status: No longer available

title: An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

lead_sponsor: Seagen Inc.

study_type: Expanded Access

location_country:
Poland
Romania
Serbia
Spain
Italy
Russian Federation
Australia
United Kingdom
Switzerland
Hungary
United States
France
Belgium
Germany
Bulgaria

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: South Lyon Hospital Center, Department of Dermatology

location_facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

location_facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Johannes Wesling Hospital Minden, Department of Dermatology

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

location_facility: University Hospital 12 de Octubre, Department of Dermatology

location_facility: Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"

location_facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

location_facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii

location_facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

location_facility: Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation

location_facility: University Hospital Zurich, Department of Dermatology

location_facility: Research Institute of Clinical Immunology

location_facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

summary: The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001


type: Other Identifier

title: A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer

summary: This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Krop IE, Suter TM, Dang CT, Dirix L, Romieu G, Zamagni C, Citron ML, Campone M, Xu N, Smitt M, Gianni L. Feasibility and cardiac safety of trastuzumab emtansine after anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer. J Clin Oncol. 2015 Apr 1;33(10):1136-42. doi: 10.1200/JCO.2014.58.7782. Epub 2015 Feb 23.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
Russian Federation
Korea, Republic of
United States
France
Belgium
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

source: euctr

location_country:
Italy
Australia
Canada
United States
France
Germany

summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).


title: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin Versus the Chemotherapy Alone in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Progressed on or After Prior Platinum-Based Chemotherapy

summary: The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.

design_allocation: Randomized

lead_sponsor: Oncolytics Biotech

location_country:
Poland
Slovenia
Greece
Italy
Russian Federation
Spain
Canada
United Kingdom
Hungary
United States
France
Belgium
Germany

location_facility: Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"

location_facility: Fovarosi Onkormanyzat Uzsoki Utcai Kórház

location_facility: Regional State Health Care Institution "Belgorod Oncology Dispensary"

location_facility: Hopital Saint-André / Service d'Oncologie-Radiothérapie

location_facility: The Royal Marsden Cancer Center, Sutton Branch

location_facility: Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region

location_facility: Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Emory University - Winship Cancer Institute

location_facility: State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department

location_facility: Fondazione IRCCS Istituto Nazionale del Tumori

location_facility: Wojewódzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Case Comprehensive Cancer Center, University Hospitals Case Medical Center

location_facility: State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"

location_facility: Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk

location_facility: Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals

location_facility: State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"

location_facility: The Royal Marsden Cancer Center, Fulham Road branch

location_facility: State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Federal State Budgetary Institution "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation

location_facility: Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie

location_facility: Centre Antoine Lacassagne / Oncologie Médicale

location_facility: Mary Bird Perkinds Cancer Center - Baton Rouge

location_facility: State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Institut Curie / Département d'Oncologie Médicale

location_facility: State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department

location_facility: State Health Care Institution "Tula Regional Oncology Dispensary"

location_facility: BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates

location_facility: Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation

intervention_type: Biological


title: SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

acronym: MS

summary: The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

lead_sponsor: ResMed

location_country:
United Kingdom
Australia
Netherlands
Finland
Czech Republic
Switzerland
France
Germany

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

location_facility: Klinikum der Universität zu Köln- Herzzentrum

location_facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

location_facility: Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

location_facility: Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

location_facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

location_facility: Klinikum der Universität zu Köln-Schlaflabor

location_facility: Gemeinschaftspraxis Kardiologie Dr. Becker

intervention_type: Device


title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

acronym: PREPARE

summary: This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).

primary_purpose: Diagnostic

ReferenceCitation: Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaçi D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Nov;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023. Epub 2013 Aug 24.

lead_sponsor: Pfizer

location_country:
Denmark
Canada
Hungary
United States
France
Belgium
Germany

location_facility: Rheumatology Practive of Scott Zashin, MD

location_facility: Klinik fuer Dermatologie, Allergologie und Venerologie

location_facility: The Skin Care Centre-Clinical Trials Unit

location_facility: Centre de Recherche Dermatologique du Quebec metropolitain

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Klinik und Poliklinik fuer Dermatologie und

location_facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely

location_facility: The Toronto Western Hospital-Division of Rheumatology

location_facility: Praxis Dres. Bredlich, Rosenbach und Thiele

location_facility: Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

intervention_type: Procedure


ipd_sharing: No

title: A Phase 3 Extension Study of Ataluren (PTC124®) in Subjects With Nonsense-Mutation-Mediated Cystic Fibrosis

lead_sponsor: PTC Therapeutics

type: Other Grant/Funding Number

design_allocation: Non-Randomized

study_start_date_type: Actual

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

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Hadassah University Hospital - Mount Scopus

summary: Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.


title: A Phase II, Multi-center, Open-label Study of AUY922 Administered IV on a Once-weekly Schedule in Patients With Advanced Non-small-cell Lung Cancer Who Have Received at Least Two Lines of Prior Chemotherapy

ReferenceCitation: Felip E, Barlesi F, Besse B, Chu Q, Gandhi L, Kim SW, Carcereny E, Sequist LV, Brunsvig P, Chouaid C, Smit EF, Groen HJM, Kim DW, Park K, Avsar E, Szpakowski S, Akimov M, Garon EB. Phase 2 Study of the HSP-90 Inhibitor AUY922 in Previously Treated and Molecularly Defined Patients with Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Apr;13(4):576-584. doi: 10.1016/j.jtho.2017.11.131. Epub 2017 Dec 13.

location_country:
Spain
Netherlands
Canada
Korea, Republic of
United States
France
Singapore
Turkey
Norway
Germany

location_facility: Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem

location_facility: St. Luke's Hospital and Health Network St Luke's

location_facility: University of California at Los Angeles UCLA - Santa Monica

summary: This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata was assigned: Patients with Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma kinase) translocations and patients that were both EGFR and Kras wild type.


ipd_sharing: Yes

title: A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

lead_sponsor: Shire

ReferenceCitation: Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.

ReferenceCitation: Willian MK, D'Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.

ReferenceCitation: Yarlas A, D'Haens G, Willian MK, Teynor M. Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study. Inflamm Bowel Dis. 2018 Jan 18;24(2):450-463. doi: 10.1093/ibd/izx041.

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.

location_country:
Poland
Belgium
Romania
Spain
Ireland
United Kingdom
Canada
Hungary
United States
France
India
South Africa
Colombia
Germany
Czechia

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Chhatrapati Shahuji Maharaj Medical University

location_facility: Center for Digestive & Liver Disease, Inc.

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium

location_facility: S R Kalla Memorial Gastro & General Hospital

location_facility: Ohio Gastroenterolgy and Liver Intstitute

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Manikya Institute of Gastroenterology & Hepatology

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat

location_facility: Emergency University Clinical Hospital Bucuresti

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Birmingham Gastroenterology Associates, PC

location_facility: Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie

location_facility: IKEM (Institute klinicke a experimentalni mediciny)

location_facility: Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii

location_facility: Karolina Korhaz, Belgyogyaszat es Gasztroenterologia

location_facility: Stawdtisches Klinikum Lueneburg Gastroenterologie

location_facility: Gastroenterology Clinic of San Antonio, PA

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Orlickoustecka nemocnice a.s. (Hospital)

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Javorszky Odon Varosi Korhaz, Gasztroenterologia

location_facility: Heilig Hart ziekenhuis vzw Roeselare-Menen

summary: This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.


title: Advisa MRI™ System Clinical Investigation

summary: The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

ReferenceType: result

ReferenceCitation: Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.

ReferenceCitation: Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Tóth A, Chang Y, van Osch D, Sommer T; Advisa MRI System Study Investigators. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. 2013 Jun;10(6):864-72. doi: 10.1016/j.hrthm.2013.02.019. Epub 2013 Feb 19.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

location_facility: Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

location_facility: Centre Hospitalier Universitaire Saint Étienne

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

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


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

ReferenceCitation: Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

ReferenceCitation: Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

ReferenceCitation: John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

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

ReferenceCitation: Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

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

ReferenceCitation: Cefalu WT, Stenlöf K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

ReferenceCitation: Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

ReferenceCitation: Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

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

ReferenceCitation: Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Greece
United Kingdom
Finland
Canada
Thailand
United States
France
India
Mexico
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

ReferenceCitation: Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.

ReferenceCitation: Blonde L, Stenlöf K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.

ReferenceCitation: Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.

ReferenceCitation: Bode B, Stenlöf K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.

location_country:
Poland
Hong Kong
Romania
Spain
Greece
United Kingdom
Australia
New Zealand
Canada
Switzerland
Ukraine
United States
France
India
South Africa
Colombia
Sweden


title: A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis

summary: This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

status: Terminated

ReferenceType: background

ReferenceCitation: Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11.

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

ReferenceCitation: Lebwohl MG, Blauvelt A, Menter A, Papp KA, Guenthner S, Pillai R, Israel RJ, Jacobson A. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2.

ipd_sharing: Undecided

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Denmark
Australia
Canada
United States
France

status_simplified: Unknown


title: Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)

lead_sponsor: UCB BIOSCIENCES GmbH

ReferenceCitation: Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, van der Heijde D. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014 Jan;73(1):48-55. doi: 10.1136/annrheumdis-2013-203696. Epub 2013 Aug 13.

ReferenceCitation: van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, Mease PJ. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol. Ann Rheum Dis. 2014 Jan;73(1):233-7. doi: 10.1136/annrheumdis-2013-203697. Epub 2013 Aug 13.

ReferenceCitation: van der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb AB, Hoepken B, Bauer L, Irvin-Sellers O, Khraishi M, Peterson L, Turkiewicz A, Wollenhaupt J, Mease PJ. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018 Mar 14;4(1):e000582. doi: 10.1136/rmdopen-2017-000582. eCollection 2018. Erratum in: RMD Open. 2018 Mar 26;4(1):.

ReferenceCitation: Walsh JA, Gottlieb AB, Hoepken B, Nurminen T, Mease PJ. Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4 years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial. Clin Rheumatol. 2018 Dec;37(12):3285-3296. doi: 10.1007/s10067-018-4227-7. Epub 2018 Sep 6. Erratum in: Clin Rheumatol. 2018 Oct 11;:.

ReferenceCitation: van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.

ReferenceCitation: Osterhaus JT, Purcaru O. Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis. Arthritis Res Ther. 2014 Jul 4;16(4):R140. doi: 10.1186/ar4602.

ReferenceCitation: Kavanaugh A, Gladman D, van der Heijde D, Purcaru O, Mease P. Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study. Ann Rheum Dis. 2015 Jan;74(1):44-51. doi: 10.1136/annrheumdis-2014-205198. Epub 2014 Jun 18.

ReferenceCitation: Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res (Hoboken). 2014 Jul;66(7):1085-92. doi: 10.1002/acr.22256.

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

summary: Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).


title: A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy

summary: A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.

location_country:
Taiwan
United Kingdom
Italy
Russian Federation
Australia
Netherlands
Canada
Switzerland
Korea, Republic of
United States
France
Singapore
Turkey
Germany

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: USC/Kenneth Norris Comprehensive Cancer Center USC/Norris

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU

location_facility: University of California at Los Angeles Dept. of UCLA (4)


title: A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies

summary:
Primary Objective:

Phase 1:

To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).

Phase 2 (stage 1):

To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone.

Phase 2 (stage 2):

To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm).

Secondary Objectives:

Phase 1:

To characterize the global safety profile including cumulative toxicities.
To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s).
To assess the pharmacodynamics (PD), immune response, and preliminary disease response.

Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:

Safety
Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.

Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):

Safety
Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.
Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status.
Pharmacokinetic profile of Isatuximab.
Immunogenicity of Isatuximab.
Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Dimopoulos M, Bringhen S, Anttila P, Capra M, Cavo M, Cole C, Gasparetto C, Hungria V, Jenner M, Vorobyev V, Ruiz EY, Yin JY, Saleem R, Hellet M, Macé S, Paiva B, Vij R. Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma. Blood. 2021 Mar 4;137(9):1154-1165. doi: 10.1182/blood.2020008209.

ReferenceCitation: Mikhael J, Richter J, Vij R, Cole C, Zonder J, Kaufman JL, Bensinger W, Dimopoulos M, Lendvai N, Hari P, Ocio EM, Gasparetto C, Kumar S, Oprea C, Chiron M, Brillac C, Charpentier E, San-Miguel J, Martin T. A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma. Leukemia. 2020 Dec;34(12):3298-3309. doi: 10.1038/s41375-020-0857-2. Epub 2020 May 14.

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

lead_sponsor: Sanofi

location_country:
Brazil
Spain
Greece
Italy
Mexico
Russian Federation
Argentina
Finland
United Kingdom
Ukraine
United States
Chile
France
Israel
Belgium
Peru
Turkey

location_facility:
Investigational Site Number 376004
Investigational Site Number 250003
Investigational Site Number 643002
Investigational Site Number 380002
Investigational Site Number 604001
Investigational Site Number 840001
Investigational Site Number 840027
Investigational Site Number 076003
Investigational Site Number 032001
Investigational Site Number 643003
Investigational Site Number 840022
Investigational Site Number 840012
Investigational Site Number 484003
Investigational Site Number 246002
Investigational Site Number 032002
Investigational Site Number 152001
Investigational Site Number 032003
Investigational Site Number 380001
Investigational Site Number 804002
Investigational Site Number 840004
Investigational Site Number 826002
Investigational Site Number 804001
Investigational Site Number 840013
Investigational Site Number 724002
Investigational Site Number 792004
Investigational Site Number 250001
Investigational Site Number 840009
Investigational Site Number 376002
Investigational Site Number 840011
Investigational Site Number 246001
Investigational Site Number 604002
Investigational Site Number 724005
Investigational Site Number 724001
Investigational Site Number 076004
Investigational Site Number 724006
Investigational Site Number 840010
Investigational Site Number 076002
Investigational Site Number 826001
Investigational Site Number 840018
Investigational Site Number 484001
Investigational Site Number 643001
Investigational Site Number 643004
Investigational Site Number 056001
Investigational Site Number 300001
Investigational Site Number 792002
Investigational Site Number 840002
Investigational Site Number 724004
Investigational Site Number 804004
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 840014
Investigational Site Number 076001
Investigational Site Number 724007
Investigational Site Number 840017
Investigational Site Number 792001
Investigational Site Number 792005
Investigational Site Number 840016

status_simplified: Ongoing


title: A Randomized, Placebo-Controlled, Phase 1/2 Study Of ARQ 197 in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Who Have Received Front-Line Systemic Therapy

summary:
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2.

After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
Russian Federation
United States
France
Germany


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

lead_sponsor: Cephalon

ReferenceCitation: Ketter TA, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder. J Affect Disord. 2015 Aug 1;181:87-91. doi: 10.1016/j.jad.2015.04.012. Epub 2015 Apr 15.

location_country:
Poland
Spain
Australia
Argentina
Canada
Ukraine
United States
France
South Africa
Bulgaria

location_facility: Midwest Center for Neurobehavioral Medicine

location_facility: Centro de Investigación y asistencia en Psiquiatria (CIAP)

location_facility: Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.)

location_facility: Donetsk National Medical University n.a. M. Horkyy

location_facility: District Department of Psychiatric Disorders With Stationary

location_facility: Vinnytsa National Medical University named by M.I. Pirogov

location_facility: Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy

location_facility: Diagnostic Consultative Center "Tchaika"

location_facility: Odessa Regional Psychoneurology Dispensary

location_facility: Behavioral Medical Research of Staten Island

location_facility: Danylo Galitsky Lviv State Medical University

location_facility: Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie

location_facility: Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"

location_facility: Psychiatric clinic, University Hospital "Alexandrovska"

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc

location_facility: Hopital Universitaire Caremeau-Batiment Polyvalent, Service

location_facility: Public Institution "Institute of Neurology, Psychiatry and N

location_facility: Belmont Center for Comprehensive Treatment

location_facility: Northern Area Mental Health Services Northern Psychiatric R

location_facility: South Coast Medical Associates/SC Clinical Trials, Inc.

location_facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM

location_facility: Kiev City Psychoneurological Hospital N 1, CNTRP

summary: The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.


acronym: COMPOSE 2

title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

lead_sponsor: Bayer

location_country:
Ireland
Austria
Mexico
Argentina
United States
France
Belgium
Philippines
Germany

summary: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


title: Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks

acronym: CONFIDENT-PD

summary: A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

lead_sponsor: Phytopharm

location_country:
Poland
Serbia
United Kingdom
Canada
Czech Republic
Hungary
United States
France
Romania
Germany

location_facility: Washington University School of Medicine

location_facility: Klinik für Neurologie Charité, Universitaetsmedizin Berlin

location_facility: Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Weil Medical College of Cornell University

location_facility: Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju

location_facility: Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril

location_facility: Southern Illinois University School of Medicine

location_facility: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus

location_facility: Neurological Institute, Cleveland Clinic

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski

location_facility: Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly

location_facility: Colorado Neurological Institute, Rocky Mountain Movement Disorders Center

location_facility: Fakultni nemocnice Hradec Kralove Neurologicka klinika

location_facility: University of Tennessee Health Science Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika

location_facility: Fakultni nemocnice Olomouc Neurologicka klinika

location_facility: Institute for Neurodegenerative Disorders

location_facility: Spitalul Clinic de Recuperare Cluj-Napoca

location_facility: Parkinsons Neurodegenerative Disorder Clinic

location_facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly

location_facility: Clinique Sainte-Anne "Memoire et mouvement"

location_facility: Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik

location_facility: Rush University Medical Center Neuroscience Inst.

location_facility: Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen

location_facility: Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju

location_facility: Luton and Dunstable Hospital Foundation Trust

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly

location_facility: Vseobecna fakultni nemocnice v Praze Neurologicka klinika

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya

location_facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi

location_facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

location_facility: Wisconsin Institute for Neurologic and Sleep Disorders

location_facility: Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

location_facility: The Royal Devon and Exeter NHS Foundation Trust

location_facility: Semmelweis Egyetem AOK Neurologiai Klinika


title: AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA

summary: This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

ReferenceCitation: Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017.

ReferenceCitation: Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. Epub 2016 May 6.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Hong Kong
United Kingdom
Canada
Korea, Republic of
United States
France
Belgium
Japan
Singapore

location_facility: Shands Hospital at the University of Florida

location_facility: Davis Cancer Pavillion and Shands Medical Plaza

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Cancer Sciences Division, Somers Cancer Research Building

location_facility: Shands Cancer Hospital At The University Of Florida

location_facility: Hopital Saint-Louis -Universite Paris VII

location_facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Saint-Louis - Service d'Hemato-Oncologie


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

acronym: INOX

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

primary_purpose: Supportive Care

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

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

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

lead_sponsor: Laval University

location_country: Canada Portugal Spain France

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

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

location_facility: Hospital Pedro Hispano Unidade Local de Saude de Matosinhos

location_facility: Hospital Pulido Valente - Centro Hospitalar Lisboa Norte

location_facility: Centro Hospitalara Vila Nova de Gaia-Espinho EPE

location_facility: Centro Hospitalar do Barlavento Algarvio - EPE

lead_sponsor_type: academique


primary_purpose: Prevention

acronym: NEuroSIS

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

lead_sponsor: University Children's Hospital Tuebingen

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

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

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

location_country:
Italy
Netherlands
Finland
Czech Republic
France
Israel
Belgium
Germany

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

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

location_facility: University Hospital Ostrava, Department of Neonatology

location_facility: University Hospital of Tomas Bati, Department of Neonatology

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

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

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

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

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

location_facility: Kaplan Medical Center Rehovot, Dept. of Neonatology

location_facility: Hospital Nuernberg Sued, Dept. of Neonatology

location_facility: Hôpital Clocheville, Service de RéanimationNéonatale

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

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

location_facility: Meir Medical Center, Premature Baby Unit

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

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

location_facility: University Hospital Plzen, Department of Neonatology

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

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

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

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

location_facility: Hadassah Medical Center, Department of Neonatology

location_facility: University Hospital Motol Prague 5, Department of Neonatology

location_facility: University Hospital Hannover, Dept. of Neonatology

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

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

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

location_facility: Erasmus MC - Sophia, Department of Neonatology

location_facility: University Hospital Brno, Department of Neonatology

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

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

location_facility: Bnai Zion Medical Center Haifa, Department of Neonatology

summary:
HYPOTHESIS:

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

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

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

RATIONALE:

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

STUDY DESIGN:

Randomised placebo-controlled, multi-centre clinical trial.

RESEARCH PLAN:

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

CLINICAL SIGNIFICANCE:

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


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

acronym: PATH

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

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Mayo Clinic - Rochester Hematology/Oncology Dept.

location_facility: Vanderbilt University Medical Center Vanderbilt Clinic - Oncology

location_facility: Georgia Health Sciences University Medical College of Georgia

location_facility: Medical University of South Carolina Oncology

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


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

acronym: CANVAS

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

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

ReferenceCitation: Ferrannini E, Baldi S, Scozzaro T, Tsimihodimos V, Tesfaye F, Shaw W, Rosenthal N, Figtree GA, Neal B, Mahaffey KW, Perkovic V, Hansen MK. Fasting Substrate Concentrations Predict Cardiovascular Outcomes in the CANagliflozin cardioVascular Assessment Study (CANVAS). Diabetes Care. 2022 Aug 1;45(8):1893-1899. doi: 10.2337/dc21-2398.

ReferenceCitation: Vaduganathan M, Sattar N, Xu J, Butler J, Mahaffey KW, Neal B, Shaw W, Rosenthal N, Pfeifer M, Hansen MK, Januzzi JL Jr. Stress Cardiac Biomarkers, Cardiovascular and Renal Outcomes, and Response to Canagliflozin. J Am Coll Cardiol. 2022 Feb 8;79(5):432-444. doi: 10.1016/j.jacc.2021.11.027.

ReferenceCitation: Waijer SW, Sen T, Arnott C, Neal B, Kosterink JGW, Mahaffey KW, Parikh CR, de Zeeuw D, Perkovic V, Neuen BL, Coca SG, Hansen MK, Gansevoort RT, Heerspink HJL. Association between TNF Receptors and KIM-1 with Kidney Outcomes in Early-Stage Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2022 Feb;17(2):251-259. doi: 10.2215/CJN.08780621. Epub 2021 Dec 7.

ReferenceCitation: Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA(1c), disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26.

ReferenceCitation: Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


type: Registry Identifier

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

acronym: ABSORB EXTEND

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

ABSORB BVS is currently in development at Abbott Vascular.

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

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

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

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

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

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

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

lead_sponsor: Abbott Medical Devices

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

location_facility: Eastern Heart Clinic, The Prince of Wales Hospital

location_facility: Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: Saiseikai Yokohama City Eastern Hospital

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

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

location_facility: Escorts Heart Institute & Research Centre

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences


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

acronym: ENABLE-ALL

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

lead_sponsor: GlaxoSmithKline

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


acronym: CLIPPER

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

lead_sponsor: Pfizer

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

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

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


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

lead_sponsor: PTC Therapeutics

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

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

location_country:
United States
Italy
Canada
France

location_facility: A.Bianchi Bonomi Hemophilia and Thrombosis Center

location_facility: The Bleeding and Clotting Disorders Institute

location_facility: Vanderbilt Hemostatis and Thrombosis Clinic

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

location_facility: Cincinnati Children's Hospital Medical Center

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


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

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

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

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

lead_sponsor: Hoffmann-La Roche

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


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

lead_sponsor: Novartis

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

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

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

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

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


title: CRYptogenic STroke And underLying AF Trial

acronym: CRYSTAL-AF

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

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

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

ReferenceCitation: Kaffenberger T, Bernhardt J, Koehler JL, Ziegler PD, Thijs VN. Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study. Ann Phys Rehabil Med. 2022 Mar;65(2):101540. doi: 10.1016/j.rehab.2021.101540. Epub 2021 Nov 13.

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

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

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

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

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

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

location_facility: Cliniques Universitaires UCL Mont-Godinne

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

location_facility: South Denver Cardiology / Swedish Medical Center

location_facility: Hamilton Health Sciences / Hamilton General Hospital

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Central Bucks Specialists / Doylestown Hospital

location_facility: University of Texas - Southwestern Medical Center

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

location_facility: Clinique Parly II - Centre Hospitalier de Versailles

location_facility: Mid America Heart Institute / St. Lukes Hospital

location_facility: Neurology clinic, Turku University Central Hospital

location_facility: Greenville Hospital System Cardiology/Cardiovascular Research


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

lead_sponsor: Janssen Research & Development, LLC

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

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

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


acronym: STRIVE

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

lead_sponsor: Vertex Pharmaceuticals Incorporated

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

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

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

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

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

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

location_facility: Cystic Fibrosis Research Office, Stanford University

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

location_facility: University of North Carolina at Chapel Hill

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Division of Pulmonary and CCM, University of Washington

location_facility: Children's Hospital of Pittsburgh of UPMC

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

location_facility: Women and Children's Hospital of Buffalo

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

location_facility: National Jewish Medical and Research Center

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

location_facility: Kinder- und Jugendklinik Universitätsklinikum Erlangen

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


acronym: PETIT

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

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

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

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

location_country:
Spain
United Kingdom
Canada
United States
France
Netherlands

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