title: A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

summary:
The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.

At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.

Ixazomib capsules, given with dexamethasone tablets
Pomalidomide capsules, given with dexamethasone tablets

All participants will take their study medicine on specific days during a 28-day cycle.

The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.

After treatment, participants will visit the clinic every 12 weeks for a check-up.

If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.

ReferenceCitation: Dimopoulos MA, Schjesvold F, Doronin V, Vinogradova O, Quach H, Leleu X, Montes YG, Ramasamy K, Pompa A, Levin MD, Lee C, Mellqvist UH, Fenk R, Demarquette H, Sati H, Vorog A, Labotka R, Du J, Darif M, Kumar S. Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial. Blood Cancer J. 2022 Jan 24;12(1):9. doi: 10.1038/s41408-021-00593-2.

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

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Denmark
Spain
Greece
Italy
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Sweden
United States
France
Israel
Turkey
Belgium
Norway
Germany
Czechia

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Centro Di Riferimento Oncologico Della Basilicata

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

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Centre Antoine Lacassagne Centre Regional de Lutte Contre Le Cancer

location_facility: Kirov Research Institute of Haematology and Blood Transfusion

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Fondazione del Piemonte per lOncologia (IRCCS)

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

location_facility: Oslo Universitetssykehus HF Rikshospitalet

location_facility: Centre Hospitalier Bretagne Atlantique Vannes

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

location_facility: Hospital d Instructions des Armees Percy

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

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

location_facility: Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico


ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

acronym: ANDHI

intervention_type: Drug

title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment

study_completion_date_type: Actual

lead_sponsor: AstraZeneca

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

ReferenceCitation: Harrison TW, Chanez P, Menzella F, Canonica GW, Louis R, Cosio BG, Lugogo NL, Mohan A, Burden A, McDermott L, Garcia Gil E, Zangrilli JG; ANDHI study investigators. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. Lancet Respir Med. 2021 Mar;9(3):260-274. doi: 10.1016/S2213-2600(20)30414-8. Epub 2020 Dec 22. Erratum in: Lancet Respir Med. 2021 Jan 25;:.

enrollment_type: Actual

location_country:
Denmark
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Finland
Sweden
United States
France
Belgium
Norway
Germany

summary: The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.

lead_sponsor_type: industriel

status_simplified: Completed


title: A 6-month Randomized, Double-blind, Parallel-group, Multicentre, Placebo-controlled Phase II Study to Compare Anti-asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

acronym: RELAX

summary: The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

ReferenceCitation: Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.

location_country:
Poland
Portugal
Italy
Argentina
Czech Republic
Canada
Switzerland
Hungary
United States
France
Mexico
Germany
Bulgaria
Slovakia


title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)

summary: Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

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:
Denmark
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Sweden
United States
France
Belgium
Norway
Germany


title: A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

summary: The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

ReferenceCitation: Fleischhacker WW, Heikkinen ME, Olié JP, Landsberg W, Dewaele P, McQuade RD, Loze JY, Hennicken D, Kerselaers W. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Int J Neuropsychopharmacol. 2010 Sep;13(8):1115-25. doi: 10.1017/S1461145710000490. Epub 2010 May 12.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
United Kingdom
Austria
Finland
Czech Republic
Switzerland
Sweden
Hungary
France
Turkey
South Africa
Germany


status: Active, not recruiting

acronym: monarchE

title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

study_completion_date_type: Anticipated

lead_sponsor: Eli Lilly and Company

type: Other Identifier

ReferenceCitation: Toi M, Boyle F, Im YH, Reinisch M, Molthrop D, Jiang Z, Wei R, Sapunar F, Grimes BR, Nabinger SC, Johnston SRD. Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1. Oncologist. 2022 Nov 7. pii: oyac234. doi: 10.1093/oncolo/oyac234. [Epub ahead of print]

ReferenceCitation: Martin M, Hegg R, Kim SB, Schenker M, Grecea D, Garcia-Saenz JA, Papazisis K, Ouyang Q, Lacko A, Oksuzoglu B, Reeves J, Okera M, Testa L, Shimizu C, Denduluri N, Adamchuk H, Dakhil S, Wei R, Forrester T, Fernandez MM, Zimmermann A, Headley D, Johnston SRD. Treatment With Adjuvant Abemaciclib Plus Endocrine Therapy in Patients With High-risk Early Breast Cancer Who Received Neoadjuvant Chemotherapy: A Prespecified Analysis of the monarchE Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1190-1194. doi: 10.1001/jamaoncol.2022.1488.

ReferenceCitation: Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599. Review.

ReferenceCitation: Polewski MD, Nielsen GB, Gu Y, Weaver AT, Gegg G, Tabuena-Frolli S, Cajaiba M, Hanks D, Method M, Press MF, Gottstein C, Gruver AM. A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone. Appl Immunohistochem Mol Morphol. 2022 Apr 1;30(4):237-245. doi: 10.1097/PAI.0000000000001009.

ReferenceCitation: Rugo HS, O'Shaughnessy J, Boyle F, Toi M, Broom R, Blancas I, Gumus M, Yamashita T, Im YH, Rastogi P, Zagouri F, Song C, Campone M, San Antonio B, Shahir A, Hulstijn M, Brown J, Zimmermann A, Wei R, Johnston SRD, Reinisch M, Tolaney SM; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 Jun;33(6):616-627. doi: 10.1016/j.annonc.2022.03.006. Epub 2022 Mar 23.

ReferenceCitation: Royce M, Osgood C, Mulkey F, Bloomquist E, Pierce WF, Roy A, Kalavar S, Ghosh S, Philip R, Rizvi F, Mixter BD, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. J Clin Oncol. 2022 Apr 10;40(11):1155-1162. doi: 10.1200/JCO.21.02742. Epub 2022 Jan 27.

ReferenceCitation: Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortés J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.

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.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária

location_facility: University of Southern Florida School of Medicine

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Loma Linda University School of Medicine

location_facility: Willamette Valley Cancer Institute & research Ctr.

location_facility: Instituto de Investigaciones Metabolicas

location_facility: Instituto de Assistência Médica ao Servidor Público Estadual

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hematology Oncology Associates of Fredericksburg Inc.

location_facility: Centros de Investigaciones Cli-nicas. Clinica Viedma

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

location_facility: St-Petersburg scientifical practical cente spec medical care

location_facility: Brig Center For Cancer Care and Survivorship

location_facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaz

location_facility: Saitama Medical University International Medical Center

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut

location_facility: New England Cancer Specialists - Scarborough

location_facility: Columbus Community Clinical Oncology Program

location_facility: Gynäkologisch-onkologische Schwerpunktpraxis am Pelikanplatz

location_facility: Hospital de Base Fac de Medicina de Sao Jose do Rio Preto

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

location_facility: Seoul National University Bundang Hospital

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung

location_facility: Post Graduate Institute of Medical Education & Research

location_facility: Hacettepe University Faculty of Medicine

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

location_facility: Texas Oncology-El Paso Cancer Treatment Center

location_facility: Ibcc-Instituto Brasileiro de Controle Do Câncer

location_facility: National Center for Global Health and Medicine

location_facility: COI Centro Oncológico Internacional S.A.P.I de C.V.

location_facility: California Cancer Associates Research and Excellence (cCARE)

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Istituto Tumori Fondazione G. Pascale IRCCS

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Poltava Regional Clinical Oncological Dispensary

location_facility: The Fifth Medical Center of PLA General Hospital

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Centro de Estudios y Prevencion del Cancer A.C.

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

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

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Commu Instit "Krivorizhskiy oncology dispensary" Dnip reg Co

location_facility: Ordination Dr. Hubalek - Brustzentrum Schwaz

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: King Abdulaziz Medical City - National Guard Hospital

location_facility: Fovarosi Onkormanyzat Szent Margit Korhaza

location_facility: Dongnam Institute of Radiological and Medical Sciences

location_facility: Texas Oncology-Deke Slayton Cancer Center

location_facility: Instituto Português de Oncologia Dr. Francisco Gentil

location_facility: Orenburg Regional Clinical Oncology Dispensary

location_facility: University of Texas Health Science Center - San Antonio

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: Ankara Gulhane Training ve Research Hospital

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: Centro para la Atencion Integral del Paciente Oncologico

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: Azienda Ospedaliero-Universitaria S.Giovanni Battista

location_facility: Principal Military Clinical Hospital n.a. N. N. Burdenko

location_facility: MVZ Onkologie Barmbek - Asklepios Klinik Barmbek

location_facility: Instituto COI de Pesquisa Educação e Gestão

location_facility: University of California, Davis - Health Systems

location_facility: The First Affiliated Hospital, Sun-Yat Sen University

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University Hospitals Case Medical Center

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

location_facility: Wake Forest University School of Medicine

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: CHU de Quebec-Hopital de Saint-Sacrement

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council

location_facility: Fujian Medical University Union Hospital

location_facility: Fundacion CENIT para la Investigacion en Neurociencias

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: ASST Monza - Presidio Ospedaliero di Monza

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke - CHUS

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli

location_facility: Communal Enterprise "Volyn Regional Medical Oncology Center"

location_facility: Centre de Lutte Contre le Cancer Leon Berard

location_facility: Institutul Oncologic Dr Trestioreanu Bucuresti

location_facility: Soonchunhyang University Hospital Cheonan

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Araujo Jorge da Assoc. Combate ao Cancer em Goias

location_facility: WellSpan Health/York Cancer Center Oncology Research

location_facility: St Marianna University School of Medicine Toyoko Hospital

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Consultorio Centro Hemato Oncologico Privado

location_facility: California Cancer Associates in Research and Excellence

location_facility: Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Deenanth Mangeshkar Hospital and Research Centre

location_facility: St. Petersburg City Clinical Oncological Dispensary

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau

location_facility: S.C. R.T.C. Radiology Therapeutic Center S.R.L.

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Centre Hospitalier de Vendee Les Oudairies

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga

location_facility: Semmelweis Egyetem III. sz Belgyogyaszati Klinika

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: St. Elisabeth Gruppe - Marien Hospital Witten

location_facility: Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Joaquin Gabriel Reinoso Toledo (Consultorios de Medicina Especializada)

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Providence Cancer Center Oncology Hematology Care

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: The Hospital of Hyogo College of Medecine

location_facility: Unidad de Investigacion en Salud de Chihuahua S.C.

location_facility: KH Hietzing mit neurologischem Zentrum Rosenhügel

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: Health Pharma Professional Research, S.A. de C.V.

location_facility: Volgograd regional clinical oncology dispensary

location_facility: Yaroslavl region regional clinical oncology hospital

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: Hospital Clinico Universitario San Cecilio

summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

status_simplified: Ongoing


title: Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study

acronym: POSE

summary: The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Kowark A, Berger M, Rossaint R, Schmid M, Coburn M; POSE-Study group. Association between benzodiazepine premedication and 30-day mortality rate: A propensity-score weighted analysis of the Peri-interventional Outcome Study in the Elderly (POSE). Eur J Anaesthesiol. 2022 Mar 1;39(3):210-218. doi: 10.1097/EJA.0000000000001638.

ReferenceCitation: POSE-Study group. Peri-interventional outcome study in the elderly in Europe: A 30-day prospective cohort study. Eur J Anaesthesiol. 2022 Mar 1;39(3):198-209. doi: 10.1097/EJA.0000000000001639.

ipd_sharing: No

lead_sponsor: Mark Coburn

location_country:
Denmark
Poland
Portugal
Romania
Serbia
Greece
Austria
Georgia
Ireland
Netherlands
Russian Federation
Spain
Switzerland
Ukraine
North Macedonia
France
Israel
Turkey
Belgium
Germany

location_facility: Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia

location_facility: General Hospital of Volos "Achillopouleio"

location_facility: Baskent University Konya Research Center

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Urology Hospital, Clinical center of Serbia

location_facility: Republic of Turkey Ministry of Health Tunceli State Hospital

location_facility: Medical Corporation Evex, Tbilisi Referral Hospital

location_facility: Centro Hospitalar Lisboa Norte - Hospital Santa Maria

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: NN Blokhin National Medical Cancer Research Center

location_facility: Saglik Bilimleri University Tepecik Education and Research Hospital

location_facility: Universitätsklinikum Schleswig-Holstein Campus Luebeck

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Clinic for orthopedics surgery and traumatology Clinical center of Serbia

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Clinical Emergency Hospital of Bucharest

location_facility: Marien Hospital Herne, UK der Ruhr-Universität Bochum

location_facility: GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

location_facility: Huriez Hospital, University Hospital of Lille

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Acad. N. Kipshidze Central University Clinic

location_facility: Emergency Center, Clinical Center of Serbia

location_facility: Neurologic Hospital-Hospices Civils de Lyon

location_facility: Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral

location_facility: Klinikum der Ludwigs-Maximilians-Universität München (LMU)

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

location_facility: Department of Anesthesiology, University Hospital Aachen

location_facility: University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine

location_facility: University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"

location_facility: Medical School, Aristotle University of Thessaloniki

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Federal State Autonomous Institution N.N. Burdenko National medical research center of neurosurgery of the ministry of health of the Russian federation (N.N. Burdenko NMRCN)

location_facility: Ankara University Faculty of Medicine-Ibni Sina Hospital

location_facility: Kliniverbund St. Antonius und St. Josef GmbH

location_facility: Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery

location_facility: TR Ministry of Health Erzurum Palandoken State Hospital

location_facility: Istanbul University, Istanbul Faculty of Medicine

location_facility: P.A. Herzen Moscow Cancer Research Institute

location_facility: Universitary General Hospital of Ciudad Real

location_facility: University Emergency Central Military Hospital

location_facility: University Hospital Knappschaftskrankenhaus Bochum

location_facility: Medical Corporation Evex - Zugdidi Referral Hospital

location_facility: University Clinic for Gyn & Ob / Clinical Center Mother Teresa

intervention_type: Procedure


title: The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.

acronym: EXTEND

summary: This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.

status: Terminated

primary_purpose: Prevention

ReferenceCitation: Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.

location_country:
Denmark
Poland
Portugal
Spain
Austria
Mexico
Netherlands
Finland
Switzerland
Sweden
Hungary
France
South Africa
Belgium
Norway
Germany

status_simplified: Unknown


title: Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.

summary:
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Edan G, Kappos L, Montalbán X, Polman CH, Freedman MS, Hartung HP, Miller D, Barkhof F, Herrmann J, Lanius V, Stemper B, Pohl C, Sandbrink R, Pleimes D; BENEFIT Study Group. Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1183-9. doi: 10.1136/jnnp-2013-306222. Epub 2013 Nov 11.

ReferenceCitation: Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

ReferenceCitation: Penner IK, Stemper B, Calabrese P, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Pleimes D, Lanius V, Pohl C, Kappos L, Sandbrink R. Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis. Mult Scler. 2012 Oct;18(10):1466-71. Epub 2012 Apr 4.

ReferenceType: result

ReferenceCitation: Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Radü EW, Metzig C, Bauer L, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009 Nov;8(11):987-97. doi: 10.1016/S1474-4422(09)70237-6. Epub 2009 Sep 10.

ReferenceCitation: Hartung HP, Freedman MS, Polman CH, Edan G, Kappos L, Miller DH, Montalbán X, Barkhof F, Petkau J, White R, Sahajpal V, Knappertz V, Beckmann K, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Interferon β-1b-neutralizing antibodies 5 years after clinically isolated syndrome. Neurology. 2011 Aug 30;77(9):835-43. doi: 10.1212/WNL.0b013e31822c90d7. Epub 2011 Aug 17. Erratum in: Neurology. 2011 Sep 27;77(13):1317.

ReferenceCitation: Freedman MS, Metzig C, Kappos L, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Yarden J, Spector L, Fire E, Dotan N, Schwenke S, Lanius V, Sandbrink R, Pohl C. Predictive nature of IgM anti-α-glucose serum biomarker for relapse activity and EDSS progression in CIS patients: a BENEFIT study analysis. Mult Scler. 2012 Jul;18(7):966-73. doi: 10.1177/1352458511432327. Epub 2011 Dec 19.

ReferenceCitation: Waschbisch A, Sandbrink R, Hartung HP, Kappos L, Schwab S, Pohl C, Wiendl H. Evaluation of soluble HLA-G as a biomarker for multiple sclerosis. Neurology. 2011 Aug 9;77(6):596-8. doi: 10.1212/WNL.0b013e318228c14d. Epub 2011 Jul 27.

ReferenceCitation: Moraal B, Pohl C, Uitdehaag BM, Polman CH, Edan G, Freedman MS, Hartung HP, Kappos L, Miller DH, Montalban X, Lanius V, Sandbrink R, Barkhof F. Magnetic resonance imaging predictors of conversion to multiple sclerosis in the BENEFIT study. Arch Neurol. 2009 Nov;66(11):1345-52. doi: 10.1001/archneurol.2009.243.

ReferenceCitation: Polman C, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Selmaj K, Uitdehaag BM, Dahms S, Bauer L, Pohl C, Sandbrink R; BENEFIT investigators. Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. J Neurol. 2008 Apr;255(4):480-7. Epub 2007 Nov 15.

ReferenceCitation: Caloyeras JP, Zhang B, Wang C, Eriksson M, Fredrikson S, Beckmann K, Knappertz V, Pohl C, Hartung HP, Shah D, Miller JD, Sandbrink R, Lanius V, Gondek K, Russell MW. Cost-effectiveness analysis of interferon beta-1b for the treatment of patients with a first clinical event suggestive of multiple sclerosis. Clin Ther. 2012 May;34(5):1132-44. doi: 10.1016/j.clinthera.2012.03.004. Epub 2012 Apr 27.

ReferenceCitation: Nielsen JM, Pohl C, Polman CH, Barkhof F, Freedman MS, Edan G, Miller DH, Bauer L, Sandbrink R, Kappos L, Uitdehaag BM. MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome. BMC Neurol. 2009 May 20;9:19. doi: 10.1186/1471-2377-9-19.

ReferenceCitation: Barkhof F, Polman CH, Radue EW, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalbán X, Poppe P, de Vos M, Lasri F, Bauer L, Dahms S, Wagner K, Pohl C, Sandbrink R. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol. 2007 Sep;64(9):1292-8.

ReferenceCitation: Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalbán X, Barkhof F, Radü EW, Bauer L, Dahms S, Lanius V, Pohl C, Sandbrink R; BENEFIT Study Group. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007 Aug 4;370(9585):389-97.

ReferenceCitation: De Jager PL, Chibnik LB, Cui J, Reischl J, Lehr S, Simon KC, Aubin C, Bauer D, Heubach JF, Sandbrink R, Tyblova M, Lelkova P; Steering committee of the BENEFIT study; Steering committee of the BEYOND study; Steering committee of the LTF study; Steering committee of the CCR1 study, Havrdova E, Pohl C, Horakova D, Ascherio A, Hafler DA, Karlson EW. Integration of genetic risk factors into a clinical algorithm for multiple sclerosis susceptibility: a weighted genetic risk score. Lancet Neurol. 2009 Dec;8(12):1111-9. doi: 10.1016/S1474-4422(09)70275-3. Epub 2009 Oct 29.

lead_sponsor: Bayer

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


title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)

summary: The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).

ReferenceCitation: Le RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042.

ReferenceCitation: Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.

ReferenceCitation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

lead_sponsor: Incyte Corporation

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
India
Israel
Turkey
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Jordan
Greece
Korea, Republic of
France
Netherlands

location_facility:
Novartis Investigative Site
Incyte Investigative Site
Novartis Investigational Site


acronym: OReO

title: A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy

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

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Canada
France
Israel
Belgium
Norway
Germany

summary: The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)


status: Recruiting

title: An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5). pii: e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.

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

enrollment_type: Anticipated

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Romania
Poland
Portugal
Slovenia
Austria
Australia
Argentina
Turkey
Mexico
Norway
Sweden
Slovakia
Kuwait
Brazil
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Finland
France
Netherlands

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: Box Hill Hospital; Department of Neurology

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika LF UK a UNB

location_facility: Austin Hospital; Department of Neurology

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: VALEOMED Diagnosztikai Központ; VALEOMED Diagnosztikai Központ

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Royal North Shore Hospital; Department of Neurology

location_facility: Akershus universitetssykehus HF; Nevroklinikken S203

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso

location_facility: Palo Alto Medical Foundation Research Center

location_facility: Dudley Group of Hospitals NHS Foundation Trust, Russells Hall Hospital

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Mustafa Kemal UTF; Department of norology

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

location_facility: AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie

location_facility: Asklepios Fachklinikum Teupitz; Klinik für Neurologie und klinische Neurophysiologie

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Helsinki University Central Hospital; Department of Neurology

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

location_facility: Turku Uni Central Hospital; Neurology Dept

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus

location_facility: Istanbul University Istanbul Medical Faculty; Neurology

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

location_facility: Spitalul Clinic Judetean de Urgenta Mures

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: American University of Beirut - Medical Center

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: Hospital General Universitario de Alicante; Servicio de Neurología

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Dokuz Eylul University Medicine Faculty; Noroloji Departmani

location_facility: Gazi University Medical Faculty; Departmant of Neurology.

location_facility: Perron Institute for Neurological and Translational Science

location_facility: WESTMEAD HOSPITAL; Deparment of Neurology

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: UN Bratislava Nemocnica Ruzinov; Neurologicka klinika

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: University of Maryland Medical Center; Department of Neurology

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie

location_facility: Arcispedale Sant'Anna; Neurochirurgia - Dipartimento Neuroscienze e Riabilitazione

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: Montreal Neurological Institute and Hospital

location_facility: Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie

location_facility: MultipEL Studies - Institut für klinische Studien

location_facility: Luzerner Kantonsspital Luzern Medizin Neurologie

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie

location_facility: Centre Hospitalier Départemental Les Oudairies; Service de Neurologie

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Hospital General Universitario Morales Meseguer; Servicio de Neurología

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

location_facility: Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: A.C.O. San Filippo Neri; Centro Sclerosi Multipla, Neuroriabilitazione, Centro studio spasticità

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Neuropsychiatricum; Zentrum für Neurologie, Psychiatrie und Psychotherapie

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: AUSL 11 Empoli - Ospedale "San Giuseppe"; U.O.C Neurologia

location_facility: London Health Sciences Centre Uni Campus

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Univerzitna nemocnica L. Pasteura, Neurologicka klinika

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy; Neurologie

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Neurologia

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: UBC Hospital; Div of Neurology, Dept of Medicine

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

summary:
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.


title: An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

acronym: STRONG

summary: To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

ReferenceCitation: Sonpavde GP, Sternberg CN, Loriot Y, Marabelle A, Lee JL, Fléchon A, Roubaud G, Pouessel D, Zagonel V, Calabro F, Banna GL, Shin SJ, Vera-Badillo FE, Powles T, Hellmis E, Miranda PAP, Lima AR, Emeribe U, Oh SM, Hotte SJ. Primary results of STRONG: An open-label, multicenter, phase 3b study of fixed-dose durvalumab monotherapy in previously treated patients with urinary tract carcinoma. Eur J Cancer. 2022 Mar;163:55-65. doi: 10.1016/j.ejca.2021.12.012. Epub 2022 Jan 15.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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

intervention_type: Biological


title: A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis

summary: This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Costa Rica
Peru
Belgium
Philippines
Romania
South Africa
Poland
Austria
Russian Federation
Argentina
Puerto Rico
India
Mexico
Norway
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Latvia
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands


title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, When Administered as 30, 50, and 75 mg Once Daily for 12 Weeks in Subjects With

summary: SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

ReferenceCitation: McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH; TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007 Nov 29;357(22):2227-36.

location_country:
United Kingdom
Puerto Rico
United States
France
Germany

intervention_type: Other


title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

summary:
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

ReferenceCitation: Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.

location_country:
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Finland
Czech Republic
Sweden
Hungary
United States
France
South Africa
Turkey
Belgium
Norway
Germany
Bulgaria


title: Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

summary: Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
Poland
Taiwan
Belarus
Spain
Greece
Georgia
Australia
Mexico
Russian Federation
Ukraine
Hungary
Korea, Republic of
United States
France
Peru
Belgium
Czechia

location_facility:
Research Site 8
Research Site 7
Research Site 3
Research Site 6
Research Site 10
Research Site 4
Research Site 1
Research Site 5
Research Site
Research Site 2
Research Site 9


acronym: ICARIA-MM

title: A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

lead_sponsor: Sanofi

ReferenceCitation: Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Macé S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum in: Lancet. 2019 Dec 7;394(10214):2072.

ReferenceCitation: Sunami K, Ikeda T, Huang SY, Wang MC, Koh Y, Min CK, Yeh SP, Matsumoto M, Uchiyama M, Iyama S, Shimazaki C, Lee JH, Kim K, Kaneko H, Kim JS, Lin TL, Campana F, Tada K, Iida S, Suzuki K; ICARIA-MM study group. Isatuximab-Pomalidomide-Dexamethasone Versus Pomalidomide-Dexamethasone in East Asian Patients With Relapsed/Refractory Multiple Myeloma: ICARIA-MM Subgroup Analysis. Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e751-e761. doi: 10.1016/j.clml.2022.04.005. Epub 2022 Apr 8.

ReferenceCitation: Richardson PG, Perrot A, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Malinge L, Dubin F, van de Velde H, Anderson KC. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10. Erratum in: Lancet Oncol. 2022 Apr;23(4):e161. Lancet Oncol. 2022 Sep;23(9):e404.

ReferenceCitation: Wilmoth J, Colson K, Dubin F, Kellam C. Isatuximab: Nursing Considerations for Use in the Treatment of Multiple Myeloma. Clin J Oncol Nurs. 2021 Dec 1;25(6):706-712. doi: 10.1188/21.CJON.706-712.

ReferenceCitation: Bringhen S, Pour L, Vorobyev V, Vural F, Warzocha K, Benboubker L, Koh Y, Maisnar V, Karlin L, Pavic M, Campana F, Le Guennec S, Menas F, van de Velde H, Richardson PG. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis. Leuk Res. 2021 May;104:106576. doi: 10.1016/j.leukres.2021.106576. Epub 2021 Mar 29.

ReferenceCitation: Schjesvold FH, Richardson PG, Facon T, Alegre A, Spencer A, Jurczyszyn A, Sunami K, Frenzel L, Min CK, Guillonneau S, Lin PL, Le-Guennec S, Campana F, van de Velde H, Bensfia S, Bringhen S. Isatuximab plus pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis. Haematologica. 2021 Apr 1;106(4):1182-1187. doi: 10.3324/haematol.2020.253450.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Turkey
Norway
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France

location_facility:
Investigational Site Number :2030003
Investigational Site Number :1240005
Investigational Site Number :0360005
Investigational Site Number :2030004
Investigational Site Number :3800001
Investigational Site Number :7240003
Investigational Site Number :7240002
Investigational Site Number :1240004
Investigational Site Number :2500014
Investigational Site Number :7920006
Investigational Site Number :2500016
Investigational Site Number :3480001
Investigational Site Number :2500002
Investigational Site Number :1580004
Investigational Site Number :5540003
Investigational Site Number :1240001
Investigational Site Number :3800008
Investigational Site Number :4100006
Investigational Site Number :4100007
Investigational Site Number :7920007
Investigational Site Number :6200002
Investigational Site Number :7920008
Investigational Site Number :3920002
Investigational Site Number :7240004
Investigational Site Number :2500007
Investigational Site Number :6430002
Investigational Site Number :2500009
Investigational Site Number :2500012
Investigational Site Number :6430001
Investigational Site Number :7920004
Investigational Site Number :7920010
Investigational Site Number :7520005
Investigational Site Number :2500005
Investigational Site Number :7030001
Investigational Site Number :3920005
Investigational Site Number :3920007
Investigational Site Number :7920005
Investigational Site Number :2500003
Investigational Site Number :0360002
Investigational Site Number :3000005
Investigational Site Number :0360006
Investigational Site Number :2030001
Investigational Site Number :3000002
Investigational Site Number :8260001
Investigational Site Number :2760001
Investigational Site Number :2500015
Investigational Site Number :2500013
Investigational Site Number :3800009
Investigational Site Number :2500018
Investigational Site Number :7520004
Investigational Site Number :0560004
Investigational Site Number :2030005
Investigational Site Number :6160005
Investigational Site Number :0360004
Investigational Site Number :2030002
Investigational Site Number :1580003
Investigational Site Number :6160002
Investigational Site Number :3800006
Investigational Site Number :2500019
Investigational Site Number :3000004
Investigational Site Number :6430004
Investigational Site Number :7240005
Investigational Site Number :3920003
Investigational Site Number :1580002
Investigational Site Number :8400002
Investigational Site Number :5540001
Investigational Site Number :3480002
Investigational Site Number :3480003
Investigational Site Number :4100005
Investigational Site Number :5780001
Investigational Site Number :3800007
Investigational Site Number :1580001
Investigational Site Number :3800004
Investigational Site Number :0560001
Investigational Site Number :3800002
Investigational Site Number :7240006
Investigational Site Number :3800010
Investigational Site Number :7240001
Investigational Site Number :8260003
Investigational Site Number :6160003
Investigational Site Number :5540004
Investigational Site Number :3920006
Investigational Site Number :6200001
Investigational Site Number :7920003
Investigational Site Number :3000003
Investigational Site Number :2500021
Investigational Site Number :5540002
Investigational Site Number :2500017
Investigational Site Number :0560002
Investigational Site Number :3800003
Investigational Site Number :2500025
Investigational Site Number :2500008
Investigational Site Number :8400006
Investigational Site Number :3920008
Investigational Site Number :0360001
Investigational Site Number :7920001
Investigational Site Number :2500023
Investigational Site Number :7920002
Investigational Site Number :3920001
Investigational Site Number :4100002
Investigational Site Number :2080002
Investigational Site Number :3920004
Investigational Site Number :0560003
Investigational Site Number :2500004
Investigational Site Number :3000001
Investigational Site Number :4100001
Investigational Site Number :2500001
Investigational Site Number :7920009
Investigational Site Number :6200004
Investigational Site Number :8260002
Investigational Site Number :6160001

summary:
Primary Objective:

To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM).

Secondary Objectives:

To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.
To compare the Overall Survival (OS) between the two arms.
To evaluate the Time To Progression (TTP) in each arm.
To evaluate the PFS in high risk cytogenetic population in each arm.
To evaluate the Duration of Response (DOR) in each arm.
To evaluate the safety in both treatment arms.
To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.
To evaluate the immunogenicity of isatuximab.
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.


title: NeuroVascular Product Surveillance Registry (PSR) Platform

acronym: INSPIRE

summary: Post market surveillance registry

ipd_sharing_description: Only multi center data will be available

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Spain
Italy
United Kingdom
South Africa
Belgium
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Slovakia
Switzerland
Hungary
China
Germany
Denmark
Greece
Finland
France
United Arab Emirates

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Chongqing University Three Gorges Hospital

location_facility: Barking, Havering and Redbridge University Hospitals - Queen's Hospital

location_facility: Almazov National Medical Research Centre

location_facility: First Affiliated Hospital of Jiamusi University

location_facility: Ziekenhuis Oost Limburg - Campus Sint-Jan

location_facility: The Affiliated Hospital of Jinggangshan University

location_facility: Charité Universitätsmedizin Berlin -Campus Charite

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Siberian Federal Biomedical Research Center

location_facility: CHU Toulouse - Hôpital Pierre-Paul Riquet

location_facility: Military Medical Institute-Wojskowy Instytut Medyczny

location_facility: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Xuanwu Hospital Capital Medical University

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: Hospital Universitario Central de Asturias

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

intervention_type: Device


title: A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

summary: This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

ReferenceCitation: Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Solá R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34.

location_country:
Spain
Italy
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

summary: This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

ReferenceCitation: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

ReferenceCitation: Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15. Erratum in: Oncologist. 2010;15(3):327. Schwarzberg, Lee S [corrected to Schwartzberg, Lee S].

ReferenceCitation: Sherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26.

ReferenceCitation: Finn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6.

ReferenceCitation: Prat A, Cheang MC, Galván P, Nuciforo P, Paré L, Adamo B, Muñoz M, Viladot M, Press MF, Gagnon R, Ellis C, Johnston S. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. 2016 Oct 1;2(10):1287-1294. doi: 10.1001/jamaoncol.2016.0922.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Tunisia
Turkey
Mexico
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Ireland
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands
Pakistan


acronym: Reach-Control

title: A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

ReferenceCitation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyên-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

location_country:
Brazil
Spain
Ireland
United Kingdom
France
Romania
Germany

location_facility:
Investigational Site Number 250050
Investigational Site Number 250034
Investigational Site Number 276009
Investigational Site Number 826003
Investigational Site Number 826021
Investigational Site Number 250021
Investigational Site Number 724022
Investigational Site Number 826027
Investigational Site Number 724016
Investigational Site Number 276013
Investigational Site Number 826033
Investigational Site Number 250056
Investigational Site Number 250053
Investigational Site Number 250026
Investigational Site Number 724005
Investigational Site Number 250032
Investigational Site Number 076004
Investigational Site Number 250058
Investigational Site Number 724009
Investigational Site Number 276012
Investigational Site Number 076009
Investigational Site Number 250007
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 724012
Investigational Site Number 250041
Investigational Site Number 724013
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 724017
Investigational Site Number 724027
Investigational Site Number 250003
Investigational Site Number 250012
Investigational Site Number 250035
Investigational Site Number 724020
Investigational Site Number 250045
Investigational Site Number 250051
Investigational Site Number 327002
Investigational Site Number 642009
Investigational Site Number 826015
Investigational Site Number 826002
Investigational Site Number 250064
Investigational Site Number 826019
Investigational Site Number 276007
Investigational Site Number 642004
Investigational Site Number 250022
Investigational Site Number 250063
Investigational Site Number 276005
Investigational Site Number 250059
Investigational Site Number 724010
Investigational Site Number 250054
Investigational Site Number 276017
Investigational Site Number 826004
Investigational Site Number 250033
Investigational Site Number 276014
Investigational Site Number 724019
Investigational Site Number 250055
Investigational Site Number 276016
Investigational Site Number 076007
Investigational Site Number 250024
Investigational Site Number 250023
Investigational Site Number 724014
Investigational Site Number 724028
Investigational Site Number 250017
Investigational Site Number 276001
Investigational Site Number 724021
Investigational Site Number 826011
Investigational Site Number 250030
Investigational Site Number 250039
Investigational Site Number 826006
Investigational Site Number 372003
Investigational Site Number 276011
Investigational Site Number 250046
Investigational Site Number 250008
Investigational Site Number 276008
Investigational Site Number 826020
Investigational Site Number 250020
Investigational Site Number 250028
Investigational Site Number 724025
Investigational Site Number 642007
Investigational Site Number 724024
Investigational Site Number 826013
Investigational Site Number 724011
Investigational Site Number 642005
Investigational Site Number 642002
Investigational Site Number 250011
Investigational Site Number 076005
Investigational Site Number 724006
Investigational Site Number 250025
Investigational Site Number 724018
Investigational Site Number 642006
Investigational Site Number 076011
Investigational Site Number 076010
Investigational Site Number 250060
Investigational Site Number 826008
Investigational Site Number 276002
Investigational Site Number 276006
Investigational Site Number 724026
Investigational Site Number 724030
Investigational Site Number 250044
Investigational Site Number 250016
Investigational Site Number 250009
Investigational Site Number 724007
Investigational Site Number 250043
Investigational Site Number 250029
Investigational Site Number 250031
Investigational Site Number 076003
Investigational Site Number 826016
Investigational Site Number 250014
Investigational Site Number 642008
Investigational Site Number 250057
Investigational Site Number 076-001
Investigational Site Number 250002
Investigational Site Number 276010
Investigational Site Number 826009
Investigational Site Number 826031
Investigational Site Number 076008
Investigational Site Number 724002
Investigational Site Number 826035
Investigational Site Number 250006
Investigational Site Number 826018
Investigational Site Number 724001
Investigational Site Number 250052
Investigational Site Number 250027
Investigational Site Number 250013
Investigational Site Number 826038
Investigational Site Number 826028

summary:
Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Secondary Objectives:

To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia).
Change in fasting plasma glucose (FPG).
Change in body weight.
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
Change in hypoglycemic control subscale (HCS)
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.


title: Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

summary:
The purposes of this study are to determine:

Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

ReferenceCitation: Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.

ReferenceCitation: Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-843. doi: 10.1016/S0140-6736(07)60411-5.

location_country:
Poland
United Kingdom
Italy
Australia
Switzerland
United States
Chile
France
Mexico
Germany
Slovakia

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: Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

summary:
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.

The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

lead_sponsor: Forest Laboratories

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

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universitat Medizinische Klinik IV Abteilung Elektrophysiologie Theodor-Stern-Kai 7

location_facility: CHRU de Nantes-Hopital G. et R. Laennec-bd Jacques Monod

location_facility: Hamilton General Hospital/McMaster Clinic

location_facility: Hospital Clinic i Provincial, Servicio de Cardiologia, Villarroel, 170

location_facility: Charite Campus Buch Franz-Vollhard-Klinik Wiltbergstr. 50

location_facility: CHRU de Rennes-Hotel Dieu-2 rue l'hotel Dieu

location_facility: University of Rochester Strong mem. Hospital

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Leids Universitair Medisch Centrum Afd. Cardiologie Postbus 9600

location_facility: Hospital Clinico Universitario de Valencia, Avenida Blasco Ibanez, 17

location_facility: The Cardiovascular Grp./Attn: Mandy Murphy

location_facility: Deutsches Herzzentrum Minchen Lazarettstr. 36

location_facility: Hospital Virgen de la Victoria, Campus Universitario de Teatinos, s/n

location_facility: Medizinische Universitatsklinik Leipzigerstr. 44

location_facility: Instytut Kardiologii-Klinka Kardiologii Ogolnej, ul. Alpejska 42

location_facility: Kerckhoff Klinik Abteilung Elektrophysiologie Benekestr. 2

location_facility: Divisione di cardiologia Ospedale s. Flippo Neri, Via Martinotti 20

location_facility: Academisch ZiekenhuisRotterdam, Thoraxentrum Dr. Molewaterplein 40

location_facility: Krankenhaus Am Urban Innere Medizin I (Kardiologie) Dieffenbachstr. 1

location_facility: CHRU de Lille-Hopital Cardiologique-Bd du Pr Leclerc

location_facility: Universitatsklinikum I. Medizinische Klinik Kardiologie/Angiologie/Pneumologie Theodor-Kutzer-Ufer 1-3

location_facility: Stadtisches Klinikum Brandenburg Medizinische Klinik I Kardiologie Hochstr. 29

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Centre hospitalier L. Pradel-28 av. du doyen Lepine

location_facility: Academisch Medisch Centrum Amsterdam Afd. Cardiologie Meibergdreef 9

location_facility: Baystate Medical Center-Cardiology Research

location_facility: St Michaels Hospital 30 Bond Street 7-050 Queen

location_facility: Universitatsklinikum Dusseldorf Klinik fur Kardiologie Moorenstr. 5

location_facility: Ospedale Maggiore della carita II Divisione di cardiologia, corso mazzini 18

location_facility: Instytut Kardiologii Klinika Choroby Wiencowej,ul Spartanka 1

location_facility: Medizinische Universitats Klinik Heidelberg Medisin III (Kardiologie) Bergheimerstr. 58

location_facility: Oddzial kardiologii-Instut kardiologii, Ul Powstancow

location_facility: Klinikum Wuppwrtal GmbH Klinik Fur Herz-und Thoraxchirugie Arrenbergerstr. 20

location_facility: CHRU de TOURS-Hopital TROUSSEAU-Chanbray les Tours

location_facility: Louisville Cardiology Medical Group, PSC

location_facility: Virchow-Klinikum Franz-Volhard-Klinik Wiltbergstr. 50

location_facility: Hospital 12 de Octubre, Carretera de Andalucia, km. 5, 4

location_facility: Medizinische Klinik und Poliklinik Universitat Tubingen Ottfried-Muller-Str. 10

location_facility: Herz-kreislauf-Klinik Bevensen AG Kardiologie Akut Romstedter Str. 25

location_facility: Cardiac Arrythmia Trials/Royal Jubilee Hosp.

location_facility: Klinikum der Stadt Ludwigshafen Bremserstr. 79

location_facility: CHRU de Nancy-29 av. de Lattre de Tassigny

location_facility: Evangelische Krankenhaus Abteilung Kardiologie Kirchfeldstr. 40

location_facility: Mid-America Cardiology c/o KU medical Ctr

location_facility: Catharina Ziekenhuis Afd. Cardiologie Postbus 1350

location_facility: Memorial Health Systems/Cardiology Research Associates

location_facility: Isala Klinieken Loc Weezenlanden Afd. Cardiologie Groot Wezenland 20

location_facility: Universitats-Krankenhaus Eppendorf Abteilung Kardiologie Martinistr. 52

location_facility: 1 Klinka kardiologii Slaska Akademia Medyczna, Ziolowa 47

location_facility: Policlinico Matteo Dippartimento di cardiologia Pizza Golgi, 2

location_facility: Istituto di Malattie cardiovasolari policlinico di bari piazza G Cesare 11

location_facility: Hopital cardiologique du Haut Leveque-av. de Magellan

location_facility: Herzzentrum NRW Kardiologische Ambulanz Georgstr. 11

location_facility: ll Klinika Chorob Serca Akademii Medycznej w Gdansku Kieturakisa 1

location_facility: Klinikum Grobhadern Universitat Munchen Marchioninistr. 15

location_facility: Stadt. Klinikum Nurnberg-Sud Med. Klinik 8-Kardiologie Kardiologie KH II/8

location_facility: Universitatsklinikum Bonn Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25

location_facility: Academisch Ziekenhuis Groningen Thoraxcentrum Hanzeplein 1

location_facility: Clinica Puerta de Hierro, San Martin de Porres, 4

location_facility: University of Mass. Medical Ctr. Division of Cardiovascular Medicine

location_facility: SintAntonius Ziekenhuis Afd R&D Cardiologie Koekoekslaan 1

location_facility: Heart Place/Baylor University of Medicine


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

summary: The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

study_start_date_type: Anticipated

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Korea, Republic of
France
Netherlands

intervention_type: Combination Product


type: Other Grant/Funding Number

title: A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

summary: The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

status: Not yet recruiting

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Italy
Austria
Australia
Argentina
Canada
Korea, Republic of
United States
France
Germany

location_facility: Hematology-Oncology Associates of Central New York, PC

location_facility: Novant Health Presbyterian Medical Center


title: A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)

acronym: WAYFINDER

summary: This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Poland
Spain
Italy
Latvia
Mexico
United Kingdom
Argentina
Puerto Rico
United States
France
Belgium
Germany
Bulgaria


type: Registry Identifier

title: A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

summary: The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
United States
France
Germany

location_facility:
Local Institution - 0037
Local Institution - 0022
Local Institution - 0045
Local Institution - 0063
Local Institution - 0031
$Form.Name
Local Institution - 0006
Nemours Childrens Hospital
Local Institution - 0039
Local Institution
Local Institution - 0050
Vanderbilt-Ingram Cancer Center


title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Taiwan
Spain
Argentina
Korea, Republic of
United States
France
China
Belgium
Czechia

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

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

location_facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

location_facility: Blood Institute of the Chinese Academy of Medical science

location_facility: Tianjin Medical University General Hospital

location_facility: Hématologie Clinique et Thérapie Cellulaire

location_facility: Koo Foundation Sun Yan-Sen Cancer Center

location_facility: California Cancer Associates for Research and Excellence

location_facility: Hospital Universitario Infanta Leonor-INTERNAL MED

location_facility: American Oncology Partners of Maryland, PA

location_facility: Cancer Specialists of North Florida -St Augustine