: University of Florida Health Shands Hospital

location_facility: Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital

location_facility: Universitäts-Herz-Zentrum Freiburg - Bad Krozingen

location_facility: Cardiovascular Research Foundation of Louisiana

location_facility: The University Kansas Medical Center Research Institute Inc

location_facility: North Memorial Heart and Vascular Institute

location_facility: CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle


title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

acronym: DEPICT 1

summary: The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

ReferenceCitation: Melin J, Tang W, Rekić D, Hamrén B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.

ReferenceCitation: Groop PH, Dandona P, Phillip M, Gillard P, Edelman S, Jendle J, Xu J, Scheerer MF, Thoren F, Iqbal N, Repetto E, Mathieu C. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 2020 Oct;8(10):845-854. doi: 10.1016/S2213-8587(20)30280-1.

ReferenceCitation: Mathieu C, Dandona P, Birkenfeld AL, Hansen TK, Iqbal N, Xu J, Repetto E, Scheerer MF, Thoren F, Phillip M. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m(2). Diabetes Obes Metab. 2020 Nov;22(11):2151-2160. doi: 10.1111/dom.14144. Epub 2020 Aug 20.

ReferenceCitation: Parkinson J, Tang W, Åstrand M, Melin J, Ekholm E, Hamrén B, Boulton DW. Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2019 Jun;21(6):1381-1387. doi: 10.1111/dom.13664. Epub 2019 Mar 14.

ReferenceCitation: Dandona P, Mathieu C, Phillip M, Hansen L, Tschöpe D, Thorén F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study. Diabetes Care. 2018 Dec;41(12):2552-2559. doi: 10.2337/dc18-1087. Epub 2018 Oct 23.

ReferenceCitation: Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschöpe D, Thorén F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14. Erratum in: Lancet Diabetes Endocrinol. 2017 Dec;5(12 ):e8.

location_country:
Denmark
Romania
Spain
Italy
Austria
Australia
Mexico
Canada
Finland
United Kingdom
Sweden
Hungary
United States
France
Israel
Belgium
Germany


title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

summary: Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United States
Peru
Romania
Japan
South Africa
Poland
Russian Federation
Argentina
Puerto Rico
Mexico
Brazil
Lebanon
Canada
Hungary
Germany
Taiwan
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: CPCLIN Centro de Pesquisas Clinicas LTDA

location_facility: Instituto para el DeSarrollo Integral de la Salud S de RL de CV

location_facility: Unidad Reumatologica Las Americas, S.C. P.

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

location_facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)

location_facility: Servicos Especializados em Reumatologia SER

location_facility: The University of North Carolina at Chapel Hill

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

location_facility: Center For Rheumatology, Immunology And Arthritis

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.

location_facility: The Feinstein Institute For Medical Research

location_facility: Allegheny-Singer Research Institute (Asri)

location_facility: Hospital General De Agudos J.M. Ramos Mejia

location_facility: Toronto Western Hospital, University Health Network

location_facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

location_facility: Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar

location_facility: Instituto De Investigaciones Clinicas De Mar Del Plata

location_facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

location_facility: Centro Integral En Reumatologia Sa De Cv

location_facility: Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.

location_facility: Beth Israel Deaconess Med. Center Div. Of Gastroenterology

location_facility: Centre De Recherche Musculo-Squelettique


title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Austria
United Kingdom
Switzerland
Korea, Republic of
United States
France
Israel
Norway
Belgium
Japan
Germany
Singapore

summary:
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus

After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.


title: Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

lead_sponsor: Octapharma

location_country:
Croatia
Slovenia
Finland
Canada
North Macedonia
United States
France
Japan
Netherlands

location_facility: Centre Hospitalier Universitaire Félix Guyon

location_facility: PHI Institute of Transfusion Medicine of Republic of Macedonia

location_facility: Hôpital Purpan - Centre de Traitment Regional de l'Hemophilie Pole

location_facility: Centre Régional de Traitement de l'Hémophilie

location_facility: St. Marianna Univ School of Medicine Hospital

location_facility: Centre Régional de Traitement de l'hémophilie

location_facility: Hospital of the Univ of Occupational and Environmental Health

summary: The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.


title: A Multi-centre, Double-blind, Parallel-group, Randomized Controlled Study to Investigate the Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Alzheimer Disease

summary: The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease

ReferenceCitation: Frölich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: True North Clinical Research Kentville, Inc.

location_facility: Neurologie und Psychiatrie / Psychotherapie

location_facility: Hospital Universitari General de Catalunya

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Landeskrankenhaus Hall, Abt.f. Psychatrie & Psychotherapie A

location_facility: Private Practice for Psychiatry and Neurology

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center

location_facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: Institut universitaire de geriatrie Sherbrooke

location_facility: Orange County Neuropsychiatric Research Center LLC

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Non-Public Outpatient Clinic "Synapsa" Pawel Polrola, Kielce


title: Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

summary: This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.

ReferenceCitation: Rosenstock J, Nino A, Soffer J, Erskine L, Acusta A, Dole J, Carr MC, Mallory J, Home P. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care. 2020 Oct;43(10):2509-2518. doi: 10.2337/dc19-2316. Epub 2020 Jul 21.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Canada
Hungary
Korea, Republic of
United States
France
South Africa
Mexico
Philippines
Germany


title: A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma or Atezolizumab Administered With Obinutuzumab or Tazemetostat in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

summary: This open-label, multicenter, global study is designed to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is approximately 4.5 years.

design_allocation: Non-Randomized

ReferenceCitation: Palomba ML, Cartron G, Popplewell L, Ribrag V, Westin J, Huw LY, Agarwal S, Shivhare M, Hong WJ, Raval A, Chang AC, Penuel E, Morschhauser F. Combination of Atezolizumab and Tazemetostat in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Results From a Phase Ib Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):504-512. doi: 10.1016/j.clml.2021.12.014. Epub 2021 Dec 24.

ReferenceCitation: Palomba ML, Till BG, Park SI, Morschhauser F, Cartron G, Marks R, Shivhare M, Hong WJ, Raval A, Chang AC, Penuel E, Popplewell LL. Combination of Atezolizumab and Obinutuzumab in Patients with Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-Cell Lymphoma: Results from a Phase 1b Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):e443-e451. doi: 10.1016/j.clml.2021.12.010. Epub 2021 Dec 24.

location_country:
United Kingdom
Italy
United States
France
Germany

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: University of North Carolina at Chapel Hill

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


acronym: SUNSHINE

title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

ReferenceCitation: Wolf J, Kalocsai K, Fortuny C, Lazar S, Bosis S, Korczowski B, Petit A, Bradford D, Croos-Dabrera R, Incera E, Melis J, van Maanen R. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Clin Infect Dis. 2020 Dec 17;71(10):2581-2588. doi: 10.1093/cid/ciz1149.

ReferenceCitation: Borali E, De Giacomo C. Clostridium Difficile Infection in Children: A Review. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e130-e140. Review.

location_country:
Poland
Romania
Spain
Italy
Canada
Hungary
United States
France
Belgium
Germany

location_facility:
Site PL48004
Site BE32001
Site DE49004
Site ES34003
Site RO40005
Site US10014
Site US10027
Site PL48007
Site ES34002
Site DE49002
Site US10030
Site US10010
Site ES34007
Site US10015
Site FR33008
Site DE49003
Site PL48006
Site PL48002
Site US10032
Site IT39004
Site HU36006
Site DE49006
Site ES34004
Site IT39001
Site FR33007
Site US10008
Site DE49001
Site FR33002
Site PL48012
Site US10038
Site FR33005
Site US10028
Site DE49010
Site US10037
Site FR33001
Site US10022
Site US10025
Site HU36004
Site BE32003
Site CA15003
Site US10004
Site PL48014
Site US10034
Site BE32002

summary: The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.


title: A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer

acronym: HERMIONE

summary: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

status: Terminated

ReferenceCitation: Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer. 2016 Jun 3;16:352. doi: 10.1186/s12885-016-2385-z.

lead_sponsor: Merrimack Pharmaceuticals

location_country:
Spain
Italy
Austria
Canada
Czech Republic
United States
France
Belgium
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: North Shore Hematology Oncology Associates

location_facility: Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center

location_facility: University of Alberta- Cross Cancer Institute

location_facility: Azienda Ospedaliero-Universitaria di Bologna

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: UF Health Cancer Center at Orlando Health

location_facility: University of Miami Comprehensive Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Northwestern University- Robert H. Lurie Comprehensive Cancer Center

location_facility: Texas Oncology- Central Austin Cancer Center

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori

location_facility: University of Minnesota- Masonic Cancer Center

location_facility: Institut de Cancerologie de l'Ouest site Paul Papin

location_facility: Bon Secours Saint Francis Hospital Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Greenville Health System Cancer Institute

location_facility: Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Smilow Cancer Hospital at Yale New Haven Hospital

location_facility: AKh Allgemeines Krankenhaus der Stadt Linz

location_facility: The University of Texas- MD Anderson Cancer Center

location_facility: Indiana University Melvin and Bren Simon Cancer Center

status_simplified: Unknown


title: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma

summary: This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.

ReferenceCitation: Dummer R, Gyorki DE, Hyngstrom J, Berger AC, Conry R, Demidov L, Sharma A, Treichel SA, Radcliffe H, Gorski KS, Anderson A, Chan E, Faries M, Ross MI. Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial. Nat Med. 2021 Oct;27(10):1789-1796. doi: 10.1038/s41591-021-01510-7. Epub 2021 Oct 4.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Poland
Brazil
Spain
Greece
Russian Federation
Australia
Switzerland
United States
France

intervention_type: Procedure


title: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)

acronym: CENTER-TBI

summary:
The research aims of the CENTER-TBI study are to:

better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and
identify the most effective clinical interventions for managing TBI.

Specific aims

To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI.
To refine and improve outcome assessment and develop health utility indices for TBI.
To develop multidimensional approaches to characterisation and prediction of TBI.
To define patient profiles which predict efficacy of specific interventions ("Precision Medicine").
To develop performance indicators for quality assurance and quality improvement in TBI care.
To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder.
To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR).
To intensify networking activities and international collaborations in TBI.
To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels.
To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Rezoagli E, Petrosino M, Rebora P, Menon DK, Mondello S, Cooper DJ, Maas AIR, Wiegers EJA, Galimberti S, Citerio G; CENTER-TBI, OzENTER-TBI Participants and Investigators. High arterial oxygen levels and supplemental oxygen administration in traumatic brain injury: insights from CENTER-TBI and OzENTER-TBI. Intensive Care Med. 2022 Oct 20. doi: 10.1007/s00134-022-06884-x. [Epub ahead of print]

ReferenceCitation: Åkerlund CAI, Holst A, Stocchetti N, Steyerberg EW, Menon DK, Ercole A, Nelson DW; CENTER-TBI Participants and Investigators. Clustering identifies endotypes of traumatic brain injury in an intensive care cohort: a CENTER-TBI study. Crit Care. 2022 Jul 27;26(1):228. doi: 10.1186/s13054-022-04079-w.

ReferenceCitation: Volovici V, Pisică D, Gravesteijn BY, Dirven CMF, Steyerberg EW, Ercole A, Stocchetti N, Nelson D, Menon DK, Citerio G, van der Jagt M, Maas AIR, Haitsma IK, Lingsma HF; CENTER-TBI investigators, participants for the ICU stratum. Comparative effectiveness of intracranial hypertension management guided by ventricular versus intraparenchymal pressure monitoring: a CENTER-TBI study. Acta Neurochir (Wien). 2022 Jul;164(7):1693-1705. doi: 10.1007/s00701-022-05257-z. Epub 2022 Jun 1.

ReferenceCitation: van Essen TA, Lingsma HF, Pisică D, Singh RD, Volovici V, den Boogert HF, Younsi A, Peppel LD, Heijenbrok-Kal MH, Ribbers GM, Walchenbach R, Menon DK, Hutchinson P, Depreitere B, Steyerberg EW, Maas AIR, de Ruiter GCW, Peul WC; CENTER-TBI Collaboration Group. Surgery versus conservative treatment for traumatic acute subdural haematoma: a prospective, multicentre, observational, comparative effectiveness study. Lancet Neurol. 2022 Jul;21(7):620-631. doi: 10.1016/S1474-4422(22)00166-1. Epub 2022 May 5. Erratum in: Lancet Neurol. 2022 Jul;21(7):e7.

ReferenceCitation: Holthe IL, Dahl HM, Rohrer-Baumgartner N, Eichler S, Elseth MF, Holthe Ø, Berntsen T, Yeates KO, Andelic N, Løvstad M. Neuropsychological Impairment, Brain Injury Symptoms, and Health-Related Quality of Life After Pediatric TBI in Oslo. Front Neurol. 2022 Jan 28;12:719915. doi: 10.3389/fneur.2021.719915. eCollection 2021.

ReferenceCitation: Huijben JA, Pisica D, Ceyisakar I, Stocchetti N, Citerio G, Maas AIR, Steyerberg EW, Menon DK, van der Jagt M, Lingsma HF. Pharmaceutical Venous Thrombosis Prophylaxis in Critically Ill Traumatic Brain Injury Patients. Neurotrauma Rep. 2022 Jan 7;2(1):4-14. doi: 10.1089/neur.2021.0037. eCollection 2022.

ReferenceCitation: Galimberti S, Graziano F, Maas AIR, Isernia G, Lecky F, Jain S, Sun X, Gardner RC, Taylor SR, Markowitz AJ, Manley GT, Valsecchi MG, Bellelli G, Citerio G; CENTER-TBI and TRACK-TBI participants and investigators. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation. Lancet Neurol. 2022 Feb;21(2):153-162. doi: 10.1016/S1474-4422(21)00374-4.

ReferenceCitation: Puybasset L, Perlbarg V, Unrug J, Cassereau D, Galanaud D, Torkomian G, Battisti V, Lefort M, Velly L, Degos V, Citerio G, Bayen É, Pelegrini-Issac M; MRI-COMA Investigators CENTER-TBI MRI Participants and MRI Only Investigators. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Feb;48(2):201-212. doi: 10.1007/s00134-021-06583-z. Epub 2022 Dec 14. Erratum in: Intensive Care Med. 2022 Jan 20;:.

ReferenceCitation: Citerio G, Robba C, Rebora P, Petrosino M, Rossi E, Malgeri L, Stocchetti N, Galimberti S, Menon DK; Center-TBI participants and investigators. Management of arterial partial pressure of carbon dioxide in the first week after traumatic brain injury: results from the CENTER-TBI study. Intensive Care Med. 2021 Sep;47(9):961-973. doi: 10.1007/s00134-021-06470-7. Epub 2021 Jul 24.

ReferenceCitation: Robba C, Rebora P, Meyfroidt G, Citerio G. The authors reply. Crit Care Med. 2021 May 1;49(5):e554-e555. doi: 10.1097/CCM.0000000000004961.

ReferenceCitation: Huijben JA, Dixit A, Stocchetti N, Maas AIR, Lingsma HF, van der Jagt M, Nelson D, Citerio G, Wilson L, Menon DK, Ercole A; CENTER-TBI investigators and participants. Use and impact of high intensity treatments in patients with traumatic brain injury across Europe: a CENTER-TBI analysis. Crit Care. 2021 Feb 23;25(1):78. doi: 10.1186/s13054-020-03370-y.

ReferenceCitation: Borgen IMH, Roe C, Brunborg C, Tenovuo O, Azouvi P, Dawes H, Majdan M, Ranta J, Rusnak M, Wiegers EJA, Tverdal C, Jacob L, Cogne M, von Steinbuechel N, Andelic N; CENTER-TBI participants investigators. Care transitions in the first 6months following traumatic brain injury: Lessons from the CENTER-TBI study. Ann Phys Rehabil Med. 2021 Nov;64(6):101458. doi: 10.1016/j.rehab.2020.10.009. Epub 2021 Jul 23.

ReferenceCitation: Robba C, Banzato E, Rebora P, Iaquaniello C, Huang CY, Wiegers EJA, Meyfroidt G, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) ICU Participants and Investigators. Acute Kidney Injury in Traumatic Brain Injury Patients: Results From the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study. Crit Care Med. 2021 Jan 1;49(1):112-126. doi: 10.1097/CCM.0000000000004673.

ReferenceCitation: Gravesteijn BY, Sewalt CA, Nieboer D, Menon DK, Maas A, Lecky F, Klimek M, Lingsma HF; CENTER-TBI collaborators. Tracheal intubation in traumatic brain injury: a multicentre prospective observational study. Br J Anaesth. 2020 Oct;125(4):505-517. doi: 10.1016/j.bja.2020.05.067. Epub 2020 Jul 31.

ReferenceCitation: Gao G, Wu X, Feng J, Hui J, Mao Q, Lecky F, Lingsma H, Maas AIR, Jiang J; China CENTER-TBI Registry Participants. Clinical characteristics and outcomes in patients with traumatic brain injury in China: a prospective, multicentre, longitudinal, observational study. Lancet Neurol. 2020 Aug;19(8):670-677. doi: 10.1016/S1474-4422(20)30182-4.

ReferenceCitation: Robba C, Rebora P, Banzato E, Wiegers EJA, Stocchetti N, Menon DK, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Participants and Investigators. Incidence, Risk Factors, and Effects on Outcome of Ventilator-Associated Pneumonia in Patients With Traumatic Brain Injury: Analysis of a Large, Multicenter, Prospective, Observational Longitudinal Study. Chest. 2020 Dec;158(6):2292-2303. doi: 10.1016/j.chest.2020.06.064. Epub 2020 Jul 4.

ReferenceCitation: Riemann L, Beqiri E, Smielewski P, Czosnyka M, Stocchetti N, Sakowitz O, Zweckberger K, Unterberg A, Younsi A; CENTER-TBI High Resolution ICU (HR ICU) Sub-Study Participants and Investigators. Low-resolution pressure reactivity index and its derived optimal cerebral perfusion pressure in adult traumatic brain injury: a CENTER-TBI study. Crit Care. 2020 May 26;24(1):266. doi: 10.1186/s13054-020-02974-8.

ReferenceCitation: Gravesteijn BY, Nieboer D, Ercole A, Lingsma HF, Nelson D, van Calster B, Steyerberg EW; CENTER-TBI collaborators. Machine learning algorithms performed no better than regression models for prognostication in traumatic brain injury. J Clin Epidemiol. 2020 Jun;122:95-107. doi: 10.1016/j.jclinepi.2020.03.005. Epub 2020 Mar 20.

ReferenceCitation: Huijben JA, Wiegers EJA, Ercole A, de Keizer NF, Maas AIR, Steyerberg EW, Citerio G, Wilson L, Polinder S, Nieboer D, Menon D, Lingsma HF, van der Jagt M; CENTER-TBI investigators and participants for the ICU stratum. Quality indicators for patients with traumatic brain injury in European intensive care units: a CENTER-TBI study. Crit Care. 2020 Mar 4;24(1):78. doi: 10.1186/s13054-020-2791-0.

ReferenceCitation: Van Essen TA, Volovici V, Cnossen MC, Kolias A, Ceyisakar I, Nieboer D, Peppel LD, Heijenbrok-Kal M, Ribbers G, Menon D, Hutchinson P, Depreitere B, de Ruiter GCW, Lingsma HF, Steyerberg EW, Maas AI, Peul WC. Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe. BMJ Open. 2019 Oct 16;9(10):e033513. doi: 10.1136/bmjopen-2019-033513.

ReferenceCitation: Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbüchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK; CENTER-TBI Participants and Investigators. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. Lancet Neurol. 2019 Oct;18(10):923-934. doi: 10.1016/S1474-4422(19)30232-7.

ReferenceCitation: Maas AI, Menon DK, Steyerberg EW, Citerio G, Lecky F, Manley GT, Hill S, Legrand V, Sorgner A; CENTER-TBI Participants and Investigators. Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study. Neurosurgery. 2015 Jan;76(1):67-80. doi: 10.1227/NEU.0000000000000575.

lead_sponsor: University Hospital, Antwerp

location_country:
Denmark
Romania
Serbia
Spain
Italy
Austria
Latvia
Netherlands
Finland
Lithuania
Switzerland
United Kingdom
Sweden
Hungary
France
Israel
Belgium
Norway
Germany

location_facility: Azienda Ospedaliera Università di Padova

location_facility: Riga Eastern Clinical University Hospital

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Poloclinico

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Hadassah-hebrew University Medical Center

location_facility: Kaunas University of technology and Vilnius University

location_facility: Center of neurovascular surgery, Clinic of neurology and neurosurgery, Vilnius University

location_facility: St Olavs Hospital/Norwegian University of science and technology

location_facility: Pauls Stradins Clinical University Hospital

location_facility: University Hospitals Southampton NHS Trust

lead_sponsor_type: academique


title: A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary:
This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7.

HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

ReferenceCitation: Shah D, Driessen M, Risebrough N, Baker T, Naya I, Briggs A, Ismaila AS. Cost-effectiveness of umeclidinium compared with tiotropium and glycopyrronium as monotherapy for chronic obstructive pulmonary disease: a UK perspective. Cost Eff Resour Alloc. 2018 May 10;16:17. doi: 10.1186/s12962-018-0101-3. eCollection 2018.

ReferenceCitation: Feldman G, Maltais F, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA, Trivedi R. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 μg compared with tiotropium 18 μg in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Apr 7;11:719-30. doi: 10.2147/COPD.S102494. eCollection 2016.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Denmark
Italy
Russian Federation
Argentina
Canada
Ukraine
Korea, Republic of
United States
Chile
France
South Africa
Romania
Germany


type: Registry Identifier

title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant

summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

ReferenceCitation: Kaiser M, Beksaç M, Gulbrandsen N, Schjesvold F, Hájek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1. Erratum in: Ann Hematol. 2021 Jan;100(1):297-302.

ReferenceCitation: Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22.

ReferenceCitation: Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.

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

lead_sponsor: Takeda

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Aarhus Universitetshospital Arhus Sygehus

location_facility: Pamukkale Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Instituto Nacional de Cancerologia Colombia

location_facility: Gachon University Gil Medical Center Pharmacy

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Mae de Deus Center Hospital Giovanni Battista

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: Chang Gung Medical Foundation-Kaoshiung Branch

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Evangelisches Krankenhaus Essen Werden gGmbH

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Hospital Das Clinicas Da Universidade Federal de Minas Gerais

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Universidade Federal do Rio de Janeiro - UFRJ

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario HM Sanchinarro CIOCC

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: IRCCS Az. Osp. Universitaria San Martino- IST

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Vestre Viken HF Sykehuset Asker Og Barum

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: National Hospital Organization Okayama Medical Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council

location_facility: Centre Hospitalier Universitaire Ambroise Pare

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: National Hospital Organaization Shibukawa Medical Center

location_facility: Klinikum Mannheim Universitatsklinikum gGmbH

location_facility: Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital

location_facility: University College London Hospitals (UCLH)

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

location_facility: Klinik Ottakring (fruher: Wilhelminenspital)

location_facility: University of Arkansas for Medical Sciences

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: IRCCS Centro Di Riferimento Oncologico Della Basilicata

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Germans Trias i Pujol


title: Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Fontaine-Sylvestre C, Létourneau-Guillon L, Moumdjian RA, Berthelet F, Lacroix A. Corticotroph tumor progression during long-term therapy with osilodrostat in a patient with persistent Cushing's disease. Pituitary. 2021 Apr;24(2):207-215. doi: 10.1007/s11102-020-01097-1. Epub 2020 Oct 19.

ReferenceCitation: Pivonello R, Fleseriu M, Newell-Price J, Bertagna X, Findling J, Shimatsu A, Gu F, Auchus R, Leelawattana R, Lee EJ, Kim JH, Lacroix A, Laplanche A, O'Connell P, Tauchmanova L, Pedroncelli AM, Biller BMK; LINC 3 investigators. Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase. Lancet Diabetes Endocrinol. 2020 Sep;8(9):748-761. doi: 10.1016/S2213-8587(20)30240-0. Epub 2020 Jul 27. Erratum in: Lancet Diabetes Endocrinol. 2020 Aug 5;:.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
Argentina
Canada
Thailand
United Kingdom
Korea, Republic of
United States
France
China
India
Colombia
Japan
Germany
Turkey
Bulgaria

location_facility: Mount Sinai School of Medicine SC - LCI699C2301

location_facility: Columbia University Medical Center New York Presbyterian SC - LCI699C2301

location_facility: Northwestern University SC - LCI699C2301

location_facility: University of Pennsylvania Clinical Studies Unit Unniv SC

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: Emory University School of Medicine G2304 - C2301

location_facility: Oregon Health and Science University SC LCI699C2301

location_facility: University of Colorado Hospital SC - LCI699C2301

location_facility: The Johns Hopkins University School of Medicine Johns Hopkins University

location_facility: University of Michigan Comprehensive Cancer Center

summary:
The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU.

This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.


title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

summary: This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

lead_sponsor: CSL Behring

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Philippines
Romania
Japan
Czechia
Poland
Portugal
Austria
Australia
Malaysia
Lebanon
Canada
Switzerland
Hungary
Germany
Ireland
Georgia
Thailand
France
Netherlands

location_facility:
Study Site 5280006
Study Site 3800023
Study Site 7240008
Study Site 6160038
Study Site 7240023
Study Site 8400118
Study Site 2500017
Study Site 8400184
Study Site 0360031
Study Site 6420030
Study Site 7240007
Study Site 8400204
Study Site 3920029
Study Site 6160014
Study Site 6200001
Study Site 7640005
Study Site 8400241
Study Site 0400003
Study Site 3920031
Study Site 8040005
Study Site 8260008
Study Site 3920025
Study Site 2760087
Study Site 0360014
Study Site 2500015
Study Site 8400041
Study Site 2030017
Study Site 3920064
Study Site 7240021
Study Site 8040007
Study Site 5280007
Study Site 6420037
Study Site 7640003
Study Site 3920033
Study Site 6080001
Study Site 3480007
Study Site 2500002
Study Site 0360028
Study Site 7640001
Study Site 5280008
Study Site 4220007
Study Site 2500018
Study Site 8400116
Study Site 2760034
Study Site 6160013
Study Site 6160035
Study Site 6080002
Study Site 8400213
Study Site 7100001
Study Site 7560010
Study Site 2680001
Study Site 1240022
Study Site 2500028
Study Site 8400154
Study Site 0400002
Study Site 8400240
Study Site 4580001
Study Site 7640002
Study Site 7640004
Study Site 2760091
Study Site 2760066
Study Site 3720002
Study Site 0400001
Study Site 0400012


acronym: LOTUS

title: A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

lead_sponsor: Genentech, Inc.

ReferenceCitation: Kim SB, Dent R, Im SA, Espié M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. doi: 10.1016/S1470-2045(17)30450-3. Epub 2017 Aug 8. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

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

location_country:
Taiwan
Spain
Italy
Korea, Republic of
United States
France
Belgium
Singapore

location_facility: Chi Mei Medical Center, Yong kang; Endocrinology

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

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Farmacia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: Seoul National University Bundang Hospital

summary: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.


title: A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis)

summary:
Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis.

Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis.

CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Zavidij O, Haradhvala NJ, Meyer R, Cui J, Verstovsek S, Oh S, Mead A, Taverna P. MPN-238 Single-Cell RNA Profiling of Myelofibrosis Patients Reveals Pelabresib-Induced Decrease of Megakaryocytic Progenitors and Normalization of CD4+ T Cells in Peripheral Blood. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S331-S332. doi: 10.1016/S2152-2650(22)01448-3.

lead_sponsor: Constellation Pharmaceuticals

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

location_facility: Institut de cancérologie du Gard - Hematologie clinique

location_facility: Academisch Ziekenhuis Vrije Universiteit

location_facility: Universitätsklinikum Jena, Innere Medizin II

location_facility: AZ Sint-Jan Burgge-Oostende - Campus Sint-Jan

location_facility: Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: Washington University School of Medicne Neuromuscular Division Department of neurology

location_facility: Northwestern University - Lurie Comprehensive Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: Institue of Hematology "L. and A. Seràgnoli"

location_facility: Guys and St Thomas' Hospital - Haematology

location_facility: Erasmus Universitair Medisch Centrum Rotterdam

location_facility: Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale (AUSL) di Rimini - Ospedale Infermi di Rimini

location_facility: Mayo Clinic - Cancer Clinical Research Office

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

location_facility: CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

location_facility: University College London Hospital's NHS foundation Trust

location_facility: CHU - Hopital Saint Louis - Centre D'Investigations Clinique

location_facility: Froedtert & Medical College of Wisconsin


title: A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis

summary: This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

ReferenceCitation: VanDevanter DR, Hamblett NM, Simon N, McIntosh J, Konstan MW. Evaluating assumptions of definition-based pulmonary exacerbation endpoints in cystic fibrosis clinical trials. J Cyst Fibros. 2021 Jan;20(1):39-45. doi: 10.1016/j.jcf.2020.07.008. Epub 2020 Jul 15.

ReferenceCitation: Konstan MW, VanDevanter DR, Rowe SM, Wilschanski M, Kerem E, Sermet-Gaudelus I, DiMango E, Melotti P, McIntosh J, De Boeck K; ACT CF Study Group. Efficacy and safety of ataluren in patients with nonsense-mutation cystic fibrosis not receiving chronic inhaled aminoglycosides: The international, randomized, double-blind, placebo-controlled Ataluren Confirmatory Trial in Cystic Fibrosis (ACT CF). J Cyst Fibros. 2020 Jul;19(4):595-601. doi: 10.1016/j.jcf.2020.01.007. Epub 2020 Jan 23.

ipd_sharing: No

lead_sponsor: PTC Therapeutics

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
Netherlands
Argentina
Canada
United Kingdom
United States
France
Israel
Belgium
Germany
Bulgaria

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: University of Toronto Hospital for Sick Children

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

location_facility: NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii

location_facility: General Hospital of Thessaloniki Ippokration

location_facility: Szpital Dzieciecy Polanki im Macieja Plazynskiego w Gdansku

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Southampton University Hospitals NHS Trust

location_facility: University of Texas Health Science Center

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Hospital de Niños Superiora Sor Maria Ludovica

location_facility: New York University Langone Medical Center

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Hospital de Sabadell, Consorci Sanitari Parc Tauli

location_facility: Hospital Regional Universitario de Malaga

location_facility: Instituto da Criança - Hospital das Clínicas


title: A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF

summary:
This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF.

This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

ReferenceCitation: Gallant JE, Daar ES, Raffi F, Brinson C, Ruane P, DeJesus E, Johnson M, Clumeck N, Osiyemi O, Ward D, Morales-Ramirez J, Yan M, Abram ME, Plummer A, Cheng AK, Rhee MS. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016 Apr;3(4):e158-65. doi: 10.1016/S2352-3018(16)00024-2. Epub 2016 Mar 14.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Italy
Canada
Puerto Rico
United States
France
Belgium

location_facility: University Health Network/Toronto General Hospital

location_facility: Community Research Initiative of New England

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Brighton and Sussex University Hospitals

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: North Texas Infectious Diseases Consulants

location_facility: University Hospital of Montpellier (CHU-Gui de Chauliac)

location_facility: IRCCS Ospedale San Raffaele, Centro San Luigi

location_facility: La Playa Medical Group and Clinical Research

location_facility: Maple Leaf Medical Clinic/Maple Leaf Research

location_facility: Kaiser Permanente Medical Group San Francisco

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Tarrant County Infectious Disease Associates

location_facility: AIDS Research & Treatment Center of the Treasure Coast

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: University of Puerto Rico School of Medicine

location_facility: Highland Hospital - Alameda Health System (formerly Alameda County medical Center)

location_facility: Kaiser Permanente Sacramento Medical Center


acronym: The JANUS 2 Study

title: A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)

lead_sponsor: Incyte Corporation

ReferenceCitation: Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.

location_country:
Denmark
Portugal
Ireland
Austria
Mexico
Switzerland
Sweden
Puerto Rico
United States
Chile
France
Israel
Colombia
Netherlands

summary: This was to determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer.


title: A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies

summary: To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

ReferenceCitation: Voss MH, Azad AA, Hansen AR, Gray JE, Welsh SJ, Song X, Kuziora M, Meinecke L, Blando J, Achour I, Wang Y, Walcott FL, Oosting SF. A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Clin Cancer Res. 2022 Jul 15;28(14):3032-3041. doi: 10.1158/1078-0432.CCR-21-4115.

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

lead_sponsor: MedImmune LLC

location_country:
United Kingdom
Australia
Canada
United States
France
Netherlands


title: A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate

summary:
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.

Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.

Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

lead_sponsor: Coherus Biosciences, Inc.

location_country:
Poland
Belarus
Spain
United Kingdom
Russian Federation
Hungary
United States
France
Israel
South Africa
Japan
Germany

location_facility: Otsuka Clinica of Rheumatism and Medicine

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: Medical Corporation Kojyokai Hirose Clinic

location_facility: University of Occupational and Environmental Health Hospital

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Yoshida Orthopaedic and Rheumatology Clinic

location_facility: Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

location_facility: University of Szeged, Faculty of Medicine

location_facility: State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov

location_facility: The Center for Rheumatology and Bone Research

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Rheumatoid Arthritis Investigational Network

location_facility: Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev

location_facility: Tokito Clinic Rheumatology and Orthopaedics, Surgery

location_facility: Kondo Clinic for Rheumatism and Orthopaedics

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Hospital Regional Universitario de Málaga

location_facility: Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj

location_facility: SMO.MD GmbH - Zentrum fuer klinische Studien

location_facility: Rinku Hashimoto Rheumatology Orthopedics

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: St. Petersburg State Healthcare Institution "Consultative diagnostic center #85

location_facility: Wirral University Teaching Hospital NHS Foundation Trust

location_facility: Smolensk State Medical University (SSMU)

location_facility: Mazowieckie Centrum Badan Klinicznych (MCBK) SC

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Kawasaki Rheumatism and Internal Medicine Clinic


title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

ReferenceCitation: Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908.

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Ireland
Italy
Netherlands
Canada
United States
France
Israel
Belgium
Norway
Germany


title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

lead_sponsor: Debiopharm International SA

location_country:
United States
France

summary: The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.