title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

summary: The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

ReferenceCitation: Mills A, Arribas JR, Andrade-Villanueva J, DiPerri G, Van Lunzen J, Koenig E, Elion R, Cavassini M, Madruga JV, Brunetta J, Shamblaw D, DeJesus E, Orkin C, Wohl DA, Brar I, Stephens JL, Girard PM, Huhn G, Plummer A, Liu YP, Cheng AK, McCallister S; GS-US-292-0109 team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016 Jan;16(1):43-52. doi: 10.1016/S1473-3099(15)00348-5. Epub 2015 Nov 2.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.

ReferenceCitation: Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683.

ReferenceCitation: Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188.

ReferenceCitation: Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045.

ReferenceCitation: Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038.

ReferenceCitation: Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027.

ReferenceCitation: Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm.

ReferenceCitation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496.

ReferenceCitation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.

ReferenceCitation: Mills A, Andrade J, Di Perri G, Van Lunzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102.

ReferenceCitation: Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm.

ReferenceCitation: Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725.

ReferenceCitation: Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577.

ReferenceCitation: Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324.

ReferenceCitation: Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08.

ReferenceCitation: Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: Data in virologically suppressed adults through 48 weeks of treatment. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.

ReferenceCitation: Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205.

ReferenceCitation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343.

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

ReferenceCitation: Hermansson L, Yilmaz A, Price RW, Nilsson S, McCallister S, Makadzange T, Das M, Zetterberg H, Blennow K, Gisslen M. Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. 2019 Dec 11;14(12):e0226276. doi: 10.1371/journal.pone.0226276. eCollection 2019.

ReferenceCitation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50.

ReferenceCitation: Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.

ReferenceCitation: Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318.

ReferenceCitation: Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04.

ReferenceCitation: Kim YS, Oka S, Chetchotisakd P, Clarke A, Supparatpinyo K, Avihingsanon A, Ratanasuwan W, Kiertiburanakul S, Ruxrungtham K, Yang S, Guo S, Liu Y, Das M, Tran D, McColl D, Corales R, Nguyen C, Piontkowsky D. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. HIV Res Clin Pract. 2019 Jul 8:1-9. doi: 10.1080/15284336.2019.1589232. Online ahead of print.

ReferenceCitation: Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519.

ReferenceCitation: Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104.

ReferenceCitation: Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.

ReferenceCitation: DeJesus E, Haas B, Segal-Maurer S, Ramgopal MN, Mills A, Margot N, Liu YP, Makadzange T, McCallister S. Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018 Apr;34(4):337-342. doi: 10.1089/AID.2017.0203. Epub 2018 Mar 20.

ReferenceCitation: Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90.

ReferenceCitation: Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91.

ReferenceCitation: Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068.

ReferenceCitation: Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.

ReferenceCitation: Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314.

ReferenceCitation: Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract # LB-087.

ReferenceCitation: Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.

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:
Denmark
Brazil
Portugal
Spain
Dominican Republic
Austria
Australia
Italy
Canada
Mexico
Netherlands
Switzerland
Sweden
Thailand
Puerto Rico
United States
France
United Kingdom
Belgium
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: North Shore University Hospital, Divison of Infectious Diseases

location_facility: São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz

location_facility: University of California, Davis Medical Center

location_facility: Infectious Disease Research Institute Inc.

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: University of Cologne, Department of Internal Medicine

location_facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: George Washington University Medical Faculty Associates

location_facility: Universitätsklinik für Infektiologie, Universitätsspital Bern

location_facility: Yale University HIV Clinical Trials Program

location_facility: Community Research Initiative of New England

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Michael Keith Wensley, MD, Inc., A Medical Corporation

location_facility: SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Servico De Doencas Infecciosas - Hospital De Sao Joao

location_facility: Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine

location_facility: University of Hawaii - Hawaii Center for AIDS

location_facility: Broward Health/Comprehensive Care Center

location_facility: La Playa Medical Group and Clinical Research

location_facility: Tarrant County Infectious Disease Associates

location_facility: Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

location_facility: University of NC AIDS Clinical Trials Unit

location_facility: Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Instituto Dominicano de Estudios Virologicos - IDEV

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: McGill University Health Centre (MUHC) - Montral Chest Institute

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: Beth Israel Medical Center- Division of Infectious Diseases

location_facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS

location_facility: Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: University Health Network, Toronto General Hospital

location_facility: Infektio Research GmbH / Infektiologikum Frankfurt


type: EudraCT Number

title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone

acronym: ARTS-HF

summary: To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Filippatos G, Anker SD, Böhm M, Gheorghiade M, Køber L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

ReferenceCitation: Pitt B, Anker SD, Böhm M, Gheorghiade M, Køber L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218.

lead_sponsor: Bayer

location_country:
Spain
Italy
Lithuania
United States
South Africa
Czechia
Poland
Portugal
Austria
Australia
Israel
Turkey
Norway
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

summary: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

status: Enrolling by invitation

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France
Colombia
Netherlands

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: Hopital Haut Leveque Service Maladie Du Sang

location_facility: Hospital Clinico Universitario Salamanca

location_facility: State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Weill Medical College of Cornell University

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: University College London Hospitals NHSFT

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Republican Hospital named by V.A.Baranova

location_facility: Tangdu hospital the Fourth Military Medical

location_facility: Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

location_facility: DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

location_facility: Sahlgrenska University hospital, Hematology Dept

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

location_facility: University of California San Diego Medical Center

location_facility: Laiko General Hospital - 1st department of Internal Medicine

location_facility: Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

location_facility: Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

location_facility: Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

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

location_facility: MD Anderson Cancer Center - University of Texas

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

location_facility: Semmelweis Egyetem, I. Belgyogyaszati Klinika

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

location_facility: HOPITAL SAINT LOUIS - Hematology / Oncology

location_facility: Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

location_facility: The First Affliated Hospital of Soochow University

location_facility: A.O.Citta della Salute e della Scienza di Torino

location_facility: The Ohio State University- James Cancer Hospital

location_facility: St Bartholomew's Hospital - Dept of Haematology

location_facility: Universitätsklinikum Heidelberg Med. Klinik IV

location_facility: Khmelnitskiy Regional Hospital, Hematology Department

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

location_facility: Louisville Oncology Suburban - Norton Cancer Institute

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Pennsylvania Medical Center

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku

location_facility: Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

location_facility: University Hospitals Birmingham NHS Trust,

status_simplified: Unknown


title: BENEFIT 11 a Long-term Follow-up Study of the BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment, 304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

summary: This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

ReferenceType: derived

ReferenceCitation: Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM; BENEFIT Study Group. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology. 2016 Sep 6;87(10):978-87. doi: 10.1212/WNL.0000000000003078. Epub 2016 Aug 10.

location_country:
Denmark
Poland
Portugal
Slovenia
Italy
Austria
Netherlands
Spain
Canada
Czech Republic
Finland
Switzerland
Sweden
Hungary
France
Israel
United Kingdom
Belgium
Norway
Germany

intervention_type: Procedure


type: Other Grant/Funding Number

title: An International Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy Boost With Conventional External Beam Radiotherapy Boost After Lumpectomy for Breast Cancer in Women With a High Risk of Local Recurrence.

acronym: TARGIT-B

summary:
TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial.

Eligible patients are those with a higher risk of local recurrence after breast conserving surgery.

After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually.

The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.

status: Unknown status

lead_sponsor: University College, London

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Thailand
Switzerland
Korea, Republic of
United States
France
China
South Africa
Malaysia

location_facility: Helen Rey Breast Cancer Research Foundation

location_facility: Centro Di Riferimento Oncologico Di Aviano

location_facility: Memorial Health University Medical Center

location_facility: Institut de Cancerologie de l'Ouest site René Gauducheau

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Hampshire Hospitals NHS Foundation Trust

intervention_type: Radiation

lead_sponsor_type: academique


title: An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma

source: euctr

ReferenceCitation: Balasubramanian S, Hodkinson B, Schuster SJ, Fowler NH, Trotman J, Hess G, Cheson BD, Schaffer M, Sun S, Deshpande S, Vermeulen J, Salles G, Gopal AK. Identification of a genetic signature enriching for response to ibrutinib in relapsed/refractory follicular lymphoma in the DAWN phase 2 trial. Cancer Med. 2022 Jan;11(1):61-73. doi: 10.1002/cam4.4422. Epub 2021 Nov 17.

ReferenceCitation: Gopal AK, Schuster SJ, Fowler NH, Trotman J, Hess G, Hou JZ, Yacoub A, Lill M, Martin P, Vitolo U, Spencer A, Radford J, Jurczak W, Morton J, Caballero D, Deshpande S, Gartenberg GJ, Wang SS, Damle RN, Schaffer M, Balasubramanian S, Vermeulen J, Cheson BD, Salles G. Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study. J Clin Oncol. 2018 Aug 10;36(23):2405-2412. doi: 10.1200/JCO.2017.76.8853. Epub 2018 May 31.

location_country:
Poland
Spain
United Kingdom
Russian Federation
Australia
United States
France
Belgium
Germany

summary: The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).


status: Active, not recruiting

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

ReferenceCitation: Wang ML, Jurczak W, Jerkeman M, Trotman J, Zinzani PL, Belada D, Boccomini C, Flinn IW, Giri P, Goy A, Hamlin PA, Hermine O, Hernández-Rivas JÁ, Hong X, Kim SJ, Lewis D, Mishima Y, Özcan M, Perini GF, Pocock C, Song Y, Spurgeon SE, Storring JM, Walewski J, Zhu J, Qin R, Henninger T, Deshpande S, Howes A, Le Gouill S, Dreyling M; SHINE Investigators. Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma. N Engl J Med. 2022 Jun 30;386(26):2482-2494. doi: 10.1056/NEJMoa2201817. Epub 2022 Jun 3.

location_country:
Spain
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France
Netherlands

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

status_simplified: Ongoing


title: A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

summary: This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 [Week 79] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.

ReferenceCitation: Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8. Erratum in: Alzheimers Res Ther. 2022 May 21;14(1):70.

lead_sponsor: Eisai Inc.

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

location_facility:
Eisai Trial Site #2
Facility #2
Facility #3
Facility #4
Eisai Trial Site #3
Facility #1
Eisai Trial Site #1


ipd_sharing: Yes

title: An Open-label, Randomized, Phase 2, Parallel, Dose-Ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Komrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, Sekeres MA, Berdeja J, Savona MR, Beyne-Rauzy O, Stamatoullas A, DeZern AE, Delaunay J, Borthakur G, Rifkin R, Boyd TE, Laadem A, Vo B, Zhang J, Puccio-Pick M, Attie KM, Fenaux P, List AF. Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial. Lancet Haematol. 2018 Feb;5(2):e63-e72. doi: 10.1016/S2352-3026(18)30002-4. Epub 2018 Jan 10.

location_country:
United States
France

location_facility: The Cleveland Clinic Foundation Hematology and Medical Oncology Rm 35

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

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

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Monter Cancer Center, North Shore LIJ Health Systems

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Texas Oncology Round Rock Cancer Center - Round Rock

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Institute Paoli-Calmettes Service Haematology

summary: The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).


title: A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.

summary: This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

ReferenceCitation: Søfteland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.

lead_sponsor: Boehringer Ingelheim

location_country:
Taiwan
Brazil
Spain
Australia
New Zealand
Canada
El Salvador
United States
France
Korea, Republic of
Norway

location_facility: 1275.9.01032 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01025 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01102 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01029 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01027 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01018 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01022 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88604 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88602 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01103 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34011 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01014 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01101 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01024 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33012 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88606 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01023 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01030 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01028 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01016 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88607 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01031 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01106 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88603 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01104 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01105 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01013 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01019 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01015 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01021 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01011 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88605 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01017 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34009 Boehringer Ingelheim Investigational Site


title: A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

ReferenceCitation: Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

location_country:
Germany
United States
Italy
France

location_facility: Network Office of Research and Innovation

location_facility: University Hospitals Cleveland Medical Center

location_facility: University Of California Davis Medical Center

location_facility: University Of North Carolina At Chapel Hill

location_facility: H. Lee Moffitt Cancer Center & Research Institute

summary: The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens


intervention_type: Other

title: A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

ReferenceCitation: Koroki Y, Taguri M, Matsubara N, Fizazi K. Estimation of Overall Survival with Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study. Eur Urol Open Sci. 2022 Jan 6;36:51-58. doi: 10.1016/j.euros.2021.11.012. eCollection 2022 Feb.

ReferenceCitation: Baciarello G, Özgüroğlu M, Mundle S, Leitz G, Richarz U, Hu P, Feyerabend S, Matsubara N, Chi KN, Fizazi K. Impact of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer and visceral metastases over four years of follow-up: A post-hoc exploratory analysis of the LATITUDE study. Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.

ReferenceCitation: Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee HJ, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274-282. doi: 10.1038/s41391-021-00436-y. Epub 2021 Aug 21.

ReferenceCitation: Feyerabend S, Saad F, Perualila NJ, Van Sanden S, Diels J, Ito T, De Porre P, Fizazi K. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019 Dec;14(6):681-688. doi: 10.1007/s11523-019-00685-x.

ReferenceCitation: Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12.

ReferenceCitation: Li T, Franco-Villalobos C, Proskorovsky I, Sorensen SV, Tran N, Sulur G, Chi KN. Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration-naive prostate cancer: Results from LATITUDE. Cancer. 2019 Feb 15;125(4):626-632. doi: 10.1002/cncr.31847. Epub 2018 Dec 6.

ReferenceCitation: Chi KN, Protheroe A, Rodríguez-Antolín A, Facchini G, Suttman H, Matsubara N, Ye Z, Keam B, Damião R, Li T, McQuarrie K, Jia B, De Porre P, Martin J, Todd MB, Fizazi K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Feb;19(2):194-206. doi: 10.1016/S1470-2045(17)30911-7. Epub 2018 Jan 8.

ReferenceCitation: Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.

location_country:
Spain
United Kingdom
Ukraine
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Malaysia
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
New Zealand
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

summary: The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).


title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study

acronym: ELEVATE

summary:
This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study.

This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

ReferenceCitation: Viel E, Eerdekens M, Kandaswamy P. Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin. Pain Physician. 2021 Sep;24(6):453-463.

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Spain
Armenia
Italy
United Kingdom
Romania
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Russian Federation
Turkey
Sweden
Slovakia
Hungary
Germany
Bulgaria
Belarus
Greece
Finland
France

location_facility: Site 202 Hippokration General Hospital of Athens

location_facility: Site 103 Scientific research Institute of physiotherapy

location_facility: Site 274 Saint-Petersburg State Medical University

location_facility: Site 325 Pamukkale University Medical Faculty Hospital

location_facility: Site 326 Maramara University, Pendik Training and Research Hospital

location_facility: Site 278 Semashko Regional Clinical Hospital

location_facility: Site 271 First Moscow State Medical University named after I.M. Sechenov

location_facility: Site 323 Ege University Medical Faculty Hospital

location_facility: Site 121 Vitebsk Regional Clinical Hospital # 1

location_facility: Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ

location_facility: Site 321 Hacettepe University Medical Faculty Hospital

location_facility: Site 301 Hospital General Universitario de Alicante

location_facility: Site 324 Dokuz Eylul University Medical Faculty Hospital

location_facility: Site 104 Medical Center "Surb Nerses Mets"

location_facility: Site 252 Instituto Portuges de Oncologic


intervention_type: Biological

title: Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A

lead_sponsor: Octapharma

location_country:
Poland
Portugal
Belarus
Slovenia
Italy
Georgia
Russian Federation
Spain
Canada
United Kingdom
Ukraine
United States
France
India
Germany
Morocco
Moldova, Republic of

location_facility: Great Ormond Street Hospital for Children

location_facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

location_facility: Unitat d'hemofilia, Hospital Universitari Vall d'Hebron

location_facility: Republican Scientific Practical Center for Pediatric Oncology and Hematology

location_facility: Hôtel-Dieu de Nantes, Centre Regional de Traitement de l'hemophilie

location_facility: Centre de traitement de l'hemophilie, Hôpital Bicêtre

location_facility: Christian Medical College & Hospital, Dept of Haematology

location_facility: Sahyadri Speciality Hospital, Haematology & BMT Unit

location_facility: Scientific Research Institute of Mother and Child Health Care

location_facility: National Children's Specialized Hospital "OHMATDET"

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Centro di Referimento per le Malattie Emorragiche e Trombotiche

location_facility: Institut für Experimentelle Hämatologie und Transfusionsmedizin (IHT)

location_facility: Kasturba Medical College, Dr. TMA Pai Hospital

location_facility: Haemophilia Centre, University Clinical Centre

location_facility: Institute of Haematology and Transfusiology

summary: Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.


title: A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)

summary: The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

lead_sponsor: Cytokinetics

location_country:
Spain
Ireland
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Hennepin County Medical Center - Berman Center for Research

location_facility: Hôpital Notre Dame (CHUM) Centre Hospitalier de l'Universite de Montreal

location_facility: Mayo Clinic Florida Department of Neurology

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: West Virginia University Department of Neurology

location_facility: Ohio State University Department of Neurology

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Massachusetts Medical School

location_facility: Carolinas Medical Center Department of Neurology

location_facility: Barts and the London MND & the Centre Royal London Hospital

location_facility: Sheffield Institute for Translational Neuroscience

location_facility: Wake Forest University, School of Medicine

location_facility: Indiana University Department of Neurology

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Univ. of Toronto - Sunnybrook Health Sciences Centre

location_facility: California Pacific Medical Center Forbes Norris MDA/ALS Research Center


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

summary:
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

status: Terminated

ReferenceCitation: Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

ReferenceCitation: McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.

ReferenceCitation: Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.

ReferenceCitation: Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Greece
Italy
Australia
Latvia
Canada
Russian Federation
Hungary
United States
France
Belgium


title: A Phase II, Multi-center, Open-label, Single-arm Study of the Efficacy and Safety of Oral LDE225 in Patients With Hh-pathway Activated Relapsed Medulloblastoma

lead_sponsor: Novartis Pharmaceuticals

design_allocation: Non-Randomized

location_country:
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
United States
France
Germany

location_facility: Children's Hospital of Pittsburgh Dept of Oncology

location_facility: Seattle Cancer Care Alliance Dept Oncology

location_facility: University of Texas/MD Anderson Cancer Center SC-3

location_facility: Ann & Robert H. Lurie Children Dept of Oncology

location_facility: Columbia University Medical Center- New York Presbyterian Dept of Oncology

location_facility: Cincinnati Children's Hospital Medical Center Division of Hema/Onco.

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept Onc

summary: This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.


title: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

summary: The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body does to a drug), and pharmacodynamics (study of what a drug does to the body) of JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in adult participants with advanced or refractory solid tumors or lymphoma.

ReferenceCitation: Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, Zhong B, Platero SJ, Smit JW, Stuyckens K, Chatterjee-Kishore M, Rodon J, Peddareddigari V, Luo FR, Soria JC. Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors. J Clin Oncol. 2015 Oct 20;33(30):3401-8. doi: 10.1200/JCO.2014.60.7341. Epub 2015 Aug 31.

ReferenceCitation: Valade E, Dosne AG, Xie H, Kleiman R, Li LY, Perez-Ruixo JJ, Ouellet D. Assessment of the effect of erdafitinib on cardiac safety: analysis of ECGs and exposure-QTc in patients with advanced or refractory solid tumors. Cancer Chemother Pharmacol. 2019 Sep;84(3):621-633. doi: 10.1007/s00280-019-03896-1. Epub 2019 Jul 6.

ReferenceCitation: Bahleda R, Italiano A, Hierro C, Mita A, Cervantes A, Chan N, Awad M, Calvo E, Moreno V, Govindan R, Spira A, Gonzalez M, Zhong B, Santiago-Walker A, Poggesi I, Parekh T, Xie H, Infante J, Tabernero J. Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors. Clin Cancer Res. 2019 Aug 15;25(16):4888-4897. doi: 10.1158/1078-0432.CCR-18-3334. Epub 2019 May 14.

location_country:
United States
Spain
France


title: An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer

ReferenceCitation: Royce M, Bachelot T, Villanueva C, Özgüroglu M, Azevedo SJ, Cruz FM, Debled M, Hegg R, Toyama T, Falkson C, Jeong J, Srimuninnimit V, Gradishar WJ, Arce C, Ridolfi A, Lin C, Cardoso F. Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: A Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):977-984. doi: 10.1001/jamaoncol.2018.0060.

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:
Brazil
Portugal
Spain
United Kingdom
Argentina
Thailand
Hungary
Korea, Republic of
United States
France
Turkey
Japan
Netherlands

location_facility: St. Francis Health Comprehensive Cancer Center

location_facility: Breastlink Medical Group Dept. of BreastlinkResearchGrp

location_facility: Columbia University Medical Center- New York Presbyterian Columbia

location_facility: University of Alabama Comprehensive Cancer Center SC-2

location_facility: Oncology Specialists, SC Advocate Medical Group-Niles

location_facility: Saint Barnabas Medical Center CancerCenter of Saint Barnabas

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

summary:
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.

Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.


title: MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

summary:
This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

ReferenceCitation: Lemiere C, Taillé C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z. Review.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. Review.

ReferenceCitation: Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.

ReferenceCitation: Wardlaw A, Howarth PH, Israel E, Taillé C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25.

ReferenceCitation: Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

ReferenceCitation: Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

ReferenceCitation: Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

ReferenceCitation: Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

ReferenceCitation: Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

ReferenceCitation: Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4.

ReferenceCitation: Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

ReferenceCitation: Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum in: N Engl J Med. 2015 Apr 30;372(18):1777.

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.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
United Kingdom
Ukraine
Korea, Republic of
United States
Chile
France
Belgium
Japan
Germany


title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

acronym: ACCELERATE

summary: The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

ReferenceCitation: Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413.

ReferenceCitation: Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19.

ReferenceCitation: Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22.

ReferenceCitation: Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.

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

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Estonia
New Zealand
Korea, Republic of
France
Netherlands

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


title: 30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

acronym: EINSTEINJunior

summary: The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

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


title: A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

summary:
The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects).

The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

ReferenceCitation: Sové RJ, Verma BK, Wang H, Ho WJ, Yarchoan M, Popel AS. Virtual clinical trials of anti-PD-1 and anti-CTLA-4 immunotherapy in advanced hepatocellular carcinoma using a quantitative systems pharmacology model. J Immunother Cancer. 2022 Nov;10(11). pii: e005414. doi: 10.1136/jitc-2022-005414.

ReferenceCitation: Kudo M, Matilla A, Santoro A, Melero I, Gracián AC, Acosta-Rivera M, Choo SP, El-Khoueiry AB, Kuromatsu R, El-Rayes B, Numata K, Itoh Y, Di Costanzo F, Crysler O, Reig M, Shen Y, Neely J, Tschaika M, Wisniewski T, Sangro B. CheckMate 040 cohort 5: A phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis. J Hepatol. 2021 Sep;75(3):600-609. doi: 10.1016/j.jhep.2021.04.047. Epub 2021 May 26.

ReferenceCitation: Yau T, Kang YK, Kim TY, El-Khoueiry AB, Santoro A, Sangro B, Melero I, Kudo M, Hou MM, Matilla A, Tovoli F, Knox JJ, Ruth He A, El-Rayes BF, Acosta-Rivera M, Lim HY, Neely J, Shen Y, Wisniewski T, Anderson J, Hsu C. Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):e204564. doi: 10.1001/jamaoncol.2020.4564. Epub 2020 Nov 12. Erratum in: JAMA Oncol. 2021 Jan 1;7(1):140.

ReferenceCitation: Sangro B, Melero I, Wadhawan S, Finn RS, Abou-Alfa GK, Cheng AL, Yau T, Furuse J, Park JW, Boyd Z, Tang HT, Shen Y, Tschaika M, Neely J, El-Khoueiry A. Association of inflammatory biomarkers with clinical outcomes in nivolumab-treated patients with advanced hepatocellular carcinoma. J Hepatol. 2020 Dec;73(6):1460-1469. doi: 10.1016/j.jhep.2020.07.026. Epub 2020 Jul 22.

ReferenceCitation: Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Cruz CD, Kudo M. Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis. J Hepatol. 2019 Sep;71(3):543-552. doi: 10.1016/j.jhep.2019.05.014. Epub 2019 Jun 7. Erratum in: J Hepatol. 2019 Dec;71(6):1278.

ReferenceCitation: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
Puerto Rico
Singapore
Japan
Germany

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Azienda Ospedaliera Di Bologna S. Orsola-Malpighi

location_facility: Georgetown University Medical Center Lombardi Cancer Center


title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

summary:
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.

Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

ReferenceCitation: Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31.

ReferenceCitation: Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
Japan
Romania
Czechia
Poland
Russian Federation
Argentina
Turkey
Panama
Mexico
Malaysia
Singapore
Brazil
Canada
Guatemala
Hungary
China
Germany
Taiwan
Finland
Korea, Republic of
France

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: National Cancer Center Hospital; Gastrointestinal Oncology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Affiliated Hospital of Nantong University

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: Shizuoka General Hospital; Clinical Oncology

location_facility: Istanbul Bilim University School Of Medicine; Department Of Medical Oncology

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Shizuoka Cancer Center; Gastroenterology

location_facility: Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica

location_facility: National Hospital Organization Shikoku Cancer Center; Gastroenterology

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Seoul St.Mary's Hospital; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: General Hospital of Shenyang Military Command of PLA

location_facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

location_facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2

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

location_facility: Brampton Memorial Hospital, William Osler Health Center

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

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

location_facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

location_facility: Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie

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

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

location_facility: Spitalul Clinic Judetean Mures; Oncologie Medicala

location_facility: Ibaraki Prefectural Central Hospital; Gastroenterology

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: Aichi Cancer Center Hospital; Clinical Oncology

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Tokyo Metropolitan Komagome Hospital; Chemotherapy

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

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

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: National Cancer Center Hospital East; Gastroenterology

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

location_facility: Hyogo College Of Medicine; Upper Gastroenterology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: The Cancer Institute Hospital, JFCR; Gastroenterology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Hop Europeen Georges Pompidou; Gastro Enterologie

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Kindai University Hospital; Medical Oncology

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

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: Third Affiliated Hospital of Third Military Medical University


acronym: BLISS-LN

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis

lead_sponsor: Human Genome Sciences Inc., a GSK Company

ReferenceCitation: Furie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.

ReferenceCitation: Rovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.

ReferenceCitation: Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.

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

location_country:
Spain
United Kingdom
United States
Belgium
Philippines
Czechia
Hong Kong
Russian Federation
Argentina
Mexico
Brazil
Canada
Hungary
China
Germany
Taiwan
Thailand
Korea, Republic of
France
Colombia
Netherlands

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.


title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

summary: This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Mexico
Argentina
Hungary
United States
France
Belgium
Germany
Czechia


title: A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

summary: The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

ReferenceCitation: Zeuzem S, Hézode C, Bronowicki JP, Loustaud-Ratti V, Gea F, Buti M, Olveira A, Banyai T, Al-Assi MT, Petersen J, Thabut D, Gadano A, Pruitt R, Makara M, Bourlière M, Pol S, Beumont-Mauviel M, Ouwerkerk-Mahadevan S, Picchio G, Bifano M, McPhee F, Boparai N, Cheung K, Hughes EA, Noviello S; LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J Hepatol. 2016 Feb;64(2):292-300. doi: 10.1016/j.jhep.2015.09.024. Epub 2015 Oct 8.

location_country:
Spain
Argentina
Hungary
United States
France
Germany

location_facility:
Nashville Medical Research Institute
Texas Clinical Research Institute, Llc
Metropolitan Research
Indiana University
San Francisco General Hospital
Local Institution
Kaiser Permanente Med Ctr
Johns Hopkins University